The End of HIV/AIDS Pandemic?
Positive FDA review may clear path for first drug approved to prevent HIV infection
Gilead Sciences/Associated Press – This photo provided by Gilead Sciences shows Truvada. Federal drug regulators on Tuesday affirmed landmark study results showing that a popular HIV-fighting pill can also help healthy people avoid contracting the virus that causes AIDS in the first place. While the pill appears safe and effective for prevention, scientists stressed that it only works when taken on a daily basis. The Food and Drug Administration will hold a meeting Thursday to discuss whether Truvada should be approved for people who are at risks of contracting HIV through sexual intercourse. The agency’s positive review posted Tuesday suggests the daily pill will become the first drug approved to prevent HIV infection in high-risk patients.
By Associated Press, Published: May 8
Although the FDA is legally barred from considering cost when reviewing drugs, health care providers have raised concerns about Truvada’s price tag: $900 a month, or just under $11,000 per year. Medicare and Medicaid, the nation’s largest health insurance plans, generally cover drugs approved by the FDA, and analysts expect most large health insurers to follow suit.
Additionally, some researchers say the prevention pill is not the chemical equivalent of condoms, which they say remain the best weapon against AIDS. They also worry about Truvada’s mixed success rate in preventing infection among women: Last year, a study in women was stopped early after researchers found that women taking the drug were more likely to become infected than those taking placebo.
Researchers speculated that women may require a higher dose of the drug to prevent infection. They also said the disappointing results may have resulted from women not taking the pills consistently.
“We know that if the person doesn’t take the medication every day they will not be protected,” said Dr. Rodney Wright, director of HIV programs at Montefiore Medical Center in New York and chairman of the AIDS Health Foundation. “So the concern is that there may not be adequate adherence to provide protection in the general population.”
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