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New Trial Highlights Incremental Progress Towards a Cure for HIV-1

February 13, 2024

By Kendall Daniels

CHAPEL HILL, N.C. – Antiretroviral therapies (ART) stop HIV replication in its tracks, allowing people with HIV to live relatively normal lives. However, despite these treatments, some HIV still lingers inside cells in a dormant state known as “latency.” If ART is discontinued, HIV will awaken from its dormant state, begin to replicate, and cause acquired immunodeficiency syndrome (AIDS). To create a cure, researchers have been attempting to drive HIV out of latency and target it for destruction.

A new clinical trial led by Cynthia Gay, MD, MPH , associate professor of infectious diseases, David Margolis, MD , the Sarah Kenan Distinguished Professor of Medicine, Microbiology & Immunology, and Epidemiology, and other clinicians and researchers at the UNC School of Medicine suggests that a combination of the drug vorinostat and immunotherapy can coax HIV-infected cells out of latency and attack them.

The immunotherapy was provided by a team led by Catherine Bollard, MD, at the George Washington University, who took white blood cells from the study participants and expanded them in the laboratory, augmenting the cells’ ability to attack HIV-infected cells, before re-infusion at UNC.

Their results, published in the Journal of Infectious Diseases , showed a small dent on the latent reservoir, demonstrating that there is more work to be done in the field.

“We did show that this approach can reduce the reservoir, but the reductions were not nearly large enough, and statistically speaking were what we call a “trend” but not highly statistically significant,” said David Margolis, MD , director of the HIV Cure Center and senior author on the paper. “We need to create better approaches to flush out the virus and attack it when it comes out. We need to keep chipping away at the reservoir until there’s nothing there.”

Waking up Latent HIV in Our Genes

DNA inside cell nuclei is kept in a tightly packed space by chromosomes, which act as highly organized storage facilities. When you unfurl a chromosome, you’ll find loop-de-loop-like fibers called chromatin. If you keep unfurling, you’ll see long strands of DNA wrapped around scaffold proteins known as histones, like beads on a string. Finally, when the unfurling is complete, you will see the iconic DNA double helix.

Vorinostat works by inhibiting a lock-like enzyme called histone deacetylase. By stopping this mechanism, tiny doors within the chromatin fibers unlock and open up, effectively “waking up” latent HIV from its slumber and making it vulnerable to an immune system attack. As a result, a tiny blip of HIV expression shows up on very sensitive molecular assays.

But the effects of vorinostat are short lived, only lasting a day per dose. For this reason, Margolis and other researchers are trying to find safe and effective ways to administer the drug and keep the chromatin channels open for longer periods of time.

Attacking Exposed HIV Reservoirs

For the study, six participants were given multiple doses of vorinostat. Researchers then extracted immune cells from the participants and expanded the cells that knew how to attack HIV-infected cells.

This immunotherapy method, which has been successful against other viruses such as Epstein-Barr virus and cytomegalovirus, involves giving participants back their expanded immune cells in the hopes that these cells will further multiply in number and launch an all-out attack on the newly exposed HIV-infected cells.

However, in the first part of this study, only one of the six participants saw a drop in their HIV reservoir levels. To test whether the result was simply random or something more, researchers gave three participants their usual dose of vorinostat, but introduced five times the amount of engineered immune cells. All three of the participants had a slight decline in their reservoirs.

But, statistically speaking, the results were not large enough to be definitive.

“This is not the result we wanted, but it is research that needed to be done,” said Margolis. “We are working on improving both latency reversal and clearance of infected cells, and we hope to do more studies as soon as we can, using newer and better approaches.”

A Dedicated Cohort

Many of the participants in the study have been working with Margolis’s research team for years, sacrificing their own time and blood for research efforts. Their long-term partnership and commitment have been essential for data collection. The data, which follows the size of the viral reservoir in these people over years prior to this study, makes the small changes found more compelling.

“People living with HIV come in a couple of times a year, and we measure residual traces of virus in their blood cells, which doesn’t have any immediate benefit to them,” said Margolis. “It’s a very altruistic action and we couldn’t make any progress without their help.”

Media contact:  Kendall Daniels , Communications Specialist, UNC Health | UNC School of Medicine

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Press Release

Press release

New hiv drug can only offer hope of ending aids if all have access, unaids says.

GENEVA, 10 July 2024— UNAIDS has welcomed the release of Gilead Sciences’ t

GENEVA, 10 July 2024— UNAIDS has welcomed the release of Gilead Sciences’ trial results on the injectable long-acting HIV medicine Lenacapavir for HIV prevention. The result “provides hope of accelerating efforts to end AIDS”, UNAIDS says, “but only if Gilead ensures that all people who need it can have access to this game-changing medicine.”

The recent trial of the medicine among cis-gender women in Uganda and South Africa was so successful that it was halted early. Twice-yearly injections of Lenacapavir showed overwhelming efficacy for preventing HIV infections compared to standard oral preventative HIV medicines, known as pre-exposure prophylaxis (PrEP). Additional trials are ongoing in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States.

UNAIDS has welcomed the “exciting development,” and urged the company to allow generic production of Lenacapavir to all low- and middle-income countries by negotiating voluntary licensing agreements through the Medicines Patent Pool (MPP). The MPP is a UN-backed programme with extensive experience negotiating generics agreements between originators and generic pharmaceutical companies.

Gilead has not yet announced its plans for low and middle-income countries. However, UNAIDS is concerned that Gilead’s latest statement regarding its access strategy for low and middle-income countries mentions only “high incidence countries and resource limited countries” and makes no specific mention of upper-middle-income countries or the Medicines Patent Pool. Upper middle-income countries account for 41% of new HIV infections and 37% of all people living with HIV. These countries are home to millions who cannot afford the prices Gilead charges high-income countries.

“The success of Gilead’s recent Lenacapavir trial is an exciting development. While we still await regulatory approvals, normative guidance and results from the other ongoing trials, this news offers hope that we can enable everyone who would benefit, including especially the most marginalised communities, to have access to the help they need. Enabling equitable global access to new technologies can help get the world on track to end AIDS as a public health threat by 2030,” said Winnie Byanyima, Executive Director of UNAIDS. "However, it is concerning that Gilead’s latest announcement seems to mention neither upper-middle income countries, where people cannot afford anything like Lenacapavir’s current $42,250 price tag, nor a commitment to work with the UN-backed Medicines Patent Pool. Without these safeguards, it cannot be assured that this game-changing medicine will reach all those who need it."

Data in this press release comes from UNAIDS 2023 Epidemiological estimates (aidsinfo.unaids.org)

The UNAIDS Executive Director joined more than 300 experts and activists calling for a generic version of Lenacapavir to be licensed to all low and middle-income countries through the MPP, in a letter coordinated by the People’s Medicines Alliance: https://peoplesmedicines.org/wp-content/uploads/2024/05/Gilead-Open-Letter_May-2024.pdf

The AIDS Vaccine Advocacy Coalition provides an overview of the Lenacapavir for PrEP trials: https://avac.org/resource/infographic/an-overview-of-lenacapavir-for-prep-trials/  

The Joint United Nations Programme on HIV/AIDS (UNAIDS) leads and inspires the world to achieve its shared vision of zero new HIV infections, zero discrimination and zero AIDS-related deaths. UNAIDS unites the efforts of 11 UN organizations—UNHCR, UNICEF, WFP, UNDP, UNFPA, UNODC, UN Women, ILO, UNESCO, WHO and the World Bank—and works closely with global and national partners towards ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals. Learn more at unaids.org and connect with us on Facebook , Twitter , Instagram and YouTube .

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Beginning of end of HIV epidemic?

Scientists cautiously optimistic about trial results of new preventative treatment, prospects for new phase in battle with deadly virus

Alvin Powell

Harvard Staff Writer

Researchers may have found a powerful new preventative against the AIDS virus, which has killed more than 40 million people since the epidemic began in 1981.

In late June, a trial of lenacapavir, an existing anti-HIV drug used to reduce infection, produced an astonishing result: None of the more than 2,100 young female participants in the test contracted the deadly virus. The results beat those of drugs currently being used for this purpose: Truvada, on which 16 of more than 1,000 women became infected, and Descovy, on which 39 of 2,100 plus contracted HIV, between 1 and 2 percent of those treated.

Lenacapavir, produced by drugmaker Gilead Sciences, works by preventing the virus from reproducing. Researchers wanted to know whether giving it to sexually active individuals who have not been infected — a strategy known as PrEP, or pre-exposure prophylaxis — might create a hostile environment in the body and prevent the virus from taking hold.

630,000 People died of AIDS-related causes in 2022

AIDS deaths peaked in 2004, but the condition still killed 630,000 in 2022, when there were 1.3 million new infections. In 2016, the United Nation’s member states committed to ending AIDS as a public health threat by 2030. Researchers have been unsuccessful so far in developing a vaccine.

The Gazette spoke with Roger Shapiro, professor of immunology and infectious diseases at the Harvard T.H. Chan School of Public Health, who has worked to fight AIDS in Botswana for two decades, including early trials exploring PrEP as a way to prevent mother-to-child transmission during breastfeeding. Shapiro said some caveats remain about lenacapavir, but the results are very promising.

It is clear from reading news coverage of this HIV drug trial that there’s a lot of excitement around these results. What do you think of them?

I think the excitement is warranted. We have never had a large HIV prevention trial with zero transmissions before, which is such a convincing result. The other exciting aspect of this trial is the convenience and simplicity of dosing the product just twice per year. I think that will be really attractive to people who may have been on the fence about using PrEP before.

Are these drugs different from vaccines, which also prevent infection?

Drugs are different than vaccines, although when used for PrEP they serve the same preventive purpose. Vaccines train our own immune systems to recognize and attack an infection, whereas drugs work to stop HIV from reproducing at the cellular level and need to be re-dosed to maintain activity.

With a drug such as lenacapavir that can stay effective for six months, the patient experience does start to become more similar to a vaccine, with the important difference that it always needs to be re-dosed.

“Vaccines train our own immune systems to recognize and attack an infection, whereas drugs work to stop HIV from reproducing at the cellular level and need to be re-dosed to maintain activity.”

Is there something that you thought most important about this trial that should be highlighted?

The point to highlight is that zero transmission is a novel and important finding — it received a standing ovation at the international HIV conference when it was presented this week. We have known for several years that long-acting PrEP delivered at a clinic setting is very effective, as this was shown in studies using a different HIV drug called cabotegravir.

But this new study, called PURPOSE 1, really extends those earlier findings for injectable PrEP. The study was large and placebo-controlled, and along with the main efficacy findings, had reassuring safety data.

But there are a few caveats: First, PURPOSE 1, only enrolled cisgender women. There is a companion trial, PURPOSE 2, which will include cisgender men who have sex with men, transgender men, transgender women, and gender non-binary individuals.

The results of that trial are expected in late 2024 or early 2025. So we really don’t know yet whether we will see the same impressive level of protection in those other groups. We also know that these impressive findings occurred in a controlled research setting and may differ in the real world.

Is this potentially the beginning of the end of the HIV epidemic? If so, how long might that take and what would it look like?

I think we are entering a new era where we can expect to drive down transmission to lower and lower levels using a combination of approaches. These approaches include better uptake of testing and treatment, which have been shown to reduce HIV incidence at the population level, as well as PrEP strategies that are more and more effective.

But this only works at scale. We have plenty of work ahead of us to make these approaches affordable and implementable in the places where the need is greatest, which is largely in Sub-Saharan Africa.

