Truvada Gets FDA Nod for HIV Prevention

July 16, 2012— -- The Food and Drug Adminstration today announced the approval of the first drug for use in people who are not infected with the human immunodeficiency virus (HIV), to prevent its transmission, which some are calling a landmark in the fight against AIDS.

The drug, Truvada, is actually a combination of two medicines and is manufactured by Gilead Sciences, Inc. of Foster City, Calif. While Truvada has been approved since 2004 as a treatment for those already infected with the HIV virus, this is the first time any drug has been approved for pre-exposure prophylaxis, or PrEP.

The study that led to the drug's approval found the risk of transmission among men who have sex with men decreased more than 40 percent. Furthermore, it showed a decrease of more than 70 percent in risk of transmission among heterosexual couples in which one partner was infected with HIV but the other was not.

"Truvada should not be used alone for preventing infections," cautioned Dr. Debra Birnkrant, director of the Division of Antiviral Products at the FDA's Center for Drug Evaluation and Research. "However, when used in combination with other prevention methods, such as safer sex practices, counseling, and regular testing to determine infection status, Truvada is effective in reducing the risk of transmission."

Other experts in the field agreed with this assessment.

"The approval of Truvada to prevent HIV infection in uninfected individuals who are at high risk of sexually acquired HIV infection is a significant development, providing an important addition to our toolkit of HIV prevention interventions," said Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Disease. "However, it is critical to stress that Truvada as 'pre-exposure prophylaxis' should not be considered a stand-alone method, but should be used in conjunction with other proven HIV prevention strategies."

Not everyone was in favor of the approval. The AIDS Healthcare Foundation, a global organization involved in providing treatment to AIDS/HIV patients, strongly criticized the move, calling it irresponsible and saying Truvada's approval for this use would undermine current prevention efforts.

AHF president Michael Weinstein questioned whether the fact that support provided to study participants -- such as monthly HIV testing and intensive counseling -- would not be available to the general population would lead to decreased adherence to the drug regimen, and thus to the development of drug-resistant strains. Weinstein further cautioned that the drug's side effects on the kidneys and bones might be worth accepting in patients who needed to be treated for HIV, but were not worth the risk on otherwise healthy individuals.

"Today marks a catastrophe in the history of AIDS in America," he said.

While the AHF criticized the approval, a number of experts said there are many high risk individuals who won't use condoms but might take a daily pill.

"It's argued that PrEP is far more expensive than condoms, but it's a lot cheaper than a lifetime of HIV treatment," said Dr. Joel Gallant of the Johns Hopkins Center for Global Health. "If we can target PrEP to those at highest risk, PrEP is likely to be cost-effective."