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The Friends of AIDS Foundation is deeply troubled by an advertising campaign being run by the AIDS Health Care Foundation (AHF) opposing the efforts of pharmaceutical manufacturer Gilead to obtain Food & Drug Administration (FDA) approval of Truvada for use in the prevention of HIV. We find AHF’s campaign to be anti-science and ethically problematic.We urge you to sign on to a community statement supporting FDA review of Gilead’s request for licensing of this potentially powerful new prevention tool. The sign-in statement may be accessed by visiting: http://salsa.democracyinaction.org/o/1837/p/salsa/web/common/public/signup?signup_page_KEY=5897.
The iPrEx study, conducted among 2,499 gay and bisexual men at high risk for HIV-infection in the US, South Africa, South America and Thailand, reported extremely hopeful results about the effectiveness of taking the antiretroviral Truvada daily, in combination with safe sex and condom use counseling, to prevent HIV infection. Overall results showed that 44 percent fewer men - 35 actual people – avoided becoming infected with HIV while taking Truvada than those taking a placebo. AHF says that the 44 percent result is not strong enough to warrant any consideration by the FDA of licensing of Truvada for HIV prevention. But this represents a simplistic view of the iPrEx data.
Here are some important facts. It is true that fifty percent of study participants did not take Truvada daily or even at all. But 52 percent fewer men who reported that they sometimes had unprotected receptive anal intercourse (URAI), the highest risk activity for acquiring HIV, and who did take Truvada drug 50 percent of the time or more avoided becoming infected. Men who took Truvada daily at least 90 percent of the time were between 70 and 90 percent less likely to become infected with HIV than those not taking it. Many of the men who reported that they were not taking Truvada daily also reported that they were not having sex, and therefore did not see the reason for taking the pill. But among participants who were having regular sex, and particularly among those having URAI, adherence to daily Truvada was much higher. So, too, was PrEP effectiveness.
We have a simple question for AHF. What would they say to the 35 men in the iPrEx study who could still be HIV-negative today if they had been receiving Truvada instead of a placebo? That they should not be given a choice to take it? If a young gay male saw one of AHF’s doctors and said that, despite his best intentions to use condoms when bottoming during anal intercourse, depression and substance use were making it impossible and he wanted to consider PrEP, would they refuse him the opportunity?
Not to prescribe PrEP if asked to by someone who could clearly benefit from it and who indicates that they can adhere to a regimen of daily pill use and ongoing safe sex counseling would, in our opinion, be unethical given the strong results of iPrEx. (In coming years when data are reported from trials now underway among heterosexuals and injection drug users, PrEP might also help others in their sometimes difficult efforts to remain HIV-negative, too.)
The Friends of AIDS Foundation and others are working to assure that PrEP can eventually be paid for by all public and private insurers. In order for PrEP to be available to some of the people who most need it – particularly low-income gay and bisexual men of color who obtain health insurance as a result of health care reform - Medicaid programs across the country will require FDA licensing of Truvada or any other antiretrovirals eventually shown to be effective for PrEP. And so, AHF’s actions threaten to harm the very people who could most need and could benefit from PrEP.
There is no "one size fits all" method to HIV prevention. We feel it is well past the time that the 30,000 new cases of HIV infection that occur each and every year among gay and bisexual men in the United States were eliminated. We are working to support the development of a new set of responsible options for people at risk for HIV to choose from in order to avoid becoming infected, rather than block them. We hope you will support us in these efforts by signing the statement at: http://salsa.democracyinaction.org/o/1837/p/salsa/web/common/public/signup?signup_page_KEY=5897
The Friends of AIDS Foundation is dedicated to enhancing the quality of life for HIV positive individuals and empowering people to make healthy choices to prevent the spread of the HIV virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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