FDA approves HIV prevention medication

People highly susceptible to being affected by the human immunodeficiency virus now have an additional measure to reduce HIV risk.

The Food and Drug Administration approved a new use of the drug Truvada for adults who do not have HIV but are at risk of becoming infected. Truvada was originally approved by the FDA in 2004 for use in combination with other medications to treat HIV-infected adults and children older than 12 years.

Truvada may be taken once daily and used in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection.

“It is another tool to help protect those at risk to get HIV,” IU School of Medicine professor Kenneth Fife said. “It is not to be used in place of condoms but in
addition.”

The FDA’s Division of Antiviral Products Director Debra Birnkrant said Truvada works to prevent HIV from establishing itself and multiplying in the body. 

“In the 80’s and 90’s, HIV was viewed as a life-threatening disease. In some parts of the world, it still is,” Birnkrant said in a press release. “Medical advances, along with the availability of close to 30 approved individual HIV drugs, have enabled us to treat it as a chronic disease most of the time.”

Birnkrant said Truvada is meant to be used as part of a comprehensive HIV prevention plan that includes consistent and correct condom use, risk reduction counseling, treatment of other sexually transmitted infections and regular HIV testing.

“Truvada is not a substitute for safer sex practices,” she said. “But it is still better to prevent HIV than to treat a life-long infection of HIV.”

Today, about 1.2 million Americans have HIV, and each year about 50,000 adults and adolescents in the U.S. are newly diagnosed with HIV, according to the FDA.

“The rates of new HIV infections have not significantly changed for a long time,” she said. “From FDA’s standpoint, this is not acceptable for a serious disease.”

Fife, co-author of the Partners Pre-Exposure Prophylaxis study, studied heterosexual couples from Kenya and Uganda. One partner in each of the 4,758 couples was HIV positive.

“The whole idea of the project was to try to find additional ways to prevent those at continued risk to get HIV,” Fife said.

In the study, the HIV negative partners were randomly assigned to once-daily tenofovir (Viread), a combination of emtricitabine/tenofovir (Truvada) or a placebo. Tenofovir and emtricitabine slowed the spread of HIV in the body by blocking an enzyme necessary for viral production.

Fife said this was the first time the two drugs were used together for HIV negative patients.

“The study is significant because it provides physicians a new tool for HIV prevention,” he said.

The study found that those taking anti-retroviral drugs prior to exposure to HIV provided a high level of protection against the virus in heterosexual men and women.

“We ultimately found that those taking the anti-retroviral drugs are significantly less likely (to get HIV) than those taking the placebo,” Fife said.

The only evidence of resistance to the drugs found in the study came from those who tested negative on initial tests but were actually already infected by the virus, Fife said.

“It needs to be looked at further,” he said. “Additional studies will need to be done.”

Fife said it is a concern that with this approach, many might not use condoms. This is called risk compensation.

“I don’t know the extent, but it is something that needs to be watched,” he said. “For the FDA, this was not a big enough concern to stop the drug from being approved.”