The hepatitis C virus (HCV) cure rate of AbbVie’s Mavyret (glecaprevir/pibrentasvir) is apparently unaffected by even high-dose use of acid-reducing proton pump inhibitors (PPIs). This finding held true even though PPIs reduced the level of the glecaprevir component of Mavyret.
Publishing their findings in Clinical Gastroenterology and Hepatology, researchers analyzed data from nine Phase II and III studies of eight to 16 weeks of Mavyret treatment among 2,369 people with genotypes 1 through 6 of HCV and compensated cirrhosis (the milder form of the severe liver disease). The studies included SURVEYOR-I and -II, ENDURANCE-1, -2 and -3, EXPEDITION-1and -4 and MAGELLAN-1.
The analysis looked at people who took acid-reducing agents, including PPIs, H2 blockers and antacids. High-dose PPI use was defined as taking greater than 20 milligrams of Prilosec (omeprazole) daily or the equivalent.
The study authors also looked at data regarding the metabolization of Mavyret among those on acid-reducing agents.
Of the 401 participants (17% of the total) who took acid-reducing agents, 263 (11%) took PPIs, including 109 who took a high dose and 154 who took a low dose.
Ninety-seven percent of those who took acid-reducing agents achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure), as did 97.5% of those who did not take an acid-reducing agent. Of those taking high-dose PPIs, 96.3% were cured, compared with 97.4% of those taking low-dose PPIs. The differences within each of these pairs of cure rates were not statistically significant, meaning they could have been driven by chance. None of those who received a high-dose PPI experienced virologic failure, in which their viral load rebounded or remained detectable despite Mavyret treatment.
Taking a high-dose PPI was associated with a 41% decrease in the level of glecaprevir in the body.
To read the study, click here.