Trial Outcomes & Findings for Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation (NCT NCT02728206)
NCT ID: NCT02728206
Last Updated: 2019-02-06
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2019-02-06
Participant Flow
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.
11 participants were screened.
Participant milestones
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 4 weeks starting on the day of or day after the participant's liver transplant.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
SOF/VEL
Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 4 weeks starting on the day of or day after the participant's liver transplant.
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation
Baseline characteristics by cohort
| Measure |
SOF/VEL
n=9 Participants
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.
|
|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
61 Years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Pre-Transplant Hepatitis C Virus (HCV) genotype
Genotype 1a
|
2 Participants
n=5 Participants
|
|
Pre-Transplant Hepatitis C Virus (HCV) genotype
Genotype 1/1b
|
1 Participants
n=5 Participants
|
|
Pre-Transplant Hepatitis C Virus (HCV) genotype
Genotype 3
|
5 Participants
n=5 Participants
|
|
Pre-Transplant Hepatitis C Virus (HCV) genotype
Genotype 3a
|
1 Participants
n=5 Participants
|
|
Pre-Transplant IL28b Status
CC
|
8 Participants
n=5 Participants
|
|
Pre-Transplant IL28b Status
CT
|
1 Participants
n=5 Participants
|
|
Pre-Transplant HCV RNA (log10 international units per milliliter (IU/mL))
|
6.4 log10 IU/mL
STANDARD_DEVIATION 0.63 • n=5 Participants
|
|
Pre-Transplant HCV RNA Category
< 800,000 IU/mL
|
3 Participants
n=5 Participants
|
|
Pre-Transplant HCV RNA Category
≥ 800,000 IU/mL
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set included all enrolled participants who received a liver transplant, and took at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=9 Participants
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.
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
|
77.8 Percentage of participants
Interval 40.0 to 97.2
|
PRIMARY outcome
Timeframe: Up to Week 4Population: Safety Analysis Set
Outcome measures
| Measure |
SOF/VEL
n=9 Participants
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.
|
|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
11.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Week 4Population: Full Analysis Set
SVR4 was defined as HCV RNA \< LLOQ at 4 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF/VEL
n=9 Participants
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.
|
|---|---|
|
Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
|
88.9 Percentage of participants
Interval 51.8 to 99.7
|
SECONDARY outcome
Timeframe: Days 3, 5, 7, 14, 21, and 28Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF/VEL
n=9 Participants
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.
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Day 3
|
0 Percentage of participants
Interval 0.0 to 33.6
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Day 5
|
0 Percentage of participants
Interval 0.0 to 33.6
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Day 7
|
0 Percentage of participants
Interval 0.0 to 33.6
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Day 14
|
33.3 Percentage of participants
Interval 7.5 to 70.1
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Day 21
|
85.7 Percentage of participants
Interval 42.1 to 99.6
|
|
Percentage of Participants With HCV RNA < LLOQ On Treatment
Day 28
|
85.7 Percentage of participants
Interval 42.1 to 99.6
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 12Population: Full Analysis Set
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.
Outcome measures
| Measure |
SOF/VEL
n=9 Participants
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.
|
|---|---|
|
Percentage of Participants With Overall Virologic Failure
|
0 Percentage of participants
|
Adverse Events
SOF/VEL
Serious events: 5 serious events
Other events: 9 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
SOF/VEL
n=9 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Immune system disorders
Liver transplant rejection
|
33.3%
3/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Wound infection
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
22.2%
2/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid intake reduced
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
SOF/VEL
n=9 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Supraventricular tachycardia
|
22.2%
2/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Tachyarrhythmia
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Ear discomfort
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Eye disorders
Vision blurred
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
44.4%
4/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
3/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
22.2%
2/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
22.2%
2/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Coeliac artery stenosis
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Oesophagitis
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Immune system disorders
Liver transplant rejection
|
33.3%
3/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
22.2%
2/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Cytomegalovirus infection
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Bacterial test positive
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
22.2%
2/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
22.2%
2/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Depression
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Hallucination, visual
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
22.2%
2/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
22.2%
2/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
11.1%
1/9 • Up to 4 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
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