Zobair M Younossi1,2, Maria Stepanova3, Mark Sulkowski4, David Wyles5, Shyam Kottilil6, Sharon Hunt3. 1. Department of Medicine, Center for Liver Diseases, Inova Fairfax Hospital, Falls Church, VA, USA. 2. Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA. 3. Center for Outcomes Research, Washington, DC, USA. 4. John Hopkins University, Baltimore, MD, USA. 5. University of California in San Diego, San Diego, CA, USA. 6. Division of Clinical Care and Research, Institute of Human Virology, University of Maryland, Baltimore, MD, USA.
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.
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-infectedpatients. METHODS:HIV-HCV co-infectedpatients 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-infectedpatients 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-HCVpatients. 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.
Authors: Michael J Zoratti; Ayesha Siddiqua; Rita E Morassut; Dena Zeraatkar; Roger Chou; Judith van Holten; Feng Xie; Eric Druyts Journal: EClinicalMedicine Date: 2020-01-05