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Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-7977 and Ribavirin for 24 Weeks in Subjects With Recurrent Chronic HCV Post Liver Transplant

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01687270
Enrollment
40
Registered
2012-09-18
Start date
2012-11-30
Completion date
2014-08-31
Last updated
2014-12-19

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

Conditions

Post Liver Transplant, Recurrent Chronic Hepatitis C Virus

Brief summary

This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.

Interventions

DRUGSofosbuvir

Sofosbuvir 400 mg tablet administered orally once daily

DRUGRBV

Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.

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

* Subjects with evidence of chronic HCV (all genotypes) documented pretransplantation * HCV RNA ≥ 10,000 IU/mL at screening * Absence of organ rejection as documented by post transplant liver biopsy taken no more than 12 months prior to baseline/Day 1 visit * Liver transplant ≥ 6 months and ≤ 12 years prior to screening * Naive to all nucleotide/nucleoside treatments for chronic HCV infection

Exclusion criteria

* Multiorgan transplant that includes heart or lung recipient * Subjects with de novo or recurrent Hepatocellular Carcinoma(HCC) post transplant * Current use of corticosteroids at any dose \> 5mg of prednisone/day (or equivalent dose of corticosteroid) * Infection with hepatitis B virus (HBV) or HIV at screening * Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)Posttreatment Week 12SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.
Percentage of Participants Who Discontinue Study Drug Due to an Adverse EventBaseline to Week 24—

Secondary

MeasureTime frameDescription
Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)Posttreatment Weeks 4, 24, and 48SVR4, SVR 24, and SVR 48 were defined as HCV RNA \< LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.
Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24Weeks 12 and 24—
HCV RNA and Change From Baseline at Weeks 2, 4, and 8Baseline; Weeks 2, 4, and 8—
Percentage of Participants With Virologic FailureUp to Posttreatment Week 24Virologic failure was defined as on-treatment virologic failure or virologic relapse. * On-treatment virologic failure: HCV RNA \< LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment * Virologic relapse: HCV RNA \< LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)

Countries

France, Germany, New Zealand, Spain, United States

Participant flow

Recruitment details

Participants were enrolled at a total of 12 study sites in the United States, Europe, and New Zealand. The first participant was screened on 26 October 2012. The last participant observation occurred on 14 August 2014.

Pre-assignment details

49 participants were screened.

Participants by arm

ArmCount
SOF+RBV
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
40
Total40

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLack of Efficacy11
Overall StudyLost to Follow-up1

Baseline characteristics

CharacteristicSOF+RBV
Age, Continuous59 years
STANDARD_DEVIATION 6.3
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
39 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
HCV Genotype
Genotype 1A
22 participants
HCV Genotype
Genotype 1B
11 participants
HCV Genotype
Genotype 3A
5 participants
HCV Genotype
Genotype 3B
1 participants
HCV Genotype
Genotype 4
1 participants
HCV RNA6.55 log10 IU/mL
STANDARD_DEVIATION 0.751
HCV RNA Category
< 6 log10 IU/mL
8 participants
HCV RNA Category
6 to 7 log10 IU/mL
20 participants
HCV RNA Category
> 7 log10 IU/mL
12 participants
IL28b Status
CC
13 participants
IL28b Status
CT
16 participants
IL28b Status
TT
11 participants
Prior HCV Treatment
No
5 participants
Prior HCV Treatment
Yes
35 participants
Race/Ethnicity, Customized
Asian
2 participants
Race/Ethnicity, Customized
Black
3 participants
Race/Ethnicity, Customized
Other
1 participants
Race/Ethnicity, Customized
White
34 participants
Region of Enrollment
France
3 participants
Region of Enrollment
Germany
3 participants
Region of Enrollment
New Zealand
3 participants
Region of Enrollment
Spain
3 participants
Region of Enrollment
United States
28 participants
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
31 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
39 / 40
serious
Total, serious adverse events
6 / 40

Outcome results

Primary

Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event

Time frame: Baseline to Week 24

Population: Safety Analysis Set

ArmMeasureValue (NUMBER)
SOF+RBVPercentage of Participants Who Discontinue Study Drug Due to an Adverse Event5.0 percentage of participants
Primary

Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, \< 25 IU/mL) 12 weeks following the last dose of study drug.

Time frame: Posttreatment Week 12

Population: Full Analysis Set: participants were enrolled and received at least one dose of study medication.

ArmMeasureValue (NUMBER)
SOF+RBVPercentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)70.0 percentage of participants
Secondary

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

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

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

ArmMeasureGroupValue (MEAN)Dispersion
SOF+RBVHCV RNA and Change From Baseline at Weeks 2, 4, and 8Week 2 (n = 39)1.65 log10 IU/mLStandard Deviation 0.37
SOF+RBVHCV RNA and Change From Baseline at Weeks 2, 4, and 8Change from baseline at Week 2 (n = 39)-4.89 log10 IU/mLStandard Deviation 0.692
SOF+RBVHCV RNA and Change From Baseline at Weeks 2, 4, and 8Week 4 (n = 40)1.38 log10 IU/mLStandard Deviation 0
SOF+RBVHCV RNA and Change From Baseline at Weeks 2, 4, and 8Change from baseline at Week 4 (n = 40)-5.17 log10 IU/mLStandard Deviation 0.751
SOF+RBVHCV RNA and Change From Baseline at Weeks 2, 4, and 8Week 8 (n = 40)1.38 log10 IU/mLStandard Deviation 0.005
SOF+RBVHCV RNA and Change From Baseline at Weeks 2, 4, and 8Change from baseline at Week 8 (n = 40)-5.17 log10 IU/mLStandard Deviation 0.752
Secondary

Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24

Time frame: Weeks 12 and 24

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

ArmMeasureGroupValue (NUMBER)
SOF+RBVPercentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24Week 12 (n = 40)100.00 percentage of participants
SOF+RBVPercentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24Week 24 (n = 38)100.00 percentage of participants
Secondary

Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)

SVR4, SVR 24, and SVR 48 were defined as HCV RNA \< LLOQ 4, 24, and 48 weeks following the last dose of study drug, respectively.

Time frame: Posttreatment Weeks 4, 24, and 48

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
SOF+RBVPercentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)SVR472.5 percentage of participants
SOF+RBVPercentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)SVR2470.0 percentage of participants
SOF+RBVPercentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)SVR4870.0 percentage of participants
Secondary

Percentage of Participants With Virologic Failure

Virologic failure was defined as on-treatment virologic failure or virologic relapse. * On-treatment virologic failure: HCV RNA \< LLOQ during treatment with subsequent detectable HCV RNA while continuing treatment * Virologic relapse: HCV RNA \< LLOQ at last observed on-treatment HCV RNA measurement and HCV RNA ≥ LLOQ after stopping treatment (2 consecutive HCV RNA measurements or last available HCV RNA measurement)

Time frame: Up to Posttreatment Week 24

Population: Full Analysis Set

ArmMeasureGroupValue (NUMBER)
SOF+RBVPercentage of Participants With Virologic FailureOn-treatment virologic failure0 percentage of participants
SOF+RBVPercentage of Participants With Virologic FailureVirologic relapse30.0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026