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

Study Overview
=================
Brief Summary
-----------------
The primary objectives of this study are to describe the efficacy of: 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6 12-week treatment of SOF/LED for all other HCV-6 populations

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

Official Title
-----------------
Comparative Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir for 8 or 12 Weeks for Chronic Hepatitis C Genotype 6

Conditions
-----------------
PT-NANBH

Intervention / Treatment
-----------------
* Drug: 8 weeks SOF/LED
* Drug: 12 weeks SOF/LED


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age ≥18 years HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6 Selected to start on treatment by their treating providers Willing and able to provide informed consent Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception Lactating females must agree to discontinue nursing before the study drug is administered Exclusion Criteria: Previous recipient of a liver transplant Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 8 weeks SOF/LED<br>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. | Drug: 8 weeks SOF/LED<br>* 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.<br>* Other names: Solvaldi;|
| Experimental: 12 weeks SOF/LED<br>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. | Drug: 12 weeks SOF/LED<br>* 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.<br>* Other names: Solvaldi;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment |  | 12 weeks after end of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment. | Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE) | Day 1 of treatment to 12 weeks post treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis C, genotype 6