The FDA today approved Gilead Sciences’ Truvada medication as a daily HIV preventive for “some high-risk populations.” The medication had been under FDA review for such use for several months and today’s decision was strongly opposed by some HIV activism groups although a coalition of other groups endorsed the plan. Gilead has published a press release:
Data supporting the approval of Truvada for PrEP came primarily from two large placebo-controlled trials known as the Pre-Exposure Prophylaxis Initiative (iPrEx), sponsored by the U.S. National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation, and Partners PrEP, sponsored by the University of Washington and funded by the Bill and Melinda Gates Foundation. The iPrEx and Partners PrEP trials found that Truvada reduced the risk of acquiring HIV infection by 42 percent and 75 percent, respectively. Several other clinical studies also support the use of Truvada for HIV risk reduction. “This approval is a major milestone in our 30-year fight against AIDS,” said Robert M. Grant, MD, MPH, Betty Jean and Hiro Ogawa Endowed Investigator, Gladstone Institute of Virology and Immunology, University of California, San Francisco and lead investigator of the iPrEx trial. “The use of PrEP alongside routine HIV testing gives us a tremendous opportunity to reduce the rate of new HIV infections in this country and around the world.”
The group that most loudly protested in advance of today’s decision was the AIDS Healthcare Foundation, which published anti-Truvada ads in a California newspaper near the Gilead headquarters and sent the below mailer to more than 50,000 homes in that area. The FDA’s decision to approve Truvada as a PrEP medication was supported by the San Francisco AIDS Foundation. All groups concede that the long-term effects of a daily HIV medication by uninfected persons is not yet fully known.UPDATE: The AIDS Healthcare Foundation responds to today’s decision.
“The FDA’s approval of Gilead’s Truvada as a form of HIV prevention today without any requirement for HIV testing is completely reckless and a move that will ultimately set back years of HIV prevention efforts,” said Michael Weinstein, AHF’s President. “From the beginning we believe there was a rush to judgment by government officials and others in favor of such approval despite decidedly mixed studies offered in support. And while FDA recommends a negative HIV test prior to use of Truvada as PrEP and states that use by people with an ‘…unknown or HIV positive status…’ is ‘contraindicated,’ it in no way actually requires HIV testing in any manner—just strengthening of the ‘Boxed Warning’ on Gilead’s packaging. The FDA’s move today is negligence bordering the equivalence of malpractice which will sadly result in new infections, drug resistance and serious side effects among many, many people.’
UPDATE II: The SF AIDS Foundation reacts:
“Today’s decision by the FDA heralds a new era in HIV prevention—one with great promise for expanded access to HIV testing and prevention counseling and support,” said Neil Giuliano, CEO of San Francisco AIDS Foundation. “The approval paves the way for increased work with the federal government and Gilead Sciences to ensure they realize the incredible impact they can now have to get Truvada to the communities that stand to benefit most, especially gay men and people of color.” “The groundbreaking decision by the FDA has widespread implications for efforts to stop the spread of HIV both here in the United States and beyond our borders,” said James Loduca, vice president of public affairs at San Francisco AIDS Foundation. “Now the hard work begins to ensure that health care providers, clinics, and our community know how and when to use Truvada—and to ensure that price and delivery systems are never a barrier to access for anyone who stands to benefit from it.”