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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

Primary Purpose

Chronic Hepatitis C

Status
Completed
Phase
Phase 2
Locations
New Zealand
Study Type
Interventional
Intervention
LDV/SOF
SOF
RBV
Peg-IFN
GS-9669
VEL
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Auckland Clinical Studies Ltd.
  • Christchurch Clinical Studies Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Arm Description

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

Secondary Outcome Measures

Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
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)
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)
Percentage of Participants With On-treatment Virologic Failure
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)
Percentage of Participants Experiencing Viral Relapse
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.

Full Information

First Posted
April 1, 2013
Last Updated
October 19, 2018
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01826981
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
359 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1,Group 1: LDV/SOF + RBV 12 wk (GT1 SOF retreatment)
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 1,Group 2:SOF+Peg-IFN+RBV 12 wk (GT2,3 SOF retreatment)
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, liver disease)
Arm Type
Experimental
Arm Description
LDV/SOF+RBV for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Arm Title
Cohort 2,Group 2: LDV/SOF+GS-9669 12wk (GT1 TE, liver disease)
Arm Type
Experimental
Arm Description
LDV/SOF + GS-9669 for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Arm Title
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)
Arm Type
Experimental
Arm Description
LDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection
Arm Title
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)
Arm Type
Experimental
Arm Description
LDV/SOF + RBV for 12 weeks in treatment-naive participants with genotype 3 HCV infection
Arm Title
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)
Arm Type
Experimental
Arm Description
LDV/SOF for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
Arm Title
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)
Arm Type
Experimental
Arm Description
LDV/SOF + RBV for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
Arm Title
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 cirrhotic CPT B)
Arm Type
Experimental
Arm Description
LDV/SOF for 12 weeks in participants with genotype 1 HCV infection and Child-Pugh Turcotte (CPT) B cirrhosis
Arm Title
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN noncirrhotic)
Arm Type
Experimental
Arm Description
SOF+VEL (25 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Arm Title
Cohort 4,Group 2:SOF+VEL 25mg+RBV 8 wk (GT3 TN noncirrhotic)
Arm Type
Experimental
Arm Description
SOF+VEL(25 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Arm Title
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN noncirrhotic)
Arm Type
Experimental
Arm Description
SOF+VEL (100 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Arm Title
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN noncirrhotic)
Arm Type
Experimental
Arm Description
SOF+VEL (100 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Arm Title
Cohort 5,Group 1: LDV/SOF + RBV 24 wk (SOF retreatment)
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HBV coinfection)
Arm Type
Experimental
Arm Description
LDV/SOF for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Intervention Type
Drug
Intervention Name(s)
LDV/SOF
Other Intervention Name(s)
Harvoni®, GS-5885/GS-7977
Intervention Description
Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
SOF
Other Intervention Name(s)
GS-7977, Sovaldi®
Intervention Description
SOF 400 mg tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
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
Intervention Name(s)
Peg-IFN
Other Intervention Name(s)
Pegasys®
Intervention Description
pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly
Intervention Type
Drug
Intervention Name(s)
GS-9669
Intervention Description
GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily
Intervention Type
Drug
Intervention Name(s)
VEL
Other Intervention Name(s)
GS-5816
Intervention Description
Velpatasvir (VEL) tablet(s) administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
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 Measure Information:
Title
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Time Frame
Weeks 1 and 2
Title
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Time Frame
Weeks 4, 6, and 8
Title
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Time Frame
Week 10
Title
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Time Frame
Week 12
Title
Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Time Frame
Weeks 16, 20, and 24
Title
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
Title
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
Title
Percentage of Participants With On-treatment Virologic Failure
Description
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)
Time Frame
Up to Posttreatment Week 24
Title
Percentage of Participants Experiencing Viral Relapse
Description
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.
Time Frame
Up to Posttreatment Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H Hyland, DPhil
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Auckland Clinical Studies Ltd.
City
Auckland
Country
New Zealand
Facility Name
Christchurch Clinical Studies Trust
City
Christchurch
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
http://www.gilead.com/research/disclosure-and-transparency
Citations:
PubMed Identifier
26261007
Citation
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.
Results Reference
result
PubMed Identifier
27367295
Citation
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.
Results Reference
result

Learn more about this trial

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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