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R&D across health areas | HIV/AIDS

R&D for HIV/AIDS

How new tools can transform the fight

Since emerging in the 1980s, the HIV/AIDS pandemic has claimed the lives of more than 42 million people around the world—reversing gains in life expectancy and economic development in the world’s most under-resourced places. The development of antiretroviral drugs (ARVs) turned the trajectory of the global pandemic, extending the life expectancy of people living with HIV and preventing transmission between mothers and children and people of different HIV statuses.

Yet, progress toward ending the HIV pandemic has slowed in recent years, and major gaps remain in our arsenal of treatment and prevention tools. We will not bring about an end to the HIV pandemic without new and improved technologies.

  • 3.79 million
    people living with HIV/AIDS
  • 1.3 million
    people became newly infected with HIV in 2023
  • 250 children
    die every day from AIDS-related causes

Research successes

Technologies have transformed the fight against HIV/AIDS:

  • ARVs—developed with NIH support—are today used to treat 30.7 million people globally and have cumulatively averted 16.5 million AIDS-related deaths since 2001.
  • Pre-exposure prophylaxis (PrEP)—the use of ARVs to prevent infection—was shown to be effective through NIH, CDC, and USAID research and is now widely used globally.
  • Approaches to prevent mother-to-child HIV transmission—developed with NIH support—have contributed to a 62% decline in new infections in children since 2010.
  • New long-acting PrEP options, including a monthly vaginal ring and an every-two-month injectable, developed with NIH and USAID support, now offer an alternative for those who struggle to take daily pills.
  • Child-friendly therapies—including a sweet-tasting, heat-stable combination therapy—are improving care for HIV-positive children.
  • New diagnostic innovations, such as rapid tests, urine and oral tests, and at-home tests, have increased the percentage of people aware of their HIV status.
  • Recency tests, which distinguish if an infection occurred in the last year or before, are enabling health programs to identify HIV transmission clusters and better target services.

Continued progress is possible, not inevitable Continued progress is possible, not inevitable

Continued progress is possible, not inevitable

Key missing tools Key missing tools

To end HIV/AIDS, we need new prevention and treatment tools, including:

  • Vaccines to prevent and reduce new infections.
  • A cure to control infection or eliminate it from the body.
  • New treatment and PrEP regimens to help expand choice and improve adherence, including additional long-acting options, fixed-dose combinations, and simplified treatments with fewer side effects.
  • Additional microbicide options to prevent infections in women and men who have sex with men—populations disproportionately impacted by the pandemic.
  • Expanded therapies for young children that are safe, palatable, and easy to administer.
  • Additional treatment options to combat resistance to existing regimens.
  • Additional multipurpose prevention technologies that simultaneously prevent HIV, other sexually transmitted infections, and/or unintended pregnancy.

Breakthroughs on the brink Breakthroughs on the brink

  • Long-acting biomedical products that could revolutionize both HIV treatment and prevention in hard-to-reach populations by reducing frequency of use and providing a more discreet, convenient alternative to daily pills. Products now in development include a once-weekly ARV pill, a three-month vaginal ring, injectable preventative drugs taken every four or six months, and implants that slowly release anti-HIV drugs over time for continuous protection.
  • Multipurpose prevention products—including pills, injections, and vaginal rings that combine HIV protection with contraception—could provide more convenient options for women. The two products furthest in development are a dual prevention pill and a multipurpose vaginal ring, both of which were developed with USAID support.
  • Many clinical trials are underway to test broadly neutralizing antibodies (bNAbs)—proteins shown to neutralize many different genetic variants of HIV—as treatment and prevention products delivered via infusion or injection. These include trials of several bNAbs developed or isolated at NIH labs.
  • Several mRNA-based HIV vaccine candidates have advanced into first-in-human trials, including candidates supported by NIH, USAID, and PEPFAR, bringing new hope to the quest for an HIV vaccine. Additionally, new vaccine research strategies are reinvigorating the field, including approaches to induce bNAbs such as germline targeting, which uses a series of stepwise shots to coax the immune system to create bNAbs, and T-cell approaches, which induce T cells that act as either killer cells to directly attack the virus or helper cells that support other B cells that generate antibodies against HIV.
  • Seven patients appear to have been effectively cured of HIV or are in long-term remission, demonstrating that a cure for HIV infection, while difficult, is scientifically possible. Several cure strategies are also advancing in the research pipeline including a “kick and kill” approach to prompt latent HIV to reactivate so it can be targeted and neutralized and gene modification approaches to change human DNA in immune cells to produce cells that are resistant to HIV.

