Emtricitabine

Emtriva is indicated in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infected adults and children aged 4 months and over. This indication is based on studies in treatment-naïve patients and treatment-experienced patients with stable virological control.

1). When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient.

Where available, resistance testing may be appropriate.

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).

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1 INDICATIONS AND USAGE BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

BIKTARVY is a three-drug combination of bictegravir (BIC), a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI), and emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg: who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.