“There are still over 1.3 million HIV infections per year — but we now have the tools to really make a dent in these numbers.”

What might stand in the way?

The cost of drugs, for starters. I sincerely hope that lenacapavir will be made available at very low cost for resource-poor parts of the world if it is approved for PrEP by the necessary regulators. There are some encouraging efforts to allow generic manufacturing of this drug for low resource parts of the world, and these need to move forward quickly.

We also need to improve access to HIV testing and linkage to care in hard-to-reach populations, to know who needs to be on treatment and who can benefit from PrEP. And we need simple, community-based implementation strategies to expand access to all of it.

Getting back to whether we might see the end of the HIV epidemic, I think it depends on whether you are asking if we will be able to eliminate all HIV or end its epidemic spread. Humans are complicated. There will always be some who are hard to reach and remain outside of care. And we are still a long way from a one-shot vaccine for HIV, which could ultimately break the cycle of HIV transmission for the next generation.

Until that occurs, our best strategy is to use the amazing new drugs that we have to maximum effect for treatment and prevention and drive new infections to very low levels. This will be no small achievement — there are still over 1.3 million HIV infections per year — but we now have the tools to really make a dent in these numbers. When that happens, we can start talking about the end of the epidemic, while still working toward the ultimate goal of complete elimination.

Is the one-injection-every-six-months treatment model important?

I think so. Many patients really like the current PrEP injections that are once every two months. This strategy removes the need to think about taking a pill each day and can reduce stigma as well. Pushing that out to every six months is almost certainly going to be even better.

For decades, HIV has eluded efforts to control it. What makes lenacapavir different?

We still have a few boxes to check before we can call lenacapavir a game-changer in the PrEP space, but right now it looks very promising. With the right public health messaging and delivery strategies, a highly effective twice-per-year injection to prevent HIV might greatly expand the use of PrEP and drive down new HIV infections. But it needs to be affordable globally, and it needs to be deliverable in hard-to-reach places. Any PrEP strategy, including lenacapavir, will need to be low cost in resource-poor parts of the world to make an impact. I can’t stress this enough.

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A seventh case of HIV cure reported at AIDS 2024

During the 25th International AIDS Conference (AIDS 2024), being held in Munich, Germany, a new case of long HIV remission was reported and fuels optimism for an eventual HIV cure. 

In 2007, Timothy Brown, the so-called first Berlin patient, was the first person to be considered cured of HIV. He underwent a stem cell transplant to treat leukaemia from a donor carrying a rare genetic mutation CCR5-delta 32, which is known to provide genetic resistance to HIV – making his reconstituted immune cells (CD4 cells) unable to be infected with HIV. 

Although Timothy died due to recurrent leukaemia in 2020, the success of his treatment has led to four other people following similar treatments and being in sustained remission. One additional case reported in 2023 has been treated with a non-HIV resistant stem cell transplant (taken from a donor who does not carry this mutation) and is also in prolonged HIV remission. 

The new case (1) presented at AIDS 2024 is a 60-year-old German man living with HIV who was diagnosed with acute myeloid leukaemia and underwent a blood stem cell transplant in 2015 from a donor with the CCR5-delta 32 mutation. However, the stem cell donor had a single instead of a double CCR5-delta 32 mutation, which is an important difference, as the cells were not fully immune to HIV. He stopped his antiretroviral treatment in late 2018 and since then, HIV has not been found in multiple samples, including biopsies of intestinal tissue and ultrasensitive viral techniques.

This case does not have immediate or direct clinical implications, as stem cell transplant procedures are complex, carry significant risk and have been reserved only for those patients requiring the transplant due to the presence of a malignancy. However, the results reinvigorate the call for continued research into techniques that can simulate these resistant cells in HIV patients, such as gene editing techniques. 

This report confirms the existence of several routes to explore different interventions to stimulate specific stem cells to reach long-term HIV control and cure. If patients can use stem cell transplant donors with only a single mutation in the CCR5 receptor, this potential HIV cure strategy could be more widely used, as this genetic profile is more frequently found.

“The second Berlin patient confirms that we are moving in the right direction, but we have to support more research before long-term HIV remission or HIV cure becomes a reality for people living with HIV,” said Dr Meg Doherty, Director of WHO Global HIV, Hepatitis and STI Programmes. “While we are very excited about this next case of potential HIV cure, we recognize that to achieve the goal of ending the AIDS epidemic by 2030, the global HIV response must continue to promote HIV testing, expand effective ART coverage, and focus on reaching the people most affected and at greatest risk.”

1. Gaebler C et al. The next Berlin patient: sustained HIV remission surpassing five years without antiretroviral therapy after heterozygous CCR5 WT/Δ32 allogeneic hematopoietic stem cell transplantation. 25th International AIDS Conference, Munich, Germany, 22-26 July 2024. Oral abstract .

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FDA Approves New HIV Drug for Adults with Limited Treatment Options

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Cross-posted from FDA News Release

[On December 22, 2022], the U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral medication for adult patients living with human immunodeficiency virus type 1 (HIV-1), whose HIV infections cannot be successfully treated with other available treatments due to resistance, intolerance, or safety considerations. After the starting dose is completed, Sunlenca is administered as subcutaneous (under the skin) injections once every six months, allowing convenient dosing for patients.

“Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “The availability of new classes of antiretroviral medications may possibly help these patients live longer, healthier lives.”

Sunlenca is the first of a new class of drugs called capsid inhibitors to be FDA-approved for treating HIV-1. Sunlenca works by blocking the HIV-1 virus’ protein shell (the capsid), thereby interfering with multiple essential steps of the viral lifecycle. Sunlenca’s starting dose is given as oral tablets and subcutaneous injections, followed by maintenance injections every six months; Sunlenca is given in combination with other antiretroviral(s). 

The safety and efficacy of Sunlenca were established through a multicenter  clinical trial  with 72 patients whose HIV infections were resistant to multiple classes of HIV medications. These patients had to have high levels of virus in their blood despite being on antiretroviral drugs. Patients were enrolled into one of two study groups. One group was randomized to receive either Sunlenca or placebo in a double-blind fashion, and the other group received open-label Sunlenca. The primary measure of efficacy was the proportion of patients in the randomized study group who achieved a certain level of reduction in virus during the initial 14 days compared to baseline. In this group, 87.5% of patients who received Sunlenca achieved such a decrease in virus compared to 16.7% of patients who received a placebo. After 26 weeks of Sunlenca plus other antiretrovial drugs, 81% of participants in the first group achieved HIV RNA suppression, where levels of HIV were low enough to be considered undetectable. After 52 weeks, 83% of participants continued to have HIV RNA suppression.

The most common adverse reactions with Sunlenca were injection site reactions and nausea. Most injection site reactions were described as swelling, pain or redness. Sunlenca comes with certain warnings and precautions. Injection site reactions described as nodules or indurations may be persistent in some patients. Additional warnings and precautions include the risk of developing immune reconstitution syndrome, which is when the immune system overreacts after starting HIV treatment. Also, small (residual) amounts of Sunlenca can remain in the body for up to a year or longer; low levels of drug caused by missing doses of Sunlenca or failing to maintain a fully suppressive HIV treatment regimen after stopping Sunlenca could lead to an increased risk of developing viral resistance. Residual amounts of Sunlenca could also lead to potential drug interactions.

Patients should not receive Sunlenca if they also take certain drugs that cause reduced levels of Sunlenca. This may result in losing virologic response and developing viral resistance. 

The FDA granted Sunlenca  Priority Review ,  Fast Track  and  Breakthrough Therapy  designations for this indication. 

The FDA granted the approval of Sunlenca to Gilead Sciences.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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HIV/AIDS: Current Updates on the Disease, Treatment and Prevention

Praveen kumar gupta.

Department of Biotechnology, R.V College of Engineering, Bangalore, 560059 India

Apoorva Saxena

CCR5-delta 32 homozygous stem cell transplantation for HIV-infected individuals is being treated as a milestone in the global AIDS epidemic. Since 2008, when the second Berlin patient was cured from HIV after undergoing transplantation from a donor with delta-32 mutation, scientists are aiming for a long-term cure for the wider population. In 2019, a London patient became the second person to be free of HIV and came off the antiretroviral drugs completely. CCR5 gene is now being treated as a viable target for HIV treatment. It can be used in the treatment of HIV either through administration of drugs that bind to CCR5 and stop the receptor from working or through gene therapy to alter the CCR5 gene using CRISPR/Cas9 and prevent protein production. This review article aims to identify the obstacles and the need to overcome them in order to bridge the gap between current research and future potential cures for HIV.

Introduction

Human immunodeficiency virus or HIV is the cause of HIV infection that leads to the autoimmune disorder acquired immune deficiency syndrome (AIDS) [ 1 ] (Fig.  1 ). The major cause of spreading of HIV is through unprotected sex, during pregnancy from mother to foetus, through contaminated hypodermic needles and infected blood transfusions [ 1 ]. In the year 2016, an estimated 37 million people were living with HIV and 1 million deaths were reported. HIV/AIDS is a pandemic condition—an epidemic of diseases that spreads across large areas like multiple continents or even worldwide [ 1 ]. The first time AIDS was recognized was in the year 1981 by the United States Center for Disease Control and Prevention (CDC). Since the reported case of an individual who had successfully undergone a stem cell transplant from a person who showed a homozygous CCR5-delta 32 mutation, after receiving extensive high dose chemotherapy, there has been a greater interest in finding a potential cure.

Human Immunodeficiency Virus [ 5 ]

HIV is a type of retrovirus that adversely infects the immune system of a human, mainly targeting the CD4 + T-helper cells, accessory cells and the macrophages [ 2 ]. When it gains entry into the target cell, the viral genomic RNA undergoes a process of the reverse transcription with the help of reverse transcriptase enzyme and forms double stranded DNA (ds-DNA). This ds-DNA then gets integrated into the target cellular DNA with the help of enzyme integrase and other host co-factors [ 3 ]. The virus now can either become dormant or conceal itself and the target cell detection by the host immune system or it can get transcribed into new viral RNA and proteins that are released from the cell and begin the cycle again. HIV can be characterized into 2 major classes—HIV-1 and HIV-2. HIV-1, which is more virulent, infective and the major cause of HIV in humans, was discovered first and was initially referred to as HTLV-III or LAV [ 4 ] (Fig.  2 ). HIV-2 is less infective and far fewer people exposed to it are infected.

Structure of HIV-1 [ 8 ]

The crucial factor in gaining entry into target cell is through binding of HIV to the CD4 receptor present on the T-helper cells and to one of the chemokine receptors- either CCR5 or CXCR4 [ 6 , 7 ]. Binding to the co-receptor depends on the virus’s tropism which is the ability to bind to a specific receptor. Naturally, there are two types of tropic strains—R5 that bind to CCR5 and X4 which bind to CXCR4. Dual tropic strains are capable of binding to both. Of these two co-receptors, CCR5 is the prime receptor for virus’s entry into the target cell. R5-tropic strains prevail during early stages of infection, whereas the X4-tropic strains emerge later with disease progression. The envelope-like glycoprotein structure of HIV-1 is paramount in ensuring the viral entry into a target host cell [ 7 ]. This glycoprotein has 2 protein subunits: the gp41 (transmembrane) subunit and gp120 (external) subunit, which mimics a chemokine [ 6 , 7 ]. It does not manifest the unique structure of the chemokine but somehow manages to bind to both the co-receptors [ 6 ]. It forms a heterotrimeric complex wherein the gp120 subunit binds to the CD4 protein and specific co-receptor present on the target cell [ 6 ]. When this complex is formed, it triggers the release of a peptide which facilitates cell–cell fusion, that causes the viral membrane to fuse with the target cell membrane [ 6 ]. Binding to CD4 alone is not sufficient as it can result in gp120 shedding. So, it has to bind to the specific co-receptor for the fusion to proceed. The V1–V2 region of gp120 is recognized by the co-receptor, that influences which co-receptor will bind to the protein and is determined by degree of N-linked glycosylation and peptide composition. The highly variable V3 loop is the one that determines co-receptor specificity. The binding of gp120 glycoprotein to the CCR5 co-receptor is determined by two essential factors—the tyrosine-sulphated amino terminus of CCR5 receptor and following which there must be reciprocal action between the transmembrane domains of CCR5 and gp120 protein, i.e., inter-communication and synergy.

