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Trial Outcomes & Findings for Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant (NCT NCT02781571)

NCT ID: NCT02781571

Last Updated: 2018-11-14

Results Overview

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

79 participants

Primary outcome timeframe

Posttreatment Week 12

Results posted on

2018-11-14

Participant Flow

Participants were enrolled at study sites in Spain, Switzerland, and the United Kingdom. The first participant was screened on 27 July 2016. The last study visit occurred on 28 July 2017.

85 participants were screened.

Participant milestones

Participant milestones
Measure
SOF/VEL
Sofosbuvir/Velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Overall Study
STARTED
79
Overall Study
COMPLETED
79
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
SOF/VEL
n=79 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Age, Continuous
62 Years
STANDARD_DEVIATION 8.7 • n=99 Participants
Sex: Female, Male
Female
15 Participants
n=99 Participants
Sex: Female, Male
Male
64 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
77 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
12 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=99 Participants
Race (NIH/OMB)
White
65 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Region of Enrollment
United Kingdom
41 Participants
n=99 Participants
Region of Enrollment
Switzerland
7 Participants
n=99 Participants
Region of Enrollment
Spain
31 Participants
n=99 Participants
IL28b Status
CC
39 Participants
n=99 Participants
IL28b Status
CT
34 Participants
n=99 Participants
IL28b Status
TT
6 Participants
n=99 Participants
HCV RNA
6.4 log10 IU/mL
STANDARD_DEVIATION 0.55 • n=99 Participants
HCV RNA Category
< 800,000 IU/mL
18 Participants
n=99 Participants
HCV RNA Category
≥ 800,000 IU/mL
61 Participants
n=99 Participants
HCV genotype
Genotype 1
37 Participants
n=99 Participants
HCV genotype
Genotype 2
3 Participants
n=99 Participants
HCV genotype
Genotype 3
35 Participants
n=99 Participants
HCV genotype
Genotype 4
4 Participants
n=99 Participants

PRIMARY outcome

Timeframe: Posttreatment Week 12

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

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.

Outcome measures

Outcome measures
Measure
SOF/VEL
n=79 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Cessation of Therapy (SVR12)
96.2 percentage of participants
Interval 89.3 to 99.2

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Safety Analysis Set: participants who took at least 1 dose if the study drug.

Outcome measures

Outcome measures
Measure
SOF/VEL
n=79 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Percentage of Participants Who Prematurely Discontinued Study Drug Due to Any Adverse Event
1.3 percentage of participants

SECONDARY outcome

Timeframe: Posttreatment Week 4

Population: Full Analysis Set

SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.

Outcome measures

Outcome measures
Measure
SOF/VEL
n=79 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Percentage of Participants With Sustained Virologic Response 4 Weeks After Cessation of Therapy (SVR4)
97.5 Percentage of participants
Interval 91.2 to 99.7

SECONDARY outcome

Timeframe: Week 2

Population: Full Analysis Set

Outcome measures

Outcome measures
Measure
SOF/VEL
n=79 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Percentage of Participants With HCV RNA < LLOQ at Week 2
40.5 percentage of participants
Interval 29.6 to 52.1

SECONDARY outcome

Timeframe: Week 4

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=78 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Percentage of Participants With HCV RNA < LLOQ at Week 4
85.9 percentage of participants
Interval 76.2 to 92.7

SECONDARY outcome

Timeframe: Week 8

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=78 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Percentage of Participants With HCV RNA < LLOQ at Week 8
98.7 percentage of participants
Interval 93.1 to 100.0

SECONDARY outcome

Timeframe: Week 12

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=78 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Percentage of Participants With HCV RNA < LLOQ at Week 12
100.0 percentage of participants
Interval 95.4 to 100.0

SECONDARY outcome

Timeframe: Week 2

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=75 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
HCV RNA at Week 2
1.59 log10 IU/mL
Standard Deviation 0.596

SECONDARY outcome

Timeframe: Week 4

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=78 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
HCV RNA at Week 4
1.23 log10 IU/mL
Standard Deviation 0.251

SECONDARY outcome

Timeframe: Week 8

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=77 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
HCV RNA at Week 8
1.15 log10 IU/mL
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Week 12

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=78 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
HCV RNA at Week 12
1.15 log10 IU/mL
Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline; Week 2

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=75 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Change From Baseline in HCV RNA at Week 2
-4.75 log10 IU/mL
Standard Deviation 0.635

SECONDARY outcome

Timeframe: Baseline; Week 4

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=78 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Change From Baseline in HCV RNA at Week 4
-5.13 log10 IU/mL
Standard Deviation 0.551

SECONDARY outcome

Timeframe: Baseline; Week 8

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=77 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Change From Baseline in HCV RNA at Week 8
-5.20 log10 IU/mL
Standard Deviation 0.548

SECONDARY outcome

Timeframe: Baseline; Week 12

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

Outcome measures

Outcome measures
Measure
SOF/VEL
n=78 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Change From Baseline in HCV RNA at Week 12
-5.22 log10 IU/mL
Standard Deviation 0.554

SECONDARY outcome

Timeframe: Up to Posttreatment Week 12

Population: Full Analysis Set

Virologic failure was defined as On-treatment virologic failure: * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ on 2 consecutive measurements 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 12 weeks of treatment) Virologic relapse: * HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA \< LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement

Outcome measures

Outcome measures
Measure
SOF/VEL
n=79 Participants
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Percentage of Participants With Virologic Failure
2.5 percentage of participants

Adverse Events

SOF/VEL

Serious events: 3 serious events
Other events: 42 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
SOF/VEL
n=79 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Infections and infestations
Pneumonia klebsiella
1.3%
1/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders
Joint swelling
1.3%
1/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
1.3%
1/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.

Other adverse events

Other adverse events
Measure
SOF/VEL
n=79 participants at risk
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with chronic HCV infection who received a liver transplant
Gastrointestinal disorders
Diarrhoea
7.6%
6/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
Gastrointestinal disorders
Nausea
7.6%
6/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
General disorders
Asthenia
6.3%
5/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
General disorders
Fatigue
20.3%
16/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
Infections and infestations
Influenza
6.3%
5/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
Infections and infestations
Viral upper respiratory tract infection
6.3%
5/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
Metabolism and nutrition disorders
Decreased appetite
5.1%
4/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
Musculoskeletal and connective tissue disorders
Myalgia
5.1%
4/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
Nervous system disorders
Headache
24.1%
19/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.
Respiratory, thoracic and mediastinal disorders
Cough
10.1%
8/79 • Up to 12 weeks plus 30 days
Safety Analysis Set: participants who took at least 1 dose of the study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Results disclosure agreements

  • Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
  • Publication restrictions are in place

Restriction type: OTHER