Drug used to treat H.I.V. now may be used to prevent it
Doctors have already been prescribing Truvada to sexually active homosexuals
An advisory panel to the Food and Drug Administration says that Truvada, a drug already used to treat H.I.V. infection should also be approved to prevent it. The recommendation is the first time government advisers have advocated giving antiviral medicine to healthy people who might be exposed through sexual activity to the virus that causes AIDS. Used alone and correctly, Truvada greatly reduces chances of infection.
The panel recommended that Truvada be prescribed for people at high risk of infection, like gay men who have multiple sex partners, as well as people engaged in sexual acts with someone who is H.I.V.-positive. Young black men who have sex with other men are at the highest risk.
The panel recommended that Truvada be prescribed for people at high risk of infection, like gay men who have multiple sex partners, as well as people in relationships with someone who is H.I.V.-positive. Young black men who have sex with other men are at the highest risk. Truvada would also be recommended for other high-risk people, like prostitutes.
Doctors reiterate that the drug is meant not to replace condoms and what are called by some safe-sex measures, but to be used with them for added protection. Of course, abstinence from sexual acts outside of a monogamous marriage is the full treatment to avoid sexually transmitted sisaeases.
Experts say better methods of prevention are needed because there are 50,000 new H.I.V. infections a year in the United States. That rate has not budged in 15 to 20 years. Counseling and condoms are not doing the job, they said, and many of the newly infected are men whose sexual partners do not realize they are H.I.V.-positive.
Some panelists mentioned the possibility that people who become infected while taking Truvada could develop dangerous drug-resistant strains of the virus, but the panel decided that the benefits of preventing new infections outweighed the risks.
An F.D.A. analysis found that people who are older and more educated are more likely to take the drug faithfully. There is no data to tell whether Truvada would prevent H.I.V. infection spread by sharing needles.
Because Truvada has already been approved to treat H.I.V. infection, doctors are free to prescribe it for prevention, and some have been doing so. Prescribing a drug for something other than its approved purpose, called off-label use, is allowed by the F.D.A., though drug companies are not permitted to market or promote drugs for such uses.
Advocates of providing Truvada for prevention say that patients should be tested for H.I.V. infection before starting the drug, because if someone who is already infected takes Truvada alone, drug-resistant strains of the virus may quickly develop. Some patients may also need to have their kidney function checked.
In the 30-year battle against AIDS, "it's the first time we have talked about a medication for prevention of HIV," one medical official said.
Doctors are allowed to prescribe Truvada "off-label" for prevention, but FDA approval would formally allow the pill's maker Gilead Sciences to market it for that use. It would probably lead many more insurance companies to pay for the costly drug. The FDA usually follows advisers' recommendations and a decision is expected by June 15.
© 2014 - Distributed by THE NEWS CONSORTIUM
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