Cogent Medicine (Jan 2020)

Prescription and efficacy of daclatasvir and sofosbuvir ± ribavirin for hepatitis C infection, including patient-reported outcomes, in routine practice in three European countries: The CMPASS-EU cohort study

  • Stefan Bourgeois,
  • Karel van Erpecum,
  • Jean Delwaide,
  • Uwe Naumann,
  • Stefan Christensen,
  • Christophe Moreno,
  • Anita Pathil,
  • Emile Schippers,
  • Nancy van Emmerik,
  • Benoit Caritey,
  • Conrad Fischer,
  • Florence Mercier,
  • Joerg Petersen

DOI
https://doi.org/10.1080/2331205X.2020.1727169
Journal volume & issue
Vol. 7, no. 1

Abstract

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Prescription and efficacy of daclatasvir and sofosbuvir ± ribavirin, including patient-reported outcomes, in routine practice in three European countries: the CMPASS-EU cohort study. Objectives: To identify patient characteristics associated with routine prescription of daclatasvir (DCV) in chronic hepatitis C virus (HCV) infection and evaluate effectiveness, safety and quality-of-life (QoL) changes for DCV-based regimens. Methods: A prospective, observational cohort study in Germany, Belgium and the Netherlands collected baseline data from all patients initiating a new HCV regimen, with 12-month follow-up of DCV-based treatments. Baseline predictors of prescription, longitudinal efficacy, and patient-reported QoL outcomes (EQ-5D, EQ-VAS and SF-36 global physical/mental health) on DCV were assessed. Results: Of 914 patients analyzed, 470 were prescribed DCV (469 with sofosbuvir [SOF] ± ribavirin [RBV]) and 444 non-DCV regimens. A high proportion prescribed DCV were cirrhotic (36%) and/or illicit drug users (IDU; 24%). Multivariate predictors of DCV treatment included genotype 3 infection (odds ratio 85.9 [95% confidence interval 43.5–170]), age ≥65 years (2.0 [1.2–3.3]), and cirrhosis (3.3 [2.0–5.3]). Sustained virologic response on DCV+SOF±RBV (observed) was 96–100% across subgroups of IDU, HIV co-infection, HCV genotype and cirrhosis status. Statistically significant improvements in all QoL outcomes were observed over 12 months of DCV+SOF±RBV irrespective of RBV use or cirrhosis status, but IDU had no change in SF-36 global mental health although other outcomes improved. Conclusions: In this cohort, DCV+SOF±RBV was efficacious for HCV treatment across a range of subgroups and associated with QoL improvements.

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