Trial Outcomes & Findings for Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients (NCT NCT01188772)
NCT ID: NCT01188772
Last Updated: 2014-04-21
Results Overview
Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
Baseline to Week 12 plus 30 days
Results posted on
2014-04-21
Participant Flow
Subjects were enrolled in a total of 22 study sites in the United States. The first participant was screened on 16 August 2010. The last participant observation was on 11 May 2012.
147 participants were randomized, and 146 participants received at least one dose of study drug, and comprise the Safety Analysis Set.
Participant milestones
| Measure |
Sofosbuvir 200 mg (Genotype 1)
Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+pegylated interferon alfa-2a (PEG)+ribavirin (RBV) for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
|
Sofosbuvir 400 mg (Genotype 1)
Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
|
Placebo (Genotype 1)
Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
|
Sofosbuvir 400 mg (Genotype 2/3)
Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
26
|
25
|
|
Overall Study
Randomized and Treated
|
48
|
47
|
26
|
25
|
|
Overall Study
COMPLETED
|
43
|
45
|
15
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
11
|
1
|
Reasons for withdrawal
| Measure |
Sofosbuvir 200 mg (Genotype 1)
Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+pegylated interferon alfa-2a (PEG)+ribavirin (RBV) for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
|
Sofosbuvir 400 mg (Genotype 1)
Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
|
Placebo (Genotype 1)
Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
|
Sofosbuvir 400 mg (Genotype 2/3)
Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks.
|
|---|---|---|---|---|
|
Overall Study
Randomized but Not Treated
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
1
|
1
|
|
Overall Study
Non-responder
|
0
|
0
|
3
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
|
Overall Study
Terminated by Sponsor
|
0
|
0
|
1
|
0
|
|
Overall Study
Treatment Failure
|
0
|
0
|
1
|
0
|
|
Overall Study
Virologic Failure
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
Baseline Characteristics
Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
Baseline characteristics by cohort
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=47 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=26 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
n=25 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
48.4 years
STANDARD_DEVIATION 11.49 • n=99 Participants
|
51.4 years
STANDARD_DEVIATION 9.37 • n=107 Participants
|
48.6 years
STANDARD_DEVIATION 9.35 • n=206 Participants
|
47.2 years
STANDARD_DEVIATION 11.07 • n=7 Participants
|
49.2 years
STANDARD_DEVIATION 10.41 • n=31 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
57 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
89 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
125 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
1 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=99 Participants
|
7 participants
n=107 Participants
|
5 participants
n=206 Participants
|
4 participants
n=7 Participants
|
22 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
0 participants
n=206 Participants
|
1 participants
n=7 Participants
|
5 participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
39 participants
n=99 Participants
|
37 participants
n=107 Participants
|
21 participants
n=206 Participants
|
20 participants
n=7 Participants
|
117 participants
n=31 Participants
|
|
Hepatitis C (HCV) RNA
|
6.54 log10 IU/mL
STANDARD_DEVIATION 0.630 • n=99 Participants
|
6.39 log10 IU/mL
STANDARD_DEVIATION 0.827 • n=107 Participants
|
6.50 log10 IU/mL
STANDARD_DEVIATION 0.762 • n=206 Participants
|
6.07 log10 IU/mL
STANDARD_DEVIATION 0.794 • n=7 Participants
|
6.40 log10 IU/mL
STANDARD_DEVIATION 0.760 • n=31 Participants
|
|
Liver Biopsy Fibrosis Score
None or Minimal Fibrosis
|
12 participants
n=99 Participants
|
7 participants
n=107 Participants
|
3 participants
n=206 Participants
|
7 participants
n=7 Participants
|
29 participants
n=31 Participants
|
|
Liver Biopsy Fibrosis Score
Portal Fibrosis
|
35 participants
n=99 Participants
|
38 participants
n=107 Participants
|
21 participants
n=206 Participants
|
18 participants
n=7 Participants
|
112 participants
n=31 Participants
|
|
Liver Biopsy Fibrosis Score
Bridging Fibrosis
|
1 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
0 participants
n=7 Participants
|
5 participants
n=31 Participants
|
|
Liver Biopsy Fibrosis Score
Cirrhosis
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
0 participants
n=31 Participants
|
|
Alanine Aminotransferase (ALT)
|
81.9 IU/L
STANDARD_DEVIATION 66.07 • n=99 Participants
|
76.1 IU/L
STANDARD_DEVIATION 67.56 • n=107 Participants
|
81.4 IU/L
STANDARD_DEVIATION 49.14 • n=206 Participants
|
74.5 IU/L
STANDARD_DEVIATION 54.81 • n=7 Participants
|
78.7 IU/L
STANDARD_DEVIATION 61.53 • n=31 Participants
|
|
IL28b Genotype
CC
|
21 participants
n=99 Participants
|
18 participants
n=107 Participants
|
11 participants
n=206 Participants
|
7 participants
n=7 Participants
|
57 participants
n=31 Participants
|
|
IL28b Genotype
CT
|
24 participants
n=99 Participants
|
19 participants
n=107 Participants
|
11 participants
n=206 Participants
|
17 participants
n=7 Participants
|
71 participants
n=31 Participants
|
|
IL28b Genotype
TT
|
3 participants
n=99 Participants
|
10 participants
n=107 Participants
|
4 participants
n=206 Participants
|
1 participants
n=7 Participants
|
18 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12 plus 30 daysPopulation: Safety Analysis Set: participants were randomized and received at least one dose of study drug
Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=47 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=26 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
n=25 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Any AE
|
97.9 percentage of participants
|
97.9 percentage of participants
|
100.0 percentage of participants
|
96.0 percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Drug-related AE
|
97.9 percentage of participants
|
95.7 percentage of participants
|
100.0 percentage of participants
|
96.0 percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Grade 3 or higher AE
|
10.4 percentage of participants
|
21.3 percentage of participants
|
11.5 percentage of participants
|
12.0 percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
AE leading to drug discontinuation
|
4.2 percentage of participants
|
6.4 percentage of participants
|
11.5 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Serious AE
|
2.1 percentage of participants
|
6.4 percentage of participants
|
3.8 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Safety Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=43 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=26 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
n=24 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Change in HCV RNA From Baseline to Week 12
|
-5.39 log10 IU/mL
Standard Deviation 0.630
|
-5.20 log10 IU/mL
