Truvada Decision Delayed, Gilead Institutes New HIV Testing Guidelines

The FDA will take an additional 3 months to review the drug application for Truvada as a preventive HIV treatment to account for updated safety materials submitted by Gilead.

The FDA will take an additional 3 months to review the drug application for Truvada as a preventive HIV treatment to account for updated safety materials submitted by Gilead.

Although the FDA initially provided an anticipated Prescription Drug User Fee Act (PDUFA) action date of June 15, 2012, for Gilead Sciences, Inc’s Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis (PrEP), the agency recently announced it will delay its decision an additional 3 months.

In May, an advisory panel recommended Truvada to prevent HIV infection in people at high risk of contracting the virus. According to sources, the next target date for a decision is September 14, 2012.

If approved for a preventive indication, a Gilead official announced at the Controlling the HIV Epidemic with ARVs Summit in London that the company will require a negative HIV test in all patients who are candidates for the drug. The company said they will also include the following (or similar) phrasing to market use of Truvada: "HIV negative test is required before every prescription.”

Many AIDS advocates are pleased that the FDA delayed its ruling on Truvada’s PrEP indication and that Gilead plans to require baseline HIV-negative tests before patients can be prescribed Truvada.

"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,” said Jorge Saavedra, MPH, Global Ambassador for AIDS Healthcare Foundation and the former head of the Mexican National AIDS Program (CENSIDA), in a press release. “Gilead is right to institute guidelines for labeling that require HIV testing."

More from Specialty Pharmacy Times on Truvada for pre-exposure prophylaxis:

FDA Panel Recommends Approval of Drug for HIV Prevention