Trial Outcomes & Findings for Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection (NCT NCT02074514)
NCT ID: NCT02074514
Last Updated: 2016-10-25
Results Overview
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
117 participants
Primary outcome timeframe
Posttreatment Week 12
Results posted on
2016-10-25
Participant Flow
Participants were enrolled at study sites in India. The first participant was screened on 31 March 2014. The last study visit occurred on 30 November 2015.
Participant milestones
| Measure |
SOF+RBV 16 Weeks
Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 16 weeks.
|
SOF+RBV 24 Weeks
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
58
|
|
Overall Study
COMPLETED
|
56
|
54
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
SOF+RBV 16 Weeks
Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 16 weeks.
|
SOF+RBV 24 Weeks
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrew Consent
|
0
|
1
|
Baseline Characteristics
Safety and Efficacy of Sofosbuvir Plus Ribavirin in Treatment-Naive Adults With Chronic Genotype 1 or 3 HCV Infection
Baseline characteristics by cohort
| Measure |
SOF + RBV 16 Weeks GT1
n=30 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
|
SOF + RBV 24 Weeks GT1
n=28 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
|
SOF + RBV 16 Weeks GT3
n=29 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
|
SOF + RBV 24 Weeks GT3
n=30 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
45 Years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
46 Years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
40 Years
STANDARD_DEVIATION 12.7 • n=206 Participants
|
37 Years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
42 Years
STANDARD_DEVIATION 12.4 • n=31 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
42 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
75 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
30 participants
n=99 Participants
|
28 participants
n=107 Participants
|
29 participants
n=206 Participants
|
30 participants
n=7 Participants
|
117 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
28 participants
n=99 Participants
|
24 participants
n=107 Participants
|
26 participants
n=206 Participants
|
28 participants
n=7 Participants
|
106 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
2 participants
n=99 Participants
|
4 participants
n=107 Participants
|
3 participants
n=206 Participants
|
2 participants
n=7 Participants
|
11 participants
n=31 Participants
|
|
HCV genotype
Genotype 1a
|
5 participants
n=99 Participants
|
5 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
10 participants
n=31 Participants
|
|
HCV genotype
Genotype 1b
|
25 participants
n=99 Participants
|
23 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
48 participants
n=31 Participants
|
|
HCV genotype
Genotype 3
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
29 participants
n=206 Participants
|
30 participants
n=7 Participants
|
59 participants
n=31 Participants
|
|
Cirrhosis Status
Absence
|
20 participants
n=99 Participants
|
19 participants
n=107 Participants
|
22 participants
n=206 Participants
|
23 participants
n=7 Participants
|
84 participants
n=31 Participants
|
|
Cirrhosis Status
Presence
|
10 participants
n=99 Participants
|
9 participants
n=107 Participants
|
7 participants
n=206 Participants
|
7 participants
n=7 Participants
|
33 participants
n=31 Participants
|
|
HCV RNA
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.44 • n=99 Participants
|
5.9 log10 IU/mL
STANDARD_DEVIATION 0.72 • n=107 Participants
|
6.2 log10 IU/mL
STANDARD_DEVIATION 0.68 • n=206 Participants
|
6.5 log10 IU/mL
STANDARD_DEVIATION 0.70 • n=7 Participants
|
6.3 log10 IU/mL
STANDARD_DEVIATION 0.67 • n=31 Participants
|
|
IL28b Status
CC
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
17 participants
n=206 Participants
|
23 participants
n=7 Participants
|
69 participants
n=31 Participants
|
|
IL28b Status
CT
|
13 participants
n=99 Participants
|
8 participants
n=107 Participants
|
11 participants
n=206 Participants
|
7 participants
n=7 Participants
|
39 participants
n=31 Participants
|
|
IL28b Status
TT
|
3 participants
n=99 Participants
|
5 participants
n=107 Participants
|
1 participants
n=206 Participants
|
0 participants
n=7 Participants
|
9 participants
n=31 Participants
|
|
HCV RNA Category
< 800,000 IU/mL
|
5 participants
n=99 Participants
|
14 participants
n=107 Participants
|
10 participants
n=206 Participants
|
6 participants
n=7 Participants
|
35 participants
n=31 Participants
|
|
HCV RNA Category
≥ 800,000 IU/mL
|
25 participants
n=99 Participants
|
14 participants
n=107 Participants
|
19 participants
n=206 Participants
|
24 participants
n=7 Participants
|
82 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Posttreatment Week 12Population: Full Analysis Set (FAS): participants with genotype 1 or 3 HCV infection who were randomized into the study and received at least 1 dose of study drug.
SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks following the last dose of study drug.
Outcome measures
| Measure |
SOF + RBV 16 Weeks GT1
n=30 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
|
SOF + RBV 24 Weeks GT1
n=28 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
|
SOF + RBV 16 Weeks GT3
n=29 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
|
SOF + RBV 24 Weeks GT3
n=30 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
|
90 percentage of participants
Interval 73.5 to 97.9
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
100.0 percentage of participants
Interval 88.1 to 100.0
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: Safety Analysis Set
Outcome measures
| Measure |
SOF + RBV 16 Weeks GT1
n=59 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
|
SOF + RBV 24 Weeks GT1
n=58 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
|
SOF + RBV 16 Weeks GT3
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
|
SOF + RBV 24 Weeks GT3
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
|
0 percentage of participants
|
3.4 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Posttreatment Weeks 4 and 24Population: Full Analysis Set
SVR4 and SVR24 were defined as HCV RNA \< LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Outcome measures
| Measure |
SOF + RBV 16 Weeks GT1
n=30 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
|
SOF + RBV 24 Weeks GT1
n=28 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
|
SOF + RBV 16 Weeks GT3
n=29 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
|
SOF + RBV 24 Weeks GT3
n=30 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR4
|
90.0 percentage of participants
Interval 73.5 to 97.9
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
100.0 percentage of participants
Interval 88.1 to 100.0
|
96.7 percentage of participants
Interval 82.8 to 99.9
|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
SVR24
|
90.0 percentage of participants
Interval 73.5 to 97.9
|
96.4 percentage of participants
Interval 81.7 to 99.9
|
100.0 percentage of participants
Interval 88.1 to 100.0
|
93.3 percentage of participants
Interval 77.9 to 99.2
|
SECONDARY outcome
Timeframe: Up to Posttreatment Week 24Population: Full Analysis Set
Virologic failure was defined as: * On-treatment virologic failure: * 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) * Virologic relapse: * 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=30 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
|
SOF + RBV 24 Weeks GT1
n=28 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
|
SOF + RBV 16 Weeks GT3
n=29 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
|
SOF + RBV 24 Weeks GT3
n=30 Participants
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Failure and Viral Relapse
Overall Virologic Failure
|
10.0 percentage of participants
|
3.6 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
|
Percentage of Participants With Virologic Failure and Viral Relapse
Relapse
|
10.0 percentage of participants
|
3.6 percentage of participants
|
0 percentage of participants
|
3.3 percentage of participants
|
Adverse Events
SOF + RBV 16 Weeks
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
SOF + RBV 24 Weeks
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOF + RBV 16 Weeks
n=59 participants at risk
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF + RBV 24 Weeks
n=58 participants at risk
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.7%
1/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Cellulitis
|
1.7%
1/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.7%
1/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
Other adverse events
| Measure |
SOF + RBV 16 Weeks
n=59 participants at risk
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
|
SOF + RBV 24 Weeks
n=58 participants at risk
SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.1%
3/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
4/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Blood and lymphatic system disorders
Haemolysis
|
6.8%
4/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.7%
1/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.2%
3/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.3%
6/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
2/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.2%
3/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Asthenia
|
27.1%
16/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
19.0%
11/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Fatigue
|
13.6%
8/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
2/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Pain
|
8.5%
5/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
4/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
General disorders
Pyrexia
|
8.5%
5/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
6.9%
4/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
4/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
0.00%
0/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.1%
3/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
3.4%
2/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
3/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
1.7%
1/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
5.2%
3/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
11.9%
7/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
13.8%
8/58 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.9%
7/59 • Up to 24 weeks plus 30 days
Safety Analysis Set
|
10.3%
6/58 • 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