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Clin Gastroenterol Hepatol. 2014 Aug;12(8):1349-59.e13. doi: 10.1016/j.cgh.2013.11.032. Epub 2013 Dec 6.

Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C.

Author information

1
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia. Electronic address: zobair.younossi@inova.org.
2
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia; Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
3
Betty and Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, Virginia.
4
Auckland City Hospital, Auckland, New Zealand.
5
Weill Cornell Medical College, New York, New York.
6
Texas Liver Institute, University of Texas Health Science Center, San Antonio, Texas.
7
University of Florida, Gainesville, Florida.
8
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, Virginia.

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 (Chronic Liver Disease Questionnaire-HCV version [CLDQ-HCV]), Functional Assessment of Chronic Illness Therapy-Fatigue, and Work Productivity 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 with 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 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:

On the basis of an analysis 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 sustained virologic responses 12 weeks after treatment had significant improvements in PROs in both studies.

KEYWORDS:

CLDQ-HCV; FACIT-F; Hepatitis C; Liver Disease; Quality of Life; WPAI

PMID:
24316172
DOI:
10.1016/j.cgh.2013.11.032
[Indexed for MEDLINE]

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