Antiretroviral Therapy

The usage of a combination of three or more antiretroviral drugs for suppression of the HIV infection is called antiretroviral therapy. Using multiple drugs in combination to increase the effectivity on various viral targets is called highly active antiretroviral therapy (HAART). It helps in maintaining the immune system to function, preventing HIV from developing resistance and other infections that potentially lead to death. The five classes of drugs used in combination to treat HIV infection are: entry inhibitors, nucleoside/nucleotide reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, integrase inhibitors and protease inhibitors.

Zidovudine/ZVD (also called azidothymidine) is an extensively used antiretroviral medication [ 9 ]. It is a thymidine analogue and is dosed twice daily in combination with other antiretrovirals. Its function is to particularly inhibit the reverse transcriptase enzyme which is necessary for the production of ds-DNA.

Cellular enzymes are used in converting AZT into the 5′-triphosphate form. Research studies suggest that the termination of forming ds-DNA chains is a crucial factor that leads to an inhibitory effect.

Studies have also shown that at very high dosage of this drug, its triphosphate form may inhibit the DNA polymerase enzyme which is used for cell division by the uninfected cells and mitochondria for replication. It may lead to toxic but reversible effects on certain skeletal and the cardiac muscles, causing the condition of myositis [ 10 ]. However, zidovudine also shows greater affinity for the reverse transcriptase enzyme, which is around 100-fold. This selectivity has been proven by the cell's ability to quickly repair its DNA strands if broken by AZT during its formation, whereas the HIV virus will lack this ability (Fig.  3 ).

Structure of zidovudine [ 11 ]

Zidovudine is commonly used in combination with nucleotide reverse transcriptase inhibitor, non-nucleoside reverse transcriptase inhibitor, HIV integrase strand transfer inhibitor and protease inhibitor [ 9 ]. The combination of lamivudine and zidovudine is not recommended for non-pregnant HIV-infected adults and adolescents due to greater toxicity but is used as an alternative, though not a preferred one, in antiretroviral-naive pregnant women as an initial treatment [ 9 ]. However, for paediatric patients (neonates, infants and children of age 12 or less), zidovudine with lamivudine/emtricitabine is a preferred option. For adolescents greater than the age of 12, it is an alternative [ 9 ].

Zidovudine Administration and Pharmacokinetics

Administration and dosage.

It is usually administered orally or by continuous IV infusion, although not rapid infusion and IM injection [ 9 ] (Tables ​ (Tables1, 1 , ​ ,2). 2 ). The dosage for paediatric patients and adult patients depends on their body weight (Tables ​ (Tables3, 3 , ​ ,4 4 ).

Oral administration [ 9 ]

IV administration [ 9 ]

Dosage for paediatric patients [ 9 ]

Dosage for adult patients [ 9 ]

Administration

Zidovudine: 1 mg/kg every 4 h [ 9 ].

Pharmacokinetics

Pharmacokinetics gives a detailed view of the fate of drugs in the human system. It includes various components like absorption, distribution, excretion or elimination and metabolism (Tables ​ (Tables5, 5 , ​ ,6, 6 , ​ ,7). 7 ). The stability of such retroviral drugs should also be taken into account for both oral and parenteral dosage forms (Table ​ (Table8 8 ).

Absorption [ 9 ]

Distribution [ 9 ]

Elimination process [ 9 ]

Stability of antiretrovirals [ 9 ]

Contraindications [ 9 ]

• Zidovudine has a history of life-threatening hypersensitivity reactions like Stevens–Johnson syndrome and anaphylaxis to the drug or maybe due to some ingredient in the formulation.
• Lamivudine/zidovudine: hypersensitivity history.
• Abacavir/zidovudine/lamivudine: history of hypersensitivity to abacavir, zidovudine or lamivudine; hepatic impairments may be mild or severe.

CCR5 Gene Structure

C–C chemokine receptor type 5 (also called CCR5 or CD195) is a receptor for chemokines present on the white blood cells. The CCR5 gene in humans is located on the short arm (p) at position 21 on chromosome number 3 (Fig.  4 ). It is mainly expressed cells like T-cells, macrophages, microglia, dendritic cells and eosinophils and is found within a cluster of genes coding for some other receptors like XCR1, CCBP2, etc. [ 12 , 13 ]. The gene has two promoters, three exons and two introns. Pu or PR2, the upstream promoter, has a 1.9 kb region, 57 bp in length and precedes the exon 1 [ 12 ]. Exon 1, which is the start of the coding region, is followed by the first intron, 501 bp in length. The second exon 2 is intron-less. It is found as exon 2a, 235 bp in length, and exon 2b, 54 bp in length. Pd or PR1, the second promoter, accommodates the intron 1 and exon 2 regions [ 12 ]. A 1.9 kb length intron is located between exon 2 and exon 3. Exon 3 is also intron-less and consists of the full ORF of the CCR5 gene, 11 bp of the 5′ untranslated regions and the complete 3′ untranslated regions [ 12 ].

Location of CCR5 gene on chromosome 21 [ 14 ]

These two promoters are devoid of the consensus TATA and CCAAT sequences, although the Pd promoter has a non-consensus TATA sequence and have an unusually high content of pyrimidine in them [ 12 ]. The upstream Pu promoter was found to be weaker than the downstream Pd promoter which had exhibited up to fivefold greater activity. But these results were established as erroneous [ 13 ]. With the help of RT-PCR technique, it was later identified that the Pu promoter was used in stimulated T-cells and the Pd promoter was used in unstimulated primary T-cells [ 13 ]. The error resulted due to the use of transformed T-cells affecting the overall expression of CCR5 protein via the Pu promoter [ 13 ]. Results also showed that transcription of the CCR5 gene when controlled by the Pu promoter containing exon 1 resulted in CCR5A or B and when controlled by the Pd promoter resulted in truncated isoforms [ 13 ].

CCR5 Gene Expression Regulation

The expression of CCR5 gene is regulated at three levels: 1. genetic factors, 2. factors involved in activation, signalling and trafficking of the receptor which includes desensitization, internalization and recycling and 3. environmental triggers [ 13 ].

CCR5 receptor is part of the G-protein coupled receptor family, which binds to its ligand and releases αi and βγ G-protein subunits. This results in a mediated effector response. Such responses stimulate the release of phospholipase Cβ and adenylyl cyclase. This in turn facilitates the release of intracellular calcium and form inositol triphosphate [ 13 ]. This leads to activation of phosphorylation of the CCR5 receptor which occurs at the serine and C-terminal residues via protein kinase C and G-protein coupled receptor kinases [ 13 ]. The regulatory proteins, β-arrestin 1 and 2, bind to the activated serine and the conserved DRY motif in the intracellular loop [ 13 ]. The β-arrestin proteins have functions like desensitizing the receptor to further stimulation and participating in endocytosis. The CCR5 expression level is controlled by the rates of recycling and endocytosis [ 13 ]. In the endocytosis process, β-arrestin protein facilitates the binding process between clathrin-coated pits and the phosphorylated receptor. Infection and entry of HIV into cells do not require CCR5 signalling, but the chemokine-induced endocytosis decreases the available receptor for HIV entry. This is the process of chemokine-mediated anti-HIV activity [ 13 ].

Environmental factors affecting CCR5 expression are infectious pathogenic agents like Mycobacterium tuberculosis , which increases the CCR5 expression. Studies have shown that CCR5 expression is considerably increased in all leukocyte subset cells during tuberculosis and dual infection with HIV [ 13 ]. However, the level of CCR5 expression on CD4 + T-cells was not increased. Conversely, it was also shown that HIV affects the level of expression of CCR5, due to a correlation with HIV disease progression. Individuals with end stage HIV were shown to have the highest percentages of CCR5 expressing CD4 + T-cells [ 13 ].

The regulation of CCR5 is complex. The introns as well as sequences in the 5′ UTR and 3′ UTR affect CCR5 gene regulation [ 13 ]. Therefore, mutations in these regions should be considered critical in the regulation process.

CCR5-Delta 32 Mutation

The discovery of CCR5-delta 32 mutation in the CCR5 gene in 1996 which exhibited some protection against HIV was a ground breaking one. Studies showed that the CD4 + T-cells when expressing this mutation prevented HIV envelope fusion [ 12 ] (Fig.  5 ). The mutant allele has a length of 215 in comparison to the wild type which contains 352 amino acid residues [ 13 ]. This mutation basically results due to the deletion of 32 base pairs from the position of nucleotides starting from 794 till 825, a frameshift mutation, and seven new amino acids are incorporated between amino acid 174 and stop codon at amino acid 182 [ 13 ] (Fig.  6 ). This mutation affects the region of second extracellular loop where the resultant protein lacked the last three transmembrane domains and also some regions necessary for G-protein interaction and signal transduction.

Comparison of HIV infecting cell with CCR5 and without CCR5 [ 15 ]

Difference between wild type CCR5 and CCR5-delta 32 [ 16 ]

This mutation is majorly restricted to people of European descent. The gene frequencies are found to be around 10% and shows a decline from north to south latitude. A 2–5% gene frequency in Europe, the Middle East and parts of the Indian subcontinent was observed in more than 3000 individuals. The highest frequency, at 20.93%, was discovered in the Ashkenazi Jewish population. The mutant allele is absent in Black populations excluding the African American group who may have acquired the mutation through genetic admixture [ 13 ].

The origin of the delta-32 mutant allele has been dated back to the year 275–1875, which increased over a period of time as a result of selective pressure, mainly the Black plague. However, historical data have shown that Black plague may not in fact be the cause [ 13 ]. The distribution of the delta-32 mutant allele in a north to south gradient does not correlate to the casualties of the plague and instead follows a south to the north gradient. The Black plague has shown the greatest casualties in areas like the Mediterranean region and China, with lowest allele frequencies of the mutation [ 13 ].

Studies suggested that delta-32 arose without a selective event. Tandem repeats found in the coding region of the CCR5 gene could cause unequal homologous recombination, which results in the delta-32 allele. The origins of the delta-32 mutation, however, remain a mystery [ 13 ].

The hype about the delta-32 mutation comes from its ability to protect homozygous individuals from HIV. The protective effect of the delta-32 mutation is a result of eliminating the expression of CCR5 protein on the cell surface, which prevents HIV’s entry into the cell. In the year 1997, however, studies showed that some of them having the homozygous delta-32 mutation were HIV-infected [ 13 ]. Further studies revealed the HIV virus was of the X4 type, which led to very rapid CD4 + T cell decline. Hence, this mutation is limited in its function and does not protect against viral strains which utilize other receptors or show dual-tropism [ 13 ].

