Following disappointing results from the VOICE trial released at the recent 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta, a new U.S. Women and PrEP Working Group has called on the federal government to help American women use antiretroviral pre-exposure prophylaxis (PrEP) safely and effectively. But the AIDS Healthcare Foundation (AHF) responded by urging the Food and Drug Administration to rescind its approval of Truvada (tenofovir/emtricitabine) for HIV prevention.
On March 5, AHF president Michael Weinstein once again called on the FDA to reverse its 2012 approval of Truvada as a preventive tool for people at high risk for HIV infection, and specifically "as a form of HIV prevention in women."
This latest salvo in AFH's long campaign against the use of Truvada for PrEP was triggered by the fact that the VOICE trial results, unveiled on March 4, did not show that either Truvada or tenofovir effectively reduced women’s risk of HIV acquisition. Researchers believe this lack of protection likely resulted from very low usage of the study drugs by trial participants.
AHF’s opposition to PrEP is ongoing, but its emphasis on women this time was interesting, given that the day before the new U.S. Women and PrEP Working Group unveiled a position statement with quite a different message.
A coalition of more than 50 women from leading AIDS and women's health organizations, the Working Group called on the Office of National AIDS Policy and the Centers for Disease Control and Prevention (CDC) to work with them on putting in place what American women need to use PrEP safely and effectively.
The group's convener, Dazon Dixon Diallo of SisterLove, Inc., said that the Working Group has specifically defined how federal agencies should collaborate with non-government organizations (NGOs), researchers, and advocates to "develop and fund demonstration projects that will help answer a range of questions about real-world use of PrEP by American women and move toward an integrated plan for PrEP rollout in our communities that includes support for healthcare providers, social workers and others who will help women use PrEP effectively."
The Working Group recognizes PrEP as an important option for women despite the disappointing VOICE results. Since using condoms -- both traditional male and internal female condoms -- requires some degree of partner cooperation, it is morally imperative to provide women with unimpeded and well-informed access to available non-condom prevention tools with proven effectiveness.
The issue of women making their own choices appears to be a consistent sticking point for Weinstein, which makes his opposition to PrEP to protect women all the more questionable. AHF is obviously aware of the urgent need among women and girls for effective HIV prevention tools, given that 52% of its clients globally are women, and 47% of its pediatric patients are girls. The organization's website states that "AHF is committed to providing women with the tools to protect themselves and their partners and to live the healthiest lives possible."
AHF claims that the data showing PrEP's efficacy for women is insufficient, despite strong evidence of its effectiveness among women in the Partners PrEP trial and the CDC's TDF2 trial, in which adherence rates were relatively high. AHF also argues that access to PrEP will just give people an excuse not to use condoms. In an interview last year, Weinstein said, "You've got to really be paranoid about your pants falling down to wear a belt and suspenders," so access to PrEP "may well give people an excuse to stop using them [condoms].”
This argument conveniently sidesteps the fact that, according to a recent study published in the Journal of Sexual Medicine, only 28% of men and 22% of women reported using a condom during their most recent sexual experience. Among U.S. women at highest risk for HIV infection, that figure drops to 18%. It also implies that rational women will not be able to grasp the harm reduction approach of using PrEP if their partners do not use condoms consistently, while also insisting on condom use when they can.
The Working Group's statement, by contrast, affirms PrEP's potential value while recognizing that its promise cannot be realized until crucial questions are answered. Chief among these is the question of "why daily adherence rates, especially among younger and unmarried women, tend to be low and what other approaches might be more successful."
Answering these questions will require data "collected through pilot and demonstration projects that can assess how well PrEP works at the population level, in real-world settings beyond clinical trials." These will inform the subsequent design of PrEP introduction strategies -- a process that cannot succeed without "the full participation and leadership of individuals and communities most in need of effective, comprehensive HIV prevention," according to the statement.
Which sounds more like the HIV/AIDS activist approach -- the one that assumes that people can't grasp the nuances of harm reduction, or the one that recognizes the realities of people's lives and says that consumers must have a voice in shaping the research, services, and support that they need?
The U.S. Women and PreP Working Group came together this month because we recognized that a "coherent and comprehensive vision of how PrEP implementation among U.S. women will occur has yet to be well articulated." We accepted responsibility for the fact that there had been no "consistent voice for women on the subject of PrEP implementation proportionate to women's presence in the U.S. HIV/AIDS epidemic" and set out to correct that by becoming such a voice.
What is politely left unsaid in the Working Group's statement is that some of us were, and are, offended when Michael Weinstein speaks for women on this and other issues.
So, Mr. Weinstein, please stop telling us -- and the rest of the world -- what women need. We do not need your guidance on when to get tested, when to use condoms, when to tell our partners, and what HIV prevention tools and services the government should and should not approve and provide for us. We find your advocacy for us, rather than with us, to be patronizing. It does not appear to us that you are listening to what we are expressing on our own behalf, so thanks, but no thanks.
Anna Forbes (firstname.lastname@example.org) is a writer, organizer and women's health activist specializing in work to expand HIV prevention options for women. She is a founding member of the U.S. Women and PrEP Working Group. This article was originally published on HIVandHepatitis.com.
AIDS Healthcare Foundation. AHF Demands FDA Reversal on Use of Gilead’s HIV Prevention Pill for Women. Press release. March 5, 2013.
AVAC and SisterLove. Coalition of U.S. Women's Health and HIV Advocates Call for Accelerated US Government Plan for Demonstrating Feasibility of PrEP for Women. Press release. March 4, 2013.
Working Group on U.S. Women and PrEP Statement. March 4, 2013.
J Marrazzo, G Ramjee, G Nair, et al. Pre-exposure prophylaxis for HIV in women: daily oral tenofovir, oral tenofovir/emtricitabine or vaginal tenofovir gel in the VOICE study (MTN 003). 20th Conference on Retroviruses and Opportunistic Infections. Atlanta, GA, March 3-6, 2013. Abstract 26LB.
D Herbenick, V Schick, M Reece, et al. Characteristics of Condom and Lubricant Use among a Nationally Representative Probability Sample of Adults Ages 18–59 in the United States. Journal of Sexual Medicine 10(2):474-483. February 2013.
SL Hodder, J Justman, JP Hughes, et al. HIV acquisition among women from selected areas of the United States. Annals of Internal Medicine 158(1):10-18. January 1, 2013.