December 12, 2013

Journal of Hepatology

Article in Press

Minimal Impact of Sofosbuvir and Ribavirin on Health Related Quality of Life in Chronic Hepatitis C (CH-C)

Zobair M. Younossi, Maria Stepanova, Linda Henry, Edward Gane, Ira M. Jacobson, Eric Lawitz, David Nelson, Fatema Nader, Sharon Hunt

Received 17 September 2013; received in revised form 29 November 2013; accepted 4 December 2013. published online 11 December 2013.
Accepted Manuscript

Abstract

Background

Treatment for CH-C contains interferon with substantial associated side effects and health-related quality of life (HRQL) impairment. Currently, there is no published data assessing the impact of interferon-free regimens on HRQL.

Aim

To report the HRQL of patients who participated in clinical trials of sofosbuvir (SOF) for CH-C.

Methods

CH-C patients were treated with sofosbuvir (SOF), pegylated interferon (PEG-IFN), ribavirin (RBV), or placebo in different combinations and duration (POSITRON, FISSION, FUSION, and NEUTRINO phase III trials). HRQL was assessed using SF- 36 at baseline, during, at the end of treatment, and at follow-up, and compared between treatment arms.

Results

HRQL scores decreased over the course of treatment for all treatment arms in all studies; however, patients returned to their baseline score by the end of follow-up. Compared to placebo, SOF and RBV was not associated with HRQL impairment (POSITRON). Compared to SOF and RBV, HRQL was significantly more impaired in the PEG-IFN and RBV arm (FISSION). For those treated with SOF and RBV, there was no difference in HRQL between 12 weeks or 16 weeks of treatment (FUSION). Multivariate analysis demonstrated that depression, fatigue, and insomnia were important predictors of patients’ HRQL prior, during or after treatment. Additionally, anemia and receiving interferon were predictors of HRQL impairment during treatment. Achieving sustained virologic response after 12 weeks of follow-up (SVR-12) with SOF and RBV was associated with improvement in HRQL scores from baseline.

Conclusions

Treatment-related HRQL impairment during SOF and RBV regimen is mild, and does not increase with longer treatment duration. Achieving SVR-12 with SOF and RBV is associated with an improvement in HRQL.

Keywords: Quality of life, Clinical trials, Hepatitis C

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