At the ‘Controlling the HIV Epidemic with ARVs’ Summit in London this week, a Gilead official stated that use of Truvada for Pre-Exposure Prophylaxis (PrEP) to have labeling with the phrasing, “HIV negative test is required before every prescription”.
Announcement was welcomed by AIDS advocates who were astounded by recent recommendation by an FDA Advisory Panel to allow Gilead to market use of its blockbuster AIDS treatment as a form of HIV prevention in uninfected individuals without any HIV testing requirement whatsoever
WASHINGTON (June 12, 2012) AIDS Healthcare Foundation (AHF), the nation’s largest HIV/AIDS nonprofit medical provider welcomed the news today that Gilead Sciences will include the following (or similar) phrasing: “HIV negative test is required before every prescription,” when, or if, Gilead begins marketing its blockbuster AIDS treatment Truvada as a form of an HIV prevention pill in uninfected individuals in the United States. At the ‘Controlling the HIV Epidemic with ARVs’ Summit, held in London June 11-12, a Gilead official publicly disclosed in a plenary session in which he was participating that use of its blockbuster AIDS treatment Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP) to prevent possible HIV infection will now have labeling indicating that a negative HIV test will be required before a prescription can be filled for such use.
The statement by Gilead’s representative was welcomed by AIDS advocates, included those from AHF, who were astounded by a recent recommendation by an FDA Advisory Panel to allow Gilead to market use of Truvada as a form of HIV prevention in uninfected individuals, particularly when the panel—comprised of 23 physicians, scientists and members of the general public—also recommended that FDA allow Gilead to market the drug for such use without any requirement for HIV testing whatsoever.
Late last week, advocates also cheered the news that the Food and Drug Administration (FDA) was delaying a ruling on Gilead’s application for the approval of the use of Truvada as a form of HIV prevention pill. Gilead had filed a supplemental new drug application (sNDA) for such use in December; in February 2012, the FDA granted an expedited review of Gilead’s application for approval by the FDA to market once-daily Truvadafor Pre-Exposure Prophylaxis (PrEP) to reduce the risk of HIV in uninfected adults. On May 10th, the FDA held an Advisory Committee hearing on the issue during which public comment opposing such use of the drug was heard from by more than 25 members of the audience. At the conclusion of the meeting, the Advisory Committee voted to advise the FDA to grant approval of Gilead’s application. Under statutory regulations, it was expected that a ruling by the FDA would be issued by next Friday, June 15th.
“We strongly opposed Gilead’s application to the FDA for approval to market the use of Truvada as a form of HIV prevention, given the results of the currently available research studies submitted in support of such use,” said Michael Weinstein, President of AIDS Healthcare Foundation. “However, we were shocked that the FDA advisory panel actually recommended that the FDA allow such use of the drug for HIV prevention without also instituting any requirement for HIV testing at all. We are heartened that the FDA has delayed a ruling on Truvada as PrEP and also that Gilead will ultimately require labeling indicating a requirement for negative HIV tests prior to prescribing Truvada as prevention.”
“We still have very grave concerns about Truvada as PrEP, but the fact that not even a baseline HIV-negative test would have been required before prescribing Truvada for preventive use is astonishing,” added Dr. Jorge Saavedra, Global Ambassador for AHF and the former Head of the Mexican National AIDS Program (CENSIDA), and who was at the London Summit. “If an HIV-infected individual who did not know his or her HIV status was prescribed and used Truvada as PrEP, the outcome could be devastating, ultimately leading to drug resistance to an otherwise potentially lifesaving AIDS treatment. Gilead is right to institute guidelines for labeling that require HIV testing.”