Mavixen

Chronic Hepatitis C

Take with food at the same time once daily

Chronic Hepatitis C Treatment-naïve adults and adolesents with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with compensated cirrhosis Treatment-experienced patients with HCV genotype 1 who have been previously treated with a regimen containing either an NS5A inhibitor or an NS3/4A protease inhibitor, but not both 3 tablets (ie, 300 mg/120 mg total dose) PO once daily with food Recommended duration for treatment-naïve patients Genotypes 1-6, no cirrhosis: 8 wk Genotypes 1-6, compensated cirrhosis (Child-Pugh A): 12 wk Recommended duration for treatment-experienced patients No cirrhosis Genotype 1 and NS5A inhibitor prior treatment: 16 wk Genotype 1 and NS3/4A protease inhibitor prior treatment: 12 wk Genotypes 1, 2, 4, 5, or 6 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 8 wk Genotype 3 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 16 wk Compensated cirrhosis (Child-Pugh A) Genotype 1 and NS5A inhibitor prior treatment: 16 wk Genotype 1 and NS3/4A protease inhibitor prior treatment: 12 wk Genotypes 1, 2, 4, 5, or 6 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 12 wk Genotype 3 (prior treatment with simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin): 16 wk Hepatic impairment Mild (Child-Pugh A): No dosage adjustment required Moderate (Child-Pugh B): Not recommended Severe (Child-Pugh C): Contraindicated

Renal impairment Mild, moderate, or severe, including patients on dialysis: No dosage adjustment required

Severe hepatic impairment (Child-Pugh C) Coadministration with atazanavir or rifampin

Glecaprevir: HCV NS3/4A protease inhibitor; necessary for the proteolytic cleavage of the HCV-encoded polyprotein (into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins) and is essential for viral replication Pibrentasvir: HCV NS5A inhibitor; essential for viral RNA replication and virion assembly

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

>10% Headache (9-17%) Fatigue (11-14%) Nausea (6-12%) 1-10% Diarrhea (3-7%) Increased bilirubin, ≥2x ULN (3.5%) Pruritus (7%)

Pregnancy No adequate human data are available to establish whether or not glecaprevir/pibrentasvir poses a risk to pregnancy outcomes Animal studies No adverse developmental effects were observed when glecaprevir and pibrentasvir were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommended dose Lactation 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 Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Coadministration is contraindicated with rifampin or atazanavir Coadministration is not recommended with carbamazepine, efavirenz, or St John’s wort