Health-Related Quality of Life in Chronic HCV-Infected Patients Switching to Pegylated-Interferon-Free Regimens (ANRS CO20 CUPIC Cohort Study and SIRIUS Trial)

Patient. 2017 Oct;10(5):605-614. doi: 10.1007/s40271-017-0232-1.

Abstract

Objective: We aimed to compare health-related quality of life (HRQL) during and after hepatitis C virus (HCV) treatment in patients receiving pegylated-interferon (PEG-IFN)-containing therapy (including boceprevir or telaprevir-ANRS CO20 CUPIC cohort) who subsequently switched to PEG-IFN-free regimens (sofosbuvir + ledipasvir with or without ribavirin [RBV]-SIRIUS trial).

Methods: Two analyses were performed. The first compared physical (PCS) and mental (MCS) HRQL (MOS SF-12) scores during treatment between CUPIC and SIRIUS. The second compared PCS and MCS scores after treatment end between CUPIC and SIRIUS. The analyses used linear regression mixed models adjusted for pre-treatment HRQL scores, gender, and age at each visit.

Results: Among patients enrolled successively in both studies, 43 (corresponding to 212 HRQL assessments) and 43 (82 HRQL assessments) were eligible for the 'during' and 'post' treatment analyses, respectively. In the 'during-treatment' analysis, we found significantly higher PCS and MCS values during PEG-IFN-free treatment than for PEG-IFN-containing treatment. In the 'post-treatment' analysis, results showed significantly higher MCS values after PEG-IFN-free treatment than after PEG-IFN-containing treatment. No significant difference was found for PCS in the post-treatment analysis.

Conclusions: These results highlight an improvement in both physical and mental HRQL during HCV treatment, but no major improvement in physical HRQL after treatment end, when comparing PEG-IFN-free regimens with PEG-IFN-containing regimens. This suggests that in the PEG-IFN-free regimens era, screening and comprehensive care of comorbidities and residual somatic symptoms during treatment, and especially after HCV clearance, are still needed to improve patient outcomes.

Keywords: Mental Component Summary; Mental Component Summary Score; Physical Component Summary; Sustained Virologic Response; Telaprevir.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Age Factors
  • Aged
  • Antiviral Agents / administration & dosage
  • Antiviral Agents / adverse effects
  • Antiviral Agents / therapeutic use*
  • Benzimidazoles / administration & dosage
  • Benzimidazoles / adverse effects
  • Benzimidazoles / therapeutic use*
  • Cohort Studies
  • Comorbidity
  • Double-Blind Method
  • Female
  • Fluorenes / administration & dosage
  • Fluorenes / adverse effects
  • Fluorenes / therapeutic use*
  • Health Status
  • Hepatitis C, Chronic / drug therapy*
  • Hepatitis C, Chronic / psychology*
  • Humans
  • Male
  • Mental Health
  • Middle Aged
  • Oligopeptides / therapeutic use
  • Patient Reported Outcome Measures
  • Polyethylene Glycols
  • Proline / analogs & derivatives
  • Proline / therapeutic use
  • Quality of Life*
  • Severity of Illness Index
  • Sex Factors
  • Sofosbuvir
  • Sustained Virologic Response
  • Uridine Monophosphate / administration & dosage
  • Uridine Monophosphate / adverse effects
  • Uridine Monophosphate / analogs & derivatives*
  • Uridine Monophosphate / therapeutic use

Substances

  • Antiviral Agents
  • Benzimidazoles
  • Fluorenes
  • Oligopeptides
  • ledipasvir, sofosbuvir drug combination
  • Polyethylene Glycols
  • telaprevir
  • N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide
  • Proline
  • Uridine Monophosphate
  • Sofosbuvir