In a very promising step forward, a U.S. Food and Drug Administration panel has taken the unusual step of recommending approval of the first once-a-day pill to prevent HIV. The panel suggested the pill be prescribed for people at high-risk of infection, such as gay men with multiple sex partners. The hope is to reduce the number of new infections in the United States, which reached 56,000 last year (in a talk last month at Stanford, Anthony Fauci, MD, head of NIAID, called this number “embarrassing”).
The move comes on the heels of a Stanford study (subscription required) that found use of the pill, marketed as Truvada, could be cost-effective if targeted at these high-risk groups. The Stanford study, published last month, found that if the pill were prescribed to just 20 percent of high-risk gay men – those with five or more sexual partners a year – some 41,000 new infections could be prevented over 20 years at a cost of about $16.6 billion.
“Adopting (the pill) for men who have sex with men at high risk of acquiring HIV is an investment with good value that does not break the bank,” Jessie Juusola, a PhD candidate and the study’s lead author said at the time.
A landmark trial published in 2010 found the pill could reduce an individual’s risk of infection by 44 percent when taken daily. Patients who religiously followed the daily regimen reduced their risk to an even greater extent – by 73 percent, the trial results showed.
Scientists caution, however, that patients still need to be monitored for side-effects from the pill, which can affect the kidneys. Moreover, they need to be counseled to continue to use condoms and other protective measures, as the pill isn’t foolproof.