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Patient-reported outcomes in HCV patients with cirrhosis treated with sofosbuvir-containing regimens

This month's Hepatology investigates patient-reported outcomes in chronic hepatitis C patients with cirrhosis treated with sofosbuvir-containing regimens.

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Whether the presence of cirrhosis influences patient-reported outcomes (PROs), including health-related quality of life, during treatment with newly available anti-HCV (hepatitis C virus) regimens is unclear.

Dr Zobair Younossi and colleagues from Virginia, USA assessed the association of cirrhosis with PROs in patients treated with sofosbuvir (SOF)-containing regimens.

Four PRO questionnaires, Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), and the Work Productivity and Activity Impairment Questionnaire: Specific Health Problem [WPAI-SHP]) were administered to subjects receiving SOF and ribavirin.

The team observed that HCV patients with cirrhosis showed significant impairment of PROs before initiation of treatment.

During treatment, patients with cirrhosis treated with the IFN-free regimen experienced moderate decline in their PRO scores.

Patients showed decline in PRO scores that ranged from 3% to 16%
Hepatology

In contrast, the team noted that patients with cirrhosis treated with IFN-containing regimen showed decline in PRO scores that ranged from 3% to 16%.

Nevertheless, by follow-up week 12, no PRO decrement from baseline was observed in patients with cirrhosis regardless of the treatment regimen.

Furthermore, in patients with cirrhosis with HCV who achieved sustained virological response at 12 weeks, some improvement in PROs from baseline was observed.

During treatment, the team noted that changes in PRO scores were similar between patients with and without cirrhosis for both treatment regimens.

Independent predictors of lower PROs in patients with cirrhosis included baseline depression, anxiety, fatigue, high HCV viral load, female gender, and receiving IFN-containing treatment.

Dr Younossi's team concludes, "Treatment with SOF+RBV with or without Peg-IFN is tolerated by HCV patients with and without cirrhosis in terms of their PRO scores."

"After achieving SVR-12 with the IFN-free regimen, patients with cirrhosis showed improvement in some aspects of their PROs."

Hepatology 2014: 59(6): 2161–2169
16 June 2014

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