BREAKING: First Generic For HIV Prevention Approved by FDA, Critical Step Toward Ending Epidemic

by Sarah McBride

The move could dramatically expand access to Pre-Exposure Prophylaxis (PrEP), the one-daily pill regimen that prevents HIV.

Today, HRC Foundation responded to the important decision by the Food and Drug Administration (FDA) to approve a generic version of Truvada, the potentially lifesaving antiretroviral medication used for HIV treatment and prevention. Before today’s decision, Truvada was the only medication FDA-approved for PrEP in the United States.

“While the timeline is uncertain for when a generic drug will be available to consumers, today’s decision by the FDA is a much-needed breakthrough in our ongoing efforts to expand HIV prevention options, especially for those most vulnerable to HIV and AIDS” said Mary Beth Maxwell, HRC Senior Vice President for Programs, Research and Training. “Despite growing use of PrEP nationally, the drug remains out-of-reach for many in the communities hardest hit by the epidemic, including young gay and bisexual men and transgender women of color. We implore Gilead to continue their critical payment assistance programs and urge other companies to provide similar financial relief.”

HRC is committed to working with our allies, partners, members, and supporters to end the dual epidemics of HIV and HIV-related stigma. In 2014, HRC endorsed the use of PrEP, recognizing that when taken as prescribed by a healthcare provider, PrEP has been shown to be safe and highly effective at reducing one's chances of contracting HIV. PrEP is not right for all individuals, and any medical decision should be made in concert with a knowledgeable healthcare provider.

To learn more about PrEP, visit http://www.hrc.org/resources/is-prep-right-for-me.