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Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02202980
Acronym
LEPTON
Enrollment
273
Registered
2014-07-29
Start date
2014-08-04
Completion date
2016-05-09
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

Chronic Hepatitis C

Brief summary

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic 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)

DRUGSOF/VEL

400/100 mg FDC tablet administered orally once daily

DRUGVOX

100 mg tablet administered orally once daily with food

Sponsors

Gilead Sciences
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

Key Inclusion Criteria: * Willing and able to provide written informed consent * Chronic HCV infection * Cirrhosis determination (liver biopsy may be required) * Screening laboratory values within specified limits * Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception * Specific genotype, prior medical history, or concurrent disease as required by the specific study group Key

Exclusion criteria

* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol * Pregnant or nursing female, or male with pregnant female partner * Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage) * Use of any prohibited concomitant medications 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 24 weeks—

Secondary

MeasureTime frameDescription
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)Posttreatment Weeks 4 and 24SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Percentage of Participants With Virologic FailureUp to Posttreatment Week 24Virologic 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.
Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)—

Countries

New Zealand

Participant flow

Recruitment details

Participants were enrolled at study sites in New Zealand. The first participant was screened on 04 August 2014. The last study visit occurred on 09 May 2016.

Pre-assignment details

349 participants were screened.

Participants by arm

ArmCount
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 24 weeks in participants who previously received LDV/SOF+RBV for ≥ 12 weeks without achieving SVR12
14
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotype 2 HCV infection
26
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)
LDV/SOF (90/400 mg) for 8 weeks in participants with genotype 2 HCV infection
27
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)
LDV/SOF (90/400 mg) for 12 weeks in participants with genotypes 1, 2, or 4 HCV infection and extrahepatic manifestations of chronic HCV infection
32
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)
LDV/SOF (90/400 mg) + RBV (1000 or 1200 mg daily based on weight) for 12 weeks in participants with genotype 3 HCV infection and extrahepatic manifestations of chronic HCV infection
13
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)
VOX 100 mg with food on Day 1, followed by SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
15
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 4 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
15
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 1 HCV infection with cirrhosis
15
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in treatment-naive participants with genotype 3 HCV infection with cirrhosis
18
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 1 HCV infection with cirrhosis
17
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in treatment-experienced participants with genotype 3 HCV infection with cirrhosis
19
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in NS3/4A PI-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
28
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 6 weeks in DAA-treatment-experienced participants with genotype 1 HCV infection with or without cirrhosis
30
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)
SOF/VEL (400/100 mg) + VOX 100 mg once daily with food for 8 weeks in DAA-treatment-experienced participants with genotype 3 HCV infection with or without cirrhosis
4
Total273

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013
Overall StudyLack of Efficacy1070311122003100
Overall StudyLost to Follow-up01110001100010
Overall StudyProtocol Violation00033000000000
Overall StudyWithdrew Consent01200000100000

