Medication Monitor



Generic Name (Trade Name—Company)
Notes
October 30, 2019

Emtricitabine 200 mg/tenofovir alafenamide 25 mg

(Descovy—Gilead Sciences)
FDA approves second drug to prevent HIV in at-risk adults and adolescents

On October 3, FDA approved emtricitabine 200 mg and tenofovir alafenamide 25 mg for HIV-1 pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents weighing at least 35 kg to reduce the risk of HIV-1 infection from sex. The agent is not indicated in individuals at risk of HIV-1 infection from receptive vaginal sex because the effectiveness in this population has not been evaluated.

The combination agent should be used as part of a comprehensive strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually acquired infections.

A boxed warning cautions individuals who also have hepatitis B virus (HBV) to be aware of the risk of exacerbations of HBV in those who discontinue products with emtricitabine or tenofovir disproxil fumarate. 

Emtricitabine 200 mg/tenofovir alafenamide 25 mg for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status and should only be prescribed to individuals confirmed to be HIV negative immediately before initiation of treatment and at least every 3 months during use.