Authors' recommendations: There were four RCTs included in this review that enrolled patients with genotypes 2 or 3 (FISSION, FUSION, POSITRON, and VALENCE), but only one single-arm study (NEUTRINO) that included patients with genotypes 1 or 4. The genotype 2/3 studies featured a variety of populations and interventions, and with respect to SVR12 responses, the combination of 12 weeks of sofosbuvir+ribavirin demonstrated non-inferiority to 24 weeks of Peg-INF/RBV in a treatment-naive population (FISSION), and superiority to placebo in a population that was ineligible for, intolerant to, or unwilling to take pegylated interferon (POSITRON). Subgroup data from FUSION and findings from the descriptive VALENCE study suggest that genotype 3 patients may benefit from a longer duration of sofosbuvir+ribavirin (up to 24 weeks), compared with genotype 2 patients (12 weeks); however, due to design limitations, these findings are hypothesis-generating only. The shorter and potentially more tolerable sofosbuvir+ribavirin regimen might be expected to provide relatively better quality of life compared with Peg-INF/RBV, but there was no evidence of this from the included studies, in part due to a considerable amount of missing data for this outcome that rendered questionable results.

Project Status: Completed

Year Published: 2014

URL for published report: http://www.cadth.ca/media/cdr/clinical/SR0356_Sovaldi_CL_Report_e.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Canadian Agency for Drugs and Technologies in Health

Contact Address: 600-865 Carling Avenue, Ottawa, ON K1S 5S8 Canada. Tel: +1 613 226 2553; Fax: +1 613 226 5392;

Contact Name: requests@cadth.ca

Contact Email: requests@cadth.ca

Copyright: Canadian Agency for Drugs and Technologies in Health (CADTH)