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Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation

A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir Fixed Dose Combination Administered for Four Weeks in Patients Infected With Chronic HCV in the Peri-Operative Liver Transplantation Setting

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02728206
Enrollment
9
Registered
2016-04-05
Start date
2016-06-12
Completion date
2018-01-16
Last updated
2019-02-06

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

Conditions

Hepatitis C Virus Infection

Brief summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.

Interventions

DRUGSOF/VEL

400/100 mg FDC tablet administered orally once daily

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: * HCV-infected, male and non-pregnant/non-lactating females, who are undergoing liver transplantation Key

Exclusion criteria

* Receiving an HCV-infected liver * HIV or hepatitis B virus (HBV) co-infected 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 Week 4—

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 On TreatmentDays 3, 5, 7, 14, 21, and 28—
Percentage of Participants With Overall Virologic FailureUp to Posttreatment Week 12Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA ≥ 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA ≥ 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA \< 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.

Countries

New Zealand

Participant flow

Recruitment details

Participants were enrolled at a study site in New Zealand. The first participant was screened on 12 June 2016. The last study visit occurred on 16 January 2018.

Pre-assignment details

11 participants were screened.

Participants by arm

ArmCount
SOF/VEL
SOF/VEL (400/100 mg) FDC tablet orally once daily for 4 weeks starting on the day of or day after the participant's liver transplant.
9
Total9

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyDeath1

Baseline characteristics

CharacteristicSOF/VEL
Age, Continuous61 Years
STANDARD_DEVIATION 3.1
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Pre-Transplant HCV RNA Category
< 800,000 IU/mL
3 Participants
Pre-Transplant HCV RNA Category
≥ 800,000 IU/mL
6 Participants
Pre-Transplant HCV RNA (log10 international units per milliliter (IU/mL))6.4 log10 IU/mL
STANDARD_DEVIATION 0.63
Pre-Transplant Hepatitis C Virus (HCV) genotype
Genotype 1/1b
1 Participants
Pre-Transplant Hepatitis C Virus (HCV) genotype
Genotype 1a
2 Participants
Pre-Transplant Hepatitis C Virus (HCV) genotype
Genotype 3
5 Participants
Pre-Transplant Hepatitis C Virus (HCV) genotype
Genotype 3a
1 Participants
Pre-Transplant IL28b Status
CC
8 Participants
Pre-Transplant IL28b Status
CT
1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
3 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
5 Participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
1 / 9
other
Total, other adverse events
9 / 9
serious
Total, serious adverse events
5 / 9

Outcome results

Primary

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

Time frame: Up to Week 4

Population: Safety Analysis Set

ArmMeasureValue (NUMBER)
SOF/VELPercentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event11.1 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 included all enrolled participants who received a liver transplant, and took at least 1 dose of study drug.

ArmMeasureValue (NUMBER)
SOF/VELPercentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)77.8 Percentage of participants
Secondary

Percentage of Participants With HCV RNA < LLOQ On Treatment

Time frame: Days 3, 5, 7, 14, 21, and 28

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

ArmMeasureGroupValue (NUMBER)
SOF/VELPercentage of Participants With HCV RNA < LLOQ On TreatmentDay 30 Percentage of participants
SOF/VELPercentage of Participants With HCV RNA < LLOQ On TreatmentDay 50 Percentage of participants
SOF/VELPercentage of Participants With HCV RNA < LLOQ On TreatmentDay 70 Percentage of participants
SOF/VELPercentage of Participants With HCV RNA < LLOQ On TreatmentDay 1433.3 Percentage of participants
SOF/VELPercentage of Participants With HCV RNA < LLOQ On TreatmentDay 2185.7 Percentage of participants
SOF/VELPercentage of Participants With HCV RNA < LLOQ On TreatmentDay 2885.7 Percentage of participants
Secondary

Percentage of Participants With Overall Virologic Failure

Virologic failure was defined as 1) End of Treatment Virologic Failure: HCV RNA ≥ 15 IU/mL at last observed HCV RNA measurement on or prior to last dose date of SOF/VEL + 3 days after completion of 28 ± 3 days of SOF/VEL treatment, or 2) Relapse: HCV RNA ≥ 15 IU/mL during the posttreatment follow-up period having achieved HCV RNA \< 15 IU/mL at the end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.

Time frame: Up to Posttreatment Week 12

Population: Full Analysis Set

ArmMeasureValue (NUMBER)
SOF/VELPercentage of Participants With Overall Virologic Failure0 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)
SOF/VELPercentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)88.9 Percentage of participants

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