Triple Combination DAAs for Treating HCV GT1b Subjects

Humanity and Health Research Centre

Overview

There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is \<500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Chronic Hepatitis C Infection

Interventions

SOF+DCV+SMVDRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. HCV RNA positive \>2000 IU/ml or NAT POC positive 2. Genotype 1b 3. CP score ≤6 Exclusion Criteria: 1. Pregnant or nursing female or male with pregnant female partner 2. Hematologic or biochemical parameters at Screening outside the protocol- specified requirements 3. Active or recent history (≤ 1 year) of drug or alcohol abuse 4. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers) 5. History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Locations (1)

Humanity and Health Medical Centre

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Proportion of participants with plasma HCV viral load below the lower limit of quantification for 12 weeks after treatment completion (SVR12)

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

Secondary Outcomes

Frequency and severity of adverse events

Time frame: Baseline up to Week 24

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

Time frame: Baseline up to Week 24

Kinetics of circulating HCV RNA during treatment and after treatment discontinuation

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 up to 24 weeks.

Time frame: Baseline up to Week 24

Data from ClinicalTrials.gov

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