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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 global HIV/AIDS epidemic has claimed the lives of more than 32 million people around the world—reversing gains in life expectancy and economic development in the world’s poorest places. The development of antiretroviral drugs (ARVs) has turned the trajectory of the epidemic, extending life expectancy of those living with HIV/AIDS and enabling the prevention of transmission between mothers and children and HIV-positive and negative partners.

Yet progress against the epidemic has slowed in recent years, and major gaps remain in our arsenal of treatment and prevention tools. We will not reach targets to end the HIV/AIDS epidemic without new and improved technologies.

  • 37.9 million
    people are living with HIV/AIDS globally
  • 1.7 million
    people became newly infected with HIV in 2018
  • 300+ 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 21.7 million people globally and have cumulatively averted more than 9.5 million AIDS-related deaths since 1995, with global economic benefits of US$1.05 trillion.
  • Pre-exposure prophylaxis, or PrEP—the use of ARVs to prevent infection—was shown to be effective through NIH, CDC, and USAID research and is today being introduced worldwide.
  • Approaches to prevent mother-to-child HIV transmission—developed with NIH support—that involve treating women during pregnancy and their newborns with ARVs have contributed to a 41% decline in new infections in children since 2010.
  • New diagnostic innovations, from rapid tests, to urine and oral tests, to 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:

  • HIV/AIDS vaccines to prevent and reduce new infections.
  • A cure to control or eliminate infection from the body.
  • Microbicides to prevent infections in women and men who have sex with men—populations disproportionately impacted by the epidemic.
  • Improved therapies for young children that are safe, palatable, shorter course, and easier to administer.
  • New treatment and PrEP regimens to help expand choice and improve adherence, such as long-acting injectable ARVs, fixed-dose combinations, and simplified treatments with fewer side effects.
  • Additional treatment options for those whose infection has become resistant to existing treatments.

Breakthroughs on the brink Breakthroughs on the brink

  • A first-of-its-kind, monthly ARV-based microbicide vaginal ring, supported by NIH and USAID, is now under regulatory review and could expand prevention options for at-risk women.
  • A promising “mosaic” vaccine designed to address several HIV strains at once is one of two HIV vaccine candidates now in late-stage clinical trials in sub-Saharan Africa. This and other scientific breakthroughs bring new hope to the quest for an HIV/AIDS vaccine, with around 40 vaccine candidates now in late-stage development.
  • A 4-in-1 child-friendly ARV regimen for infants and young children that is palatable, easy-to-administer, and requires no refrigeration is now under regulatory review.
  • Many clinical trials are underway to test broadly neutralizing antibodies (bNabs)—proteins shown to neutralize many different genetic variants of HIV—as treatment and preventions products, including late-stage clinical trials of a bNAb developed at NIH labs.
  • Long-acting injectable formulations of PrEP, which could be administered monthly or every two months, are now in late-stage clinical trials and could soon offer a new option for patients.
  • Multipurpose prevention products, including pills, injections, and a vaginal ring that combines ARVs with contraception, could expand HIV prevention options for women.
  • A second patient appears to be effectively cured of HIV as of 2019, demonstrating that a cure for HIV infection, while difficult, is scientifically possible.

US government investment in HIV/AIDS R&D for low-resource settings (in 2018) 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 conducts basic science and clinical research for new therapies, vaccines, microbicides, and a cure for HIV/AIDS, as well as research to improve use of existing interventions.
  • US Agency for International Development advances R&D for HIV/AIDS technologies designed for low-resource settings, including research for a vaccine and microbicides, and helps accelerate introduction 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.
  • Centers for Disease Control and Prevention develops improved diagnostics and conducts research to inform 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 from HIV/AIDS, 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

HIV/AIDS epidemic claimed the lives of more than 32 mllion people; 37.9 million living with HIV/AIDS, 1.7 people became newly infected: UNAIDS website. Global HIV & AIDS statistics — 2019 fact sheet page. https://www.unaids.org/en/resources/fact-sheet. Accessed August 26, 2019.

300+ children die every day form AIDS-related causes: UNICEF. UNICEF Data. New York City, NY: UNICEF; 2019. https://data.unicef.org/topic/hivaids/global-regional-trends/. Accessed August 26, 2019.

