New data out of 19th Conference on Retroviruses and Opportunistic Infections (CROI) demonstrate that “adherence makes all the difference” in effectiveness of HIV prevention pill (also known as pre-exposure prophylaxis and PrEP) and self-reporting on adherence by study participants is highly unreliable
LOS ANGELES, CA (March 7, 2012)⎯ Today AIDS Healthcare Foundation (AHF), the largest global AIDS organization, responded to new data presented at the 19th Conference on Retroviruses and Opportunistic Infections (CROI) that demonstrated that adherence is the key factor in the effectiveness of using Gilead Sciences’ HIV treatment drug Truvada for HIV prevention (also known as pre-exposure prophylaxis or PrEP). Data from two studies both demonstrated that the majority of study participants—despite saying otherwise—had little or no drug in their systems.
According to a report from www.aidsmap.org: “Further data were presented from two trials of PrEP (giving anti-HIV drugs to HIV-negative people to prevent infection), which announced dramatically different results last year. The FEM-PrEP study had found that giving HIV-negative women Truvada (a combination of the anti-HIV drugs tenofovir and FTC) pills to prevent their acquiring HIV was totally ineffective: there was no difference in HIV incidence between women taking Truvada and women taking placebo. While the women said that they took their pills 95% of the time and pill counts suggested 85% adherence, testing of blood samples told a different story. Among those given Truvada and who remained uninfected, 38% had detectable drug levels in their blood. Among those who were infected, 21% had detectable drug levels.”
“Today’s news out of CROI is more damning evidence that Gilead’s HIV prevention pill is a failure. This new data should be a clear indication to the FDA that Truvada is not ready for approval as PrEP and that widespread use of the drug will, in fact, do great harm to the public’s health,” said Michael Weinstein, AIDS Healthcare Foundation President. “The issue of adherence is key to effectiveness. In these two studies, the overwhelming majority of study participants had poor adherence—despite reporting otherwise. The consequences were severe: becoming infected with HIV. There is no reason to believe that it will be any different in the real world – especially when patients are not being paid to participate or monitored as closely as they would be in a research study. Adherence will, in fact, likely be even lower. Self-reporting about condom use in these studies is just as unreliable. There is a significant risk that people who take PrEP haphazardly will mistakenly believe that they are completely protected from HIV and other STDs. These individuals will engage in unprotected sex, which will ultimately lead to an increase in HIV and other infections.”
AIDS Healthcare Foundation has been leading efforts to halt the premature approval of Gilead’s Truvada for HIV prevention by the U.S. Food and Drug Administration (FDA). The agency, despite numerous failed clinical trials such as the FEM-PrEP study, has been going ahead with the approval process over the objections of AHF who has raised serious concerns regarding public health implications. More information about AHF’s campaign can be found at www.nomagicpills.org.
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AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 125,000 individuals in 26 countries worldwide in the US, Africa, Latin America/Caribbean, the Asia/Pacific Region and Eastern Europe. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare.