Common TitleNIAID Retreatment of Sofosbuvir Failures (Genotype 1)
Official Title Re-Treatment of Chronic Hepatitis C Virus Genotype 1 Infection after Relapse: an Open-Label Pilot Study.
Purpose / Description
This open-label, phase 2a trial enrolled patients with genotype 1 HCV who previously had failed a 24-week course of sofosbuvir plus ribavirin and retreated them using fixed-dose combination of ledipasvir-sofosbuvir for 12 weeks. A total of 14 patients enrolled and all had prior relapse as the cause of treatment failure. Among the 14 patients, 13 were male and 13 were black. One half of those enrolled had advanced fibrosis (Knodell Histology Activity Index score of 3 or 4). The virologic response rates were excellent, with 14 (100%) of 14 patients achieving an SVR12. This small study is very promising but should be confirmed by larger future studies, which could include prior nonresponders.
Phase Phase II
ClinicalTrials.gov NCT01805882
Treatments
Ledipasvir-Sofosbuvir

Ledipasvir-Sofosbuvir
Tradename:HarvoniOther Names:LDV-SOFClass:FDA-ApprovedFunding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)