The Food and Drug Administration okayed Truvada, calling the little blue pill “an important milestone” in the struggle to curb a disease once considered a killer.
The FDA’s decision comes less than two weeks after the agency approved the first over-the-counter HIV home test.
And such testing is key, activists said, because too many New Yorkers have the virus that causes AIDS yet don’t know it.
As a result, the approval of Truvada, manufactured by Gilead Sciences, was greeted with some apprehension.
“We celebrate Truvada, [but] we still want to tell people to be sure they use all the tools . . . to prevent HIV,” said Marjorie Hill, CEO of the Gay Men’s Health Crisis. “The reality is this is one good tool, but it’s only one tool. We still need education, education, education.”
About 50,000 Americans are diagnosed with HIV every year, and about 1.2 million people nationwide are living with the virus.
Truvada has been on the market since 2004, but only as a treatment for people already infected by the human immunodeficiency virus.
The FDA backing will allow the Foster City, Calif., company to market the breakthrough drug as an AIDS prevention med. It also sent the company’s share price soaring by 1.5%, up to $51.94 a share — not that the company was celebrating the bump.
“Today’s decision is the culmination of almost 20 years of research involving investigators, academic and medical institutions, funding agencies and nearly 20,000 trial participants around the world,” said Norbert Bischofberger, a Gilead executive vice president.
Clinical trials showed a daily dose of the compound can cut the risk of infection in healthy gay and bisexual men by 42%.
For heterosexual couples in which one partner is HIV positive, the drug is 75% effective in preventing the disease.
“It is exciting to consider the potential impact of this new HIV prevention tool, which could contribute to significantly reducing new HIV infections,” said Dr. Connie Celum of the University of Washington, who conducted some of the drug’s clinical trials.
But Hill warned the drug should not be construed as a green light to toss the condoms and engage in promiscuity.
“There’s always a concern when there’s good news that people will take that good news for more than what it’s worth,” Hill said. “This is not a cure. There’s no cure for HIV and AIDS.”
FDA Commissioner Dr. Margaret Hamburg strongly recommended that people with a high risk for HIV continue to get tested and seek counseling for sexually transmitted diseases.
“Today’s approval marks an important milestone in our fight against HIV,” Hamburg said.
Dr. Debra Birnkrant, director of the Division of Antiviral Products at FDA, said the prevention pill is a giant leap from the 1980s and 1990s when HIV was considered a death sentence.
“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. “But it is still better to prevent HIV than to treat a life-long infection of HIV.”
Gilead Sciences officials said the drug will not be cheap. A prescription will run about $13,900 a year — but that’s cheaper than the yearly cost of a course of anti-HIV medications.
Officials said Truvada’s side effects include headaches, nausea, vomiting, muscle pain, weakness, weight loss and a decrease in bone density.