Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients

Phase 4CompletedNCT02482077

Humanity and Health Research Centre112 enrolled

Overview

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

112

Conditions

Chronic Hepatitis C Infection

Interventions

SOF+RBVDRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).

SOF+DCVDRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.

LDV/SOFDRUG

Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age equal to or greater than 18 years, with chronic genotype 2 HCV infection; 2. Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen; 3. HCV RNA \> 10,000 IU/mL at Screening; 4. Screening laboratory values within defined thresholds 5. Use of two effective contraception methods if female of childbearing potential or sexually active male Exclusion Criteria: 1. Pregnant or nursing female or male with pregnant female partner; 2. HIV or chronic hepatitis B virus (HBV) infection; 3. Hematologic or biochemical parameters at Screening outside the protocol-specified requirements; 4. Active or recent history (≤ 1 year) of drug or alcohol abuse; 5. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).

Locations (2)

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital

Beijing, Beijing Municipality, China

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, China

Outcomes

Primary Outcomes

Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy

SVR12 is defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.

Time frame: Post treatment Week 12

Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)

Time frame: Baseline up to Week 24

Secondary Outcomes

Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment

Time frame: Baseline up to Week 24

HCV RNA levels and change during and after treatment.

Time frame: Baseline up to Week 24

Proportion of participants with on-treatment virologic breakthrough and relapse

Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA \< LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.

Time frame: Baseline up to Week 24

Data from ClinicalTrials.gov

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