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Gilead’s Descovy Nabs Limited HIV Prophylaxis Indication Pending A New Study In Women

 
• By Sue Sutter

US FDA approves a PrEP indication for emtricitabine/tenofovir alafenamide that excludes cisgender women due to a lack of efficacy evidence; Gilead will conduct a new randomized trial with a novel design in women comparing Descovy's efficacy and safety against external controls and Truvada.

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Descovy’s PrEP indication is narrower than Gilead would have liked. • Source: Shutterstock

The US Food and Drug administration concluded that efficacy questions about Gilead Sciences Inc.’s Descovy for HIV pre-exposure prophylaxis in cisgender women are best answered through a new clinical study before the indication goes on the label.

On 3 October, the agency approved Descovy (emtricitabine/tenofovir alafenamide) for PrEP, but the indication excludes cisgender women because the drug’s effectiveness has

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