December 10, 2013

Clinical Gastroenterology and Hepatology

Article in Press

Zobair M. Younossi,Maria Stepanova, Linda Henry, Edward Gane Ira M. Jacobson, Eric Lawitz, David Nelson, Lynn Gerber, Fatema NaderSharon Hunt

Received 7 November 2013; accepted 17 November 2013. published online 09 December 2013.
Accepted Manuscript

Abstract

Background

& Aims: Interferon-based treatment of chronic hepatitis C virus (HCV) infection can negatively affect patient-reported outcomes (PROs) and work productivity (WP). We assessed these factors in patients with chronic hepatitis C treated with sofosbuvir and ribavirin, with or without pegylated interferon.

Methods

The HCV-specific Quality of Life (CLDQ-HCV), Functional Assessment of Chronic Illness Therapy-Fatigue, and WP and Activity Index: Specific Health Problem questionnaires were completed before, during, and after treatment of patients infected with HCV genotypes 2 or 3 who received sofosbuvir and ribavirin for 16 or 12 weeks (the FUSION study, n=201), or patients infected with HCV genotype 1 who received pegylated interferon, sofosbuvir, and ribavirin for 12 weeks (the NEUTRINO study, n=327).

Results

Patients in each group of the FUSION study had similar PRO and WP scores at each time point (all comparisons, P>.05). Compared to baseline, patients had modest reductions in fatigue, HCV-specific quality of life, and WP and Activity Index scores during treatment (P=.02 to <.0001). However, by 4 weeks after treatment, all scores returned to baseline levels or higher. Subjects in the NEUTRINO study had greater reductions in these scores during treatment; most remained significant through 4 weeks after treatment (P<.05). Significant improvements in PROs were observed among patients with sustained virologic responses 12 weeks after treatment (SVR12) in the FUSION and NEUTRINO studies (all P<.05). In multivariate analyses, after adjustment for confounders, interferon therapy was independently associated with worse PROs after 12 weeks of treatment.

Conclusions

Based on an analyses of 2 large clinical trials (FUSION and NEUTRINO), patient outcome and productivity are more negatively affected by the inclusion of pegylated interferon in treatment than by interferon-free regimens. Patients with SVR12 had significant reported improvements in outcome in both studies.

Key Words: CLDQ-HCV, WPAI, FACIT-F, quality of life, liver disease, hepatitis C

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