FDA Approves First Drug for HIV Prevention
Truvada Approved for HIV-Negative People at High Risk of Infection
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Other AIDS groups feel differently. The Black AIDS Institute supports the use of PrEP, as does Fenway Health, a provider of health services to Boston's lesbian, gay, bisexual, and transgender community.
"This approach can prevent many new infections and could dramatically impact HIV transmission worldwide as part of the tools we have available to stop the epidemic," Fenway medical director Kenneth H. Mayer, MD, says in a news release.
Last May, an FDA advisory panel voted in favor of approving Truvada for PrEP. The panel voted overwhelmingly to approve PrEP for men who have sex with men and for uninfected partners of HIV-infected people. But the panel approved Truvada PrEP by only a 12-8 vote for others at risk of HIV infection.
Birnkrant noted that the FDA approval comes with a risk-reduction program. Doctors prescribing Truvada PrEP must ensure that patients test negative for HIV before taking the drug. New tests are advised every three months at least.
In addition, people must be monitored for signs of kidney or bone problems -- which are among the long-term side effects sometimes seen with Truvada.
And the FDA says it will stay in close touch with those prescribing and taking Truvada PrEP to fine-tune the risk-reduction program.
"Education is the key," Birnkrant said. "We are committed to working with our public health colleagues to learn how best to use Truvada for PrEP so we can fully achieve the public health benefit it represents."
Truvada costs about $1,100 a month. It's not yet clear whether Truvada PrEP will be covered by insurance.