Trial Outcomes & Findings for Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection (NCT NCT01896193)
NCT ID: NCT01896193
Last Updated: 2015-05-29
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
127 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2015-05-29
Participant Flow
Participants were enrolled at a total of 16 study sites in Russia. The first participant was screened on 06 June 2013. The last study visit occurred on 27 July 2014.
139 participants were screened.
Participant milestones
| Measure |
SOF+RBV 16 Weeks
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
65
|
|
Overall Study
COMPLETED
|
41
|
53
|
|
Overall Study
NOT COMPLETED
|
21
|
12
|
Reasons for withdrawal
| Measure |
SOF+RBV 16 Weeks
Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
20
|
11
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Withdrew Consent
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy Study of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Genotype 1 and 3 Chronic HCV Infection
Baseline characteristics by cohort
| Measure |
SOF+RBV 16 Weeks, GT1
n=32 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
|
SOF+RBV 24 Weeks, GT1
n=34 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
|
SOF+RBV 16 Weeks, GT3
n=30 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
|
SOF+RBV 24 Weeks, GT3
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
42 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
38 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
40 years
STANDARD_DEVIATION 9.6 • n=4 Participants
|
40 years
STANDARD_DEVIATION 10.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
67 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
32 participants
n=5 Participants
|
34 participants
n=7 Participants
|
30 participants
n=5 Participants
|
31 participants
n=4 Participants
|
127 participants
n=21 Participants
|
|
Cirrhosis Status
No
|
28 participants
n=5 Participants
|
28 participants
n=7 Participants
|
23 participants
n=5 Participants
|
26 participants
n=4 Participants
|
105 participants
n=21 Participants
|
|
Cirrhosis Status
Yes
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
5 participants
n=4 Participants
|
21 participants
n=21 Participants
|
|
Cirrhosis Status
Missing
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
|
IL28b Status
CC
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
15 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
IL28b Status
CT
|
19 participants
n=5 Participants
|
23 participants
n=7 Participants
|
16 participants
n=5 Participants
|
15 participants
n=4 Participants
|
73 participants
n=21 Participants
|
|
IL28b Status
TT
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
11 participants
n=21 Participants
|
|
HCV RNA
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.60 • n=5 Participants
|
6.1 log10 IU/mL
STANDARD_DEVIATION 0.60 • n=7 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.81 • n=5 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.77 • n=4 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.69 • n=21 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
10 participants
n=5 Participants
|
10 participants
n=4 Participants
|
43 participants
n=21 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
20 participants
n=5 Participants
|
23 participants
n=7 Participants
|
20 participants
n=5 Participants
|
21 participants
n=4 Participants
|
84 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set: participants with genotype 1 or 3 HCV infection who were randomized and received at least one dose of study drug
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 25 IU/mL) at 12 weeks after stopping study treatment.
Outcome measures
| Measure |
SOF+RBV 16 Weeks, GT1
n=32 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
|
SOF+RBV 24 Weeks, GT1
n=34 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
|
SOF+RBV 16 Weeks, GT3
n=30 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
|
SOF+RBV 24 Weeks, GT3
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
|
50.0 percentage of participants
|
76.5 percentage of participants
|
86.7 percentage of participants
|
90.3 percentage of participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Outcome measures
| Measure |
SOF+RBV 16 Weeks, GT1
n=32 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
|
SOF+RBV 24 Weeks, GT1
n=34 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
|
SOF+RBV 16 Weeks, GT3
n=30 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
|
SOF+RBV 24 Weeks, GT3
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR 24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Outcome measures
| Measure |
SOF+RBV 16 Weeks, GT1
n=32 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
|
SOF+RBV 24 Weeks, GT1
n=34 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
|
SOF+RBV 16 Weeks, GT3
n=30 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
|
SOF+RBV 24 Weeks, GT3
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
53.1 percentage of participants
|
76.5 percentage of participants
|
90.0 percentage of participants
|
90.3 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
46.9 percentage of participants
|
76.5 percentage of participants
|
86.7 percentage of participants
|
90.3 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Full Analysis Set
On-treatment virologic failure was defined as * Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA \< LLOQ 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 8 weeks of treatment)
Outcome measures
| Measure |
SOF+RBV 16 Weeks, GT1
n=32 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
|
SOF+RBV 24 Weeks, GT1
n=34 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
|
SOF+RBV 16 Weeks, GT3
n=30 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
|
SOF+RBV 24 Weeks, GT3
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing On-treatment Virologic Failure
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 12Population: Full Analysis Set
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA \< LLOQ at last on-treatment visit.
Outcome measures
| Measure |
SOF+RBV 16 Weeks, GT1
n=32 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
|
SOF+RBV 24 Weeks, GT1
n=34 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
|
SOF+RBV 16 Weeks, GT3
n=30 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
|
SOF+RBV 24 Weeks, GT3
n=31 Participants
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing Virologic Relapse
|
50.0 percentage of participants
|
23.5 percentage of participants
|
13.3 percentage of participants
|
9.7 percentage of participants
|
Adverse Events
SOF+RBV 16 Weeks
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
SOF+RBV 24 Weeks
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF+RBV 16 Weeks
n=62 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=65 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
1.6%
1/62 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/65 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/62 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.5%
1/65 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF+RBV 16 Weeks
n=62 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks
|
SOF+RBV 24 Weeks
n=65 participants at risk
SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
General disorders
Asthenia
|
11.3%
7/62 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.2%
4/65 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
3.2%
2/62 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.2%
4/65 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Respiratory tract infection viral
|
4.8%
3/62 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
7.7%
5/65 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
8.1%
5/62 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
15.4%
10/65 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Psychiatric disorders
Insomnia
|
1.6%
1/62 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.2%
4/65 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.6%
1/62 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.2%
4/65 • 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