In contrast, however, the delta-32 protein product which is localized to the endoplasmic reticulum is an important factor. It is shown to exert a trans-dominant negative effect on the wild-type CCR5 protein, which inhibits its transport to the cell surface. Further analysis in vitro showed the reduction of surface expression of wild type CCR5 and CXCR4 through dimerization by this mutant protein product [ 13 ]. This confers an inhibition to R5, X4 and R5X4 HIV infections [ 13 ]. Homozygous delta-32 individuals with this mutant protein were shown to have suppressed CXCR4 surface protein expression and decreased susceptibility to X4 infection. Experimental proofs also suggested that delta-32 heterozygous individuals with HIV infection do not stably express the mutant protein, are devoid of the molecular mechanism of complete protection and only maybe partially protected [ 13 ].

Stem Cell Transplantation

Stem cells are undifferentiated cells that can differentiate into specialized cells and can also undergo mitosis to produce more stem cells. There are mainly two classes—embryonic stem cells (ECS) and adult stem cells. Stem cells are also taken from the umbilical cord blood just after birth. These act as a repair mechanism for the body, such as skin, blood or intestinal tissues. Adult stem cells are majorly used in medical therapies like bone marrow transplantation. Bone marrow is the spongy tissue present inside the bones which serves as a rich source of adult stem cells. Long-term control of HIV is possible with CCR5-delta 32 stem cell transplantation [ 13 ].

Allogeneic transplantation of stem cells with this mutation in patients with HIV infection and malignancy has been considered as an option since the late 1990s (Fig.  7 ). Human leukocyte antigen (HLA) is a critical factor to be considered during the process of transplantation. The HLA should be a proper match; otherwise, it would lead to rejection by the recipient’s immune system. The limited availability of HLA-matched unrelated donors has made it even more difficult. Only about 1% of Caucasians possess this CCR5 null allele [ 13 ].

Allogeneic hematopoietic stem cell transplant [ 17 ]

Gene Therapy

Zinc finger nuclease technology is a popular tool which can be used for targeting specific DNA sequences in the genome. It falls in the class of restriction enzymes and is artificially made by fusing a zinc finger DNA-binding domain and DNA-cleavage domain. This technique is also engineered to eliminate the CCR5 expression over CD4 + T-cells, and the modified cells have shown to have a half-life of 48 weeks [ 13 ]. But it has its own issues. It is difficult to ensure that the desired repair mechanism is one which is used to repair the double stranded break (DBS) [ 13 ]. It is also challenging to scale it upwards and is an expensive technique.

A breakthrough technique, the CRISPR/Cas9 gene-editing system, is also used to eliminate the CCR5 receptor on the blood stem cells which can give rise to differentiated blood cells that are devoid of this receptor [ 18 ] (Fig.  8 ). These gene-edited stem cells can be established into an HIV-infected patient through bone marrow transplantation and give rise to an HIV-resistant immune system [ 18 ]. This technique, however, can also go sideways which leads to unwanted results that can cause ethical issues to rise. As seen in the highly controversial case of the Chinese scientist, He Jiankui, who with the help of this technology deleted the CCR5 gene in the twins, Lulu and Nana, introduced some unintended mutations in their genetic codes. There is still a lot of research needed to make this technology bioethically a safe tool.

CRISPR/Cas9 gene editing [ 19 ]

Researchers have also engineered a molecule called the chimeric antigen receptor (CAR) and introduced a gene for that molecule into blood-forming stem cells [ 18 ]. This molecule has two receptors that will recognize the antigen (HIV) and direct the immune cells to locate and kill the HIV-infected cells [ 18 ]. When transplanted into mice, which would have the CAR-carrying blood stem cells, it would result in reduced levels of HIV by inducing the immune cells to fight effectively against the virus [ 18 ]. An 80% to 95% drop in viral load was observed in the mice [ 18 ]. It was concluded that gene therapy could be a feasible option for treatment in HIV-positive humans.

Immunological Approaches

Studies have shown that vaccine can contribute effectively in viral clearance such as the Rhesus CMV vaccine vector [ 18 ]. A vaccine vector is a kind of vaccine which consists of chemically weakened viruses that are transported in the body to generate an immune response. The genes used in these vaccines are antigen coding surface proteins from that particular pathogen.

SAV001-H is the first and only preventive HIV vaccine which uses killed HIV-1 virus [ 18 ]. It is unique from other vaccines, as it uses genetically engineered whole virus genome, eliminating its pathogenicity and inactivating its virulence through irradiation and chemical treatments, finally approaching to the first “whole-killed virus”-based HIV vaccine [ 18 ]. The results of Phase 1 clinical trial, which were completed in the year 2013, were found to have serious and adverse effects in the 33 participants [ 18 ]. There was also a surprising boost in the antibody production against p24 and gp120. The HIV viral core is mostly made up of the structural protein, p24, which is called the capsid. A crucial factor in the diagnosis of primary HIV-infected individuals is the p24 antigen assay. High levels of p24 are found in the blood serum during the period between infection and seroconversion. The antibody production is found to increase as much as 64-fold [ 18 ]. The antibody production against gp120, which is a glycoprotein, necessary for attachment to a cell receptor and allow HIV entry, is found to increase up to eight-fold [ 18 ].

Another promising vaccine called the Kang's vaccine also uses the “whole-killed HIV-1,” which is similar to vaccines developed for rabies, polio and influenza [ 18 ]. However, HIV-1 is genetically engineered in such vaccines and raises questions about safety and possibility of large quantity production.

Researchers have also tested an immunogen called eOD-GT8 60mer, a protein nanoparticle, which is designed to mimic a crucial part of the HIV envelope protein which will bind to and activate the B cells to produce plasma cells that secrete antibodies needed to fight HIV [ 18 ]. This nanoparticle was developed in the Schief laboratory and tested in mouse models engineered by the Nemazee laboratory [ 18 ]. The researchers showed that immunization with eOD-GT8 60mer produced antibody progenitors with some of the characters crucial to recognize and block the HIV infection, proposing that it could be a promising first step in a series of immunizations against HIV [ 18 ]. The vaccine appears to work well in mouse models. The researchers are now investigating other immunogens that could work in coexistence with eOD-GT8 60mer [ 18 ].

Case Studies

The berlin patient [ 20 ].

The strongest proof available in favour of a HIV cure stems from the case of Timothy Brown who is popularly known as the Berlin patient (Fig.  9 ). He is considered the first person ever to be cured of HIV. The victory was predicated on doctors taking advantage of nature’s own experiment—the genetic mutation of CCR5 gene that produces a protein co-receptor present on the surface of CD4 + T-cells that HIV uses to gain entry. He was attending university in Berlin when was diagnosed HIV positive. His initial treatment include ART, and he was taking low doses of zidovudine and protease inhibitors. He continued to live a normal life for the next 10 years. But one day, he was again feeling extremely exhausted and the doctor had diagnosed it to be anaemia. He had received red blood cell transfusion for nearly a week and was then sent to an oncologist, Dr Huetter, when the previous doctor was unable to resolve the situation. The oncologist performed a painful bone marrow biopsy and after further diagnosis he was informed that he had acute myeloid leukaemia (AML).

Timothy Ray Brown a.k.a. “The Berlin patient” [ 21 ]

He then started receiving treatment at one of the Berlin University hospitals and had to receive four rounds of chemotherapy treatment. During the third round of chemotherapy, he had gotten a fatally dangerous infection and was immediately put into an induced coma. His blood sample was collected and sent to a stem cell donor bank with the German Red Cross to find matches in case he needed transplantation. Luckily, he had 267 matches which sparked an idea to locate donors with a homozygous CCR5 delta-32 mutation on CD4 + T-cells who are almost immune to HIV infection. A donor was found at the 61st attempt and had agreed to donate when necessary (Fig.  10 ).

Adam Castillejo a.k.a “The London patient” [ 23 ]

However, Timothy Brown had been reluctant and had said no to transplantation as the success rate was only 50–50. But at the end of 2006, leukaemia had rebounded and he desperately needed transplantation to survive. He received the stem cell transplant on February 6, 2007 and stopped taking his antiretroviral medication. Nearly 3 months after he underwent transplantation, HIV was no longer found in his body and he had thrived until the end of the year.

Unfortunately, life had other plans for him. After coming back from a trip to the USA, he was diagnosed with pneumonia and the leukaemia was back. The doctors decided to treat him with a second transplantation from the same donor in February 2008. The recovery was a tough one. He was almost paralyzed and went nearly blind. He had, however, eventually learnt to walk again and fully recovered 6 years later. He was continuously tested for HIV with extensive and precise tests. It was finally good news for him! Since 2010, when he decided to go public, he had interviewed for various magazines: POZ Magazine , New York Magazine and Science Magazine among others and decided to devote his life in supporting research for cures against HIV. In July 2012, he started the Timothy Ray Brown Foundation under World AIDS Institute and has worked with many scientists, organizations, research laboratories and universities to work on cures such as vaccination against HIV.

The London Patient [ 22 ]

The London patient may be the second person with HIV to no longer have the virus. In March 2019, in a report published in journal Nature , a group of investigators had announced the cure of a second HIV-positive patient. His success story depicts that CCR5 is a viable target for HIV research and treatment.

The London patient, who had chosen to remain anonymous, came out in public on March 9 th 2020. Adam Castillejo grew up in Caracas, Venezuela, and later shifted to London with his mother, as his parents were divorced. He was first diagnosed with HIV in 2003 and had started taking drugs to control the HIV infection in 2012. He had taken antiretroviral therapy for years before being diagnosed with an advanced form of blood cancer called Hodgkin’s lymphoma. Again, as in the case of the Berlin patient, the cancer was resistant to standard chemotherapy, so his doctors had advised more intensive chemotherapy along with bone marrow stem cell transplant. In 2016, he had agreed to transplantation and received it from a healthy donor who carried the CCR5 mutation. So, when his immune system regrew, it lacked the protein and was impervious to HIV. His virologist, Dr Ravindra Gupta, from the University of Cambridge, thinks it is a cure because a year had passed and they had carried out a few more tests for the viral load. In Adam Castillejo’s own words, “I don’t want people to think, “Oh, you’ve been chosen.” No, it just happened. I was in the right place, probably at the time right time, when it happened.” Adam Castillejo wants to be the “ambassador of hope” for people with this illness.

Although the scientists describe this case as a long-term remission, experts are calling it a potential cure. Such transplants are, however, dangerous and can be fatal. They are also an impractical approach to cure the millions already infected. These are highly risky procedures and can lead to serious complications. There still has to be a lot of research done to extend this type of treatment to a wider population infected with HIV.

A comparative study of the two patients reveals that their cases were in fact quite similar (Table ​ (Table9 9 ).

Summary of the two cases—the Berlin patient and the London patient [ 24 ]

Lifestyle Practices to Prevent HIV Infection

Prevention is better than cure. And with HIV infections, one should practice prevention with utmost care and sincerity. An HIV diagnosis could turn one’s life upside down. So, it’s better to lead a healthy lifestyle by making the correct choices.

Measures for Protection Against HIV Infection

HIV is majorly spread through unprotected vaginal or anal sex. Choose less risky behaviour and be cautious. Not taking medicines to prevent or treat HIV is equally responsible for HIV infection. The number of sexual partners should be limited. One should get tested for sexually transmitted diseases and also know the sexual partner’s status. One can talk about pre-exposure prophylaxis to their respective healthcare provider. It is a preventive option for people who are not infected yet but are exposed to high risks of being HIV positive. HIV is also spread through intravenous injections and blood transfusions. Use of sterile equipment in such cases is a necessity.

