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Clinical Trial
. 2014 Aug;61(2):228-34.
doi: 10.1016/j.jhep.2014.04.003. Epub 2014 Apr 5.

Patient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: the VALENCE study

Zobair M Younossi  1 , Maria Stepanova  2 , Stefan Zeuzem  3 , Geoffrey Dusheiko  4 , Rafael Esteban  5 , Christophe Hezode  6 , Hendrik W Reesink  7 , Ola Weiland  8 , Fatema Nader  9 , Sharon L Hunt  2
Affiliations
Clinical Trial

Patient-reported outcomes assessment in chronic hepatitis C treated with sofosbuvir and ribavirin: the VALENCE study

Zobair M Younossi et al. J Hepatol. 2014 Aug.

Abstract

Background & aim: Interferon (IFN) negatively impacts patients' well-being and patient-reported outcomes (PROs). Our aim was to assess PROs during treatment with an IFN-free regimen [sofosbuvir (SOF)+ribavirin (RBV)].

Methods: Four PRO questionnaires [Short Form-36 (SF-36), Chronic Liver Disease Questionnaire-HCV (CLDQ-HCV), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Work Productivity and Activity Index: Specific Health Problem (WPAI:SHP)] were administered at baseline, end-of-treatment and post-treatment to 334 HCV genotype 2 and 3 patients (naïve or treatment-experienced) enrolled in the VALENCE study. Of these, 250 genotype 3 patients were treated for 24 weeks while 73 genotype 2 and 11 genotype 3 patients received 12 weeks of treatment.

Results: Baseline PRO scores were similar between the two arms of the study. Throughout and after treatment, patients receiving 12 or 24 weeks had similar FACIT-F, CLDQ-HCV, SF-36 and WPAI:SHP scores (all p>0.05). Compared to their own baseline scores, patients receiving SOF+RBV experienced modest declines in some aspects of SF-36, CLDQ-HCV, fatigue and WPAI:SHP scores (p = 0.04 to <0.0001). By follow-up week 12, all PRO scores returned to the pre-treatment levels (p>0.05). In patients achieving SVR-12 (regardless of the regimen), significant improvements were noted in general health (p = 0.0004), CLDQ-HCV (p<0.0001), fatigue (p = 0.005), emotional well-being (p<0.0001) and physical component summary score of SF-36 (p = 0.0022). In multivariate analysis, baseline depression, fatigue, insomnia, cirrhosis, and treatment-related adverse events were the most consistent predictors of PRO impairment (all p<0.05).

Conclusions: PROs are minimally impacted by SOF+RBV regimens. An additional 12 weeks of treatment does not substantially add to the PRO burden.

Keywords: CLDQ-HCV; Clinical trial; FACIT-F; Hepatitis C; Patient-reported outcomes; SF-36; WPAI.

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