Baseline characteristics

CharacteristicLDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants2 Participants3 Participants0 Participants2 Participants0 Participants1 Participants1 Participants0 Participants1 Participants1 Participants2 Participants1 Participants0 Participants16 Participants
Age, Categorical
Between 18 and 65 years
24 Participants25 Participants29 Participants13 Participants13 Participants15 Participants14 Participants13 Participants18 Participants16 Participants18 Participants26 Participants29 Participants4 Participants257 Participants
Cirrhosis Status
No
24 Participants27 Participants23 Participants3 Participants15 Participants15 Participants0 Participants10 Participants0 Participants0 Participants0 Participants17 Participants25 Participants2 Participants161 Participants
Cirrhosis Status
Yes
2 Participants0 Participants9 Participants10 Participants0 Participants0 Participants15 Participants4 Participants18 Participants17 Participants19 Participants11 Participants5 Participants2 Participants112 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
26 Participants27 Participants32 Participants13 Participants15 Participants14 Participants15 Participants14 Participants18 Participants17 Participants19 Participants28 Participants30 Participants4 Participants272 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
HCV genotype
Genotype 1a
0 Participants0 Participants28 Participants0 Participants11 Participants11 Participants14 Participants1 Participants0 Participants15 Participants0 Participants24 Participants23 Participants0 Participants127 Participants
HCV genotype
Genotype 1b
0 Participants0 Participants3 Participants0 Participants4 Participants4 Participants1 Participants0 Participants0 Participants2 Participants0 Participants4 Participants7 Participants0 Participants25 Participants
HCV genotype
Genotype 2
2 Participants27 Participants0 Participants0 Participants0 Participants0 Participants0 Participants7 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants36 Participants
HCV genotype
Genotype 2a or 2c
8 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants8 Participants
HCV genotype
Genotype 2b
16 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants16 Participants
HCV genotype
Genotype 3
0 Participants0 Participants0 Participants12 Participants0 Participants0 Participants0 Participants2 Participants17 Participants0 Participants19 Participants0 Participants0 Participants4 Participants54 Participants
HCV genotype
Genotype 3a
0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants3 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants4 Participants
HCV genotype
Genotype 4
0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants
HCV genotype
Indeterminate
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants2 Participants
HCV RNA Category
< 800,000 IU/mL
11 Participants5 Participants8 Participants4 Participants5 Participants4 Participants4 Participants1 Participants5 Participants3 Participants3 Participants10 Participants5 Participants0 Participants68 Participants
HCV RNA Category
≥ 800,000 IU/mL
15 Participants22 Participants24 Participants9 Participants10 Participants11 Participants11 Participants13 Participants13 Participants14 Participants16 Participants18 Participants25 Participants4 Participants205 Participants
IL28b Status
CC
10 Participants14 Participants6 Participants4 Participants5 Participants5 Participants8 Participants7 Participants10 Participants6 Participants8 Participants4 Participants6 Participants3 Participants96 Participants
IL28b Status
CT
15 Participants10 Participants18 Participants6 Participants8 Participants10 Participants7 Participants7 Participants6 Participants9 Participants9 Participants21 Participants18 Participants1 Participants145 Participants
IL28b Status
TT
1 Participants3 Participants7 Participants3 Participants2 Participants0 Participants0 Participants0 Participants2 Participants2 Participants2 Participants3 Participants6 Participants0 Participants31 Participants
Prior HCV Treatment
Treatment-Experienced
5 Participants7 Participants15 Participants10 Participants0 Participants0 Participants0 Participants14 Participants0 Participants17 Participants19 Participants28 Participants30 Participants4 Participants149 Participants
Prior HCV Treatment
Treatment-Naive
21 Participants20 Participants17 Participants3 Participants15 Participants15 Participants15 Participants0 Participants18 Participants0 Participants0 Participants0 Participants0 Participants0 Participants124 Participants
Race/Ethnicity, Customized
Asian
2 Participants5 Participants1 Participants0 Participants1 Participants2 Participants0 Participants2 Participants0 Participants0 Participants0 Participants2 Participants1 Participants0 Participants16 Participants
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants3 Participants1 Participants0 Participants1 Participants1 Participants0 Participants3 Participants1 Participants1 Participants1 Participants2 Participants0 Participants15 Participants
Race/Ethnicity, Customized
Other
0 Participants0 Participants2 Participants0 Participants0 Participants0 Participants0 Participants2 Participants3 Participants0 Participants0 Participants1 Participants0 Participants1 Participants9 Participants
Race/Ethnicity, Customized
White
24 Participants21 Participants26 Participants12 Participants14 Participants12 Participants14 Participants10 Participants12 Participants16 Participants18 Participants24 Participants27 Participants3 Participants233 Participants
Sex: Female, Male
Female
9 Participants8 Participants12 Participants1 Participants8 Participants6 Participants4 Participants4 Participants8 Participants3 Participants4 Participants9 Participants6 Participants0 Participants82 Participants
Sex: Female, Male
Male
17 Participants19 Participants20 Participants12 Participants7 Participants9 Participants11 Participants10 Participants10 Participants14 Participants15 Participants19 Participants24 Participants4 Participants191 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
EG012
affected / at risk
EG013
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 260 / 270 / 320 / 130 / 150 / 150 / 150 / 180 / 170 / 190 / 280 / 300 / 4
other
Total, other adverse events
12 / 1415 / 2621 / 2724 / 3211 / 1312 / 1513 / 1510 / 1515 / 1815 / 1714 / 1921 / 2823 / 303 / 4
serious
Total, serious adverse events
2 / 141 / 262 / 273 / 322 / 130 / 150 / 150 / 150 / 180 / 172 / 191 / 280 / 300 / 4

Outcome results

Primary

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

Time frame: Up to 24 weeks

Population: Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug

ArmMeasureValue (NUMBER)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event7.1 percentage of participants
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event0 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 enrolled into the study and received at least 1 dose of study drug

ArmMeasureValue (NUMBER)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)92.9 percentage of participants
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)96.2 percentage of participants
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)74.1 percentage of participants
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)100.0 percentage of participants
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)76.9 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)93.3 percentage of participants
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)26.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)86.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)83.3 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)89.3 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)66.7 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)100.0 percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study Visit