Pre-exposure Prophylaxis

This is a preventive method of taking pills by people who are not HIV positive yet but who are at a high risk of getting infected and spreading it to others. A pill, named Truvada, contains two medicinal components, emtricitabine and tenofovir, that are used in combination with other drugs to treat HIV [ 25 ]. These medicines work on keeping the virus from creating a permanent infection.

Post-exposure Prophylaxis

Post-exposure prophylaxis (PEP) is a short course of HIV medicines taken soon after a possible exposure to HIV [ 25 ]. Every hour counts. For the treatment to be effective, the course should begin within 72 h after exposure to HIV; otherwise, it will not have any effect [ 25 ]. This treatment should be used only in cases of emergency. A person prescribed with PEP will need to take the medicines for 28 days at a stretch and then visit their respective healthcare provider for further tests [ 25 ]. Even if taken correctly, it may not be 100% effective. The sooner the medication is started, the better.

Healthy Practices to Follow When Living with HIV

A healthy, well-balanced and nutritious diet can help a person lead a better life by preventing health related issues like malnutrition and stopping the progression from HIV to AIDS. A well-balance diet is rich in whole grains, fresh fruits and vegetables, protein, low fat dairy products and multivitamins like zinc and B12. It also constitutes what should be cut down—fried foods, processed foods and sugary drinks. Smoking should be stopped when diagnosed with HIV. According to CDC, in the USA, the rate of adults with HIV, smoking is two to three times higher in adults infected with HIV than the nearly 18% of uninfected adults who smoke. Researchers at the Syracuse University analysed the data from 212 adults infected with HIV and found that the ones who smoked reported having more symptoms like dizziness and coughing.

Putting a stop to illegal drug use is equally necessary. People should seek treatment for addiction to illegal drugs like heroin, cocaine and methamphetamines. Sharing of needles for drugs can leave one exposed to other infections like hepatitis which might lead to a faster progression from HIV to AIDS. A recent study from the University of Pennsylvania School of Medicine showed a dramatic increase in the ability of HIV to attack healthy cells when methamphetamine is present in the bloodstream. This indicates that illegal drugs are also aiding in the HIV infection.

Being physically fit through a good work-out three to six times a week can help improve a person’s mood, perspective and overall quality of life. A good amount of moderate exercise can help fight HIV symptoms of nerve pain, loss of appetite and reduce the risks of other chronic diseases like heart disease, diabetes and osteoporosis. Taking the prescribed medication on time is known as adherence. This is vital to help reduce the risk of HIV becoming drug resistant and helps the immune system function for a longer time.

Nowadays, with the help of Internet of Things or IoT, patient’s health can be monitored 24/7. The quality of care provided can be increased many-folds with the help of monitoring devices enabled with current technology [ 26 ]. Concept of E-Health and M-Health is currently trending. E-Health makes use of electronic and communication processes with improved cyber security [ 26 ]. Some of the E-Health devices include GPS tracking, pedometer and electronic health records [ 26 ]. M-Health systems provide doctors with the complete medical history of the patient, so the treatment becomes easier and does not delay in case of emergencies. It makes use of mobile phones and other communication systems to help the patients with information about preventive health care services and collects data in real time as well [ 26 ]. The other important applications include chronic disease management, monitoring of diseases and tracking of epidemic outbreaks [ 26 ].

Genomic Diversity and Clinical Implications

Despite billions of dollars being invested, there is currently no HIV vaccine available that can either prevent the disease or treat those who suffer from it. An AIDS patient harbours 100 million genetically distinct variants of HIV [ 27 ]. This high diversity of HIV-1 is due to high replication rates, errors in reverse transcriptase and recombination events that mainly occur during the viral replication process. Reverse transcriptase enzyme has approximately a rate of 10 –4 nucleotide substitutions per replication cycle. Deletions, insertions and duplications are major contributing factors to the genetic variation of the virus [ 27 ]. Genetic recombination also plays an important role in creating genetic diversity. Template switches between two copies of RNA strands occur regularly during reverse transcription [ 27 ]. This generates a lot of mutations with the help of inter- and intra-molecular jumps. These mutations can either be drug resistant or inhibit the viral replication capacity.

HIV-1 can be classified into four main groups: M, N, O and the recently identified P. The M group is further identified into 4 subtypes (A to J). Studies have shown that there is a worldwide spread of non-B subtype viruses, and with the introduction of antiretroviral drugs, more research has to be conducted regarding the responsiveness of the drug resistance in non-B subtypes [ 27 ]. Different types of HIV-1 resistance are observed in different subtypes at varied levels. For example, subtypes B and G have shown to develop resistance against nelfinavir [ 27 ]. Research is also being done in the role of polymorphisms for development of drug resistance, to assess the genotypes before and after the therapy to be able to establish any association between the two [ 27 ].

Variation of Disease Progression Rate

There are 3 phases of the progression of HIV-1 infection- primary infection, chronic asymptomatic phase of infection and finally, AIDS. In the asymptomatic phase, neither signs nor symptoms of the disease are present, and this phase lasts an average of about 10 years. They can be divided as typical progressors, rapid progressors, slow progressors and long-term progressors. Rapid ones (10–20%) develop AIDS within 5 years of infection [ 28 ]. Slow progressors (5–15%) remain free of AIDS 15 years after infection [ 28 ]. Long-term progressors that constitute 1% show no signs and symptoms [ 28 ]. Factors like host genetic make-up, immune responses, co-infection and viral genetics and adaptation are attribute to this huge variation in disease progression [ 28 ]. But there is no solid evidence as such.

Some individuals known as elite controllers are able to manage the viral replication for longer durations, others are shown to rapidly lose CD4 + T-cells after seroconversion in the absence of cART (combination antiretroviral therapy). Scientists have conducted research studies that has led to the conclusion that rapid progression before administration of cART stops the recovery of CD4 + T-cells once the suppressive response to HIV-1 through cART is achieved. These findings have implications in public health policy making, clinical outcomes and science research. Ideally, cART should be initiated as soon the patient is diagnosed with HIV-1 irrespective of the CD4 + T-cell count. However, in clinical settings where cART is not widely available, these results would support strategies that may help in promoting frequent testing to reduce the proportion of patients initiating cART at low CD4 + T-cell counts. For those testing early, frequent CD4 + T-cell count should be monitored close to the time of HIV diagnoses to establish the rapid progressors phenotype in order to avoid unnecessary CD4 + T-cell count decay among rapid progressors. Finally, interpretation of the immunopathological basis of rapid progression can help improve individual clinical outcomes and limit its impact in the global HIV-1 pandemic.

Development of Drug Resistance as a Major Barrier to Treat HIV

HIV-1 has a high mutation rate. An estimated 10 10 virions per day can be produced in untreated patients that may result in variants called quasispecies. The complexity is also increased due to high recombination rate whenever more than one variant infects the same cell. All these are contributing factors that help in invading the host’s immune system and fostering drug resistance. Salvage therapy is also useful in cases when more than one regimen failed or a single regimen failed for a patient. It can be used to suppress the virus levels below the detection level and should have high genetic barrier to resistance to prevent rebound [ 29 ]. Clinicians need to focus on patient’s adherence as well as access to antiretrovirals (ARVs), drug interactions, tolerability, genotypic and phenotypic resistance testing, cross-resistance, genetic barrier and potency of ARVs [ 29 ].

Overcoming Obstacles and Future Prospects

At present, the reason for not being able to achieve a complete cure with the help of ART, in spite of achievement of undetectable viral load, is due to the presence of dormant virus or HIV latency. In a method call shock and kill, immune stimulants shock the latent virus from hidden reservoirs and then attempt to kill reactivated HIV [ 18 ]. An enzyme has been identified which is called histone deacetylase (HDAC) which is responsible for the sustained latency. Some studies show promise but are yet to be confirmed by clinical trials. Flushing these latent CD4 HIV-infected cells from their reservoirs with these HDAC-inhibitors into the blood circulation makes them susceptible to ART. Vorinostat and panobinostat are two such promising drugs [ 18 ].

Histone deacetylase inhibitors seem to have a broad spectrum of epigenetic activities. Vorinostat (also called Zolinza) is a U.S. Food and Drug Administration approved medicine, which has been used for the treatment of cutaneous T-cell lymphoma (CTCL) [ 18 ]. They help in flushing the virus from the reservoirs into the circulation. The dose is 400 mg. Other drugs on the pipeline are Protein kinase C agonist bryostatin-1 and GS-9620—TLR7 agonist [ 18 ].

Romidepsin (also called Istodax) is another HDAC inhibitor drug, which induces HIV-1 transcription to form plasma HIV-1 RNA that can be easily detected with standard assays [ 18 ]. This gives a possibility of reversing the HIV-1 latency in vivo without hindering T cell mediated immune response [ 18 ]. These findings will help the researchers with future clinical trials aiming to eliminate the HIV-1 reservoirs.

Research for curing HIV is at an infant stage but a promising one. Scientists are working on two broad types of HIV cures—a functional cure and a sterilising one.

The approach of the functional cure is to reduce the virus levels in the body to an undetectable stage, where the patient no longer needs to be on HIV medication or has no risk of progression to AIDS nor transferring the virus to others. Unlike the functional cure, however, a sterilising cure aims to get rid of HIV from the body completely by eliminating cells from latent reservoirs. It has proved to be an extremely challenging task for scientists, who believe it may be unachievable in the majority of them living with HIV. However, some findings by researchers at the University of Pittsburgh could lead to a foundation for an HIV vaccine. Clinical trials are in the works.

Abivax, a French company, is developing a drug that binds to some specific sequence of the viral RNA and inhibits its replication. During clinical trials, it has shown that this may have the potential to become a functional cure. The key is that it can target the reservoir of HIV viruses that hide inactive within our cells. It can target the reservoirs where HIV viruses act as inactive, within the infected cells. The result of phase IIa trial was quite promising. Fifteen patients were given the drug in combination with ART, and it was observed after 28 days of treatment that eight patients showed a 25% to almost 50% reduction of their HIV reservoirs compared to those only taking ART. The company is planning a phase IIb clinical trial to confirm the effects of the drug in the long term.

Research and development in HIV and its cure have come a long way since the disease was discovered in the 1980s. ART was a major milestone that has changed the lives of millions for good, but the next ambitious goal is to find an HIV cure before the year 2020. There are several approaches to an HIV cure ranging from shock and kill therapy, immunotherapy, vaccine development to gene editing using zinc finger nucleases and the CRISPR/Cas9 system, but finding the best possible solution is a challenge. One of the biggest challenges around any HIV treatment is the ability of the virus to rapidly mutate and develop resistance. Many of the new approaches do not provide any valuable insights as to whether the virus has the potential to become resistant. As of now, none of these functional cures have reached late-stage clinical trials, and the aim of finding an HIV cure until 2020 seems far-fetched. However, 2020 will likely be marked as an important milestone as the first late-stage trials will be executed. If successful, it could bring the approval of the first functional HIV cure in ten years.

