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Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis

A Phase 2, Randomized, Open-Label Study of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection and Cirrhosis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02226549
Enrollment
47
Registered
2014-08-27
Start date
2014-07-31
Completion date
2015-02-28
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

hepatitis C, Gilead, GS-9451

Brief summary

This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in treatment-experienced adults with chronic genotype 1 hepatitis C virus (HCV) infection and cirrhosis.

Interventions

DRUGLDV/SOF

LDV/SOF (90/400 mg) FDC tablet administered orally once daily

DRUGVDV

VDV 80 mg tablet administered orally once daily

DRUGRBV

RBV 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
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Age ≥ 18 years, with chronic HCV genotype 1 infection * Documentation as treatment-experienced having received pegylated interferon (Peg-IFN) + RBV ≥ 4 weeks of duration without an additional agent in the regimen without achieving sustained viral response (SVR) * Presence of compensated cirrhosis * Screening laboratory values within defined thresholds * Must use specific contraceptive methods if female of childbearing potential or sexually active male * Not pregnant or a nursing female

Exclusion criteria

* Co-infection 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 subject treatment, assessment or compliance with the protocol

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 8 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.

Countries

United States

Participant flow

Recruitment details

Participants were enrolled at 1 study site in the United States. The first participant was screened on 24 July 2014. The last study visit occurred on 06 February 2015.

Pre-assignment details

72 participants were screened.

Participants by arm

ArmCount
LDV/SOF+VDV
LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
22
LDV/SOF+VDV+RBV
LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
24
Total46

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up01
Overall StudyRandomized but Never Treated10

Baseline characteristics

CharacteristicLDV/SOF+VDV+RBVTotalLDV/SOF+VDV
Age, Continuous56 years
STANDARD_DEVIATION 7.7
57 years
STANDARD_DEVIATION 7.7
58 years
STANDARD_DEVIATION 7.9
HCV Genotype
Genotype 1a
18 participants32 participants14 participants
HCV Genotype
Genotype 1a,1b
0 participants1 participants1 participants
HCV Genotype
Genotype 1b
6 participants13 participants7 participants
IL28b Status
CC
1 participants5 participants4 participants
IL28b Status
CT
16 participants28 participants12 participants
IL28b Status
Missing
1 participants1 participants0 participants
IL28b Status
TT
6 participants12 participants6 participants
Race/Ethnicity, Customized
Black or African American
1 participants2 participants1 participants
Race/Ethnicity, Customized
Hispanic or Latino
11 participants17 participants6 participants
Race/Ethnicity, Customized
Not Hispanic or Latino
12 participants28 participants16 participants
Race/Ethnicity, Customized
Not Permitted
1 participants1 participants0 participants
Race/Ethnicity, Customized
White
23 participants44 participants21 participants
Sex: Female, Male
Female
6 Participants16 Participants10 Participants
Sex: Female, Male
Male
18 Participants30 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
7 / 2212 / 24
serious
Total, serious adverse events
0 / 220 / 24

Outcome results

Primary

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

Time frame: Up to 8 weeks

Population: Safety Analysis Set: participants who received at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
LDV/SOF+VDVPercentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
LDV/SOF+VDV+RBVPercentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event8.3 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: participants who were randomized and received at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
LDV/SOF+VDVPercentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)95.5 percentage of participants
LDV/SOF+VDV+RBVPercentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)87.5 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+VDVPercentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)95.5 percentage of participants
LDV/SOF+VDV+RBVPercentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)95.8 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026