Today The New England Journal of Medicine released the positive results of the Pre-exposure Prophylaxis Initiative (iPrEx) trial, which looked at whether daily oral dosing of two FDA-approved antiretroviral (ARV) medications used to treat HIV/AIDS — tenofovir and emtricitabine, combined in one tablet (Truvada) — can prevent HIV transmission in high-risk populations. This study looked specifically at men who have sex with men (MSM) who are at high-risk of infection. Trial investigators found that daily dosing indicated a 44 percent reduction in the incidence of HIV, with detectable levels of the study drug in participants’ blood strongly correlating with the prophylactic effect. The study enrolled nearly 2500 HIV-negative MSM at 11 locations across the globe, including Brazil, Ecuador, Peru, South Africa, Thailand and two locations in the United States. (Click here for the press release from the National Institute of Allergy and Infectious Diseases).
The Center gathered responses to the trial results from leaders in the field of HIV/AIDS medicine, policy and advocacy:
“The results represent the first demonstration that using oral medications that are already U.S. Food and Drug Administration-approved before a risky exposure can decrease the likelihood that MSM could become HIV-infected. The approach, known as pre-exposure prophylaxis, or PrEP, was found to be safe and well-tolerated. These data build on recent findings that a topical gel containing an antiretroviral drug, tenofovir, could protect South African women from HIV. These new approaches can be considered two ways of delivering chemoprophylaxis, and approach that has been used to prevent malaria, TB, and other infectious diseases and show great promise.
“The use of oral or topical medication could prevent millions of HIV infections over the next few years, but issues that need to be addressed in order to optimize implementation include: how to identify who will benefit the most from the intervention, which will need to be accompanied by counseling to decrease risk taking since the medications were not 100 percent effective; who will pay for the medications, especially in resource-constrained environments; and how will long-term side effects and the potential for the selection of resistant strains be monitored?”
Amb. Eric Goosby, MD, U.S. Global AIDS Coordinator:
“We are greatly encouraged by the important step forward represented by the iPrEx study findings on PrEP with ARV drugs for HIV prevention. PrEP has the potential to be a critical addition to our prevention arsenal, particularly for populations at high risk of HIV infection. We congratulate our colleagues at the National Institute of Allergy and Infectious Diseases (NIAID) and the Bill and Melinda Gates Foundation on this impressive result.
“We look forward to the additional steps that need to take place before the world can begin using this ARV-based PrEP. Several other ongoing trials will provide us with critical information. Key questions will include protection for women, appropriate dosing, resistance and side effects, safety with long-term use, and its impact on future treatment options among users who acquire HIV. As a supporter of program implementation, the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) will await the development of normative guidance on PrEP by the World Health Organization and others. While that process continues, however, we will continue our own process to consider the wide range of policy, ethical, cost and other considerations that PrEP will raise, so that we will be ready to provide guidance to our programs at the appropriate time.
“Prevention is the most fundamental challenge in the fight against AIDS. We all must welcome innovation to improve the impact of our prevention programs and save more lives. As we work every day to determine how each dollar invested through PEPFAR can produce the greatest results in terms of lives improved and saved, we look forward to exploring the potential of PrEP.”
Gregg Gonsalvez, HIV/AIDS Advocate
“The walls are tumbling down between prevention and treatment—antiretroviral treatment (ART) is a powerful prevention tool, as a microbicide and pre-exposure prophylaxis, for mother-to-child transmission and for post-exposure prophylaxis, and for blunting transmission from those who are already HIV positive. Those who continue to pit treatment versus prevention are flying in the face of mounting scientific evidence and being revealed as the ideologues that they truly are. It’s time to work together and get ART to all who need it, along with other powerful prevention tools, including access to male circumcision, clean syringes and substitution therapy, and condoms, while continuing to invest in new research to get us to a vaccine and a cure someday. The Obama Administration has its own choices to make: they can continue to maintain that ART isn’t cost-effective and turn their back on what the rest of the world knows is the way to fight this epidemic, by scaling up AIDS treatment and prevention hand-in-hand, or they can walk into the 21st Century with the rest of us, building on the successes of AIDS research, like today’s important advance, to build a healthier future for all Americans and people around the world.”
“Two-thousand ten is a historic year in discovering that ARVs can prevent HIV acquisition. In iPrEX, high-risk men took daily oral tenofovir-emtricitabine (Truvada). In this year’s earlier CAPRISA 004 study, women were protected using a topical one percent tenofovir gel before and after coitus. This challenges the global donor community to enable the application of pre-exposure prophylaxis to prevent HIV in the highest risk subgroups. It also challenges the global research community to identify combination strategies to maximize the overall impact of all our prevention tools.”
Cornelius Baker, HIV/AIDS expert at the Academy for Educational Development (AED) and a member of the Presidential Advisory Council on HIV/AIDS:
“It’s a promising result. If proven, it adds a new strategy in the prevention toolbox. This result points us toward — if we also develop an effective vaccine — how we can end the HIV epidemic. It is going to require leadership and investment.
“Obviously this study was with gay men and it shows that it worked for subset of gay men, primarily those who were highly adherent to the strategy. We haven’t shown this to work in women, or heterosexuals. But given the US epidemic is predominately a gay male epidemic, this has the potential to certainly have a dramatic impact in the US. We have to continue this research in order for it to have an equal impact in the rest of the world.’’
Kaitlin Christenson is Coalition Director for the Global Health Technologies Coalition, which advocates for research and development of tools to prevent, diagnose, and treat global diseases:
“It’s a moment of significant progress in the fight against HIV/AIDS. This shows how U.S. government investment in research can make a huge difference. Without the significant investment through the National Institutes of Health as well as the contributions from other partners, particularly the Bill & Melinda Gates Foundation, this research wouldn’t have happened. It’s really critical that global health research and development continue, and that U.S. policymakers continue to prioritize support for research and development.
“Just look at what we’ve seen in the last year or so — we’ve had exciting research results with the CAPRISA microbicide trial, and the [Thailand HIV] vaccine trial. Both were supported by the U.S. government. All these trial results provide new hope for the fight against HIV/AIDS.”