In mid-February, Gilead announced that the FDA granted an expedited review of its supplemental New Drug Application (sNDA) for use of Truvada as a possible HIV prevention pill—an announcement that came just days after release of study that showed one key component of Truvada is associated with significant risk of kidney damage and disease that increases over time
LOS ANGELES (April 19, 2012)⎯AIDS Healthcare Foundation (AHF) today blasted the State of California for granting over $11 million in HIV/AIDS research funding to study the expanded use Gilead Sciences’ blockbuster HIV treatment drug Truvada for use as a method of preventing HIV infection in non-infected people. The use of the drug as a possible form of HIV prevention—also known as pre-exposure prophylaxis or PrEP—has generated controversy ever since several initial studies showed modest to failing results, and since Gilead has stepped up efforts to fast track FDA approval of use of the drug for prevention.
According to the Los Angeles Times (April 18, 2012), “The program (California HIV/AIDS Research Program) awarded $11.8 million in state grants for the prevention pill studies and efforts to get about 3,000 HIV-infected people in Southern California into treatment and keep them there. The grants will go to a group of UC schools, local governments and AIDS organizations.”
In mid-February, Gilead announced that the FDA granted an expedited review of its supplemental New Drug Application (sNDA) for use of Truvada as a possible HIV prevention pill—an announcement that came just days after release of another study that showed one key component of Truvada is associated with significant risk of kidney damage and disease that increases over time.
“Given the enormity of the budget crisis facing California coupled with the fact that this drug has performed so poorly in studies so far, it is both reckless and irresponsible for the California HIV/AIDS Research Program—which is funded by California taxpayers—to fund any further research on Truvada for use as an HIV prevention pill at this time,” said Michael Weinstein, AHF’s President. “The more we have come to learn about Truvada as an idea for preventing HIV, the worse the idea is. In anyone should fund such research, it should be Gilead Sciences footing the bill—not taxpayer-funded government entities which should have far better use for such funds.”
The idea behind PrEP is that people who do not have HIV may protect themselves against HIV infection by taking Truvada, which is already approved as a daily treatment for people infected with HIV or living with AIDS. While early studies saw some initial potential, more recent studies have been halted because the drug has shown little or no preventative effect.
AHF has long been critical that PrEP will not work on a large-scale basis because, consistent with poor medication adherence rates for most diseases, people will not be able to take Truvada as directed. Because of this, there will be little or no preventative effect, and drug resistance and drug resistant strains of HIV will develop. In addition, people who falsely believe they are fully protected against HIV very likely may engage in riskier behavior, thereby increasing their risk of HIV infection.
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.