High Efficacy, Improved PROs With SOF/VEL in HCV/HIV Co-Infection
BOSTON, MA—A fixed-dose combination of the sofosbuvir (SOF) and velpatasvir (VEL) pan-genotypic hepatitis C virus (HCV) regimen is associated with improvement of patient-reported outcomes (PROs) among those with HIV co-infection, according to data from the ASTRAL-5 clinical study, presented at The Liver Meeting® 2016.
“Patients with HIV/HCV co-infection treated with SOF/VEL experience high efficacy accompanied by early and sustained improvements of PROs,” reported Zobair M. Younossi, MD, of the Center for Liver Disease, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA. “These PRO improvements are maximizing after achieving SVR-12 [sustained virological response at 12 weeks].”
The study authors enrolled 106 HIV/HCV co-infected patients, all of whom were on ART. The cohort patients' average age was 54 years. Eighteen percent had cirrhosis and 74% were genotype 1. At baseline, half of the co-infected cohort reported depression and 34% had anxiety.
Matched HCV mono-infected patients administered SOF/VEL in ASTRAL-1 (n=234) were used as a historical control group for the study, Dr. Younossi said.
At baseline, throughout treatment, and after treatment, participants repeatedly completed 4 PRO questionnaires: the Chronic Liver Disease Questionnaire HCV (CLDQ-HCV), Short Form-36 (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), and Work Productivity and Activity Index: Specific Health Problem (WPAI:SHP).
Study participants underwent 12 weeks of SOF/VEL (400mg/100mg daily).
“After 12 weeks of treatment with SOF/VEL, 94.3% of patients achieved SVR12,” Dr. Younossi said.
PRO scores had improved significantly by Week 4 (+2.3% to +11.9%; P<0.04). By Week 12, those patients who achieved SVR-12 also experienced a significant improvement in PRO scores for 19 of 26 questionnaire domains (P<0.03).
“Adjusted for clinical and demographic PRO predictors, being HCV viremic was consistently and significantly associated with PRO impairment,” (P<0.0002), Dr. Younossi concluded.