US government investment in HIV/AIDS R&D for low-resource settings (in 2022) US$ millions

Breakthroughs on the brink
US Government R&D efforts US Government R&D efforts

The US government is leading efforts to advance research and development (R&D) to end the HIV/AIDS epidemic through a whole-of-government approach:

  • National Institutes of Health (NIH) conducts basic science and clinical research to advance products to prevent, diagnose, and treat HIV/AIDS, as well as social behavioral research to improve the use of existing interventions.
  • US Agency for International Development (USAID) advances R&D for HIV/AIDS technologies designed for low-resource settings, including research for a vaccine, microbicides, and multipurpose prevention products, and helps accelerate the introduction of and access to new tools.
  • Department of State oversees the President’s Emergency Plan for AIDS Relief (PEPFAR), which finances certain HIV/AIDS research programs, alongside delivering health products and services.
  • Centers for Disease Control and Prevention (CDC) develops improved diagnostics and conducts research to inform the use of existing tools and the risk factors influencing the spread of HIV/AIDS to better target interventions to those in need.
  • Department of Defense undertakes research to protect US service members, including vaccine research.
  • Food and Drug Administration operates a tentative regulatory approval program to allow PEPFAR to distribute generic ARVs for use outside the United States.
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Introduction

39.9 million living, 1.3 million newly infected, 42 million deaths: UNAIDS. Global HIV & AIDS statistics — Fact sheet. UNAIDS; 2024. https://www.unaids.org/en/resources/fact-sheet

250 children: UNICEF. Global and regional trends. Accessed August 9, 2024. https://data.unicef.org/topic/hivaids/global-regional-trends/

Research successes

ARVs, developed with NIH support: National Institute of Allergy and Infectious Diseases. Antiretroviral drug discovery and development. Accessed August 8, 2024. https://www.niaid.nih.gov/diseases-conditions/antiretroviral-drug-development

ARVs, used to treat 30.7 million people: UNAIDS. Global HIV & AIDS statistics — Fact sheet. UNAIDS; 2024. https://www.unaids.org/en/resources/fact-sheet

ARVs, averted 16.5 million AIDS-related deaths: UNAIDS. Global roll-out of HIV treatment has saved millions of lives. September 6, 2021. Accessed July 17, 2024. https://www.unaids.org/en/resources/presscentre/featurestories/2021/september/20210906_global-roll-out-hiv-treatment

Pre-exposure prophylaxis: The Global PrEP Tracker. AVAC; 2022. Accessed July 17, 2024. https://data.prepwatch.org/

Pre-exposure prophylaxis, shown to be effective through NIH research: National Institute of Allergy and Infectious Diseases. Pre-exposure prophylaxis (PrEP) to prevent HIV. Updated March 1, 2024. Accessed July 17, 2024. https://www.niaid.nih.gov/diseases-conditions/pre-exposure-prophylaxis-prep

Pre-exposure prophylaxis, shown to be effective through CDC research:

Nicol M, Adams J, Kashuba A. HIV PrEP trials: The road to success. Clinical Investigation. 2013; 3(3): 295-308. doi:10.4155/cli.12.155

US Centers for Disease Control and Prevention. TDF2 study of pre-exposure prophylaxis (PrEP) among heterosexual men and women in Botswana: Key facts. August 26, 2011. Accessed July 17, 2024. https://stacks.cdc.gov/view/cdc/23283

Pre-exposure prophylaxis, shown to be effective through USAID research: US Agency for International Development. PrEP. Accessed July 17, 2024: https://www.usaid.gov/global-health/health-areas/hiv-and-aids/technical-areas/prep

