Gilead Pill Can Prevent HIV in Heterosexuals, CDC Guidelines Say

Gilead Sciences Inc. (GILD)’s anti-AIDS pill Truvada safely and effectively reduces the risk of HIV for healthy people having sexual intercourse, according to the first U.S. Centers for Disease Control and Prevention guidelines on using the drugs for prevention in heterosexuals.

Daily use of the pills to prevent HIV infection, known as pre-exposure prophylaxis, or PrEP, should only be used for people who are uninfected and continue to use regular testing and prevention methods, according to the interim guidelines. The Atlanta-based agency plans to release comprehensive guidelines by year-end, said Dawn Smith, lead author of the guidance.

The Food and Drug Administration approved Truvada on July 16 for use by healthy heterosexual or homosexual people who are at high risk of being infected with the AIDS virus. The PrEP method, meant for those with infected partners, requires a pill each day and constant monitoring, Smith said.

“This provides another tool that providers can use for HIV prevention,” said Smith, who is a biomedical interventions implementation officer at the CDC’s National Center for HIV and AIDS Prevention. “It will always need to be targeted at people who are very high risk. It requires a lot of work.”

The daily pill had already been deemed safe and partially effective for homosexual and bisexual men in a January 2011 CDC interim guidance, and the World Health Organization published initial guidelines in July suggesting that couples with one infected member could use the drug.

48,000 Infections

An estimated 48,000 HIV infections occurred in the U.S. in 2009 and 27 percent were among heterosexual men and women who didn’t inject drugs, the guidance states. Though this could be used to drive those numbers down, the prevention method still needs development, said Mitchell Warren, executive director of AVAC: Global Advocacy for AIDS Prevention.

“It’s still very early days, he said. ‘‘It’s not as if anyone is out there actively promoting it. Even with the FDA approval, the most important next steps are the demonstration projects, to really help us understand how to deliver PrEP, to whom we can best deliver and motivate adherent use, and really add public health impact.”

Two different studies cited in the guidance found that the method, which prevents HIV from establishing a permanent infection by making new viruses as it enters the body, is effective for heterosexual people.

Still, the prevention method’s long-term safety in adults and for pregnant users’ fetuses hasn’t yet been determined conclusively, a main reason those taking the treatment should be monitored closely, according to the guidance.

The guidelines also instruct physicians to tell patients that the drug must be taken consistently and should be used in conjunction with regular screening and prevention methods such as condoms.

To contact the reporters on this story: Jeanna Smialek in New York at jsmialek@bloomberg.net; Simeon Bennett in Geneva at sbennett9@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net