Patient‐reported outcomes in patients co‐infected with hepatitis C virus and human immunodeficiency virus treated with sofosbuvir and velpatasvir: The ASTRAL‐5 study

摘要

Abstract Background & Aim The fixed‐dose combination of sofosbuvir and velpatasvir ( SOF / VEL ) is a ribavirin‐free pan‐genotypic regimen with high efficacy. We assessed the impact of SOF / VEL on patient‐reported outcomes ( PRO ) of HIV ‐ HCV co‐infected patients. Methods HIV ‐ HCV co‐infected patients were treated with 12?weeks of SOF / VEL (400?mg/100?mg daily). All subjects completed four PRO questionnaires [ CLDQ ‐ HCV , SF ‐36, FACIT ‐F and WPAI : SHP ] before, during and post‐treatment. Results ASTRAL ‐5 enrolled 106 HIV ‐ HCV co‐infected patients on stable antiretroviral therapy (age: 54.2±0.9?years, cirrhosis: 17.9%, HCV genotype 1: 73.6%). SVR ‐12 was achieved by 95.3% of subjects. By week 4 of treatment, PRO scores improved from the baselines levels in 12 out of 26 calculated PRO domains (on average, +1.9 to +7.4 points on a universal 0‐100 PRO scale, all P .05). By the end of treatment, improvements were seen in 20/26 PRO domains (+2.5% to +11.9%, P .03). There were no significant decrements in any PRO domains during treatment. By follow‐up week 12, patients who achieved SVR ‐12 experienced significant improvement in 19/26 of their PRO domains (+3.2% to +13.3%, P .05). After controlling for baseline psychiatric co‐morbidities, improvements in PRO scores during treatment with SOF / VEL were similar to those seen in matched HCV ‐mono‐infected patients treated with the same regimen ( ASTRAL ‐1 study). In multivariate analysis, pre‐treatment anxiety and concomitant use of opioids were the most consistent significant ( P .05) predictors of PRO impairment in HIV ‐ HCV patients. Conclusions Patients with HIV ‐ HCV treated with SOF / VEL experience very high efficacy accompanied by early and sustained improvement of patient‐reported outcomes covering all aspects of patients’ experience.