Research successes

ARVs, developed with NIH support: National Institute of Allergy and Infectious Diseases website. Antiretroviral drug discovery and development page. https://www.niaid.nih.gov/diseases-conditions/antiretroviral-drugdevelopment. Accessed August 26, 2019.

ARVs used to treat 21.7 million people: UNAIDS website. Global HIV & AIDS statistics — 2019 fact sheet page. https://www.unaids.org/en/resources/fact-sheet. Accessed August 26, 2019.

ARVs, averted more than 9.5 million AIDS deaths since 1995; global economic benefits of US$1.05 trillion: Forsythe S, McGreevey W, et al. Twenty years of antiretroviral therapy for people living with HIV: global costs, health achievements, economic benefits. Health Affairs. 2019;38(7). https://doi.org/10.1377/hlthaff.2018.05391

Pre-exposure prophylaxis, shown to be effective through NIH research: National Institute of Allergy and Infectious Diseases website. Pre-exposure prophylaxis (PrEP) to reduce HIV risk page. https://www.niaid.nih.gov/diseases-conditions/pre-exposure-prophylaxis-prep. Accessed August 26, 2019.

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 Mar; 3(3): 10.4155/cli.12.155. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3882078/#!po=3.12500.

Centers for Disease Control and Prevention. TDF2 Study of Pre-exposure Prophylaxis (PrEP) Among Heterosexual Men and Women in Botswana: Key Facts. Atlanta: Centers for Disease Control and Prevention; 2011: https://www.cdc.gov/nchhstp/newsroom/docs/PrEP-Heterosexuals-Factsheet.pdf.

Garcia-Lerma JG, Paxton L, Kilmarx PH, et al. Oral pre-exposure prophylaxis for HIV prevention. Trends in Pharmacological Science. 2010; 31(2):74-81. https://doi.org/10.1016/j.tips.2009.10.009.

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

Celum C. Open Label Extension studies: Findings from Partners PrEP Study. Presented at 2014 Microbicides Trial Network Regional Meeting. October 25, 2014. https://mtnstopshiv.org/sites/default/files/attachments/CELUM2014%20MTN%20Regional%20mtg_Partners%20PrEP%20OLE.pdf.

Clinicaltrials.gov. NCT00625404: FEM-PrEP (Truvada®): Study to Assess the Role of Truvada® in Preventing HIV Acquisition in Women. https://www.clinicaltrials.gov/ct2/show/NCT00625404. Accessed January 30, 2020.

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]. Bethesda, Maryland: National Institutes of Health; November 17, 2014. https://www.nih.gov/news-events/newsreleases/nih-sponsored-study-identifies-superior-drug-regimen-preventing-mother-child-hiv-transmission.

Approaches to prevent mother-to-child HIV transmission, 41% decline in new infections in children since 2010: UNAIDS website. Global HIV & AIDS statistics — 2019 fact sheet page. https://www.unaids.org/en/resources/factsheet. Accessed August 26, 2019.

Diagnostic innovations:

Unitaid, World Health Organization. Market and Technology Landscape: HIV Rapid Diagnostic Tests For SelfTesting, 4th Edition. Geneva, Switzerland: Unitaid; 2018. https://unitaid.org/assets/HIVST-landscape-report.pdf.

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

Recency testing: PEPFAR Solution Platform (Beta) website. Surveillance of recent HIV infections: using point-ofcare recency tests to rapidly detect and respond to recent infections page. https://www.pepfarsolutions.org/emerging-technologies-innovations/2018/7/11/surveillance-of-recent-hivinfections-using-point-of-care-recency-tests-to-rapidly-detect-and-respond-to-recent-infections. Accessed October 17, 2019.

Continued progress is possible, not inevitable

Bill & Melinda Gates Foundation and Institute for Health Metrics and Evaluation. The Goalkeepers Report 2019: How Geography and Gender Stack the Deck For (or Against) You. Seattle: Bill & Melinda Gates Foundation; 2019. https://www.gatesfoundation.org/goalkeepers/report/2019-report/#ExaminingInequality.

