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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

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

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) 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

NCT ID

NCT01826981

First Posted

April 1, 2013

Last Updated

October 19, 2018

Sponsor

Gilead Sciences

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

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

Time Frame

Up to Posttreatment Week 24

Title

Percentage of Participants Experiencing Viral Relapse

Description

Time Frame

Up to Posttreatment Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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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