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ANTIINFECTIVES FOR SYSTEMIC USE › ANTIVIRALS FOR SYSTEMIC USE › DIRECT ACTING ANTIVIRALS › Antivirals for treatment of HIV infections, combinations
emtricitabine, tenofovir alafenamide and dolutegravir
J05AR29
Forms & Strengths
- Fixed-dose combination tablet: emtricitabine 200 mg / tenofovir alafenamide 25 mg / dolutegravir 50 mg
Adult Dosing
- One tablet orally once daily with or without food
Pediatric Dosing
- Safety and efficacy not established in pediatric patients weighing less than 35 kg
- Adolescents weighing >= 35 kg: One tablet orally once daily
Indications
- Complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing >= 35 kg
Mechanism of Action
- Emtricitabine: Nucleoside reverse transcriptase inhibitor (NRTI), inhibits HIV-1 reverse transcriptase
- Tenofovir alafenamide: Nucleotide reverse transcriptase inhibitor (NtRTI), prodrug converted intracellularly to tenofovir, inhibits HIV-1 reverse transcriptase
- Dolutegravir: Integrase strand transfer inhibitor (INSTI), inhibits HIV integrase by blocking strand transfer
Contraindications
- Previous hypersensitivity reaction to dolutegravir, emtricitabine, or tenofovir alafenamide
- Co-administration with dofetilide
Adverse Reactions
- Diarrhea
- Nausea
- Headache
- Fatigue
- Insomnia
- Abdominal pain
- Weight gain
Drug Interactions
- Dofetilide: Co-administration is contraindicated due to potential for increased dofetilide concentrations and serious arrhythmias
- Polyvalent cation antacids/laxatives (Mg/Al): Administer dolutegravir 2 hours before or 6 hours after
- Metformin: Dolutegravir increases metformin concentrations; monitor renal function and adjust metformin dose
- Inducers of CYP3A and/or UGT1A1 (e.g., rifampin, St. John's wort): Decrease dolutegravir levels; adjust dosing as recommended
Curated Content: Needs Vetting Before Put to Clinical Use