Elbasvir/Grazoprevir in People With Hepatitis C Genotype 1 Infection and Child-Pugh Class B Cirrhosis: The C-SALT Study

• DOI: 10.14309/ctg.0000000000000007
• Publication Date: 2019-04-13T07:13:35Z
• Authors: 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
• Keywords: Hepatitis C

INTRODUCTION: Treatment options are limited for people infected with hepatitis C virus (HCV) decompensated liver disease. The C-SALT study assessed elbasvir (EBR) plus grazoprevir (GZR) in individuals HCV genotype 1 infection and Child-Pugh class B (CP-B) cirrhosis. METHODS: In this 12-week, phase 2, nonrandomized, open-label (NCT02115321; Protocol MK-5172-059), participants CP-B cirrhosis received EBR 50 mg GZR once daily, a control group of noncirrhotic 100 daily. primary endpoint was sustained virologic response 12 weeks after the end therapy. RESULTS: Sustained at therapy achieved by 27/30 (90.0%) 10/10 (100.0%) participants. Two relapsed, one died during follow-up having undetectable RNA treatment. Most had stable or improved model end-stage disease scores week compared baseline. There no significant difference drug exposure between groups, despite differing dose. Adverse events occurring >10% were fatigue (CP-B: 30.0%; noncirrhotic: 30.0%), arthralgia (16.7%; 20.0%), nausea (10.0%; headache 50.0%). No serious treatment-related adverse hepatic clinical interest occurred. CONCLUSIONS: daily highly effective well tolerated traditionally hard-to-treat population. TRANSLATIONAL IMPACT: Although reduced-dose is not available cirrhosis, these results complement 2/3 trial data real-world experience EBR/GZR.