SAN FRANCISCO—The oral fixed-dosed elbasvir/grazoprevir (Zepatier; Merck) combination has a “positive impact” on patient-reported outcomes (PROs) in those with treatment-naïve chronic hepatitis C virus (HCV), results from a randomized Phase 3 placebo-controlled trial reported at The Liver Meeting® 2015 concluded.
In addition, “the changes in PRO scores in this study were substantially more favorable than the large declines in PROs historically associated with interferon and ribavirin-containing regimens,” stated Jean Marie Arduino, ScD, Merck & Co., Kenilworth, NJ.
The 12-week study randomly assigned 421 patients with genotype (GT) 1, 4, or 6 infection to receive immediate treatment with 1 or more doses of elbasvir 50mg/grazoprevir 100mg once daily (n=316) or placebo (n=105) or to deferred treatment with placebo for 12 weeks, then open-label elbasvir/grazoprevir starting at follow-up Week 4.
Previous results showed a 94.6% (95% confidence interval [CI]: 91.5–96.8) rate of sustained virologic response (SVR) at 12 weeks, and a safety profile similar to placebo.
During the study, patients completed five PROs—the General Health-Related Quality of Life (HRQOL) SF-36v2 Acute Health Survey (1-week recall), the EuroQoL-5D-5L/Visual Analogue Scale, and three disease-specific PROs, the FACIT-Fatigue Scale, the HCV-Chronic Liver Disease Questionnaire (CLDQ-HCV) and Work Productivity and Activity Impairment due to Hepatitis C—at baseline, treatment Week 4, treatment Week 12, and follow-up Week 4.
In this analysis, “our aim was to evaluate whether HCV treatment with elbasvir/grazoprevir altered PROs,” noted Dr. Arduino. The investigators estimated mean change from baseline in PRO scores by treatment group as well as treatment group differences in mean change scores.
Treatment with elbasvir/grazoprevir improved several dimensions of general HRQOL from baseline, they found. This included General Health, Mental Health, and Mental Component Score (MCS) at treatment Week 4; Vitality, MCS, and Overall Health (EQ-VAS) at treatment Week 12; Physical Functioning, Role-Limitations-Physical, General Health, Vitality, Social Functioning, Mental Health, Physical Component Score, MCS, Overall Health (EQ-VAS) at follow-up Week 4; and Role-Limitations: Physical, General Health, Vitality, Social Functioning, Mental Health, MCS, and Overall Health (EQ-VAS) at follow-up Week 12.
“Treatment with placebo had a negative impact on general HRQOL-SF-36 and EQ-VAS but a positive impact on some dimensions of disease-specific HRQOL (Emotion, Worry, and Total Score of CLDQ-HCV),” they reported.