Elbasvir/grazoprevir in people with hepatitis C genotype 1 infection and child-pugh class B cirrhosis: the C-salt study

Ira M. Jacobson, Fred Poordad, Roberto Firpi-Morell, Gregory T. Everson, Elizabeth C. Verna, Sanhita Bhanja, Peggy Hwang, Luzelena Caro, Michael Robertson, Edgar D. Charles, Heather Platt

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6 Scopus citations

Abstract

INTRODUCTION: Treatment options are limited for people infected with hepatitis C virus (HCV) with decompensated liver disease. The C-SALT study assessed elbasvir (EBR) plus grazoprevir (GZR) in individuals with HCV genotype 1 infection and Child-Pugh class B (CP-B) cirrhosis. METHODS: In this 12-week, phase 2, nonrandomized, open-label study (NCT02115321; Protocol MK-5172-059), participants with CP-B cirrhosis received EBR 50 mg plus GZR 50 mg once daily, and a control group of noncirrhotic participants received EBR 50 mg plus GZR 100 mg once daily. The primary endpoint was sustained virologic response 12 weeks after the end of therapy. RESULTS: Sustained virologic response at 12 weeks after the end of therapy was achieved by 27/30 (90.0%) CP-B participants and 10/10 (100.0%) noncirrhotic participants. Two participants relapsed, and one died during follow-up after having undetectable HCV RNA at the end of treatment. Most CP-B participants had stable or improved model for end-stage liver disease and Child-Pugh scores at follow-up week 12 compared with baseline. There was no significant difference in drug exposure between groups, despite the differing GZR dose. Adverse events occurring in >10% of participants were fatigue (CP-B: 30.0%; noncirrhotic: 30.0%), arthralgia (16.7%; 20.0%), nausea (10.0%; 20.0%), and headache (10.0%; 50.0%). No serious treatment-related adverse events or hepatic events of clinical interest occurred. CONCLUSIONS: EBR 50 mg plus GZR 50 mg once daily for 12 weeks was highly effective and well tolerated in a traditionally hard-to-treat population.

Original languageEnglish (US)
JournalClinical and Translational Gastroenterology
Volume10
Issue number4
DOIs
StatePublished - Mar 28 2019

ASJC Scopus subject areas

  • Gastroenterology

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    Jacobson, I. M., Poordad, F., Firpi-Morell, R., Everson, G. T., Verna, E. C., Bhanja, S., Hwang, P., Caro, L., Robertson, M., Charles, E. D., & Platt, H. (2019). Elbasvir/grazoprevir in people with hepatitis C genotype 1 infection and child-pugh class B cirrhosis: the C-salt study. Clinical and Translational Gastroenterology, 10(4). https://doi.org/10.14309/ctg.0000000000000007