FDA Approves Truvada, The First HIV Prevention Vaccine Medicine
On Monday, the US Food and Drug administration approved the first medication intended to prevent HIV infections in people having sex with infected individuals.
In a move hailed by advocates as pivotal in the 30-year battle against AIDS, the Food and Drug Administration on Monday approved for the first time a drug for preventing infection by the virus that causes the disease.
When taken daily, Truvada (emtricitabine/tenofovir disoproxil fumarate) reduced the risk of HIV infection by 42 percent compared with a placebo. That was in a clinical trial where HIV-negative individuals had unprotected sex with multiple partners, including some HIV carriers, according to the FDA. Another trial involving heterosexual couples where one partner was infected -- and condoms were used routinely -- found that Truvada reduced the risk of infections by 75 percent.
The challenge now, advocates say, is getting the expensive drug — it costs as much as $11,000 a year — to the groups in the United States who are at the highest risk for HIV: gay men in general and gay young black men in particular. Black women are also at higher-than-average risk.
Breaking with other AIDS advocates, one vocal group denounced the approval. “It’s a catastrophe,” said Michael Weinstein, president of the AIDS Healthcare Foundation, which provides AIDS treatment in clinics worldwide. Some people with Truvada prescriptions will fail to take the pill every day, Weinstein said — and thus lose protection.
The most common side effects reported with Truvada included diarrhea, nausea, abdominal pain, headache, and weight loss. In rare cases, the drug may cause kidney problems or bone toxicity.
As a condition of approval, the FDA is requiring Truvada’s manufacturer, Gilead Sciences, to study those who acquire HIV while taking Truvada to determine if anyone can develop a resistance to the drug. The company also needs to collect data on women who becom