There are two gene therapies undergoing human trials—one is to destroy the CCR5 receptor of the immune cells of people infected with HIV and the other therapy includes the CRISPR technology which is still under early trials. This mutation does not necessarily protect the person against all types of HIV. It was found that in one of the patients who had received the bone marrow treatment, it was found to have the CXCR4-tropic form. It uses a different type of receptor to enter and infect the cells. It was, however, not known whether this virus was acquired after the treatment or if some patients do contract a small amount of CXCR4-tropic virus that starts to multiply when other types are not present.

HIV research continues on many fronts that could provide the same results and only some of which rely on the CCR5 delta 32 mutation, which should be explored extensively. There are many strategies which are in the early stages of development. Scientific process can be slow but if done correctly, advances can be made to find a scalable, cost-effective cure for everyone.

Acknowledgments

The authors listed in this paper wish to express their appreciation to the RSST trust Bangalore for their continuous support and encouragement.

Authors Contribution

All authors have contributed equally with their valuable comments which made the manuscript to this form.

There was no funding provided for the above research and preparation of the manuscript.

Compliance with Ethical Standards

The authors declare that they have no conflict of interest.

All the authors listed hereby confirmed that in the above research, there were no human participants and/or animals involved in any kind of determination, evaluation or research studies.

There is also final confirmation given by all the listed authors for the submission of manuscript in its actual state. The authors listed above also confirm that the above-mentioned manuscript is in its original state and the manuscript is neither submitted anywhere nor in the submission process in any other journals. In addition, all the authors have solely contributed their original work in the preparation of this manuscript. If the copying or similarity have been found, then in all situations the listed authors are solely responsible.

Significance Statement

This article aims to increase awareness among the society about the current scenario of HIV/AIDS. The scientists are working on 2 types of cures—functional and sterilizing. The path to finding a cure is a promising one as late-phase trials begin in 2020.

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Contributor Information

Praveen Kumar Gupta, Email: ni.ude.ecvr@atpugkneevarp .

Apoorva Saxena, Email: [email protected] .

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Office of AIDS Research

• HIV Policy and Research
• Research Priorities
• NIH Strategic Plan for HIV and HIV-Related Research
• NIH HIV Research Budget
• NIH HIV Research Priority Areas
• Reduce the Incidence of HIV
• Develop Next-Generation HIV Therapies

Research Toward HIV Cure

• Address HIV-Associated Comorbidities, Coinfections, & Complications
• Cross-Cutting Areas

Viral latency and sanctuaries

Latent HIV reservoirs—small amounts of HIV that persist in people taking ART—present a significant challenge to finding a cure for HIV. Latent reservoirs remain in people with HIV when HIV becomes part of the body’s DNA in infected cells. Additionally, reservoirs of HIV can be found in certain “sanctuary” sites in the body that allow the virus to hide and be protected from both the immune system and ART. To cure HIV, the NIH supports studies to develop novel approaches and treatments that target these HIV reservoirs.

Sustained viral remission and viral eradication

Current science suggests that the path to an HIV cure involves first achieving sustained viral remission without ART. This is called sustained ART-free viral remission or a functional cure. For sustained ART-free viral remission, infectious virus must remain undetectable by sensitive testing methods for a long time without treatment. One research aim will be to prolong the time between treatments to be measured eventually not in weeks, but in months or even years. The NIH supports research into treatments leading to sustained ART-free viral remission . New cure-inducing treatments must be as safe, effective, and available for widespread use as are current-day ART regimens.

Viral eradication—eliminating the virus entirely—is the more challenging, longer-term goal.

Research Strategies

The NIH supports research to better understand how the HIV reservoir forms, persists, and reactivates, as well as investigations to develop new cure treatment strategies targeting HIV reservoirs.

A range of biomarkers and techniques, including single-cell and imaging technologies, are being studied to determine how to identify and describe the HIV reservoir. These techniques also are being used to better understand mechanisms of viral reactivation from latently infected cells.

Experimental treatments in development include therapeutic vaccines, genetically engineered immune cells that are resistant to HIV infection, drugs that reactivate latent HIV to make the virus visible to the immune system, cure-inducing immunotherapies, and interventions to permanently silence HIV in infected cells.

The search for an HIV cure involves important behavioral and social processes that complement the domains of biomedicine.  BSSR in HIV cure research is focused on important aspects such as: counseling and support interventions to address the psychosocial needs and concerns of study participants related to analytical treatment interruptions (ATIs); risk reduction in the course of ATI study participation; motivation, acceptability, and decision‐making processes of potential study participants; how cure affects the identity and social position of people with HIV; and the scalability of a proven cure strategy in the context of further advances in HIV prevention and treatment.

The NIH is leveraging resources toward an HIV cure through several public-private partnerships. NIH small business awards enable companies to help foster a diverse pipeline of experimental treatments in development. The combined support of government, industry, and nongovernmental foundations is fostering the expansion of a talented scientific workforce dedicated to advancing HIV cure research.

OAR scientist Dr. Paul Sato coordinates Research Toward an HIV Cure .

This page last reviewed on September 8, 2022

AIDS Research and Therapy

Call for papers, 20th anniversary collection, covid-19 and hiv: clinical presentation, outcomes and impact on clinical services, treatment outcomes and paving the way for an hiv cure in low and middle income countries, spatial inequality, infectious diseases and disease control.

We are excited to announce the 20th Anniversary issue of journal AIDS Research & Therapy. We invite manuscripts focused on latest research that may influence policy into curbing epidemic.

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Discussion of HIV treatment outcomes in LMICs has historically been neglected, even though it is in these countries that a cure is most crucial. This series covers the ways treatment outcomes can be improved along the way to a HIV cure in states defined as LMICs by the WHO.

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Featured Article: HIV gp120/Tat protein-induced epithelial–mesenchymal transition promotes the progression of cervical lesions

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Dr Barbara Castelnuovo - Editor in Chief

Dr Barbara Castelnuovo is an Italian/Ugandan clinical researcher. She is a specialist in Infectious Diseases trained at the University of Milan, with a PhD in Medical Sciences from the University of Antwerp. She has worked as an HIV specialist at the Infectious Diseases Institute, Makerere University, Uganda since 2004 and she is currently the Head of the Research Department. Dr Castelnuovo has designed and implemented several clinical observational studies, and clinical trials. Her research interest are HIV long term outcomes, models of care and research capacity building. 

Dr Patricia Price - Editor in Chief

A/Prof Patricia Price is an Adjunct Principal Research Fellow at Curtin University, coordinating research initiatives at Curtin University in Western Australia and at the University of Indonesia. She has published over 260 papers in international journals.

Current projects address how the varied manifestations and consequences of CMV infection arise from the infection of very few cells – evaluating the roles of immune activation, CMV burden and NK cells in healthy aging donors, HIV patients and renal transplant recipients. Recent studies in collaboration with Dr Silvia Lee address the potential of γδ T-cells to mediate the effects of CMV on cardiovascular and neurocognitive health. The group are now studying variations in HCMV-encoded homologues of immune-related genes in clinical samples.

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UN agencies urge immediate boost in HIV services to end AIDS by 2030

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An immediate increase in HIV services is needed in the countries most affected by the pandemic to end AIDS by 2030, according to a new report by the Global Alliance for Ending AIDS in Children by 2030, released on Monday.  

The Global Alliance was launched by the World Health Organization ( WHO ), UN Children’s Fund ( UNICEF ) and the Joint UN Programme on HIV/AIDS ( UNAIDS ) in 2022 and includes 12 African countries. 

The new report –  Transforming Vision Into Reality   – also highlights significant progress in averting four million infections among children aged 0-14 years old since 2000 through programmes targeting  vertical transmission of HIV- that is, from mother to child. 

Advancing nations  

Many of the countries in the Global Alliance have achieved significant coverage of lifelong antiretroviral therapy among HIV-positive pregnant and breastfeeding women. Uganda has neared a 100 per cent achievement. 

“I applaud the progress that many countries are making in rolling out HIV services to keep young women healthy and to protect babies and children from HIV,” UNAIDS Executive Director, Winnie Byanyima said.

“With the medicines and science available today, we can ensure that all babies are born – and remain – HIV-free, and that all children who are living with HIV get on and stay on treatment,” she added.

Ms. Byanyima said modern medicines and science help ensure babies are born and remain HIV-free through effective treatment. But this treatment, she said, must be increased to ensure that all children are reached.

“We cannot rest on our laurels,” she said. “The world can and must keep its promise to end AIDS in children by 2030.”

Not on track

Despite noteworthy advances, the report states that neither the world nor Global Alliance countries are on track to meet HIV-related targets for children and adolescents. Furthermore, progress in avoiding new HIV infections and AIDS-related deaths in children has decreased in recent years.

“While we have made progress in increasing access for pregnant women to testing and treatment to prevent vertical transmission of HIV, we are still far from closing the paediatric treatment gap,” Tedros Adhanom Ghebreyesus, Director-General of WHO said.

“We need to further strengthen the collaboration and reach of the Global Alliance, and we must do this work with focus, purpose and in solidarity with all affected mothers, children, and adolescents.”

Age and gender inequalities

The report noted that about 120,000 children aged 0-14 became infected with HIV in 2023 and 77,000 of those cases occurred in the Global Alliance countries. These countries also recorded 49,000 of 76,000 global AIDS-related deaths among children aged 0-14 years old.

The report also cited a continued widening treatment gap between adults and children.

“Without early and effective testing and treatment, HIV remains a persistent threat to the health and well-being of children and adolescents and puts them at risk of death,” said Anurita Bains, UNICEF Associate Director HIV/AIDS.  

“To close the treatment gap, we must support governments to scale up innovative testing approaches and ensure children and adolescents living with HIV receive the treatment and support they need.” 

Gender inequalities and human rights violations were cited as increasing women’s vulnerability to HIV and reducing their ability to access necessary treatment. 

All UN agencies involved in the Global Alliance encourage strengthened global collaboration to end AIDS by 2030.  

• HIV and AIDS

Future Directions for HIV Treatment Research

A major goal of NIAID-supported research on HIV treatment today is to develop long-acting therapies that—unlike current antiretrovirals, which require daily dosing—could be taken only once a week, once a month, or even less often. Such long-acting therapies might be easier for some people to stick to than daily pills, and might also be less toxic and more cost effective. The three types of agents under study are long-acting drugs, broadly neutralizing antibodies, and therapeutic vaccines.

Long-Acting Drugs

NIAID-supported scientists aim to develop a new array of drugs for HIV treatment that include longer-acting pills as well as alternative formulations such as injections, patches, and implants. The complexity of developing such products has led NIAID to create a consortium of experts who can facilitate relationships among the many types of researchers needed to translate an idea for a long-acting HIV drug into a workable solution. Called LEAP, for Long-Acting/Extended Release Antiretroviral Resource Program, the consortium includes scientists and clinicians from academia, industry, and government, as well as patient advocates. Read more about LEAP.

NIAID also will investigate the effectiveness of two investigational long-acting HIV drugs, rilpivirine LA and cabotegravir LA, in people for whom adhering to conventional antiretroviral therapy has been a challenge. Another study is planned to test whether the combination of monthly injections of cabotegravir LA and monthly infusions of an NIAID-discovered broadly neutralizing antibody called VRC01LS can keep HIV suppressed in people whose infection was previously controlled by antiretroviral therapy. 

Broadly Neutralizing Antibodies

Scientists at the NIAID Vaccine Research Center (VRC) and NIAID-supported scientists at other institutions are developing and testing multiple antibodies for the treatment of HIV. Antibodies are good candidates for treatment because they have few side effects and can be modified to ensure they last a long time in the body, suggesting that dosing could be every other month or even less often. Importantly, the antibodies under investigation can powerfully stop a wide range of HIV strains from infecting human cells in the laboratory and thus are known as broadly neutralizing antibodies, or bNAbs.

