via Pharmalot, by Ed Silverman

Late last year, Gilead Sciences took a widely anticipated and controversial step by seeking FDA approval to market its Truvada HIV pill to prevent infection, which is also known as pre-exposure prophylaxis or PrEP. The move was both welcomed and criticized by AIDS activists, reflecting a spectrum of views on making a preventive pill available on a large-scale basis.

To some, FDA approval would offer needed assistance in containing HIV and possibly clarify the extent to which such preventive measures are useful. To others, FDA approval raises the specter of creating a form of resistance to HIV due to widespread use, which would undermine effectiveness for existing Truvada patients and, therefore, diminish prevention efforts. In particular, critics worry people without HIV who take a preventive pill may engage in risky behavior.

A related issue, of course, is cost. Truvada carries a price of $26 a day, or roughly $10,000 a year, which may inhibit widespread usage. However, a new study suggests there is, indeed, value. Prescribing Truvada to men who have sex with men in the US would cost $495 billion over 20 years, but targeting only those at highest risk would lower costs to $85 billion, according to the study published in The Annals of Internal Medicine (here is the abstract).

Over the next two decades, the researchers calculated a total of 490,000 new infections if prevention is not undertaken, but if 20 percent of gay men take the pill daily, there would be nearly 63,000 fewer infections. And if just 20 percent of high-risk men took the drug, 41,000 new infections would be prevented over 20 years at a cost of about $16.6 billion.

Read the Rest.

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