Emtricitabine

1).

Treatment of HIV-1 Infection DESCOVY is indicated in combination with other antiretrovirals (such as non-nucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing ≥ 25 kg.

HIV-1 Pre-Exposure Prophylaxis (PrEP) DESCOVY is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing ≥ 35 kg, excluding individuals at risk from receptive vaginal sex.

ca. 1 Pediatrics Treatment of HIV-1 Infection Pediatrics (weighing ≥ 25 kg): The safety and efficacy of DESCOVY in HIV-1 infected children weighing ≥ 25 kg are based on data from an open-label clinical study (see 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS).

Pediatrics (weighing < 25 kg):

Safety and efficacy of DESCOVY for the treatment of HIV-1 infection in children weighing < 25 kg have not been established. HIV-1 PrEP Pediatrics (weighing ≥ 35 kg):The safety and efficacy of DESCOVY for HIV-1 PrEP in at-risk adolescents weighing ≥ 35 kg (excluding individuals at risk from receptive vaginal sex) is supported by data from an adequate and well-controlled trial of DESCOVY for HIV-1 PrEP in adults together with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, FTC and TAF, with EVG+COBI, in HIV-1 infected adults and pediatric subjects (see 8 ADVERSE REACTIONS, 10 CLINICAL PHARMACOLOGY and 14 CLINICAL TRIALS).

1).

1 ) Emtricitabine and tenofovir disoproxil fumarate tablet is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and is indicated: • in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg.

2 ): • Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablet for HIV-1 PrEP.

1 Treatment of HIV-1 Infection Emtricitabine and tenofovir disoproxil fumarate tablet is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Clinical Studies ( 14 )] .