March 5, 2013
Women's PrEP Trial Interventions Fail to Protect From HIV
A large trial of three different pre-exposure prophylaxis (PrEP) methods has failed to protect a large cohort of African women against HIV transmission, The New York Times reports. The disappointing results from the VOICE (Vaginal and Oral Interventions to Control the Epidemic) trial were announced at the 20th Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta.
The three PrEP methods tested in the trial included daily oral Viread (tenofovir), daily oral Truvada (emtricitabine/tenofovir) and a daily vaginal gel of 1 percent tenofovir. A lack of adherence, and not the methods themselves, was to blame for the trial’s failure. These findings are in line with the results of previous studies that have outlined a strong correlation between adherence to PrEP and its potency as an HIV prevention tool.
The study’s results are a setback in the race to find effective PrEP methods to empower women worldwide to protect themselves against HIV infection. But the AIDS Vaccine Advocacy Coalition (AVAC) stresses that the results do not invalidate the findings of previous studies showing that oral tenofovir-based PrEP was highly effective for women in stable relationships with an HIV-positive partner and that vaginal tenofovir was modestly effective, although at a different dosing schedule. AVAC calls for a renewed focus and intensified research into PrEP strategies that are not so dependent on adherence and which women may find more appealing and easier to use.
“Biomedical tools do not work in a vacuum but rather in the complex realities of women’s and girls’ lives,” Mitchell Warren, AVAC executive director, said in a statement. “The women of VOICE and other prevention trials have much to tell us. Now we need to listen to what they are saying and design prevention options based on a better understanding of their reproductive and sexual health needs and desires, their perceptions of personal risk for HIV infection, and their interest in and ability to use the products offered in those trials.”
To read the New York Times story, click here.
To read the AVAC release, click here.
Editor's Note: This article has been updated.
Search: pre-exposure prophylaxis, PrEP, The AIDS Vaccine Advocacy Coalition, AVAC, VOICE, Vaginal and Oral Interventions to Control the Epidemic, 20th Conference on Retroviruses and Opportunistic Infections, CROI, Viread, tenofovir, Truvada, emtricitabine, microbicide, Mitchell Warren
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comments 1 - 8 (of 8 total)
Laurel Sprague, Ann Arbor, 2013-03-08 13:35:29
Thanks very much to the AIDS meds team for listening to our concerns. It's good to know our community media cares about our community feedback!
Sonia Rastogi, New York, 2013-03-07 23:06:36
Agreed with the comments thus far and with Mitchell Warren's articulate quote at the end of the article. That should be the title of the article - "Now we need to listen to what they are saying and design prevention options based on a better understanding of their reproductive and sexual health needs and desires" and not furthering the stigma that women and HIV+ people are to blame.
Laurel Sprague, Ann Arbor, 2013-03-07 17:48:33
Just because researchers choose to put themselves in the best possible light when they present data does not mean OUR community media should take their framing without question! AIDSmeds should not use such an unbalanced headline for this article.
Tami Haught, Nashua, IA, 2013-03-07 13:55:03
I agree with Laurel, the title makes one believe women are not able to adhere. Did the researchers take into account, involve women when developing research methods, we have different needs than men. Study methods are not interchangeable. But don't blame women for lack of adherence for failure.
Paul Clift, London, 2013-03-07 12:42:40
“Biomedical tools do not work in a vacuum but rather in the complex realities of women’s and girls’ lives” is indeed true, but surely it's also true, or likely to be, that people take part best in trials they have been involved in from trial-concept onwards. Looks to me that these women were only ever regarded as 'subjects' not as autonomous people who could help plan, shape, deliver the trial.
David Phillips, College Park, MD, 2013-03-07 12:13:56
"A lack of adherence, and not the methods themselves, was to blame for the trial’s failure."??!! Last time I checked, a study's methods also encompass the inclusion or exclusion of the target population in study design, as well as some quantity of measures--in thie case, zero--for promoting adherence. Hence, it's more like the researchers and their funders failed the women who were unable to adhere optimally to the prescribed regimen.
Doug McColeman, Montreal, QC, 2013-03-07 11:59:59
I agree with Ms. Sprague. I believe that is was more a failure to be realistic on the part of the researchers in what they expected the subjects to be able to reproduce in a real world setting.
Laurel Sprague, Ann Arbor, 2013-03-06 11:07:36
comments 1 - 8 (of 8 total)
Could this be titled differently please? Instead of blaming women for "lack of adherence," let's follow Mitchell's example in the article and recognize that the researchers have failed women here. They have spent untold amounts of money on interventions that were not grounded in women's needs and realities and therefore did not work when taken out of the lab.
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