Approaches to prevent mother-to-child HIV transmission, developed with NIH support: NIH-sponsored study identifies superior drug regimen for preventing mother-to-child HIV transmission. Press release. National Institutes of Health; November 17, 2014. https://www.nih.gov/news-events/news-releases/nih-sponsored-study-identifies-superior-drug-regimen-preventing-mother-child-hiv-transmission

Approaches to prevent mother-to-child HIV transmission, 62% decline in new infections in children: UNAIDS. Global HIV & AIDS statistics — Fact sheet. UNAIDS; 2024. https://www.unaids.org/en/resources/fact-sheet

Long-acting PrEP options, monthly vaginal ring: Population Council. The Dapivirine Vaginal Ring for HIV prevention. Accessed July 17, 2024. https://popcouncil.org/project/the-dapivirine-vaginal-ring-for-hiv-prevention/

Long-acting PrEP options, every-two-month injectable: PrEPWatch. Injectable cabotegravir for PreP. Updated July 30, 2024. Accessed August 9, 2024. https://www.prepwatch.org/products/injectable-cab-for-prep/

Child-friendly therapies, combination therapy: Cipla and DNDi launch child-friendly 4-in-1 antiretroviral treatment for young children living with HIV in South Africa. Press release. Drugs for Neglected Diseases Initiative; June 14, 2022. https://dndi.org/press-releases/2022/cipla-dndi-launch-child-friendly-4-in-1-antiretroviral-treatment-young-children-hiv-south-africa/

Diagnostic innovations:

Unitaid, World Health Organization. Market and Technology Landscape 2020: HIV Rapid Diagnostic Tests for Self-Testing. Unitaid, World Health Organization; 2020. https://unitaid.org/assets/Unitaid-WHO-HIVST-landscape-report-2020.pdf

Unitaid, World Health Organization. HIV/AIDS Diagnostics Technology Landscape: 5th Edition. Unitaid, World Health Organization; 2015. http://www.unitaid.org/assets/UNITAID_HIV_Nov_2015_Dx_Landscape-1.pdf

Recency tests: Facente S, Grebe E, Maher D, et al. Use of HIV recency assays for HIV incidence estimation and other surveillance use cases: Systematic review. JMIR Public Health and Surveillance. 2022;8(3):e34410. https://doi.org/10.2196%2F34410

Continued progress is possible, not inevitable

Bill & Melinda Gates Foundation. Goalkeepers 2024 Report. The Race to Nourish a Warming World. Bill & Melinda Gates Foundation; 2024. https://www.gatesfoundation.org/goalkeepers/report/2024-report/

Key missing tools

AVAC. Prevention options. Accessed July 17, 2024. https://avac.org/prevention-options/

Breakthroughs on the brink

Long-acting biomedical products, once-weekly ARV pill, injectable drugs every four months, one weekly ARV pill: Mandavilli A. Long-acting drugs may revolutionize HIV prevention and treatment. The New York Times. April 17, 2024. Accessed July 18, 2024. https://www.nytimes.com/2024/04/17/health/hiv-long-acting-shots-pills.html

Long-acting biomedical products, three-month vaginal ring: HealthDay News. Vaginal ring may shield women from HIV for 3 months at a time. UPI. March 9, 2021. Accessed July 17, 2024. https://www.upi.com/Health_News/2021/03/09/vaginal-ring-protects-hiv-three-months-study/7961615322193/

Long-acting biomedical products, injectable drugs taken every six months: Gilead’s twice-yearly lenacapavir demonstrated 100% efficacy and superiority to daily Truvada® for HIV prevention. Press Release. Gilead; June 20, 2024. https://www.gilead.com/news-and-press/press-room/press-releases/2024/6/gileads-twiceyearly-lenacapavir-demonstrated-100-efficacy-and-superiority-to-daily-truvada-for-hiv-prevention

Long-acting biomedical products, implants: HIV.gov. Long-acting HIV prevention tools. Updated June 28, 2022. Accessed July 18, 2024. https://www.hiv.gov/hiv-basics/hiv-prevention/potential-future-options/long-acting-prep

Multipurpose prevention products, overall: AVAC. Advocates’ Guide to Multipurpose Prevention Technologies. AVAC; 2021. https://avac.org/resource/advocates-guide-to-multipurpose-prevention-technologies/

