1Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, United States; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, United States.
BACKGROUND AND AIM:
Whether the presence of cirrhosis influences patient-reported outcomes (PROs) including health-related quality of life during treatment with newly available anti-HCV regimens is unclear. Our aim was to assess the association of cirrhosis with PROs in patients treated with sofosbuvir-containing regimens.
Four PRO questionnaires [Short Form-36 (SF-36) Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Work Productivity and Activity Index (WPAI-SHP)] were administered to subjects receiving sofosbuvir and ribavirin (FUSION trial, N=201, 34% cirrhosis; VALENCE trial: N=333, 21% cirrhosis) and sofosbuvir, ribavirin and pegylated interferon (NEUTRINO trial, N=327, 17% cirrhosis).
HCV patients with cirrhosis have significant impairment of PROs prior to the initiation of treatment. During treatment, cirrhotic patients treated with the interferon-free regimen experienced moderate decline in their summary PRO scores (0.6%-5.2% on a normalized scale; all p>0.02). In contrast, cirrhotic patients treated with interferon-containing regimen showed decline in PRO scores that ranged 3.4% to 16.0% (all p<0.005). Nevertheless, by follow-up week 12, no PRO decrement from baseline was observed in cirrhotics regardless of the treatment regimen. Furthermore, in HCV-cirrhotics who achieved SVR-12, some improvement in PROs from baseline was observed. During treatment, changes in PRO scores were similar between cirrhotics and non-cirrhotics for both treatment regimens (all p>0.05). Independent predictors of lower PROs in patients with cirrhosis included baseline depression, anxiety, fatigue and high HCV viral load, female gender and receiving interferon-containing treatment.
Treatment with sofosbuvir+ribavirin with or without pegylated interferon is tolerated similarly by HCV patients with and without cirrhosis in terms of their PRO scores. After achieving SVR-12 with the interferon-free regimen, cirrhotic patients showed improvement in some spects of their PROs.