SAN FRANCISCO — Mavyret was highly effective and well-tolerated in patients with chronic hepatitis C genotype 1 who had experience with a combination of Sovaldi, NS5A inhibitor and ribavirin, according to data presented at The Liver Meeting 2018.
“The context of this study was that the FDA granted approval in August 2017 for [Mavyret] for 16 weeks in persons who failed an NS5A-containing regimen that did not also contain a protease inhibitor,” Mark S. Sulkowski, MD, from Johns Hopkins Hospital in Maryland, said during a press conference presentation.
Sulkowski noted, however, that Mavyret was initially considered an “alternative treatment” by U.S. treatment guidelines, requiring further trials to determine its use in different populations, including patients with cirrhosis.
Sulkowski and colleagues randomly assigned patients with chronic HCV without cirrhosis to receive Mavyret (glecaprevir/pibrentasvir, AbbVie) for 12 weeks (n = 78) or 16 weeks (n = 49). Additionally, the researchers randomly assigned patients with cirrhosis to receive glecaprevir/pibrentasvir for 12 weeks (n = 21) or 16 weeks (n = 29). All patients had previously received Sovaldi (sofosbuvir, Gilead Sciences).
Of those treated, 132 patients reached posttreatment week 12 for analysis. Sustained virologic response rate at follow-up was 92% in the 12-week group without cirrhosis, 96% in the 16-week group without cirrhosis, 86% in the 12-week group with cirrhosis who also received ribavirin, and 100% in the 16-week group with cirrhosis.
The nine patients who did not achieve SVR experienced relapse or breakthrough. There were no serious adverse events related to treatment and no discontinuations due to adverse events. The most commonly reported adverse events were fatigue, headache and nausea.
While the regimen was well-tolerated, the addition of ribavirin — which took this regimen from three tablets once daily to six tablets once in the morning plus two to three tablets in the evening — had more adverse effects, including anemia and constitutional complaints of fatigue.
“These data provide a greater comfort regarding the use of 16 weeks of [glecaprevir/pibrentasvir] in the absence of ribavirin for patients with genotype 1 who fail NS5A inhibitors,” Sulkowski said. “Among patients who had virologic failure, most acquired an additional resistance mutation and have been offered retreatment with a combination of sofosbuvir with [glecaprevir/pibrentasvir] with or without ribavirin at their discretion and many of those patients are now undergoing said treatment. – Talitha Bennett
Sulkowski MS, et al. Abstract 0226. Presented at: The Liver Meeting 2018; Nov. 9-13, 2018; San Francisco, CA.
Disclosure: Sulkowski reports he has financial connections with AbbVie, Arbutus, AssemblyBio, Gilead, Merck and Proteus Digital Health.