Abstract
The immediate prospects of antiretroviral pre-exposure prophylaxis (PrEP) suffered an unexpected setback this week, just days before the US Food and Drug Administration (FDA) was due to issue its ruling on a once-daily combination pill of tenofovir and emtricitabine (TDF–FTC, marketed as Truvada by Gilead Sciences, Foster City, CA, USA) to reduce the risk of sexually acquired HIV infection in high-risk, seronegative individuals. As the journal was going to press, the FDA pushed back the deadline for a decision from June 15 until mid-September, to give itself more time to assess Gilead's revised risk-management plan for the drug combination—the first to be assessed by the FDA for use as PrEP.
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