In the context of treatment, bNAbs can potentially thwart HIV in three ways:

• By binding directly to the virus, preventing it from entering a cell and accelerating its elimination.
• By binding to an HIV-infected cell, recruiting immune-system components that facilitate cell killing.
• By binding to a key fragment of HIV, forming a complex that may lead to the stimulation of immune cells in a manner similar to a vaccine, thereby preparing the immune system for future encounters with the virus.

Clinical studies have established that giving infusions of certain bNAbs to people living with HIV can suppress the virus, albeit to a limited degree. Further studies have shown that treating people living with HIV with just one bNAb fosters the emergence of HIV strains that are resistant to the antibody. Thus, just as antiretroviral therapy requires a combination of drugs to effectively suppress HIV, it appears that antibody-based therapy will require a combination of either multiple bNAbs or bNAbs and long-acting drugs to suppress the virus. Studies in monkeys infected with a simian version of HIV have already demonstrated that combinations of complementary bNAbs powerfully suppress the virus for an extended period. NIAID is now funding and conducting clinical trials of this strategy for treating HIV in people.

In addition, scientists are engineering changes to known bNAbs to optimize them for HIV treatment and prevention applications. These changes are designed to increase the number of HIV strains an antibody can block, how long the antibody lasts in the body, how powerfully the antibody attaches to the virus, and how efficiently the antibody triggers the immune system to attack both the virus and HIV-infected cells.

Therapeutic HIV Vaccines

Perhaps the ideal treatment for HIV infection would be a therapeutic vaccine. Unlike a vaccine designed to prevent HIV infection, a therapeutic vaccine would be given to people already infected with the virus. Such a vaccine would stimulate the immune system to be ready to control any future emergence of HIV and thereby end the need for further therapy, perhaps save periodic booster shots. Such an approach could lead to sustained viral remission , meaning treatment or vaccination that would result in prolonged undetectable levels of HIV without regular antiretroviral therapy.

The presence of rare people living with HIV who can control the virus naturally either from the time of infection or after halting antiretroviral therapy is evidence that a therapeutic vaccine could theoretically alter the immune system to achieve long-term control of HIV. Nevertheless, attempts to create effective therapeutic HIV vaccines have so far been unsuccessful. To help improve results, NIAID is working to advance the underlying science—in particular, to improve understanding of immune responses that sustainably suppress HIV and to improve the potency of those responses.

Three of the NIAID-funded Martin Delaney Collaboratories are pursuing strategies that involve therapeutic vaccines to achieve long-term control of HIV or reduction of the reservoir of all virus-carrying cells. Read more about the  Martin Delaney Collaboratories .  

Future Directions for Developing Daily HIV Drugs

At the same time, NIAID continues to support research to develop new drugs with unique mechanisms of action for daily antiretroviral therapy. Such drugs likely would be effective against HIV strains with resistance to other drug types.

For example, basic NIAID-supported research contributed to development of the experimental drug islatravir (also known as EFdA or MK-8591), which belongs to a class of drugs known as nucleoside reverse transcriptase translocation inhibitors, or NRTTIs. NIAID research also contributed to the development of maturation inhibitors, investigational drugs that target the same stage of the HIV lifecycle as protease inhibitors but act by a different mechanism.

Researchers also are attempting to target other parts of the HIV lifecycle. For example, the experimental inhibitor fostemsavir blocks HIV from infecting immune cells by attaching to the gp120 protein on the virus’ surface. Another example is development of capsid assembly inhibitors, which halt construction of the viral capsid, the protein shell that encloses HIV’s genetic material.

For more information on investigational antiretroviral treatments, see the AIDS info Drug Database.

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Home / Innovation & Research / The innovative research behind HIV/AIDS treatment

The innovative research behind HIV/AIDS treatment

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It’s been 40 years since the release of the first scientific report describing acquired immune deficiency syndrome (AIDS). Thanks to innovative research, scientists learned how the HIV virus that causes AIDS replicates and how the immune system responds to the virus. Today, many people with HIV take just one pill a day to suppress the virus, and treatment is continuing to evolve.

In this video, Dr. Stacey Rizza , Mayo Clinic infectious disease physician and HIV researcher, explains how dedicated innovative science contributed to where we are today and what scientists are working on for the future.

What did the early research find?

Because of truly dedicated innovative science, within a few years, the scientific community figured out that AIDS was due to HIV. It then took a few years to figure out how to test for that virus. Several years later, the scientific community was able to quantitate how much virus was in a person’s blood. During all this time, truly innovative research into how the virus replicates and how the immune system responds to the virus allowed bio pharmacy companies to develop what we call anti-retroviral drugs or medications to slow down the viral replication. How has medication to treat HIV evolved?

The first drug approved for HIV was in 1987, which was AZT (now known as zidovudine). At that time, it was the fastest drug ever approved by the FDA (Food and Drug Administration) and started the fast-track mechanism through the FDA.

Then several other drugs within that same class were approved in the early 1990s. In late 1995, very early 1996, the first HIV protease inhibitors were approved. At that point, it was possible to combine three different medications from two different classes and completely suppress the HIV replication.

In the last 20 years, we’ve gone from people taking multiple medicines with lots of side effects to many of my patients with HIV now take a single pill a day. That’s a combination of medicines coformulated into one pill a day that’s extremely well-tolerated and completely suppresses their virus. We know it does not eliminate the virus. If they were to stop taking that medicine, the virus would come back. But we now have a handful of people in the world who have been what we called functionally cured of HIV, meaning they’ve gone through some research protocols that eliminated the reservoir of HIV in their body.

The new drugs are so effective in people who have fully suppressed virus that many only need to use two medications to maintain HIV treatment and control. New research is investigating ways to deliver the medications differently, such as a shot that lasts several months, or maybe someday even implantable medication delivery mechanisms so that people don’t have to take the pill every day. It is very exciting that HIV therapy is moving that direction.

Why isn’t there a cure for HIV?

The reason why it is so difficult to cure HIV is that once HIV infects a person’s body, it integrates into the host genome of several cell types. Those cells then hide in any of the lymphoid tissue, such as the lymph nodes, the liver and the spleen. And they lay there as what we call “latent” or “hiding”, as long as the person is on HIV therapy. Anytime a virus does leave a cell, it gets taken care of by HIV therapy. But if the infected individual stops the HIV therapy, that latent virus will come back. To cure HIV, you have to eliminate those hiding viruses in the cells or that latent viral reservoir, which is the term. There are many ways you can approach eliminating the reservoir.

Where is the research now?

One of the more popular ways that have been investigated is something called — and there are many different terms for it — “prime, shock, and kill” or “kick, and kill”, which is essentially giving medications that first wake the virus up from latency and then find ways to make the cells that have the virus susceptible to dying. When the virus is awake, and the cell is susceptible to dying, it kills itself but does not kill any other cells in the body.

Essentially, it specifically targets the HIV-infected cells and eliminates them without hurting anything else. This new science is exciting. It’s getting closer and closer to understanding how to do this effectively. And if you can do that with oral medications rather than fancy therapies like gene therapy or bone marrow transplant, it’s scalable to large parts of the world, and you can touch millions of people that way. That’s where the area of research is on how to make those hiding cells wake up, how to make them sensitive to die, and how to target just the HIV-infected cell.

Will we see a vaccine for HIV?

HIV has been a very hard vaccine to develop. In the world of viruses, vaccines fall into one of three buckets. They fall into the bucket where they respond to antibodies induced by the vaccine, and the vaccines are outstanding. Such viruses include polio, mumps, and lucky for us, SARS-CoV-2. Then we have the second category, like the influenza vaccine, which is about 60% effective. It certainly saves lives and makes a difference, but it’s not perfect. And then we have the third bucket, which quite frankly is the vast majority of viruses that infect humans. And HIV is in that category, where simply forming an antibody to the virus is not adequate to prevent infection. You have to do very sophisticated engineering to induce T cell effects, as well as innate effects and antibody effects. Even then, sometimes it’s very hard to decide what is the part of the virus to target. After decades, and billions of dollars of research, we’re still not there for HIV. There have been many approaches of how to do this science. Many different scientific delivery mechanisms, many different areas of the viruses targeted, many different parts of the immune system targeted, and so far, none of them have been effective at preventing HIV infection.

What needs to happen next?

We still need to slow down the number of people getting infected through good public health measures and good education to stop the HIV epidemic. We still need to get more people who are infected on therapy.

We know we can do it with public health measures. But we also need to find out more about how we eliminate that reservoir and get people cured of the virus in a simple and effective way so that we can cure more people. And the last major hurdle we have is to develop an effective vaccine. We still don’t have a vaccine that can prevent infection, a preventive vaccine, or a therapeutic vaccine where you give it to people who already have the virus that can help them control the infection. A huge amount of research has happened, but we’re still not there yet.

This article originally appeared on Mayo Clinic News Network.

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Doctors, scientists and activists meet to discuss how to pummel HIV

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O n July 22nd the week-long 25th International AIDS Conference kicked off in Munich. Though these gatherings are no longer the war councils they were in the epidemic’s early days—for the strategy to defeat HIV is now pretty much settled—there remains much fighting to be done.

In a report released as the conference started, UNAIDS , the United Nations agency that deals with the disease, said that almost 40m people are now infected. There were 1.3m new infections in 2023, and 630,000 HIV -related deaths. But those numbers are down from 2.1m and 1.3m respectively in 2010. That year is the baseline for calculating the drop of 90% in annual new infections and HIV -related deaths, which experts reckon would end AIDS as a public-health threat. The hope is to reach this target by 2030. On current trends that seems unlikely. But the numbers are, mostly, heading in the right direction.

Because sub-Saharan Africa has been the worst-hit part of the world, most effort has been concentrated there. This has paid off. New infections there since 2010 have fallen by 56%. Partly as a consequence, UNAIDS ’s figures say that for the first time since the epidemic began more new infections occurred outside this part of the world than in it. Another contributor to the shift, however, was that in three areas—Latin America; eastern Europe and central Asia; and the Middle East and north Africa—new infection rates rose.

Although no cure currently exists, AIDS can nonetheless be ended. This depends on two steps: treating those already infected and preventing transmission to those who are not. Targets help, if only to clarify objectives. For treatment, UNAIDS promulgates the easy-to-remember formula “95-95-95”. This translates to an aspiration that 95% of those infected are aware of the fact, that 95% of this group are taking antiretroviral drugs to suppress their infections, and that in 95% of those so treated (ie, 86% of those infected), the treatment is successfully suppressing their viral load. Across the world the “treatment trilogy” is an encouraging 86-89-93, with 30.7m people estimated to be on antiretroviral drugs.

Crucially—and this is where treatment and prevention are linked—people taking antiretroviral drugs in the way the doctor ordered have negligible viral loads and so are unlikely to pass the infection on. This state of affairs, known in the field as U = U (undetectable=untransmissible), gives a constellation of preventive approaches (such as condoms, microbicidal vaginal rings and various prophylactic drug regimes) a better chance of working.

Using drugs for pre-exposure prophylaxis, commonly called P r EP , is a particularly promising approach. Some 3.5m people around the world already take Truvada or Descovy, the first P r EP s to be approved. But these are pills which provide only short-term protection, so must be swallowed regularly. Longer-term cover comes from an injection.

