Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

Humanity and Health Research Centre48 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 genotype 3 infection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C Infection

Interventions

sofosbuvir and daclatasvirDRUG

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

ledipasvir/sofosbuvirDRUG

Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally. once daily;

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age equal to or greater than 18 years, with chronic genotype 3 HCV infection; * Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen; * HCV RNA \> 10,000 IU/mL at Screening; * Screening laboratory values within defined thresholds; * Negative pregnancy test at baseline (females of childbearing potential only); * Use of two effective contraception methods if female of childbearing potential or sexually active male. Exclusion Criteria: * Pregnant or nursing female; * HIV infection or HBV infection (HBcAb and HBsAg positive); * Hematologic or biochemical parameters at Screening outside the protocol-specified requirements; * Active or recent history (≤ 1 year) of drug or alcohol abuse; * 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 (SVR12) after discontinuation of therapy

SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ \< 25 IU/mL) 12 weeks following the last dose of study medication

Time frame: Post treatment Week 12

Incidence of adverse events leading to permanent discontinuation of study drug

Time frame: Baseline up to Week 12

Secondary Outcomes

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

Time frame: Baseline up to Week 12

HCV RNA levels and change during and after treatment

Time frame: Baseline up to Week 12

Treatment adherence

To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)

Time frame: Baseline to Week 12

Change in health related quality of life

To evaluate the change in health-related quality of life during treatment

Time frame: Baseline to Week 24

Data from ClinicalTrials.gov

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