Effects of Sofosbuvir-based Treatment, With and Without Interferon, on Outcome and Productivity of Patients With Chronic Hepatitis C

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 Nader,  Sharon 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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