Common TitleRetreatment of Sofosbuvir Failures from prior Clinical Trials
Official Title Ledipasvir-Sofosbuvir plus Ribavirin for Patients with Genotype 1 Hepatitis C Virus Previously Treated in Clinical Trials of Sofosbuvir Regimens
Purpose / DescriptionIn this open-label, phase 2 trial, patients with genotype 1 chronic HCV who failed a sofosbuvir-containing regimen in a phase 2 or 3 Gilead-sponsored clinical trial were eligible to receive retreatment with a 12-week course of ledipasvir-sofosbuvir plus ribavirin. Patients with compensated cirrhosis were allowed to enroll in the study (27% of patients enrolled had cirrhosis). Among the patients treated with ledipasvir-sofosbuvir plus ribavirin, 50 (98%) of 51 achieved an SVR12; the one patient who failed had genotype 3 HCV and was erroneously enrolled in the trial. Overall, the 12-week regimen of ledipasvir-sofosbuvir plus ribavirin was well tolerated and it shows promise as a treatment option for patients with prior sofosbuvir failure.
Treatments
Ledipasvir-Sofosbuvir

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