FDA Approves Truvada for HIV Risk Reduction

The FDA approved Truvada for preexposure prophylaxis, making it the first agent ever to be approved for HIV prevention in uninfected adults.

In a landmark decision, the FDA recently approved Truvada (emtricitabine/tenofovir disoproxil fumarate) as a preexposure prophylactic (PrEP) for individuals at high risk of HIV infection. It is the first drug approved for this indication; the medication was originally approved in 2004 as a treatment for HIV infection in combination with other antiretroviral drugs.

In order to ensure appropriate and effective use of Truvada for PrEP, Gilead has developed FDA-approved materials to educate and inform health care providers and uninfected individuals about its use. These materials stress that the drug itself is only one part of the “comprehensive prevention strategy” to reduce the risk of infection and should be used in conjunction with other preventive measures such as safe sex, risk reduction counseling, and regular HIV testing.

“The REMS for Truvada for the PrEP indication is aimed at educating health care professionals and uninfected individuals to help ensure its safe use for this indication without placing an unnecessary burden on health care professionals and patients," said Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, in an FDA press release.

Because patients who already have the virus could develop resistance to the drug, Truvada’s boxed warning states that the medication should only be used for PrEP in individuals who are confirmed to be HIV-negative and HIV screening should be repeated at least every 3 months during use. Gilead will also be required to track pregnancy outcomes for women who become pregnant while taking the drug, and will evaluate drug adherence of patients with prescriptions for Truvada. If individuals taking the drug remain adherent, it is estimated that they can lower their risk of getting HIV by 90%.

For those taking Truvada for PrEP, Gilead will also offer a service for regular reminders about HIV testing, vouchers for free condoms and HIV testing, and subsidized HIV resistance testing for any patient who becomes HIV-positive while taking Truvada for PrEP.

The Centers for Disease Control and Prevention is currently developing formal guidelines for the use of Truvada as PrEP among both men and women.

“It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections as part of a combination HIV prevention strategy,” said Connie Celum, MD, MPH, lead investigator of the Partners PrEP trial and professor of global health and medicine at the University of Washington, in a press release. “Although the implementation of PrEP will bring challenges, they can be anticipated and systems developed to address these challenges.”

The number of prescriptions for Truvada will likely increase now that Gilead is allowed to market the drug’s preventive benefits, yet the pill will retain its original price tag of nearly $14,000 per year, with a lifetime cost exceeding $600,000.

The approval of Truvada for PrEP comes fresh on the heels of the approval of the first at-home HIV test from OraQuick.

For more on this topic, see the following articles on Specialty Pharmacy Times:

-Truvada Decision Delayed, Gilead Institutes New HIV Testing Guidelines

-FDA Panel Recommends Approval of Drug for HIV Prevention

-HIV Drugs: What's New?