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J Hepatol. 2016 Jul;65(1):33-39. doi: 10.1016/j.jhep.2016.02.042. Epub 2016 Mar 5.

Sofosbuvir/velpatasvir improves patient-reported outcomes in HCV patients: Results from ASTRAL-1 placebo-controlled trial.

Author information

1
Center for Liver Diseases, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA; Betty & Guy Beatty Center for Integrated Research, Inova Health System, Falls Church, VA, USA. Electronic address: zobair.younossi@inova.org.
2
Center for Outcomes Research in Liver Disease, Washington DC, USA.
3
Toronto Western Hospital Liver Centre, Toronto, Ontario, Canada.
4
Johann Wolfgang Goethe University Medical Center, Frankfurt, Germany.
5
Mount Sinai Beth Israel Medical Center, NY, USA.
6
Institute of Liver Studies, Kings College Hospital, London, UK.
7
Hopital Henri Mondor, Université Paris-Est, Créteil, France.

Abstract

BACKGROUND & AIMS:

The new pan-genotypic regimen [sofosbuvir (SOF) and velpatasvir (VEL)] for hepatitis C virus (HCV) has been associated with high efficacy. The aim of this study was to assess patient-reported outcomes (PROs) of this regimen.

METHODS:

The PRO data (CLDQ-HCV, SF-36, FACIT-F, WPAI) came from the ASTRAL-1 study, a multicenter multinational blinded placebo-controlled phase 3 clinical trial of a fixed dose combination of SOF 400mg and VEL 100mg for patients with genotype 1, 2, 4, 5, and 6 compared to placebo for 12weeks.

RESULTS:

624 patients received active treatment [618 achieved sustained virologic response (SVR)], and 116 received placebo. The baseline PRO scores were similar. By treatment week 4, patients receiving SOF/VEL experienced improvements in general health (on average, +2.3points), emotional well-being (+3.4), FACIT-F (+1.3), and all domains of CLDQ-HCV (+2.1 to +7.3) (all p<0.005). On the other hand, the only PRO that improved in patients receiving placebo was the worry domain of CLDQ-HCV: +4.6 (p=0.002). By the end of treatment, improvement in PRO scores with SOF/VEL continued, and no improvement was noted in the placebo. Improvement in PROs were also noted 12 and 24weeks post-treatment: +3.7, on average, in patients with SVR-12 after SOF/VEL vs. -2.6, on average, in the placebo arm (p<0.005). Multivariate analysis showed that treatment-emergent changes in PROs were predicted by receiving SOF/VEL for some summary PRO score (p<0.005).

CONCLUSIONS:

This placebo-controlled trial shows that patients treated with SOF/VEL experience significant improvement of their PROs during treatment and after achieving SVR.

LAY SUMMARY:

In patients with chronic hepatitis C infection, health-related quality of life and work productivity are often impaired due to HCV-related fatigue. Treatment of hepatitis C with interferon-based regimens, which was the standard of care for all HCV patients until recently, had substantial and potentially debilitating side effects. These regimens caused additional impairment in health-related quality of life and work productivity during treatment and shortly after treatment cessation. The newly developed interferon-free combination of sofosbuvir and velpatasvir has been shown to improve health-related quality of life during treatment, and lead to an improvement in a number of indicators of patient-reported outcomes after successful clearance of HCV and achieving sustained virologic response.

KEYWORDS:

HCV; PRO; SOF/VEL

PMID:
26956698
DOI:
10.1016/j.jhep.2016.02.042
[Indexed for MEDLINE]

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