Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.

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Detailed Description

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Conditions

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Chronic Hepatitis C Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LDV/SOF+ASV

Participants with genotype 1b HCV infection will receive LDV/SOF FDC + ASV 3 weeks.

Group Type EXPERIMENTAL

LDV/SOF+ASV

Intervention Type DRUG

Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.

SOF+DCV+SMV

Participants with genotype 1b HCV infection will receive SOF + DCV + SMV for 3 weeks.

Group Type EXPERIMENTAL

SOF+DCV+SMV

Intervention Type DRUG

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.

SOF+DCV+ASV

Participants with genotype 1b HCV infection will receive SOF + DCV + ASV for 3 weeks

Group Type EXPERIMENTAL

SOF+DCV+ASV

Intervention Type DRUG

Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.

Interventions

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LDV/SOF+ASV

Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.

Intervention Type DRUG

SOF+DCV+SMV

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.

Intervention Type DRUG

SOF+DCV+ASV

Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.

Intervention Type DRUG

Other Intervention Names

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GS-7977 PSI-7977 GS-5885 Harvoni® BMS-650032 Sunvepra® GS-7977 PSI-7977 Sovaldi® BMS-790052 Daklinza® TMC435 OLYSIO® GS-7977 PSI-7977 Sovaldi® BMS-790052 Daklinza® BMS-650032 Sunvepra®

Eligibility Criteria

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Inclusion Criteria

* Age equal to or greater than 18 years, with chronic genotype 1b HCV infection;
* HCV RNA level \> 10,000 and \< 10,000,000 IU/ml at Screening;
* Rapid response to triple DAAs therapy with less than 500 IU/ml plasma HCV RNA level at Day 2;
* No evidence of cirrhosis. Cirrhosis defined as any 1 of the following, within 6 months of study entry:

1. Liver biopsy showing cirrhosis;
2. Fibroscan showing cirrhosis or results\>12.5 kPa ;
3. FibroTest® score \>0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) \>2 during screening.

Exclusion Criteria

* Pregnant or nursing female or male with pregnant female partner;
* HIV or chronic hepatitis B virus (HBV) infection;
* 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);
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No