Common TitleNew Zealand Genotype 3 and 6 Trial
Official Title Efficacy of Ledipasvir and Sofosbuvir, with or without Ribavirin, for 12 Weeks inPatients with HCV Genotype 3 or 6 Infection
Purpose / DescriptionIn the open-label, phase 2 New Zealand Genotype 3 and 6 trial, investigators enrolled 126 patients with chronic hepatitis C infection to receive a 12 weeks of treatment with fixed-dose combination ledipasvir-sofosbuvir, with or without ribavirin. Four groups were enrolled: (a) treatment-naive patients with genotype 3 infection who received ledipasvir-sofosbuvir, (b) (a) treatment-naive patients with genotype 3 infection who received ledipasvir-sofosbuvir plus ribavirin, (c) treatment-experienced patients with genotype 3 infection who received ledipasvir-sofosbuvir plus ribavirin, and (d) treatment-naive and -experienced patients with genotype 6 infection who received ledipasvir-sofosbuvir. The SVR 12 responses in treatment-naive patients with genotype 3 were superior in the regimen with ribavirin (100%) than without ribavirin (64%). Among the treatment-experienced patients, 41 (82%) of 50 achieved an SVR 12 with a regimen of ledipasvir-sofosbuvir plus ribavirin. The SVR 12 rate was 96% in the patients with genotype 6. In this trial, the investigators showed that patients with genotype 3 had very good SVR 12 rates with ledipasvir-sofosbuvir plus ribavirin and those with genotype 6 responded well to ledipasvir-sofosbuvir plus ribavirin without ribavirin.
Phase Phase II
ClinicalTrials.gov NCT01826981
Treatments
Ledipasvir-Sofosbuvir

Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
IndustryGilead Sciences