Shots:

• The US FDA advisory committee voted 16 to 2 for Descovy’s approval to treat proposed indication of pre-exposure prophylaxis (PrEP) in men and transgender women (TGW) who have sex with men
• The committee reviewed the P-III DISCOVER global trial data assessing Descovy vs Truvada in men and transgender women who have sex with men and are at high-risk for sexually acquired HIV infection and resulted in non-inferiority data- improvement in renal and bone laboratory parameters
• Additionally- the committee reviewed PK data for HIV and PrEP treatment in cis-gender (not part of DISCOVER study) and voted 10 out of 8 as the data was not adequate in regards to efficacy. Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablet; F/TAF) is indicated in combination with antiretroviral agents for HIV infection in patients weighing at least 35 kg. The product also has a boxed warning of Post Treatment Acute Exacerbation of Hepatitis B
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 Ref: Gilead | Image: Gilead