Mavyret Labeling Update Includes Data on HCV Genotype 3b Infection, PWID

The labeling for Mavyret (glecaprevir, pibrentasvir; AbbVie) has been updated to include efficacy data related to the treatment of patients with chronic hepatitis C virus (HCV) genotype 3b infection, as well as in people who inject drugs (PWID) and those on medication-assisted treatment (MAT) for opioid use disorder.

The VOYAGE-1 and VOYAGE-2 trials included HCV genotype 1, 2, 3, 4, or 6 infected patients with cirrhosis (VOYAGE-1) or compensated cirrhosis (VOYAGE-2) who were treatment-naive or PRS ([peg]interferon, ribavirin and/or sofosbuvir) treatment-experienced. Patients without cirrhosis received 8 weeks of treatment, while those with compensated cirrhosis were on treatment for 12 weeks; genotype 3 PRS treatment-experienced patients received 16 weeks of treatment.

Results showed that across both trials, patients with HCV genotype 3b infection had a numerically lower sustained virologic response (SVR12) rate of 70% (58% for non-cirrhotic patients [n=7/12]; 88% for patients with compensated cirrhosis [n=7/8]) compared with those infected with genotype 3a or other HCV genotypes. In addition, all 6 genotype 3b patients without SVR12 experienced virologic failure.

Among the 4655 chronic HCV genotype 1-6 patients included in Mavyret trials, 1373 patients identified as PWID; 62 patients reported being current/recent PWID and 959 reported former PWID (352 patients were not included in the analysis as they did not specify current or former PWID). Compared with former/non-PWID patients (n=4241), current/recent PWID patients were more frequently treatment-naïve (94%), and had higher proportions of HCV genotype 3 infection (44%) and HIV co-infection (24%); the majority of current/recent PWID patients were non-cirrhotic (73%), similar to the former/non-PWID patients. 

Data analysis showed that the overall SVR12 rate was 98% in former/non-PWID patients and 89% in current/recent PWID patients; the difference between the 2 groups was reported as being primarily due to missing data in the current/recent PWID group at the time of the SVR12 measurement window. Virologic failure rates were found to be similar in both groups (2% in current/recent PWID patients and 1% in former/non-PWID patients).

Studies assessing Mavyret also included patients who reported concomitant use of MAT for opioid use disorder (n=225). These patients were more frequently  treatment-naïve (89%) and had a higher proportion of HCV genotype 3 infection (50%). The analysis showed that SVR12 rates were similar between patients on MAT and those not on MAT (96% vs 98%, respectively); low rates of virologic failure were also noted in both groups (<1% and 1%, respectively).

Mavyret is a once-daily treatment that combines glecaprevir, an HCV NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor. Both direct-acting antivirals work by targeting and inhibiting proteins required for HCV replication. 

The fixed-dose combination product is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45kg with chronic HCV genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for the treatment of HCV genotype 1 infection, in patients previously treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both.

Mavyret is available as 100mg/40mg fixed-dose tablets in a 4-week (monthly) or 8-week carton. Each carton contains 7 daily dose wallets.

For more information visit abbvie.com.