What to do when HIV-infection rates stop going down--and condom use continues to fall? If you're U.S. health officials, you recommend that Americans at high risk of infection take a pill: Gilead Sciences' ($GILD) Truvada, an AIDS fighter that's the only drug approved for HIV prevention.
It's something of an about-face for the Centers for Disease Control and Prevention (CDC), which had declined to recommend the drug to stave off HIV infection, despite its 2012 FDA approval for that use.
For Gilead, it's a victory that could boost sales by 50-fold, The New York Times reports. Right now, fewer than 10,000 patients use Truvada; if the new guidelines are adopted, that could shoot up to 500,000. And at a sticker price of $13,000 per year, that's a lot of additional revenue.
Gilead has been on a roll the past couple of years, with this groundbreaking preventive approval for Truvada; an FDA nod for its four-in-one HIV fighter Stribild; and the agency's blessing for its breakthrough hepatitis C therapy Sovaldi, which immediately broke the blockbuster barrier and has since set a new record for the fastest drug launch ever.
The preventive payoff for Truvada could take some time, however, as Dr. Jonathan Mermin, director of the CDC center for AIDS, tells the NYT. "On average, it takes a decade for a scientific breakthrough to be adopted," Mermin told the newspaper. "We hope we can shorten that time frame and increase people's survival."
Beyond the usual lag in adopting new treatment approaches, Truvada faces some other obstacles. Infectious-disease physicians have written very few prescriptions for the drug for preventive use; in one survey, almost three-fourths of doctors said they were in favor of the idea, but fewer than 10% had actually written a script.
Then there's the cost of treatment. At $13,000, it's far less than Sovaldi's much-debated $84,000-per-treatment-course price. But Truvada would be used indefinitely, year after year, whereas Sovaldi is a once-off cure. Medicaid programs and private insurers have tended to cover preventive treatment, the NYT notes. But if the scripts start surging, that could change--or pressure for lower prices or larger rebates could build.
The prevention idea isn't without opposition in the gay community, either. Some stigma is attached to that use. Plus there's the worry that Truvada-takers would then stop using condoms, putting them at risk of syphilis or gonorrhea. But prevention advocates say those diseases are treatable with antibiotics--if less so, with gonorrhea, than in the past--but HIV infection is for life.
- read the NYT piece
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