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

Stanford University

Status and phase: Completed; Phase 4

Conditions: PT-NANBH

Treatments: Drug: 8 weeks SOF/LED; Drug: 12 weeks SOF/LED

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02480166

33196

Details and patient eligibility

About

The primary objectives of this study are to describe the efficacy of:

1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6
2. 12-week treatment of SOF/LED for all other HCV-6 populations

Full description

The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, age ≥18 years
2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6
3. Selected to start on treatment by their treating providers
4. Willing and able to provide informed consent
5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline
7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
8. Lactating females must agree to discontinue nursing before the study drug is administered

Exclusion criteria

1. Previous recipient of a liver transplant
2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

8 weeks SOF/LED

Experimental group

Description:

Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.

Treatment:

Drug: 8 weeks SOF/LED

12 weeks SOF/LED

Experimental group

Description:

Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.

Treatment:

Drug: 12 weeks SOF/LED