This is a bibliographic record of a published health technology assessment from a member of INAHTA. No evaluation of the quality of this assessment has been made for the HTA database.
CADTH. Clinical review report. Sofosbuvir (Sovaldi — Gilead Sciences Canada, Inc.) indication: chronic hepatitis C infection. Ottawa: Canadian Agency for Drugs and Technologies in Health (CADTH). CDR Clinical Review Report; SR0356. 2014
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.
Subject indexing assigned by CRD
Antiviral Agents; Canada; Chronic Disease; Drug Therapy, Combination; Hepacivirus; Hepatitis C, Chronics; Patient Safety
Country of organisation
An English language summary is available.
Address for correspondence
Canadian Agency for Drugs and Technologies in Health (CADTH), 865 Carling Avenue, Suite 600, Ottawa, Ontario Canada, K1S 5S8 Email: email@example.com
Date abstract record published