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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

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ClinicalTrials.gov Identifier: NCT01826981
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : September 16, 2016
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: LDV/SOF Drug: SOF Drug: RBV Drug: Peg-IFN Drug: GS-9669 Drug: VEL Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 359 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection
Study Start Date : April 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

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)
Experimental: 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
 Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • Sovaldi®

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)

Drug: Peg-IFN
pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly
Other Name: Pegasys®
Experimental: 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
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

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)
Experimental: 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
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

Drug: GS-9669
GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily
Experimental: Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
LDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: 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
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

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)
Experimental: 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
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: 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
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

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)
Experimental: 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
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977
Experimental: 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
 Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • Sovaldi®

Drug: VEL
Velpatasvir (VEL) tablet(s) administered orally once daily
Other Name: GS-5816
Experimental: 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
 Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • Sovaldi®

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)

Drug: VEL
Velpatasvir (VEL) tablet(s) administered orally once daily
Other Name: GS-5816
Experimental: 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
 Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • Sovaldi®

Drug: VEL
Velpatasvir (VEL) tablet(s) administered orally once daily
Other Name: GS-5816
Experimental: 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
 Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • GS-7977
  • Sovaldi®

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)

Drug: VEL
Velpatasvir (VEL) tablet(s) administered orally once daily
Other Name: GS-5816
Experimental: 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
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977

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)
Experimental: 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
 Drug: LDV/SOF
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
  • Harvoni®
  • GS-5885/GS-7977


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]
    SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.

  2. Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [ Time Frame: Up to 24 weeks plus 30 days ]

Secondary Outcome Measures :
  1. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Weeks 1 and 2 ]
  2. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Weeks 4, 6, and 8 ]
  3. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Week 10 ]
  4. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Week 12 ]
  5. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment [ Time Frame: Weeks 16, 20, and 24 ]
  6. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24) [ Time Frame: Posttreatment Weeks 2, 4, 8, and 24 ]
  7. For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20) [ Time Frame: Posttreatment Weeks 16 and 20 ]
  8. Percentage of Participants With On-treatment Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]

    On-treatment virologic failure was defined as:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

  9. Percentage of Participants Experiencing Viral Relapse [ Time Frame: Up to Posttreatment Week 24 ]
    Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826981


Locations
New Zealand
Auckland Clinical Studies Ltd.
Auckland, New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Robert H Hyland, DPhil Gilead Sciences
More Information
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Publications of Results:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01826981     History of Changes
Other Study ID Numbers: GS-US-337-0122
First Posted: April 9, 2013    Key Record Dates
Results First Posted: September 16, 2016
Last Update Posted: November 16, 2018
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 18 months after study completion
Access Criteria: A secured external environment with username, password, and RSA code.
URL: http://www.gilead.com/research/disclosure-and-transparency

Additional relevant MeSH terms:
Infection
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
 RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Sofosbuvir
Antiviral Agents
Anti-Infective Agents