prevent HIV

Pill to prevent HIV gets an FDA endorsement

An advisory panel recommends approval for Truvada, a daily pill that is the first drug shown to protect from the virus that causes AIDS. Critics worry the pill could lead to risky behavior.

Associated PressMay 11, 2012

SILVER SPRING, Md. — The first drug shown to prevent HIV infection won the endorsement of anFDA advisory panel Thursday, clearing the way for a landmark approval in the 30-year fight against the virus that causes AIDS.

The Food and Drug Administration panel recommended approval of the daily pill Truvada for healthy people who are at high risk of contracting HIV, including gay and bisexual men and heterosexual couples with one HIV-positive partner.

The FDA is not required to follow the panel's advice, but it usually does. A final decision is expected by June 15.

Gilead Sciences, based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus.

Although panelists ultimately backed Truvada for prevention, Thursday's 12-hour meeting highlighted a number of concerns. In particular, they debated whether Truvada might lead to reduced use of condoms, the most reliable defense against HIV. The experts also questioned the drug's effectiveness in women, who have shown much lower rates of protection in studies.

Panelists struggled to outline steps that would ensure patients take the pill every day. In clinical trials, patients who didn't take their medication diligently were not protected, and patients in the real world are even more likely to forget than those in studies.

"The trouble is adherence, but I don't think it's our charge to judge whether people will take the medicine," said Dr. Tom Giordano of Baylor College of Medicine, who voted in favor of the drug. "I think our charge is to judge whether it works when it's taken and whether the risks outweigh the benefits."

Truvada first made headlines in 2010, when government researchers showed it could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 42%, when accompanied by condoms and counseling. Last year another study found that Truvada reduced infection by 75% in heterosexual couples in which one partner was infected with HIV and the other was not.

But Truvada's groundbreaking preventive ability has exposed stark disagreements within the HIV community. While Truvada's supporters say the drug is an important new option, critics worry that the drug could give users a false sense of security and encourage risky behavior.

During the meeting's public comment period, some speakers worried that wide use of Truvada would divert limited funding from more cost-effective options. Truvada sells for about $900 a month, or just under $11,000 per year. The AIDS Healthcare Foundation, which opposes approval, estimates that 20 HIV-positive patients could be treated for the cost of treating one patient with Truvada.

The FDA is legally barred from considering cost when reviewing drugs. Medicare and Medicaid, the nation's largest health insurance plans, generally cover all drugs approved by the FDA, and many large insurers take their cues from the government plans.

An estimated 1.2 million Americans have HIV, which develops into AIDS unless treated with antiviral drugs. AIDS causes the body's immune system to break down, leading to infections that are eventually fatal. Gay and bisexual men account for nearly two-thirds of cases.