FDA Approves First Generic Truvada in U.S.

On June 9, The U.S. Food and Drug Administration (FDA) approved the first generic version of emtricitabine/tenofovir disoproxil (Truvada, Gilead Sciences) to both treat and prevent HIV infections in this country.

Medscape reported that while the manufacturer of the generic is Teva Pharmaceutical Industries, the leader of an HIV prevention organization told them more generic drug makers are likely to introduce their versions of emtricitabine/tenofovir disoproxil.

Generic versions of the drug are already marketed in other nations. In 2013, the FDA approved a generic form of emtricitabine/tenofovir disoproxil made by Strides Arcolab Limited in India for use outside the United States under a White House AIDS relief program. The generic was not made available in the United States because the drug was under patent protection.

The specific indication for emtricitabine/tenofovir disoproxil in the United States is for the treatment of HIV-1 in combination with other antiretroviral agents and for preexposure prophylaxis (PrEP) along with safer sex practices to prevent sexually acquired HIV infections in high-risk adults. Although the FDA has approved some 40 drugs to treat HIV infections, emtricitabine/tenofovir disoproxil is the only one approved for PrEP.

The list price for Gilead Science's Truvada is roughly $1,500 for a month's regimen of one pill per day, or about $18,000 a year, although health insurance and patient-assistance programs reduce the price considerably. Generic versions of Truvada in other countries cost as little as $70 a year, according to Mitchell Warren, executive director of AVAC, an international organization that promotes HIV prevention.

In an interview with Medscape Medical News, Warren said that the debut of a generic version of emtricitabine/tenofovir disoproxil in this country will lower the price barrier to PrEP.

"This is an exciting day," he said. "We've seen momentum for PrEP programs and policies. Having a lower cost alternative will only increase that momentum."

He estimates that Teva Pharmaceutical's generic version of Truvada could reduce the cost of PrEP by as much as 80 percent. He said he hopes that the drug maker will follow in Gilead Science's footsteps and create a patient-assistance program for those in financial need.

The Human Rights Campaign Foundation championed the move, saying they have supported the use of PrEP since 2014, recognizing that when taken as prescribed, it is a safe and highly effective way to reduce one's chance of contracting HIV.

"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."
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