Glecaprevir/​Pibrentasvir

DEA Class; Rx

Common Brand Names; Mavyret

• HCV NS5A Inhibitors; 
• HCV NS3/4A Protease Inhibitors

Combination oral antiviral containing an HCV NS3/4A protease inhibitor and NS5A inhibitor
For the treatment of chronic HCV infections (all genotypes) in adults and pediatric patients 3 years and older without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Contraindicated in patients with moderate to severe hepatic impairment and in those with any history of prior hepatic decompensation

Moderate or severe hepatic impairment (Child-Pugh B or C)

History of prior hepatic decompensation

Coadministration with atazanavir or rifampin

• Headache (9-17%)
• Fatigue (11-14%)
• Nausea (6-12%)
• Diarrhea (3-7%)
• Increased bilirubin, ≥2x ULN (3.5%)
• Pruritus (7%)
• Skin and SC tissue disorders: Angioedema
• Hepatobiliary disorders: Hepatic decompensation, hepatic failure

Hepatitis B virus reactivation in patients coinfected with HCV/HBV may occur

Postmarketing cases of hepatic decompensation/failure, including those with fatal outcomes, have been reported

No dosage adjustment of required in people who inject drugs (PWID) or those who are on medication-assisted treatment (MAT) for opioid use disorder; safety and efficacy reported to be similar to those not reporting history of injection drug use

No adequate human data are available to establish whether or not glecaprevir/pibrentasvir poses a risk to pregnancy outcomes

Unknown if distributed in human breast milk

When administered to lactating rodents, glecaprevir and pibrentasvir were present in milk, without effect on growth and development observed in the nursing pups