Author information
1Institute of Clinical Medicine, Akershus University, Oslo, Norway.
2Prisma Health/University of South Carolina School of Medicine Greenville, Clemson University, Greenville, SC, USA.
3Liver Unit, Department of Gastroenterology, Tel Aviv Medical Center and Tel Aviv University, Tel Aviv, Israel.
4The Kirby Institute, UNSW Sydney, Sydney, NSW, Australia.
5ID Care, Hillsborough, NJ, USA.
6Yale University School of Medicine, New Haven, CT, USA.
7Vancouver Infectious Diseases Centre, Vancouver, BC, Canada.
8Auckland City Hospital, Auckland, New Zealand.
9University of California, San Francisco, San Francisco, CA, USA.
10China Medical University Hospital, Taichung City, Taiwan.
11The Alfred Hospital, Melbourne, VIC, Australia.
12Merck & Co., Inc, Kenilworth, NJ, USA.
Abstract
Background: In people with chronic hepatitis C virus (HCV) infection, viral eradication is associated with improved health-related quality of life (HRQOL).
Objective: To assess changes in HRQOL among participants receiving opioid agonist therapy undergoing treatment for HCV infection.
Methods: COSTAR (NCT02251990) was a randomized, double-blind, placebo-controlled study. Adults with HCV infection on opioid agonist therapy received elbasvir (50 mg)/grazoprevir (100 mg) or placebo for 12 weeks. HRQOL was evaluated using the Medical Outcomes Study 36-Item Short Form Health Survey version 2 (SF-36v2) Acute Form. Participants remained blinded until 4 weeks after end of treatment.
Results: Overall, 201 participants received elbasvir/grazoprevir and 100 participants received placebo. Treatment difference mean change from baseline scores (elbasvir/grazoprevir minus placebo) indicated an improvement in HRQOL at 4 weeks after end of treatment in participants receiving elbasvir/grazoprevir versus those receiving placebo, driven by declining HRQOL in those receiving placebo and improved HRQOL in certain domains among participants receiving elbasvir/grazoprevir. Notable differences in SF-36v2 scores were evident in the general health (mean treatment difference [MTD], 6.00; 95% CI, 1.37-10.63), vitality (MTD, 6.81; 95% CI, 1.88-11.75), and mental health (MTD, 5.17; 95% CI, 0.52-9.82) domains and in the mental component summary score (mean, 2.83; 95% CI, 0.29-5.37). No notable between-treatment differences were evident at treatment weeks 4 or 12.
Conclusion: HRQOL in patients receiving medication for opioid dependence was improved following treatment for HCV infection with elbasvir/grazoprevir, suggesting that eradication of HCV infection with direct-acting antivirals is associated with improved HRQOL.
Trial registration number: ClinicalTrials.gov, NCT02251990.