Institute of Clinical Medicine, Akershus University, Oslo, Norway.
Prisma Health/University of South Carolina School of Medicine Greenville, Clemson University, Greenville, SC, USA.
J Addict Dis. 2023 Jul-Sep;41(3):213-224. doi: 10.1080/10550887.2022.2088978. Epub 2022 Aug 3.
In people with chronic hepatitis C virus (HCV) infection, viral eradication is associated with improved health-related quality of life (HRQOL).
To assess changes in HRQOL among participants receiving opioid agonist therapy undergoing treatment for HCV infection.
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.
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.
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.
ClinicalTrials.gov, NCT02251990.
在慢性丙型肝炎病毒（HCV）感染者中，病毒清除与健康相关的生活质量（HRQOL）改善相关。
评估接受阿片类药物激动剂治疗的 HCV 感染者接受 HCV 感染治疗后 HRQOL 的变化。
COSTAR（NCT02251990）是一项随机、双盲、安慰剂对照研究。正在接受阿片类药物激动剂治疗的 HCV 感染成人接受了 elbasvir（50mg）/grazoprevir（100mg）或安慰剂治疗 12 周。使用医疗结局研究 36 项简短健康调查问卷第 2 版（SF-36v2）急性形式评估 HRQOL。参与者在治疗结束后 4 周内保持盲态。
总体而言，201 名参与者接受了 elbasvir/grazoprevir 治疗，100 名参与者接受了安慰剂治疗。治疗结束后 4 周时，与安慰剂相比，接受 elbasvir/grazoprevir 治疗的参与者 HRQOL 平均变化（elbasvir/grazoprevir 减去安慰剂）表明 HRQOL 得到改善，这是由于安慰剂组 HRQOL 下降，而接受 elbasvir/grazoprevir 治疗的参与者在某些领域的 HRQOL 得到改善。在 SF-36v2 评分中，一般健康（平均治疗差异 [MTD]，6.00；95%CI，1.37-10.63）、活力（MTD，6.81；95%CI，1.88-11.75）和心理健康（MTD，5.17；95%CI，0.52-9.82）领域以及心理成分综合评分（均值，2.83；95%CI，0.29-5.37）有明显差异。在治疗第 4 周或第 12 周时，未观察到治疗之间的明显差异。
接受阿片类药物依赖药物治疗的患者在接受 elbasvir/grazoprevir 治疗 HCV 感染后，HRQOL 得到改善，这表明直接作用抗病毒药物清除 HCV 感染与改善 HRQOL 相关。
ClinicalTrials.gov，NCT02251990。
