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Why Doctors and AIDS Advocates Oppose the FDA’s New HIV-Prevention Pill

While trials show that the new HIV-prevention pill reduces the likelihood of transmitting the virus, doctors worry that misdiagnoses and poor compliance will result in a drug-resistant HIV.

What’s the Latest Development?

The FDA has approved the first pill ever designed to prevent HIV infection after a series of tests, performed mostly in Africa, suggested that daily doses greatly reduce the risk of transmitting the virus. Called Truvada, the pill performed especially well in a an East African trial: “It reduced the incidence of HIV by 75% in people with partners who had been infected. In an earlier trial in the United States, HIV incidence dropped by 44% in men who have sex with men.” Now US health insurers must decide whether they will pay for the treatment, which costs about $10,000 for a year’s supply. 

What’s the Big Idea?

The drug’s approval was not without significant controversy. While most members of the FDA panel voted to approve the drug, many researchers, doctors and patient advocates expressed worries over drug resistance. Trials have shown that if HIV is exposed to emtricitabine and tenofovir, the two drugs in Truvada, in the acute phase of infection, the virus can develop a resistance. “To mitigate these risks, the FDA requires that Truvada be prescribed only once an individual has tested negative for HIV.” Doctors have also expressed concern over patient compliance. If the drug is not taken regularly (and physicians say in many cases it will not be), HIV is more likely to become resistant. 

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