Criticism comes on the heels of new guidance from U.S. Centers for Disease Control and Prevention (CDC) expanding recommended use for Gilead’s HIV/AIDS drug Truvada for pre-exposure prophylaxis (PrEP) from high-risk gay and bisexual men, to women and heterosexuals
WASHINGTON D.C. (August 9, 2012)⎯AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider, today strongly criticized new guidance from the U.S. Centers for Disease Control and Prevention (CDC) for expanding recommended use of Gilead Sciences’ HIV/AIDS treatment drug Truvada for use as pre-exposure prophylaxis (PrEP) from high-risk gay and bisexual men to women and heterosexuals. AHF’s concerns are over the potential safety and health risks of PrEP, particularly as there has been no evidence from clinical trials to show sufficient efficacy in women.
According to an article in Bloomberg News today: “Gilead Sciences Inc. (GILD)’s anti-AIDS pill Truvada safely and effectively reduces the risk of HIV for healthy people having sexual intercourse, according to the first U.S. Centers for Disease Control and Prevention guidelines on using the drugs for prevention in heterosexuals. Daily use of the pills to prevent HIV infection, known as pre-exposure prophylaxis, or PrEP, should only be used for people who are uninfected and continue to use regular testing and prevention methods, according to the interim guidelines. The Atlanta-based agency plans to release comprehensive guidelines by year-end, said Dawn Smith, lead author of the guidance.”
“The CDC’s support for Gilead’s HIV prevention pill for women is utterly reckless. There is simply no basis for such a recommendation,” said Michael Weinstein, AHF’s President. “Firstly, leading public health experts, including The Lancet; American Public Health Association; British HIV Association and British Association for Sexual Health have echoed AHF and other public health advocates in raising serious concerns about the health and safety risks associated with PrEP. Secondly, the two major studies of using Truvada as PrEP in women—FEM-PrEP and VOICE—were both prematurely halted for failing to demonstrate efficacy.”
In April 2011, a large clinical trial known as FEM-PrEP—which recruited 1951 HIV-negative women aged 18 to 35 at risk of HIV infection in South Africa, Kenya and Tanzania—was abruptly closed when it appeared that Truvada as PrEP provided no significant protection against HIV infection. The PrEP arm of another large study known as VOICE—of 5,000 women in South Africa, Zimbabwe and Uganda—was called off in September 2011 when it failed to show that it was effective at preventing HIV transmission.
# # #
AIDS Healthcare Foundation (AHF), the largest global AIDS organization, currently provides medical care and/or services to more than 176,000 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