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Long-term Patient-Centered Outcomes in Cirrhotic Patients With Chronic Hepatitis C After Achieving Sustained
Zobair M Younossi1, Andrei Racila2, Andrew Muir3
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.
Insights
Achieving sustained virologic response (SVR) in hepatitis C virus (HCV) patients improves patient-reported outcomes (PROs). While improvements are seen in decompensated cirrhosis, a decline occurs after two years.
Area of Science:
- Hepatology
- Virology
- Patient-Reported Outcomes
Background:
- Hepatitis C virus (HCV) infection can lead to cirrhosis, significantly impacting patients' quality of life.
- Sustained virologic response (SVR) achieved through direct-acting antiviral agents (DAAs) is associated with improvements in patient-reported outcomes (PROs).
Purpose of the Study:
- To evaluate the long-term trends of patient-reported outcomes (PROs) after achieving SVR in patients with HCV-related cirrhosis.
- To compare PRO trajectories between patients with compensated cirrhosis (CC) and decompensated cirrhosis (DCC) post-SVR.
Main Methods:
- Prospective enrollment of HCV patients with cirrhosis who achieved SVR-12 after DAA treatment into a long-term registry.
- Collection of PROs using SF-36v2, CLDQ-HCV, and WPAI-HCV questionnaires every 24 weeks.
Main Results:
- Patients with decompensated cirrhosis (DCC) reported more severe baseline PRO impairment than those with compensated cirrhosis (CC).
- Significant PRO improvements were observed post-SVR in both CC and DCC groups, with CC patients showing gains in 19/20 domains and DCC patients in 11/20 domains.
- PRO gains persisted for at least 3.5 years in CC patients, while improvements in DCC patients lasted up to 96 weeks, with a declining trend thereafter.
Conclusions:
- HCV cirrhosis patients experience significant PRO impairment at baseline, which sustainably improves after achieving SVR.
- While PROs improve in DCC patients post-SVR, a decline in outcomes is observed after two years, highlighting the need for continued monitoring.
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.
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