Despite failed results from numerous clinical trials of Gilead’s HIV/AIDS drug Truvada as an HIV prevention pill (pre-exposure prophylaxis or PrEP), the drug company recently submitted an application to the U.S. Food & Drug Administration (FDA) for approval of this new use of the drug
AHF questions the lack of transparency in the FDA’s process after the government agency repeatedly denied its Freedom of Information Act (FOIA) requests for correspondence between the FDA and Gilead over Truvada
WASHINGTON, D.C. (December 16, 2011)⎯AIDS Healthcare Foundation (AHF) today slammed drug company Gilead Sciences Inc. for submitting an application to the U.S. Food & Drug Administration (FDA) for a new use of its HIV treatment drug Truvada as an “HIV prevention pill” – also known as a pre-exposure prophylaxis or PrEP. Despite numerous failed clinical trials, the company went ahead with its application. AHF also questions the lack of transparency of the FDA’s application process after the Foundation’s repeated Freedom of Information Act (FOIA) requests for correspondence between the FDA and Gilead over Truvada were denied.
“We are disappointed that Gilead has irresponsibly decided to proceed with their application for an indication for PrEP despite the failed results from numerous trials. This is yet another example of a drug company putting profit before ethical conduct,” said Michael Weinstein, President of AIDS Healthcare Foundation. “Gilead’s request for priority review is completely unjustified under these circumstances. AHF will aggressively pursue our opposition to this application.”
Added Weinstein: “We also question the FDA’s process and are critical of the lack of transparency offered by the government agency. Repeated requests by AHF to gain what ought to be public information regarding correspondence between the FDA and Gilead over Truvada have been denied.”
In September of this year, AHF filed a lawsuit against the Food and Drug Administration (FDA) over its denial of AHF’s Freedom of Information Act (FOIA) requests regarding correspondence between the FDA and Gilead Sciences regarding its potential application to the FDA to expand the use of its AIDS drug, Truvada, for use as an HIV prevention pill for pre-exposure prophylaxis (PrEP) in uninfected individuals. The legal action was filed in the United States District Court, Central District of California. According to AHF’s suit, the action is being, “…brought under the Freedom of Information Act, 5 U.S.C. Section 552, as amended, to enjoin defendants from withholding from public disclosure certain records of the United States Food and Drug Administration (“FDA”),” and seeks, “To enjoin the FDA from withholding FDA records,” and “To order the production of any FDA records improperly withheld from AHF.”
Gilead’s pursuit of FDA-approval for expanding the use of its best-selling $35 per day AIDS drug to include use as a form of HIV prevention comes following a widely-reported study released earlier this year of 2,500 high risk gay men using Truvada as prevention which showed a 44% effectiveness rate in preventing HIV transmission. AHF believes such modest results are insufficient to support FDA approval of Truvada as an HIV prevention tool—and a move that AHF and other AIDS advocates believe would set a dangerous precedent.
According to the Washington Post (AIDS strategy testing yields failures, by David Brown, December 1, 2011): “The use of antiretroviral drugs to prevent HIV infection – a strategy known as ‘pre-exposure prophylaxis’ or PrEP – is the object of great hope in AIDS research. The strategy worked in a number of clinical trials but unexpectedly has begun to fail. The abrupt closure last week of one part of a complicated study called VOICE marked the third time in eight months that antiretroviral drugs did not prevent infection in those assigned to use them. ‘People are upset. It’s a big head-scratcher as to why it didn’t work,’ said Lynn A. Paxton, an epidemiologist at the Centers for Disease Control and Prevention who oversaw a study completed last summer that showed a strong protective effect of an antiretroviral pill. Researchers were hoping that if a vaginal gel containing an AIDS drug was as protective in VOICE as it had been in an earlier study, it might be approved for use and on the market by late 2014. Now it won’t be available until 2016 at the earliest – and only if further testing proves it works.”
In addition to the failed VOICE study, conducted by the National Institute of Allergy and Infectious Disease, a similar study called FEM-PrEP testing Truvada as an “HIV prevention pill” in 2,000 South African, Kenyan and Tanzanian women was stopped in April because it also showed no difference between the drug and the placebo. Another part of the VOICE study was stopped earlier in October due to the pill’s ineffectiveness to prevent HIV infection.
“Given the abject failure of the clinical trials, it is inconceivable Gilead would try to foist this on the public,” said Tom Myers, AHF’s Chief of Public Affairs and General Counsel.
Truvada, a drug compound that consists of Gilead’s drugs Viread (tenofovir DF) and Emtriva (emtricitabine), is currently FDA-approved for use as part of antiretroviral therapy combinations for individuals already living with HIV or AIDS. FDA-approval for pre-exposure use as a possible form of HIV prevention for those NOT infected with the virus would be a first for the FDA, and a move that AHF and many other AIDS advocates believe would set a dangerous precedent.
In 2010, Truvada was Gilead’s second-best selling product generating over $2.6 billion in revenue. One analyst told Bloomberg that FDA-approval to prescribe the drug for pre-exposure prophylaxis may add $1 billion to Gilead’s sales of Truvada.