Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
PT-NANBH
Interventions
DRUG

8 weeks SOF/LED

Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.

DRUG

12 weeks SOF/LED

Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.

Trial Locations (4)

75093

Digestive Health Associates, Plano

77072

Liver and Digestive Consultants, Houston

94304

Stanford University Medical Center, Palo Alto

95128

San Jose Gastroenterology, San Jose

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Gilead Sciences

INDUSTRY

lead

Stanford University

OTHER