Author information

• ¹Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA; Inova Medicine, Inova Health System, Falls Church, VA, USA. Electronic address: Zobair.Younossi@inova.org.
• ²Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA; Inova Medicine, Inova Health System, Falls Church, VA, USA.
• ³Duke University Medical Center, Department of Medicine, Durham, NC, United States.
• ⁴Department of Hepato- Gastroenterology, Hospital Saint Joseph, Marseille, France.
• ⁵IRCCS Casa Sollievo della Sofferenza Hospital, Liver Unit, Medical Sciences, San Giovanni Rotondo, Italy.
• ⁶Liver Unit, Hospital Universitari Vall d'Hebron and Ciberehd del Instituto Carlos III, Barcelona, Spain.
• ⁷Department of Medicine I at the Goethe University Hospital, Frankfurt, Germany.
• ⁸Liver Center for Translational Research, IRCCS Humanitas, Milan, Italy.
• ⁹Hannover Medical School (MHH), Hannover, Germany.
• ¹⁰Academic Gastroenterology Department of Laiko Hospital of Athens, Greece.
• ¹¹Gilead Sciences, Foster City, CA, United States.
• ¹²Center for Outcomes Research in Liver Disease, Washington DC, United States.

Abstract

Objective: Achieving sustained virologic response (SVR) among patients with hepatitis C virus (HCV) leads to patient reported outcome (PRO) improvement. We aimed to assess the long-term post-SVR PRO trends in HCV patients with cirrhosis.

Design: Patients with HCV and cirrhosis treated in clinical trials with direct acting antiviral agents (DAA's) who achieved SVR-12 were prospectively enrolled in a long-term registry (clinicaltrials.gov #NCT02292706). PROs were collected every 24 weeks using the Short Form-36v2 (SF-36), CLDQ-HCV, and WPAI-HCV.

Results: Pre-treatment baseline data were available for 854 cirrhotic patients who achieved SVR after DAAs. Of these, 730 had compensated (CC) and 124 had decompensated cirrhosis (DCC) before treatment- patients with DCC reported severe impairment in their PROs in comparison to CC patients (by mean -5% to -16% of a PRO range size; p<0.05 for 16 out of 20 studied PROs]. After achieving SVR and registry enrollment, significant PRO improvements were noted from pre-treatment levels in 11/20 domains for those with DCC (+4% to +21%) and 19/20 PRO domains in patients with CC (+3% to +17%). Patients with baseline DCC had higher rates of hepatocellular carcinoma and mortality (P<0.05). In patients with CC, the PRO gains persisted up to 168 weeks (3.5 years) of registry follow-up. In patients with DCC, the improvements lasted for at least 96 weeks but a declining trend after year 2.

Conclusion: Patients with HCV cirrhosis experience severe PRO impairment at baseline with sustainable improvement after SVR. Though those with DCC experience improvement, there is a decline after two years.