Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-02-28

Brief Summary

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This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

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Detailed Description

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Conditions

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Chronic Genotype 4 HCV Chronic Genotype 5 HCV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Genotype 4

LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 4 hepatitis C virus (HCV) infection

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

Genotype 5

LDV/SOF for up to 12 weeks in treatment-naive and treatment-experienced participants with genotype 5 hepatitis C virus (HCV) infection

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

Interventions

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LDV/SOF

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

Intervention Type DRUG

Other Intervention Names

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Harvoni® GS-5885/GS-7977

Eligibility Criteria

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Inclusion Criteria

* HCV RNA ≥ 10\^4 IU/mL at screening
* Chronic genotype 4 or 5 HCV Infection
* Individuals may be treatment naive or treatment experienced
* Presence or absence of cirrhosis, a liver biopsy may be required
* Healthy according to medical history and physical examination with the exception of HCV diagnosis
* Agree to use two forms of highly effective contraception for the duration of the study

Exclusion Criteria

* 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 individual's participation for the full duration of the study or not be in the best interest of the individual in the opinion of the investigator
* Prior exposure to approved or experimental HCV specific direct acting antiviral(s) (DAA) other than NS3/4A protease inhibitors
* History of any other clinically significant chronic liver disease
* Evidence of or history of decompensated liver disease
* HIV or chronic hepatitis B (HBV) infection
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of immunosuppressive agents or immunomodulatory agents

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No