The summaries are free for public
use. The Chronic Liver Disease
Foundation will continue to add and
archive summaries of articles deemed
relevant to CLDF by the Board of
Trustees and its Advisors.
Abstract Details
Long-term Patient-Centered Outcomes in Cirrhotic Patients With Chronic Hepatitis C After Achieving Sustained Virologic Response
Clin Gastroenterol Hepatol. 2022 Feb;20(2):438-446.doi: 10.1016/j.cgh.2021.01.026. Epub 2021 Jan 22.
1Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Inova Medicine, Inova Health System, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia. Electronic address: Zobair.Younossi@inova.org.
2Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Inova Medicine, Inova Health System, Falls Church, Virginia.
3Department of Medicine, Duke University Medical Center, Durham, North Carolina.
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, Hannover, Germany.
10Academic Gastroenterology Department, Laiko Hospital, Athens, Greece.
11Gilead Sciences, Foster City, California.
12Center for Outcomes Research in Liver Disease, Washington, District of Columbia.
Abstract
Background & aims: 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.
Methods: Patients with HCV and cirrhosis treated in clinical trials with direct acting antiviral agents (DAAs) 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 < .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 < .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.
Conclusions: 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 2 years.