MedDataX Logo

Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

NCT ID: NCT01826981

Last Updated: 2018-11-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

359 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02202980

Chronic Hepatitis C
COMPLETED PHASE2

Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

NCT01808248

Hepatitis C
COMPLETED PHASE2

Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection

NCT01909804

Hepatitis C
COMPLETED PHASE2

Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

NCT01858766

Hepatitis C
COMPLETED PHASE2

Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection

NCT02021643

Chronic HCV Infection
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis C

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1,Group 1: LDV/SOF + RBV 12 wk (GT1 SOF retreatment)

LDV/SOF + RBV for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir study

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

RBV

Intervention Type DRUG

Ribavirin (RBV) 200 mg 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)

Cohort 1,Group 2:SOF+Peg-IFN+RBV 12 wk (GT2,3 SOF retreatment)

SOF + PEG + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

SOF 400 mg tablet administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) 200 mg 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)

Peg-IFN

Intervention Type DRUG

pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly

Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, liver disease)

LDV/SOF+RBV for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

RBV

Intervention Type DRUG

Ribavirin (RBV) 200 mg 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)

Cohort 2,Group 2: LDV/SOF+GS-9669 12wk (GT1 TE, liver disease)

LDV/SOF + GS-9669 for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

GS-9669

Intervention Type DRUG

GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily

Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)

LDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)

LDV/SOF + RBV for 12 weeks in treatment-naive participants with genotype 3 HCV infection

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

RBV

Intervention Type DRUG

Ribavirin (RBV) 200 mg 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)

Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)

LDV/SOF for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)

LDV/SOF + RBV for 12 weeks in treatment-experienced participants with genotype 3 HCV infection

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

RBV

Intervention Type DRUG

Ribavirin (RBV) 200 mg 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)

Cohort 3,Group 1: LDV/SOF 12 wk (GT1 cirrhotic CPT B)

LDV/SOF for 12 weeks in participants with genotype 1 HCV infection and Child-Pugh Turcotte (CPT) B cirrhosis

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN noncirrhotic)

SOF+VEL (25 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

SOF 400 mg tablet administered orally once daily

VEL

Intervention Type DRUG

Velpatasvir (VEL) tablet(s) administered orally once daily

Cohort 4,Group 2:SOF+VEL 25mg+RBV 8 wk (GT3 TN noncirrhotic)

SOF+VEL(25 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

SOF 400 mg tablet administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) 200 mg 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)

VEL

Intervention Type DRUG

Velpatasvir (VEL) tablet(s) administered orally once daily

Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN noncirrhotic)

SOF+VEL (100 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

SOF 400 mg tablet administered orally once daily

VEL

Intervention Type DRUG

Velpatasvir (VEL) tablet(s) administered orally once daily

Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN noncirrhotic)

SOF+VEL (100 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

SOF 400 mg tablet administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) 200 mg 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)

VEL

Intervention Type DRUG

Velpatasvir (VEL) tablet(s) administered orally once daily

Cohort 5,Group 1: LDV/SOF + RBV 24 wk (SOF retreatment)

LDV/SOF+RBV for 24 weeks in participants with genotype 1, 2, 3, or 6 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

RBV

Intervention Type DRUG

Ribavirin (RBV) 200 mg 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)

Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HBV coinfection)

LDV/SOF for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LDV/SOF

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

Intervention Type DRUG

SOF

SOF 400 mg tablet administered orally once daily

Intervention Type DRUG

RBV

Ribavirin (RBV) 200 mg 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

Peg-IFN

pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly

Intervention Type DRUG

GS-9669

GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily

Intervention Type DRUG

VEL

Velpatasvir (VEL) tablet(s) administered orally once daily

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Harvoni® GS-5885/GS-7977 GS-7977 Sovaldi® Pegasys® GS-5816

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Chronic genotype 1, 2, 3, or 6 HCV infection
* Cirrhosis determination; a liver biopsy may be required
* Screening laboratory values within defined thresholds
* Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria

* Pregnant or nursing female or male with pregnant female partner
* Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Robert H Hyland, DPhil

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Auckland Clinical Studies Ltd.

Auckland, , New Zealand

Site Status

Christchurch Clinical Studies Trust

Christchurch, , New Zealand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

New Zealand

References

Explore related publications, articles, or registry entries linked to this study.

Gane EJ, Hyland RH, An D, Svarovskaia E, Pang PS, Brainard D, Stedman CA. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015 Nov;149(6):1454-1461.e1. doi: 10.1053/j.gastro.2015.07.063. Epub 2015 Aug 7.

Reference Type RESULT
PMID: 26261007 (View on PubMed)

Gane EJ, Hyland RH, An D, Svarovskaia ES, Brainard D, McHutchison JG. Ledipasvir and sofosbuvir for HCV infection in patients coinfected with HBV. Antivir Ther. 2016;21(7):605-609. doi: 10.3851/IMP3066. Epub 2016 Jul 1.

Reference Type RESULT
PMID: 27367295 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GS-US-337-0122

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection
NCT01682720 COMPLETED PHASE3
Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
NCT02074514 COMPLETED PHASE3
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection
NCT01768286 COMPLETED PHASE3
Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
NCT01726517 COMPLETED PHASE2
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
NCT01896193 COMPLETED PHASE3
Ledipasvir/Sofosbuvir Fixed-Dose Combination With Ribavirin or GS-9669 in Subjects With Chronic Genotype 1 HCV Infection
NCT01984294 COMPLETED PHASE2
Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies
NCT01625338 COMPLETED PHASE3
Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816
NCT02468648 COMPLETED PHASE2
SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
NCT01962441 COMPLETED PHASE3
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination With or Without Ribavirin in Participants With Chronic Genotype 1 HCV Infection Previously Treated With a Direct Acting Antiviral Regimen
NCT02536313 COMPLETED PHASE2
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2 and 3 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
NCT01667731 COMPLETED PHASE3
Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
NCT01965535 COMPLETED PHASE2
Sofosbuvir + Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection Who Are Interferon Intolerant, Interferon Ineligible or Unwilling to Take Interferon
NCT01542788 COMPLETED PHASE3
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Japanese Adults With Chronic Genotype 2 HCV Infection
NCT01910636 COMPLETED PHASE3
Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV
NCT02671500 COMPLETED PHASE3
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
NCT01641640 COMPLETED PHASE3
Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study
NCT02300103 COMPLETED PHASE2
Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
NCT01987453 COMPLETED PHASE2
Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection
NCT02346721 COMPLETED PHASE3
Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection
NCT02073656 COMPLETED PHASE3
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV
NCT01701401 COMPLETED PHASE3
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 HCV Infection
NCT02220998 COMPLETED PHASE3
Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 or 24 Weeks in Participants With Chronic Genotype 1 or 2 Hepatitis C Virus Infection Who Have Previously Failed a Direct-Acting Antiviral-Containing Regimen
NCT02822794 COMPLETED PHASE3
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
NCT02996682 COMPLETED PHASE3
Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION)
NCT01604850 COMPLETED PHASE3