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January 7, 2022January 7, 2022 – Descovy® (emtricitabine/tenofovir alafenamide – Gilead) has been approved to treat HIV-1 infection in pediatric patients [weighing at least 14kg (31 pounds) and less than 35kg (77 pounds)] when used in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor.
- This indication was previously approved for pediatric patients 25kg (55 pounds) to under 35kg.
- Recommended dosing under the indication is:
- For patients 25kg to less than 35kg: One 200mg/25mg tablet taken by mouth once daily.
- For patients 14kg to less than 25kg: One 120mg/15mg tablet taken by mouth once daily.
- First FDA approved in 2016, Descovy is also indicated for use in in adults and pediatric patients
weighing at least 35kg to:
- Treat HIV-1 infection when used in combination with other antiretroviral agents; or
- Provide pre-exposure prophylaxis (prevention) of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex.