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

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.