Multipurpose prevention products, dual prevention pill: Population Council. Dual prevention pill for the prevention of HIV and unintended pregnancy. Accessed July 18, 2024. https://popcouncil.org/project/dual-prevention-pill-for-the-prevention-of-hiv-and-unintended-pregnancy/

Multipurpose prevention products, multipurpose vaginal ring: Population Council. The Dapivirine-Levonorgestrel vaginal ring for HIV prevention and contraception. Accessed July 18, 2024. https://popcouncil.org/project/the-dapivirine-levonorgestrel-vaginal-ring-for-hiv-prevention-and-contraception/

Multipurpose prevention products, USAID support: US Agency for International Development. Microbicides: New HIV prevention products for women. Accessed July 18, 2024. https://www.usaid.gov/basic-page/microbicides-new-hiv-prevention-products-women-0

Broadly neutralizing antibodies, overall:

AVAC. Antibody related research. Accessed July 18, 2024. https://avac.org/prevention-option/antibody-related-research/

HIV Prevention Clinical Trials Database. AVAC; 2024. Accessed July 18, 2024. https://avac.org/hiv-prevention-clinical-trials-database/?_prevention_options=antibody-related-research&_pxrd_trial_status=ongoing

Broadly neutralizing antibodies, trials with NIH support: AVAC. Broadly Neutralizing Antibody Combinations. AVAC; 2021. https://avac.org/resource/infographic/broadly-neutralizing-antibody-combinations-2/

mRNA-based HIV vaccine candidates:

AVAC. Phase 1 mRNA HIV Vaccine Trials. AVAC; 2023. https://avac.org/resource/report/phase-1-mrna-hiv-vaccine-trials/

Jefferys R. Pipeline Report 2023: HIV Vaccines and Passive Immunization. Treatment Action Group; 2023. https://www.treatmentactiongroup.org/wp-content/uploads/2023/07/pipeline_HIV_VAX_2023_final.pdf

New vaccine strategies:

AVAC. Vaccines for prevention. Accessed July 18, 2024. https://avac.org/prevention-option/vaccines/

AVAC. HIV Vaccines: An Introductory Factsheet. AVAC; 2023. https://avac.org/resource/hiv-vaccines-an-introductory-factsheet/

Russel S. A promising HIV vaccine candidate gets a little help. Fred Hutch New Service. May 24, 2023. Accessed July 18, 2024. https://www.fredhutch.org/en/news/center-news/2023/05/hiv-vaccine-broadly-neutralizing.html

Seven patients cured/in remission: AmfAR. Curing HIV—How Far Have We Come? July 31, 2024. Accessed July 18, 2024. https://www.amfar.org/news/how-many-have-been-cured/

Cures strategies:

AVAC. Cure. Accessed July 18, 2024. https://avac.org/prevention-option/cure/

Treatment Action Group. Research Toward a Cure Trials. July 16, 2024. Accessed July 18, 2024. https://www.treatmentactiongroup.org/cure/trials/

Jefferys R. Pipeline Report 2023: Research Toward a Cure and Immune-Based Therapies. Treatment Action Group; 2023. https://www.treatmentactiongroup.org/wp-content/uploads/2023/07/pipeline_HIV_cures_ibt_2023_final.pdf

US government investment in HIV R&D for low-resource settings

G-FINDER data portal. Policy Cures Research; 2023. Accessed May 14, 2024. https://gfinderdata.policycuresresearch.org/

US Government R&D efforts

US federal funding for HIV/AIDS: Trends over time. Kaiser Family Foundation. March 26, 2024. Accessed July 18, 2024. https://www.kff.org/hivaids/fact-sheet/u-s-federal-funding-for-hivaids-trends-over-time/

Michaud J, Moss K, Kates J. The U.S. Department of Defense and Global Health. Kaiser Family Foundation; 2012. https://www.kff.org/global-health-policy/report/the-u-s-department-of-defense-global/

US Food & Drug Administration. President's Emergency Plan for AIDS Relief (PEPFAR). Updated May 15, 2022. Accessed July 18, 2024. https://www.fda.gov/international-programs/presidents-emergency-plan-aids-relief-pepfar

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