The first injectable P r EP was cabotegravir, made by ViiV Healthcare and approved by America’s Food and Drug Administration ( FDA ) in 2021. This gives protection for two months, and a trial in Uganda showed it was more popular than pills. The second is lenacapavir, from Gilead Sciences, which also makes Truvada and Descovy. The meeting coincided with the publication of complete results from PURPOSE -1, a trial of this in South Africa and Uganda. PURPOSE -1, which began in 2021 and involved 5,300 women, showed it gave 100% protection for six months. This is seen as a real breakthrough, and activists called on Gilead to make it available cheaply.

On the question of a cure, some news announced just before the conference caused particular interest. This was the revelation of the seventh known individual to reach apparently permanent remission from HIV infection after a bone-marrow transplant to treat leukaemia. Bone marrow is the source of the immune system’s CD 4 T -cells, which are attacked by HIV . So, in a few cases where a leukaemia patient was also HIV -positive, surgeons deliberately sought a donor who had a mutation in the gene for a T -cell surface protein called CCR 5 (which the virus uses to enter those cells), in the hope of curing two diseases for the price of one. That’s because HIV finds it difficult to infect T -cells of people with mutated CCR 5 proteins.

What is special about the latest case, that of an anonymous individual known as the second Berlin patient (the first, Timothy Brown, was treated in Germany’s capital in 2007), is that the donor had inherited this mutation from only one parent, meaning half the relevant protein molecules in her bone marrow were unmutated and thus remained HIV -friendly. Moreover, news of the second Berlin patient comes after a yet-more-puzzling case reported last year from Geneva, in which the donor had completely normal CCR 5 proteins.

Surprise twist

All this suggests that something more complex is going on. Sharon Lewin, president of the International AIDS Society, which organises the meeting, is a leading light in the search for a cure for AIDS . She suspects that, in the patients who have been cured, preparations for transplant intended to kill the existing marrow, and also the immune response of the new marrow to remaining old marrow, are shrinking the reservoirs in which HIV hides and giving the CCR 5 mutation a helping hand.

Such reservoir-shrinkage, by means of special drugs, is something she is already investigating. Combined with infusions of T -cells genetically engineered to disrupt CCR 5, it might form the basis of a cure. ■

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This article appeared in the Science & technology section of the print edition under the headline “The war on AIDS”

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HIV: Latest Research

HIV research has made remarkable progress since scientists first identified the disease in the 1980s. There are new prevention methods and therapies to extend the lives of those living with the disease. So what does the future hold for HIV research? Here’s a look at what’s on the horizon.

HIV Prevention

Stopping the spread of HIV is an important step toward ending the outbreak of the disease around the world. Today, there are several methods to slow HIV, and scientists are working on new tools.

HIV is constantly evolving into new strains. This makes it hard to develop a vaccine , but scientists are making progress. The National Institutes of Health (NIH) is researching two HIV vaccines and testing them in people around the world. The goal of these vaccines is to turn on an immune response to a wide range of HIV strains.

Another vaccine candidate from IAVI and Scripps Research works by prompting the immune system to turn on in response to different versions and mutations of HIV. Early research results show it’s 97% effective.

Long-acting prevention

Researchers are also working on HIV prevention methods that last for months or even years. They could offer new choices for protecting yourself against the virus or improve products that you already use.

• Vaginal ring: This flexible silicone ring steadily releases the anti-HIV drug dapivirine. You replace it monthly. Women ages 18 to 45 who took part in two large clinical trials lowered their chance of HIV infection by about 30% when using it.
• Injections: The FDA has approved cabotegravir ( Apretude ) to protect you from HIV for as long as 1 to 6 months.  You get it as a shot once every 8 weeks. Studies show it may be just as safe and work better than the daily oral drug emtricitabine /tenofovir.
• Implants: One promising new technology is long-acting implants in your arm. The matchstick-sized implant slowly releases an anti-HIV drug and could offer protection against HIV for 1 year or longer. Several of these implants are in the works but are still in the early stages of development.
• Oral pills: Researchers are also studying a pill that could protect you from HIV for 30 days. Two other HIV prevention pills, Truvada and Descovy , have been around for years, but you take them daily. Research shows that although these drugs lower your chance of getting HIV by anywhere from 74% to 99%, many people aren’t aware of them or are afraid they would be shamed for taking them.
• Monoclonal antibodies: These lab-created immune system proteins may work to prevent HIV. Scientists are looking at how a mix of assorted antibodies could be a tool in long-term HIV prevention and treatment.

HIV Treatment

There’s no cure for HIV, but medicine can help you manage the disease and ward off other health problems. Scientists and drugmakers continue to develop new treatments for people living with HIV , turning their focus to long-acting therapies.

Once-monthly HIV therapy

In January 2021, the FDA approved the first long-acting injectable treatment for adults with HIV. Cabenuva is a combo of two drugs ( cabotegravir and rilpivirine ) that you take as a shot once a month or every two months. It’s considered a breakthrough in treatment since most HIV drugs require an oral daily dose.

One small survey of people living with HIV shows that more people prefer long-acting shots than pills you take every day. Most (73%) who responded to the survey said they were definitely or probably interested in trying an injectable. This type of medicine could help with issues of missed doses and medical privacy.

Twice Yearly HIV Treatment

Lenacapavir ( Sunlenca ) is the first of a new class of drugs called capsid inhibitors to be FDA-approved and is for treating adults with HIV that is not adequately controlled by their current treatment regimen. It blocks the HIV virus’ protein shell called the capsid which interrupts an important step in the virus life cycle. Sunlenca’s starting dose is given as oral tablets and subcutaneous injections which is followed by maintenance injections every six months. It is given in combination with other antiretroviral(s). 

Other HIV treatments

The FDA has also recently approved two other drugs to treat HIV in kids and adults.

• Dolutegravir ( Tivicay ) for children: There are 1.8 million children (birth to 14 years old) living with HIV. This drug is the first integrase inhibitor (a class of anti-HIV drugs) dissolved in water that’s available for children as young as 4 weeks old.
• Fostemsavir ( Rukobia ): This medicine is an attachment inhibitor (antiretroviral drug) for adults who haven’t had success with other HIV treatments .

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UN says nearly 40 million people had HIV in 2023, lack of treatment means someone died every minute

by Edith M. Lederer

Nearly 40 million people were living with the HIV virus that causes AIDS last year, over 9 million weren't getting any treatment, and the result was that every minute someone died of AIDS-related causes, the U.N. said in a new report launched Monday.

While advances are being made to end the global AIDS pandemic, the report said progress has slowed, funding is shrinking, and new infections are rising in three regions: the Middle East and North Africa, Eastern Europe and Central Asia, and Latin America.

In 2023, around 630,000 people died from AIDS-related illnesses, a significant decline from the 2.1 million deaths in 2004. But the latest figure is more than double the target for 2025 of fewer than 250,000 deaths, according to the report by UNAIDS, the U.N. agency leading the global effort to end the pandemic.

Gender inequality is exacerbating the risks for girls and women, the report said, citing the extraordinarily high incidence of HIV among adolescents and young women in parts of Africa.

The proportion of new infections globally among marginalized communities that face stigma and discrimination—sex workers, men who have sex with men, and people who inject drugs also increased to 55% in 2023 from 45% in 2010, it said.

UNAIDS Executive Director Winnie Byanyima said, "World leaders pledged to end the AIDS pandemic as a public health threat by 2030, and they can uphold their promise, but only if they ensure that the HIV response has the resources it needs, and that the human rights of everyone are protected."

As part of that pledge, leaders vowed to reduce annual new HIV infections to below 370,000 by 2025, but the report said in 2023 new infections were more than three times higher at 1.3 million.

Last year, among the 39.9 million people globally living with HIV, 86% knew they were infected, 77% were accessing treatment , and for 72% the virus was suppressed, the report said

César Núñez, director of the UNAIDS New York office, told a news conference there has been progress in HIV treatments—injections that can stay in the body for six months, but the two doses cost $40,000 yearly, out of reach for all but the richest people with the virus.

He said UNAIDS has been asking the manufacturer to make it available at lower cost to low and middle-income countries .

Núñez said there have also been seven cases where people with HIV who were treated for leukemia emerged with no sign of the HIV virus in their system.

He said injections and the seven cases will be discussed at the 25th International AIDS Conference which began Monday in Munich.

At present, he said, daily treatment with pills costs about $75 per person per year. It has allowed many countries to increase the number of people with HIV to receive treatment.

Núñez said UNAIDS will continue advocating for a vaccine to prevent AIDS.

© 2024 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed without permission.

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HIV infections (human immunodeficiency virus infections) include the spectrum of infections caused by the virus HIV that range from asymptomatic seropositivity to acquired immunodeficiency syndrome (AIDS)-related complex (ARC) and AIDS.

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UN says nearly 40 million people had HIV in 2023, lack of treatment means someone died every minute

FILE - This electron microscope image made available by the U.S. National Institutes of Health shows a human T cell, in blue, under attack by HIV, in yellow, the virus that causes AIDS. (Seth Pincus, Elizabeth Fischer, Austin Athman/National Institute of Allergy and Infectious Diseases/NIH via AP, File)

• Copy Link copied

UNITED NATIONS (AP) — Nearly 40 million people were living with the HIV virus that causes AIDS last year, over 9 million weren’t getting any treatment, and the result was that every minute someone died of AIDS-related causes, the U.N. said in a new report launched Monday.

While advances are being made to end the global AIDS pandemic, the report said progress has slowed, funding is shrinking, and new infections are rising in three regions: the Middle East and North Africa, Eastern Europe and Central Asia, and Latin America.

In 2023, around 630,000 people died from AIDS-related illnesses, a significant decline from the 2.1 million deaths in 2004. But the latest figure is more than double the target for 2025 of fewer than 250,000 deaths, according to the report by UNAIDS, the U.N. agency leading the global effort to end the pandemic.

Gender inequality is exacerbating the risks for girls and women, the report said, citing the extraordinarily high incidence of HIV among adolescents and young women in parts of Africa.

The proportion of new infections globally among marginalized communities that face stigma and discrimination – sex workers, men who have sex with men, and people who inject drugs also increased to 55% in 2023 from 45% in 2010, it said.

UNAIDS Executive Director Winnie Byanyima said: “World leaders pledged to end the AIDS pandemic as a public health threat by 2030, and they can uphold their promise, but only if they ensure that the HIV response has the resources it needs, and that the human rights of everyone are protected.”

As part of that pledge, leaders vowed to reduce annual new HIV infections to below 370,000 by 2025, but the report said in 2023 new infections were more than three times higher at 1.3 million.

Last year, among the 39.9 million people globally living with HIV, 86% knew they were infected, 77% were accessing treatment, and for 72% the virus was suppressed, the report said

César Núñez, director of the UNAIDS New York office, told a news conference there has been progress in HIV treatments — injections that can stay in the body for six months, but the two doses cost $40,000 yearly, out of reach for all but the richest people with the virus.

He said UNAIDS has been asking the manufacturer to make it available at lower cost to low and middle-income countries.

Núñez said there have also been seven cases where people with HIV who were treated for leukemia emerged with no sign of the HIV virus in their system.

He said injections and the seven cases will be discussed at the 25th International AIDS Conference which began Monday in Munich.

At present, he said, daily treatment with pills costs about $75 per person per year. It has allowed many countries to increase the number of people with HIV to receive treatment.

Núñez said UNAIDS will continue advocating for a vaccine to prevent AIDS.