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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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02413593
Enrollment
111
Registered
2015-04-10
Start date
2015-04-30
Completion date
2016-01-31
Last updated
2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGLDV/SOF

90/400 mg FDC tablet administered orally once daily

DRUGRBV

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)

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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/

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)Posttreatment Week 12SVR12 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 EventUp to 12 weeks—

Secondary

MeasureTime frameDescription
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)Posttreatment Week 4SVR4 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 12Weeks 1, 2, 4, 8, and 12—
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12Baseline; Weeks 1, 2, 4, 8, and 12—
Percentage of Participants With Virologic FailureUp to Posttreatment Week 12Virologic 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.

Countries

Canada

Participant flow

Recruitment details

Participants were enrolled at study sites in Canada. The first participant was screened on 15 April 2015. The last study visit occurred on 08 January 2016.

Pre-assignment details

127 participants were screened.

Participants by arm

ArmCount
LDV/SOF+RBV
LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
111
Total111

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event1
Overall StudyLost to Follow-up3

Baseline characteristics

CharacteristicLDV/SOF+RBV
Age, Continuous48 years
STANDARD_DEVIATION 10.7
Cirrhosis Status
Absent
70 Participants
Cirrhosis Status
Missing
2 Participants
Cirrhosis Status
Present
39 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
111 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
HCV Genotype
Genotype 3a
105 Participants
HCV Genotype
Genotype 3b
3 Participants
HCV Genotype
Genotype 3 (no confirmed subtype)
3 Participants
HCV RNA6.2 log10 IU/mL
STANDARD_DEVIATION 0.66
HCV RNA Category
< 800,000 IU/mL
35 Participants
HCV RNA Category
≥ 800,000 IU/mL
76 Participants
IL28b Status
CC
40 Participants
IL28b Status
CT
56 Participants
IL28b Status
Missing
2 Participants
IL28b Status
TT
13 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
Race (NIH/OMB)
Asian
28 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
78 Participants
Sex: Female, Male
Female
43 Participants
Sex: Female, Male
Male
68 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
89 / 111
serious
Total, serious adverse events
4 / 111

Outcome results

Primary

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time frame: Up to 12 weeks

Population: Safety Analysis Set

ArmMeasureValue (NUMBER)
LDV/SOF+RBVPercentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0.9 percentage of participants
Primary

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.

Time frame: Posttreatment Week 12

Population: Full Analysis Set: all enrolled participants who received at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
LDV/SOF+RBVPercentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)89.2 percentage of participants
Secondary

Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12

Time frame: Baseline; Weeks 1, 2, 4, 8, and 12

Population: Participants in the Full Analysis Set with available data were analyzed.

ArmMeasureGroupValue (MEAN)Dispersion
LDV/SOF+RBVChange From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12Change at Week 1-4.33 log10 IU/mLStandard Deviation 0.572
LDV/SOF+RBVChange From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12Change at Week 2-4.85 log10 IU/mLStandard Deviation 0.659
LDV/SOF+RBVChange From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12Change at Week 4-5.05 log10 IU/mLStandard Deviation 0.664
LDV/SOF+RBVChange From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12Change at Week 8-5.06 log10 IU/mLStandard Deviation 0.664
LDV/SOF+RBVChange From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12Change at Week 12-5.06 log10 IU/mLStandard Deviation 0.669
Secondary

Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12

Time frame: Weeks 1, 2, 4, 8, and 12

Population: Participants in the Full Analysis Set with available data were analyzed.

ArmMeasureGroupValue (NUMBER)
LDV/SOF+RBVPercentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12Week 120.7 percentage of participants
LDV/SOF+RBVPercentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12Week 264.9 percentage of participants
LDV/SOF+RBVPercentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12Week 497.3 percentage of participants
LDV/SOF+RBVPercentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12Week 8100.0 percentage of participants
LDV/SOF+RBVPercentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8 and 12Week 1299.1 percentage of participants
Secondary

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.

Time frame: Posttreatment Week 4

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
LDV/SOF+RBVPercentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)91.9 percentage of participants
Secondary

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.

Time frame: Up to Posttreatment Week 12

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
LDV/SOF+RBVPercentage of Participants With Virologic Failure7.2 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026