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ANTIINFECTIVES FOR SYSTEMIC USE › ANTIVIRALS FOR SYSTEMIC USE › DIRECT ACTING ANTIVIRALS › Antivirals for treatment of HCV infections
glecaprevir and pibrentasvir
J05AP57
Forms & Strengths
- Fixed-dose combination tablet: glecaprevir 100 mg / pibrentasvir 40 mg
Adult Dosing
- Chronic hepatitis C virus (HCV) genotypes 1-6: 3 tablets (glecaprevir 300 mg / pibrentasvir 120 mg) orally once daily with food
- Treatment-naive patients without cirrhosis: 8 weeks
- Treatment-naive patients with compensated cirrhosis (Child-Pugh A): 12 weeks
- Treatment-experienced without cirrhosis (genotype 1, 2, 4, 5, 6): 8 weeks
- Treatment-experienced with compensated cirrhosis (genotype 1): 12 weeks
- Treatment-experienced previously treated with an NS5A inhibitor or protease inhibitor (genotype 1): 16 weeks
Pediatric Dosing
- Pediatric patients 12 years and older or weighing at least 45 kg: Same as adult dosing (3 tablets once daily with food)
- Pediatric patients aged 3 to <12 years: Weight-based dosing using specific pediatric pellets/tablets per weight bands, taken with food for 8 to 12 weeks
Indications
- Treatment of chronic hepatitis C virus (HCV) genotypes 1, 2, 3, 4, 5, or 6 infection in adults and pediatric patients 3 years and older without cirrhosis or with compensated cirrhosis (Child-Pugh A)
- Treatment of HCV genotype 1 infection in patients previously treated with an HCV NS5A inhibitor or an NS3/4A protease inhibitor (but not both)
Mechanism of Action
- Glecaprevir is an HCV NS3/4A protease inhibitor required for viral replication
- Pibrentasvir is an HCV NS5A inhibitor targeting viral replication and virion assembly
- Combined dual-action mechanism provides high barrier to resistance across pan-genotypic HCV variants
Contraindications
- Moderate to severe hepatic impairment (Child-Pugh B or C) or history of prior hepatic decompensation
- Co-administration with atazanavir or rifampin
Adverse Reactions
- Headache
- Fatigue
- Nausea
- Pruritus
- Diarrhea
Drug Interactions
- Rifampin: Strongly contraindicated due to significant risk of decreased plasma concentrations and loss of therapeutic effect
- Atazanavir: Co-administration is contraindicated due to increased risk of ALT elevations
- P-gp and BCRP substrates (e.g., digoxin): Potential for increased concentrations of victim drug
- Statins (e.g., atorvastatin, rosuvastatin): Co-administration may increase statin exposure, requiring dose adjustment or monitoring
- Immunosuppressants (e.g., cyclosporine): Significant increases in glecaprevir and pibrentasvir concentrations; co-administration not recommended
Curated Content: Needs Vetting Before Put to Clinical Use