Breakthroughs on the brink

Microbicide vaginal ring: IPM’s application for dapivirine vaginal ring for reducing HIV risk in women now under review by European Medicines Agency [press release]. Silver Spring, Maryland: International Partnership for Microbicides; July 13, 2017. https://www.ipmglobal.org/content/ipm%E2%80%99s-application-dapivirine-vaginalring-reducing-hiv-risk-women-now-under-review-european.

Mosaic vaccine: Leary, K. A vaccine for HIV is about to be tested in thousands of people. Futurism. November 30, 2017. https://futurism.com/neoscope/vaccine-hiv-tested-thousands-people.

Two HIV vaccine candidates in late-stage clinical trials: Engel M. New HIV vaccine study launched for World AIDS Day. Fred Hutch News Service. December 2, 2017. https://www.fredhutch.org/en/news/centernews/2017/12/new-hiv-vaccine-test-launched-world-aids-day.html.

40 vaccine candidates in late-stage development: Policy Cures Research. Neglcted Disease R&D Product Pipeline. Sydney, Australia: Policy Cures Research; 2015. https://www.pipeline.policycuresresearch.org/august2017. Accessed August 26, 2019.

Child-friendly ARV regimen: Drugs for Neglected Diseases initiative. Ending the Neglect of Paediatric HIV: Improving HIV Treatment for Children: An Update. Geneva, Switzerland: Drugs for Neglected Diseases initiative; 2018. https://www.dndi.org/wp-content/uploads/2018/08/DNDi_Paediatric-HIV_2018.pdf.

Several clinical trials are underway to test broadly neutralizing antibodies: AVAC. Broadly Neutralizing Antibody Combinations. Seattle; AVAC; 2019: https://www.avac.org/infographic/bnab-combinations

BNAb developed at NIH lab: NIH Launches Large Clinical Trials of Antibody-Based HIV Prevention [press release]. Bethesda, Maryland: National Institute of Allergy and Infectious Diseases; April 7, 2016. https://www.niaid.nih.gov/news-events/nih-launches-large-clinical-trials-antibody-based-hiv-prevention

Long-acting injectable formulations of PrEP: NIH trial evaluates long-acting HIV medication unable to adhere to strict daily regimens [press release]. Bethesda, Maryland: National Institutes of Health; May 9, 2019. https://www.nih.gov/news-events/news-releases/nih-trial-evaluates-long-acting-hiv-medication-unable-adherestrict-daily-regimens.

Multipurpose prevention products: AVAC. Multipurpose Prevention Technologies (MPTs): An Introductory Factsheet. New York City, NY: AVAC; 2016. https://www.avac.org/resource/multipurpose-prevention-technologiesmpts-introductory-factsheet.

Multipurpose prevention products, vaginal ring: International Partnership for Microbicides website. Our products page. https://www.ipmglobal.org/our-work/product-pipeline. Accessed August 26, 2019.

Second patient appears to be effectively cured of HIV: Mandavilli A. H.I.V. is reported cured in a second patient, a milestone in the global AIDS epidemic. The New York Times. March 4, 2019. https://www.nytimes.com/2019/03/04/health/aids-cure-london-patient.html.

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

Policy Cures Research. G-FINDER Public Search Tool. Sydney, Australia: Policy Cures Research; 2019. https://gfinder.policycuresresearch.org/PublicSearchTool/. [Early access to 2018 data was provided by Policy Cures Research in December 2019. Data is now available online as of January 30, 2019.]

US government R&D efforts

Kaiser Family Foundation. U.S. Federal Funding for HIV/AIDS: Trends Over Time. Washington, DC: Kaiser Family Foundation; 2019. https://www.kff.org/hivaids/fact-sheet/u-s-federal-funding-for-hivaids-trends-over-time/.

Kaiser Family Foundation. The U.S. Department of Defense & Global Health. Washington, DC: Kaiser Family Foundation; 2012. https://www.kff.org/global-health-policy/report/the-u-s-department-of-defense-global/.

U.S. Food & Drug Administration website. President's Emergency Plan for AIDS Relief (PEPFAR) page. https://www.fda.gov/international-programs/presidents-emergency-plan-aids-relief-pepfar. Accessed August 26, 2019.

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