Ribavirin-Free Regimen with Sofosbuvir and Velpatasvir Is Associated with High Efficacy and Improvement of Patient-Reported Outcomes in Patients with Genotypes 2 and 3 Chronic Hepatitis C: Results from Astral-2 and -3 Clinical Trials

Zobair M. Younossi, Maria Stepanova, Mark Sulkowski, Graham R. Foster, Nancy Reau, Alessandra Mangia, Keyur Patel, Norbert Bräu, Stuart K. Roberts, Nezam Afdhal, Fatema Nader, Linda Henry, Sharon Hunt

Research output: Contribution to journalArticlepeer-review

Abstract

Background. Until recently, the approved treatment regimens for patients with hepatitis C virus (HCV) genotypes (GTs) 2 and 3 contain sofosbuvir (SOF) and ribavirin (RBV) for 12 or 24 weeks. The impact of RBV-free pan-genotypic regimen with SOF and velpatasvir (SOF/VEL) on patient-reported outcomes (PROs) of patients with genotype 2 and 3 has not been described. Methods. PROs data were collected from participants of ASTRAL-2 and ASTRAL-3 studies before, during, and after treatment using 4 PRO instruments (Short Form-36, Chronic Liver Disease Questionnaire-HCV, Functional Assessment of Chronic Illness Therapy-Fatigue, and Work Productivity and Activity Index: Specific Health Problem), and compared between the SOF/VEL and SOF + RBV groups. Results. A total of 818 HCV patients were included: 78% treatment naive, 25% cirrhosis. The rates of nearly all adverse events were lower in the RBV-free SOF/VEL group (all P <. 03). The SOF/VEL group also experienced improvement of their PROs by treatment week 4 (+1.8% on average across all PROs), which continued throughout treatment (+4.1%) and post-treatment (+5.5%). In contrast, those in the SOF + RBV group had a modest decline in their PROs starting at treatment week 4 (up to -3.7%), which lasted until the end of treatment (up to -6.4%). In multiple regression analysis, the association of a treatment regimen with end-of-treatment PROs was significant for nearly all PROs; the average beta was +5.0% for the use of SOF/VEL (reference: SOF + RBV). Conclusions. Patients receiving ribavirin-free SOF/VEL reported significantly better PRO scores during treatment compared with those receiving the RBV-containing regimen. Furthermore, the interferon- and ribavirin-free SOF/VEL regimen resulted in a rapid improvement of PROs in HCV GTs 2 and 3 patients during treatment and after achieving sustained virologic response.

Original languageEnglish
Pages (from-to)1042-1048
Number of pages7
JournalClinical Infectious Diseases
Volume63
Issue number8
DOIs
Publication statusPublished - Oct 15 2016

Keywords

  • Direct-acting antivirals
  • Fatigue
  • Health-related quality of life
  • Hepatitis C
  • Work productivity

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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