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Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

NCT ID: NCT02202980

Last Updated: 2018-11-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

273 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-04

Study Completion Date

2016-05-09

Brief Summary

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This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

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Detailed Description

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Conditions

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Chronic Hepatitis C

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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LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)

Participants who previously received ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) plus ribavirin (RBV) for ≥ 12 weeks without achieving sustained virologic response at 12 weeks following treatment (SVR12) will receive LDV/SOF+RBV for 24 weeks.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg FDC tablet administered orally once daily

RBV

Intervention Type DRUG

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

LDV/SOF+RBV 12 Weeks (Cohort 1 Group 2)

Participants who previously received a sofosbuvir-based regimen without achieving SVR12 were initially enrolled to receive LDV/SOF+RBV for 12 weeks (excluding participants who previously received LDV/SOF+RBV for ≥ 12 weeks). Participants who did not achieve sustained virologic response at 12 weeks were then moved to Cohort 1 Group 1.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg FDC tablet administered orally once daily

RBV

Intervention Type DRUG

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)

Participants with genotype 2 (GT2) HCV infection will receive LDV/SOF FDC for 12 weeks.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg FDC tablet administered orally once daily

LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)

Participants with GT2 HCV infection will receive LDV/SOF FDC for 8 weeks.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg FDC tablet administered orally once daily

LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)

Participants with genotypes 1 (GT1), 2 (GT2), or 4 (GT4) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC for 12 weeks.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg FDC tablet administered orally once daily

LDV/SOF+RBV 12 Weeks GT3 (Cohort 3 Group 2)

Participants with genotype 3 (GT3) HCV infection and extrahepatic manifestations of chronic HCV infection will receive LDV/SOF FDC plus RBV for 12 weeks.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

90/400 mg FDC tablet administered orally once daily

RBV

Intervention Type DRUG

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)

Treatment-naive participants with GT1 HCV infection without cirrhosis will receive VOX only on Day 1 followed by sofosbuvir/velpatasvir (SOF/VEL) + voxilaprevir (VOX) for 6 weeks.

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

VOX

Intervention Type DRUG

100 mg tablet administered orally once daily with food

SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)

Treatment-naive participants with GT1 HCV infection without cirrhosis will receive SOF/VEL+VOX for 4 weeks.

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

VOX

Intervention Type DRUG

100 mg tablet administered orally once daily with food

SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)

Treatment-naive participants with GT1 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

VOX

Intervention Type DRUG

100 mg tablet administered orally once daily with food

SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)

Treatment-naive participants with GT3 HCV infection with cirrhosis will receive SOF/VEL+VOX for 6 weeks.

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

VOX

Intervention Type DRUG

100 mg tablet administered orally once daily with food

SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)

Treatment-experienced participants with GT1 HCV infection with cirrhosis who were previously treated with pegylated interferon (Peg-IFN)+RBV will receive SOF/VEL+VOX for 6 weeks.

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

VOX

Intervention Type DRUG

100 mg tablet administered orally once daily with food

SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)

Treatment-experienced participants with GT3 HCV infection with cirrhosis who were previously treated with Peg-IFN+RBV will receive SOF/VEL+VOX for 6 weeks.

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

VOX

Intervention Type DRUG

100 mg tablet administered orally once daily with food

SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)

Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with non-structural protein (NS3/4A) protease inhibitor (PI) will receive SOF/VEL+VOX for 6 weeks.

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

VOX

Intervention Type DRUG

100 mg tablet administered orally once daily with food

SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)

Treatment-experienced participants with GT1 HCV infection with or without cirrhosis who were previously treated with direct-acting antivirals (DAA) will receive SOF/VEL+VOX for 6 weeks.

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

VOX

Intervention Type DRUG

100 mg tablet administered orally once daily with food

SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)

Treatment-experienced participants with GT3 HCV infection with or without cirrhosis who were previously treated with DAA will receive SOF/VEL+VOX for 8 weeks.

Group Type EXPERIMENTAL

SOF/VEL

Intervention Type DRUG

400/100 mg FDC tablet administered orally once daily

VOX

Intervention Type DRUG

100 mg tablet administered orally once daily with food

Interventions

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LDV/SOF

90/400 mg FDC tablet administered orally once daily

Intervention Type DRUG

RBV

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Intervention Type DRUG

SOF/VEL

400/100 mg FDC tablet administered orally once daily

Intervention Type DRUG

VOX

100 mg tablet administered orally once daily with food

Intervention Type DRUG

Other Intervention Names

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Harvoni® GS-5885/GS-7977 Epclusa® GS-7977/GS-5816 GS-9857

Eligibility Criteria

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Inclusion Criteria

* Willing and able to provide written informed consent
* Chronic HCV infection
* Cirrhosis determination (liver biopsy may be required)
* Screening laboratory values within specified limits
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Specific genotype, prior medical history, or concurrent disease as required by the specific study group

Exclusion Criteria

* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Pregnant or nursing female, or male with pregnant female partner
* Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
* Use of any prohibited concomitant medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Auckland, , New Zealand

Site Status

Christchurch, , New Zealand

Site Status

Countries

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New Zealand

References

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Gane EJ, Svarovskaia ES, Hyland RH, Stamm LM, Osinusi A, Brainard DM, Chodavarapu K, Miller MD, Mo H, Schwabe C. Resistance Analysis of Treatment-Naive and DAA-Experienced Genotype 1 Patients with and without Cirrhosis Who Received Short-Duration Treatment with Sofosbuvir/GS-5816+ GS-9857 [Poster 713]. J Hepatol 2015;62:563A

Reference Type RESULT

Gane EJ, Schwabe C, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CA. Efficacy of the Combination of Sofosbuvir, Velpatasvir, and the NS3/4A Protease Inhibitor GS-9857 in Treatment-Naive or Previously Treated Patients With Hepatitis C Virus Genotype 1 or 3 Infections. Gastroenterology. 2016 Sep;151(3):448-456.e1. doi: 10.1053/j.gastro.2016.05.021. Epub 2016 May 27.

Reference Type RESULT
PMID: 27240903 (View on PubMed)

Gane EJ, Hyland RH, Yang Y, Svarovskaia E, Stamm LM, Brainard DM, McHutchison JG, Stedman CAM. Efficacy of Ledipasvir Plus Sofosbuvir for 8 or 12 Weeks in Patients With Hepatitis C Virus Genotype 2 Infection. Gastroenterology. 2017 May;152(6):1366-1371. doi: 10.1053/j.gastro.2017.01.017. Epub 2017 Jan 27.

Reference Type RESULT
PMID: 28137593 (View on PubMed)

Other Identifiers

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GS-US-337-1468

Identifier Type: -

Identifier Source: org_study_id

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