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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

Primary Purpose

Chronic Hepatitis C Infection

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

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection focused on measuring PSI-7977, Sofosbuvir, GS-7977, GS-5885, GS-9669, FDC, ribavirin, RBV, Pegylated Interferon, PEG-IFN, Chronic Hepatitis C Infection, HCV, Hepatitis, Genotype 1, Genotype 2, Genotype 3, GT 1, GT 2, GT 3, Hemophilia

Eligibility Criteria

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

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

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 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Arm Description

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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

Outcomes

Primary Outcome Measures

Percentage of Participants Who Experienced Adverse Events
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.

Secondary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.
Percentage of Participants With HCV RNA < LOD at Week 6
Percentage of Participants With HCV RNA < LOD at Week 8
Data are not presented for Group 21 which ended treatment after Week 6.
Percentage of Participants With HCV RNA < LOD at Week 12
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.
Change From Baseline in HCV RNA at Week 6
Change From Baseline in HCV RNA at Week 8
Data are not presented for Group 21 which ended treatment after Week 6.
Change From Baseline in HCV RNA at Week 12
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.
Percentage of Participants With Virologic Failure
The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized. On-treatment virologic failure was defined as: Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment), Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment) Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit.

Full Information

First Posted
December 13, 2010
Last Updated
November 7, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01260350
Brief Title
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
Official Title
A Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Naïve Patients With Chronic HCV Infection Genotype 2 or Genotype 3
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
December 2013 (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
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
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection
Keywords
PSI-7977, Sofosbuvir, GS-7977, GS-5885, GS-9669, FDC, ribavirin, RBV, Pegylated Interferon, PEG-IFN, Chronic Hepatitis C Infection, HCV, Hepatitis, Genotype 1, Genotype 2, Genotype 3, GT 1, GT 2, GT 3, Hemophilia

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group 1: SOF+RBV 12 wk: GT 2 or 3, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 5: SOF 12 wk: GT 2 or 3, TN
Arm Type
Experimental
Arm Description
Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily for 12 weeks.
Arm Title
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 7: SOF+RBV 12 wk: GT 1, TE
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 8: SOF+RBV 12 wk: GT 1, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 9: SOF+RBV 12 wk: GT 2 or 3, TE
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 10: SOF+RBV 8 wk: GT 2 or 3, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 11: SOF+RBV 12 wk: GT 2 or 3, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 12: SOF+RBV+LDV 12 wk: GT 1, TE
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 13: SOF+RBV+LDV 12 wk: GT 1, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN
Arm Type
Experimental
Arm Description
Treatment-naive participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Arm Title
Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE
Arm Type
Experimental
Arm Description
Treatment-experienced participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Arm Title
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 22: LDV/SOF FDC 6 wk: GT 1, TN
Arm Type
Experimental
Arm Description
Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
SOF
Other Intervention Name(s)
Sovaldi®, GS-7977, PSI-7977
Intervention Description
Sofosbuvir (SOF) tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Other Intervention Name(s)
Copegus®
Intervention Description
Ribavirin (RBV) capsules administered orally in a divided daily dose
Intervention Type
Drug
Intervention Name(s)
PEG
Other Intervention Name(s)
Pegasys®
Intervention Description
Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly
Intervention Type
Drug
Intervention Name(s)
LDV
Other Intervention Name(s)
GS-5885
Intervention Description
Ledipasvir (LDV) tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
GS-9669
Intervention Description
GS-9669 tablets administered orally once daily
Intervention Type
Drug
Intervention Name(s)
LDV/SOF
Other Intervention Name(s)
Harvoni®
Intervention Description
LDV/SOF fixed-dose combination (FDC) tablet administered once daily
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Adverse Events
Description
Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
Time Frame
Up to 12 weeks plus 30 days
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
Description
SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants With HCV RNA < LOD at Week 6
Time Frame
Week 6
Title
Percentage of Participants With HCV RNA < LOD at Week 8
Description
Data are not presented for Group 21 which ended treatment after Week 6.
Time Frame
Week 8
Title
Percentage of Participants With HCV RNA < LOD at Week 12
Description
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.
Time Frame
Week 12
Title
Change From Baseline in HCV RNA at Week 6
Time Frame
Baseline to Week 6
Title
Change From Baseline in HCV RNA at Week 8
Description
Data are not presented for Group 21 which ended treatment after Week 6.
Time Frame
Baseline to Week 8
Title
Change From Baseline in HCV RNA at Week 12
Description
Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.
Time Frame
Baseline to Week 12
Title
Percentage of Participants With Virologic Failure
Description
The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized. On-treatment virologic failure was defined as: Viral breakthrough (confirmed HCV RNA ≥ LOD after having previously had HCV RNA < LOD while on treatment), Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or Nonresponse (HCV RNA persistently ≥ LOD through 6 weeks of treatment) Viral relapse was defined as confirmed HCV RNA ≥ LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit.
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 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
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

Citations:
PubMed Identifier
24262278
Citation
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.
Results Reference
result
PubMed Identifier
23281974
Citation
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.
Results Reference
result

Learn more about this trial

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

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