Back to resultsSafety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
Primary Purpose
Hepatitis C Virus Infection
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
LDV/SOF
RBV
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus Infection focused on measuring HCV genotype 3 (GT-3), HCV, Sustained Virologic Response, Direct Acting Antiviral, GS-7977, GS-5885, Ribavirin, Sofosbuvir, Ledipasvir, Hepatitis C, Hepatitis C, Chronic
Eligibility Criteria
Key Inclusion Criteria:
- Chronic genotype 3 HCV infection
- HCV treatment-naive
- HCV RNA > 10,000 IU/mL at screening
- Absence of cirrhosis or compensated cirrhosis
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria:
- Pregnant or nursing female or male with pregnant female partner
- Coinfection with HIV or hepatitis B virus (HBV)
- Current or prior history of clinical hepatic decompensation
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LDV/SOF+RBV
Arm Description
LDV/SOF FDC plus RBV for 12 weeks
Outcomes
Primary Outcome Measures
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Secondary Outcome Measures
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Percentage of Participants With Virologic Failure
Virologic failure was defined as:
On-treatment virologic failure:
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)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02413593
Brief Title
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
Official Title
A Phase 2 Open- Label Study to Evaluate The Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naïve Patients With Chronic HCV Genotype 3 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (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 will evaluate the antiviral efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) plus ribavirin (RBV) in treatment-naive adults with chronic genotype 3 hepatitis C virus (HCV) infection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus Infection
Keywords
HCV genotype 3 (GT-3), HCV, Sustained Virologic Response, Direct Acting Antiviral, GS-7977, GS-5885, Ribavirin, Sofosbuvir, Ledipasvir, Hepatitis C, Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LDV/SOF+RBV
Arm Type
Experimental
Arm Description
LDV/SOF FDC plus RBV for 12 weeks
Intervention Type
Drug
Intervention Name(s)
LDV/SOF
Other Intervention Name(s)
Harvoni®, GS-5885/GS-7977
Intervention Description
90/400 mg FDC tablet administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Intervention Description
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)
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Description
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame
Posttreatment Week 12
Title
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Description
SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame
Posttreatment Week 4
Title
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12
Time Frame
Weeks 1, 2, 4, 8, and 12
Title
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Time Frame
Baseline; Weeks 1, 2, 4, 8, and 12
Title
Percentage of Participants With Virologic Failure
Description
Virologic failure was defined as:
On-treatment virologic failure:
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)
Virologic relapse:
Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame
Up to Posttreatment Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Chronic genotype 3 HCV infection
HCV treatment-naive
HCV RNA > 10,000 IU/mL at screening
Absence of cirrhosis or compensated cirrhosis
Screening laboratory values within defined thresholds
Use of two effective contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria:
Pregnant or nursing female or male with pregnant female partner
Coinfection with HIV or hepatitis B virus (HBV)
Current or prior history of clinical hepatic decompensation
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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 4B9
Country
Canada
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1H2
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M1
Country
Canada
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4P9
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
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:
Citation
Feld JJ, Ramji A, Shafran S, Willems B, Marotta P, Huchet E, et al. Ledipasvir/Sofosbuvir with ribavirin for 12 Weeks is effective and safe in treatment-naïve genotype 3 HCV-infected patients in Canada [Abstract SAT-183]. Presented at: The 51st Annual Congress of the European Association for the Study of Liver: The International Liver Congress (EASL); 2016 April 13-17; Barcelona, Spain.
Results Reference
result
PubMed Identifier
28535298
Citation
Feld JJ, Ramji A, Shafran SD, Willems B, Marotta P, Huchet E, Vachon ML, Svarovskaia ES, Huang KC, Hyland RH, Yun C, Massetto B, Brainard DM, McHutchison JG, Tam E, Bailey R, Cooper C, Yoshida EM, Greenbloom S, Elkhashab M, Borgia S, Swain MG. Ledipasvir-Sofosbuvir Plus Ribavirin in Treatment-Naive Patients With Hepatitis C Virus Genotype 3 Infection: An Open-Label Study. Clin Infect Dis. 2017 Jul 1;65(1):13-19. doi: 10.1093/cid/cix289.
Results Reference
derived
Learn more about this trial
Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection
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