Trial Outcomes & Findings for Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant (NCT NCT01687270)
NCT ID: NCT01687270
Last Updated: 2014-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2014-12-19
Participant Flow
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.
49 participants were screened.
Participant milestones
| Measure |
SOF+RBV
Sofosbuvir (SOF) 400 mg tablet once daily plus ribavirin (RBV) tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
SOF+RBV
Sofosbuvir (SOF) 400 mg tablet once daily plus ribavirin (RBV) tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
Overall Study
Lack of Efficacy
|
11
|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
Safety and Efficacy of Sofosbuvir and Ribavirin in Adults With Recurrent Chronic Hepatitis C Virus (HCV) Post Liver Transplant
Baseline characteristics by cohort
| Measure |
SOF+RBV
n=40 Participants
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
34 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
|
Region of Enrollment
France
|
3 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
3 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
3 participants
n=5 Participants
|
|
HCV RNA
|
6.55 log10 IU/mL
STANDARD_DEVIATION 0.751 • n=5 Participants
|
|
HCV RNA Category
< 6 log10 IU/mL
|
8 participants
n=5 Participants
|
|
HCV RNA Category
6 to 7 log10 IU/mL
|
20 participants
n=5 Participants
|
|
HCV RNA Category
> 7 log10 IU/mL
|
12 participants
n=5 Participants
|
|
Prior HCV Treatment
No
|
5 participants
n=5 Participants
|
|
Prior HCV Treatment
Yes
|
35 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1A
|
22 participants
n=5 Participants
|
|
HCV Genotype
Genotype 1B
|
11 participants
n=5 Participants
|
|
HCV Genotype
Genotype 3A
|
5 participants
n=5 Participants
|
|
HCV Genotype
Genotype 3B
|
1 participants
n=5 Participants
|
|
HCV Genotype
Genotype 4
|
1 participants
n=5 Participants
|
|
IL28b Status
CC
|
13 participants
n=5 Participants
|
|
IL28b Status
CT
|
16 participants
n=5 Participants
|
|
IL28b Status
TT
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants were enrolled and received at least one dose of study medication.
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.
Outcome measures
| Measure |
SOF+RBV
n=40 Participants
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
70.0 percentage of participants
|
PRIMARY outcome
Timeframe: Baseline to Week 24Population: Safety Analysis Set
Outcome measures
| Measure |
SOF+RBV
n=40 Participants
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event
|
5.0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4, 24, and 48Population: Full Analysis Set
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.
Outcome measures
| Measure |
SOF+RBV
n=40 Participants
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
SVR4
|
72.5 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
SVR24
|
70.0 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4, 24, and 48 Weeks After Discontinuation of Therapy (SVR4, SVR24, and SVR48)
SVR48
|
70.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 12 and 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV
n=40 Participants
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24
Week 12 (n = 40)
|
100.00 percentage of participants
|
|
Percentage of Participants With HCV RNA < LLOQ at Weeks 12 and 24
Week 24 (n = 38)
|
100.00 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, and 8Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
SOF+RBV
n=40 Participants
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
HCV RNA and Change From Baseline at Weeks 2, 4, and 8
Week 2 (n = 39)
|
1.65 log10 IU/mL
Standard Deviation 0.370
|
|
HCV RNA and Change From Baseline at Weeks 2, 4, and 8
Change from baseline at Week 2 (n = 39)
|
-4.89 log10 IU/mL
Standard Deviation 0.692
|
|
HCV RNA and Change From Baseline at Weeks 2, 4, and 8
Week 4 (n = 40)
|
1.38 log10 IU/mL
Standard Deviation 0.000
|
|
HCV RNA and Change From Baseline at Weeks 2, 4, and 8
Change from baseline at Week 4 (n = 40)
|
-5.17 log10 IU/mL
Standard Deviation 0.751
|
|
HCV RNA and Change From Baseline at Weeks 2, 4, and 8
Week 8 (n = 40)
|
1.38 log10 IU/mL
Standard Deviation 0.005
|
|
HCV RNA and Change From Baseline at Weeks 2, 4, and 8
Change from baseline at Week 8 (n = 40)
|
-5.17 log10 IU/mL
Standard Deviation 0.752
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
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)
Outcome measures
| Measure |
SOF+RBV
n=40 Participants
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
Percentage of Participants With Virologic Failure
On-treatment virologic failure
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Failure
Virologic relapse
|
30.0 percentage of participants
|
Adverse Events
SOF+RBV
Serious events: 6 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF+RBV
n=40 participants at risk
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
2.5%
1/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
General disorders
Pyrexia
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Hepatobiliary disorders
Jaundice
|
2.5%
1/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Infections and infestations
Pneumonia
|
2.5%
1/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Injury, poisoning and procedural complications
Compression fracture
|
2.5%
1/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
2.5%
1/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Psychiatric disorders
Confusional state
|
2.5%
1/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Psychiatric disorders
Hallucination
|
2.5%
1/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
Other adverse events
| Measure |
SOF+RBV
n=40 participants at risk
SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
8/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Cardiac disorders
Palpitations
|
7.5%
3/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Gastrointestinal disorders
Diarrhoea
|
27.5%
11/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Gastrointestinal disorders
Nausea
|
20.0%
8/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Gastrointestinal disorders
Oral lichen planus
|
7.5%
3/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Gastrointestinal disorders
Abdominal distension
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
General disorders
Fatigue
|
30.0%
12/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
General disorders
Asthenia
|
10.0%
4/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
General disorders
Oedema peripheral
|
7.5%
3/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
General disorders
Pyrexia
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Infections and infestations
Bronchitis
|
7.5%
3/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Infections and infestations
Candida infection
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Infections and infestations
Sinusitis
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Infections and infestations
Upper respiratory tract infection
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Injury, poisoning and procedural complications
Contusion
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Injury, poisoning and procedural complications
Laceration
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Investigations
Blood creatinine increased
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Metabolism and nutrition disorders
Increased appetite
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
22.5%
9/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
10.0%
4/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
3/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
2/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Nervous system disorders
Headache
|
25.0%
10/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Nervous system disorders
Dizziness
|
7.5%
3/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Psychiatric disorders
Anxiety
|
12.5%
5/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Psychiatric disorders
Insomnia
|
12.5%
5/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Psychiatric disorders
Irritability
|
10.0%
4/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Psychiatric disorders
Depression
|
7.5%
3/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.5%
7/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
4/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
3/40 • Up to 24 weeks plus 30 days
Safety Analysis set
|
Additional Information
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