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Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

NCT ID: NCT01260350

Last Updated: 2014-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

292 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

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This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.

Detailed Description

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Part 1: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily with weight-based RBV for 12 weeks. Participants will be randomized in equal proportions to: no PEG (Arm 1), PEG for 4 weeks (Arm 2), PEG for 8 weeks (Arm 3), or PEG for 12 weeks (Arm 4).

Part 2: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily (monotherapy) for 12 weeks (Arm 5), or SOF 400 mg once daily with PEG and weight-based RBV for 8 weeks (Arm 6); HCV genotype 1: null responders (did not respond to their prior treatment) will receive SOF 400 mg once daily with weight-based RBV for 12 weeks (Arm 7).

Part 3: HCV genotype 1 treatment-naive (Arm 8) or HCV genotype 2 or 3 treatment-experienced participants (Arm 9) will receive SOF 400 mg once daily in combination with weight-based RBV for 12 weeks.

Part 4: HCV genotype 2 or 3 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV for 8 weeks (Arm 10) or SOF 400 mg once daily and 800 mg RBV for 12 weeks (Arm 11). HCV genotype 1 null responders will receive SOF 400 mg once daily, ledipasvir (LDV), and weight based RBV for 12 weeks (Arm 12). HCV genotype-1 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV and LDV for 12 weeks (Arm 13).

Part 5: HCV genotype 1 null responders will receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 14). HCV genotype-1 treatment naive participants receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 15).

Part 6: HCV genotype 1 null responders with Stage F4 fibrosis will receive LDV/SOF FDC for 12 weeks (Arm 16) or LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 17). HCV genotype 2 or 3 treatment-naive participants will receive LDV/SOF FDC for 12 weeks (Arm 18). HCV genotype 2 or 3 treatment-experienced participants will receive LDV/SOF FDC for 12 weeks (Arm 19). HCV genotype 1 hemophiliacs will receive LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 20). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC with weight-based RBV for 6 weeks (Arm 21). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC for 6 weeks (Arm 22).

Conditions

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Chronic Hepatitis C Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1: SOF+RBV 12 wk: GT 2 or 3, TN

Treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN

Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

PEG

Intervention Type DRUG

Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly

Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN

Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

PEG

Intervention Type DRUG

Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly

Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN

Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily+weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

PEG

Intervention Type DRUG

Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly

Group 5: SOF 12 wk: GT 2 or 3, TN

Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN

Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

PEG

Intervention Type DRUG

Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly

Group 7: SOF+RBV 12 wk: GT 1, TE

Treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

Group 8: SOF+RBV 12 wk: GT 1, TN

Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

Group 9: SOF+RBV 12 wk: GT 2 or 3, TE

Treatment-experienced participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

Group 10: SOF+RBV 8 wk: GT 2 or 3, TN

Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

Group 11: SOF+RBV 12 wk: GT 2 or 3, TN

Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

Group 12: SOF+RBV+LDV 12 wk: GT 1, TE

Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

LDV

Intervention Type DRUG

Ledipasvir (LDV) tablets administered orally once daily

Group 13: SOF+RBV+LDV 12 wk: GT 1, TN

Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

LDV

Intervention Type DRUG

Ledipasvir (LDV) tablets administered orally once daily

Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE

Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

GS-9669

Intervention Type DRUG

GS-9669 tablets administered orally once daily

Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN

Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks.

Group Type EXPERIMENTAL

SOF

Intervention Type DRUG

Sofosbuvir (SOF) tablets administered orally once daily

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

GS-9669

Intervention Type DRUG

GS-9669 tablets administered orally once daily

Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosis

Treatment-experienced participants with genotype 1 HCV infection and Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

LDV/SOF fixed-dose combination (FDC) tablet administered once daily

Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis

Treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

Group Type EXPERIMENTAL

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

LDV/SOF

Intervention Type DRUG

LDV/SOF fixed-dose combination (FDC) tablet administered once daily

Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN

Treatment-naive participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

LDV/SOF fixed-dose combination (FDC) tablet administered once daily

Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE

Treatment-experienced participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

LDV/SOF fixed-dose combination (FDC) tablet administered once daily

Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac

Hemophiliac participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.

Group Type EXPERIMENTAL

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

LDV/SOF

Intervention Type DRUG

LDV/SOF fixed-dose combination (FDC) tablet administered once daily

Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN

Treatment-naive participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks.

Group Type EXPERIMENTAL

RBV

Intervention Type DRUG

Ribavirin (RBV) capsules administered orally in a divided daily dose

LDV/SOF

Intervention Type DRUG

LDV/SOF fixed-dose combination (FDC) tablet administered once daily

Group 22: LDV/SOF FDC 6 wk: GT 1, TN

Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.

Group Type EXPERIMENTAL

LDV/SOF

Intervention Type DRUG

LDV/SOF fixed-dose combination (FDC) tablet administered once daily

Interventions

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SOF

Sofosbuvir (SOF) tablets administered orally once daily

Intervention Type DRUG

RBV

Ribavirin (RBV) capsules administered orally in a divided daily dose

Intervention Type DRUG

PEG

Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly

Intervention Type DRUG

LDV

Ledipasvir (LDV) tablets administered orally once daily

Intervention Type DRUG

GS-9669

GS-9669 tablets administered orally once daily

Intervention Type DRUG

LDV/SOF

LDV/SOF fixed-dose combination (FDC) tablet administered once daily

Intervention Type DRUG

Other Intervention Names

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Sovaldi® GS-7977 PSI-7977 Copegus® Pegasys® GS-5885 Harvoni®

Eligibility Criteria

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Inclusion Criteria

* Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA ≥ 50,000 IU/mL
* Not co-infected with HIV
* Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria

* History of any other clinically significant chronic liver disease
* Pregnant or nursing female or male with pregnant female partner
* History of significant drug allergy to nucleoside/nucleotide analogs.
* Participation in a clinical study within 3 months prior to first dose
* Positive result for significant drug use at Screening
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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Robert H. Hyland, DPhil

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Auckland Clinical Studies Ltd.

Auckland, , New Zealand

Site Status

Christchurch Clinical Studies Trust

Christchurch, , New Zealand

Site Status

Countries

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New Zealand

References

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Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Subramanian GM, Symonds WT, McHutchison JG, Pang PS. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology. 2014 Mar;146(3):736-743.e1. doi: 10.1053/j.gastro.2013.11.007. Epub 2013 Nov 18.

Reference Type RESULT
PMID: 24262278 (View on PubMed)

Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, Hindes RG, Berrey MM. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):34-44. doi: 10.1056/NEJMoa1208953.

Reference Type RESULT
PMID: 23281974 (View on PubMed)

Other Identifiers

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Medsafe

Identifier Type: OTHER

Identifier Source: secondary_id

P7977-0523

Identifier Type: -

Identifier Source: org_study_id