Time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, and 24 (depending on treatment duration; Week 6 data was not collected for Cohorts 1-3)

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

ArmMeasureGroupValue (NUMBER)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 2092.9 percentage of participants
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 24100.0 percentage of participants
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 8100.0 percentage of participants
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 12100.0 percentage of participants
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 17.1 percentage of participants
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 4100.0 percentage of participants
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 1692.9 percentage of participants
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 264.3 percentage of participants
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 492.0 percentage of participants
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 12100.0 percentage of participants
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 260.0 percentage of participants
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 128.0 percentage of participants
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 8100.0 percentage of participants
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 896.3 percentage of participants
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 17.4 percentage of participants
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 240.7 percentage of participants
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 492.6 percentage of participants
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 19.4 percentage of participants
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 12100.0 percentage of participants
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 487.5 percentage of participants
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 8100.0 percentage of participants
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 253.1 percentage of participants
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 484.6 percentage of participants
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 17.7 percentage of participants
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 8100.0 percentage of participants
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 27.7 percentage of participants
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 12100.0 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 6100.0 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 266.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 126.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 4100.0 percentage of participants
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 253.3 percentage of participants
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 4100.0 percentage of participants
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 126.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 126.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 4100.0 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 266.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 6100.0 percentage of participants
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 116.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 6100.0 percentage of participants
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 4100.0 percentage of participants
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 288.9 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 15.9 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 241.2 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 476.5 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 6100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 8100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 8100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 15.3 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 242.1 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 484.2 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 694.7 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 8100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 17.1 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 260.7 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 485.7 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 696.4 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 113.3 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 696.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 493.3 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 243.3 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 10 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 225.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 8100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 6100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Percentage of Participants With HCV RNA < LLOQ While on Treatment by Study VisitWeek 4100.0 percentage of participants
Secondary

Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

Time frame: Posttreatment Weeks 4 and 24

Population: Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug

ArmMeasureGroupValue (NUMBER)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2492.9 percentage of participants
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR492.9 percentage of participants
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2496.2 percentage of participants
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR496.2 percentage of participants
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2474.1 percentage of participants
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR481.5 percentage of participants
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR24100.0 percentage of participants
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR4100.0 percentage of participants
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2476.9 percentage of participants
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR476.9 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR4100.0 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2493.3 percentage of participants
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2420.0 percentage of participants
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR473.3 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR486.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2486.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR488.9 percentage of participants
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2483.3 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR4100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR24100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR4100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR24100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2489.3 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR492.9 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR486.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR2466.7 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR24100.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)SVR4100.0 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 24

Population: Full Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug

ArmMeasureValue (NUMBER)
LDV/SOF+RBV 24 Weeks (Cohort 1 Group 1)Percentage of Participants With Virologic Failure7.1 percentage of participants
LDV/SOF 12 Weeks GT2 (Cohort 2 Group 1)Percentage of Participants With Virologic Failure0 percentage of participants
LDV/SOF 8 Weeks GT2 (Cohort 2 Group 2)Percentage of Participants With Virologic Failure22.2 percentage of participants
LDV/SOF 12 Weeks GT1/GT2/GT4 (Cohort 3 Group 1)Percentage of Participants With Virologic Failure0 percentage of participants
LDV/SOF 12 Weeks GT3 (Cohort 3 Group 2)Percentage of Participants With Virologic Failure23.1 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 4)Percentage of Participants With Virologic Failure6.7 percentage of participants
SOF/VEL+VOX 4 Weeks GT1 (Cohort 5 Group 1)Percentage of Participants With Virologic Failure73.3 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 2)Percentage of Participants With Virologic Failure13.3 percentage of participants
SOF/VEL+VOX 6 Weeks GT3 (Cohort 5 Group 3)Percentage of Participants With Virologic Failure11.1 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 4)Percentage of Participants With Virologic Failure0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 5)Percentage of Participants With Virologic Failure0 percentage of participants
SOF/VEL+VOX 8 Weeks GT1 (Cohort 5 Group 6)Percentage of Participants With Virologic Failure10.7 percentage of participants
SOF/VEL+VOX 6 Weeks GT1 (Cohort 5 Group 7)Percentage of Participants With Virologic Failure30.0 percentage of participants
SOF/VEL+VOX 8 Weeks GT3 (Cohort 5 Group 8)Percentage of Participants With Virologic Failure0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026