Standard Deviation 0.842
|
-4.16 log10 IU/mL
Standard Deviation 1.728
|
-4.95 log10 IU/mL
Standard Deviation 0.803
|
SECONDARY outcome
Timeframe: Week 4Population: Safety Analysis Set
Rapid virologic response was defined as HCV RNA below the limit of detection (\< 15 IU/mL) at Week 4 (Day 29)
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=47 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=26 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
n=25 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Rapid Virologic Response at Week 4
|
97.9 percentage of participants
|
97.9 percentage of participants
|
19.2 percentage of participants
|
96.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Safety Analysis Set
Complete early virologic response was defined as HCV RNA below the limit of detection (\< 15 IU/mL) at Week 12
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=47 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=26 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
n=25 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Complete Early Virologic Response at Week 12
|
100.0 percentage of participants
|
91.5 percentage of participants
|
61.5 percentage of participants
|
96.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4 to Week 12Population: Safety Analysis Set
Extended rapid virologic response was defined as HCV RNA below the limit of detection (\< 15 IU/mL) at Week 4 (Day 29) which was maintained through Week 12.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=47 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=26 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
n=25 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Extended Rapid Virologic Response
|
97.9 percentage of participants
|
91.5 percentage of participants
|
19.2 percentage of participants
|
96.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 48 (genotype 1) or Week 12 (genotype 2/3)Population: Participants in the Safety Analysis Set with available data were analyzed. One participant in the Sofosbuvir 400 mg (Genotype 2/3) Group was lost to follow up before the end of treatment and is not included in this analysis.
End-of-treatment virologic response was defined as HCV RNA below the limit of detection (\< 15 IU/mL) at the last on-treatment visit.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=47 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=26 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
n=24 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Virologic Response at the End of Treatment
|
93.8 percentage of participants
|
100.0 percentage of participants
|
61.5 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Post-treatment Weeks 12 and 24Population: Safety Analysis Set
SVR12 and SVR24 were defined as HCV RNA below the limit of detection (\< 15 IU/mL) at post-treatment Weeks 12 and 24, respectively.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=47 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=26 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
n=25 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)
SVR12
|
89.6 percentage of participants
|
91.5 percentage of participants
|
57.7 percentage of participants
|
92.0 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)
SVR24
|
89.6 percentage of participants
|
91.5 percentage of participants
|
57.7 percentage of participants
|
92.0 percentage of participants
|
SECONDARY outcome
Timeframe: 1, 2, 4, 8, and 12 hours postdosePopulation: Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed.
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=3 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=3 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=4 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8)
|
331.48 ng/mL
Standard Deviation 167.31
|
750.78 ng/mL
Standard Deviation 108.01
|
518.18 ng/mL
Standard Deviation 212.19
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 8, and 12 hours postdosePopulation: Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed.
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=4 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=1 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=5 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15)
|
269.93 ng/mL
Standard Deviation 65.71
|
1087.21 ng/mL
Standard Deviation NA
Standard deviation not available as n = 1
|
515.13 ng/mL
Standard Deviation 178.60
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 8, and 12 hours postdosePopulation: Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed.
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=5 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=2 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=5 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29)
|
285.77 ng/mL
Standard Deviation 91.43
|
897.41 ng/mL
Standard Deviation 187.80
|
574.13 ng/mL
Standard Deviation 241.39
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 8, and 12 hours postdosePopulation: Participants who had measurements of pharmacokinetic parameters at Day 8 were analyzed.
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=3 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=3 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=4 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8)
|
3020.30 ng•h/mL
Standard Deviation 1290.59
|
8620.07 ng•h/mL
Standard Deviation 1717.44
|
5738.61 ng•h/mL
Standard Deviation 2009.44
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 8, and 12 hours postdosePopulation: Participants who had measurements of pharmacokinetic parameters at Day 15 were analyzed.
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=4 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=1 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=5 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15)
|
3178.53 ng•h/mL
Standard Deviation 1179.46
|
11245.43 ng•h/mL
Standard Deviation NA
Standard deviation not available as n = 1
|
5465.41 ng•h/mL
Standard Deviation 1070.93
|
—
|
SECONDARY outcome
Timeframe: 1, 2, 4, 8, and 12 hours postdosePopulation: Participants who had measurements of pharmacokinetic parameters at Day 29 were analyzed.
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=5 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=2 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=5 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29)
|
2789.62 ng•h/mL
Standard Deviation 931.47
|
9191.86 ng•h/mL
Standard Deviation 2388.88
|
5874.52 ng•h/mL
Standard Deviation 1535.60
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed.
Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24.
Outcome measures
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 Participants
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=47 Participants
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=25 Participants
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Percentage of Participants Who Developed Resistance to Sofosbuvir
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
—
|
Adverse Events
Sofosbuvir 200 mg (Genotype 1)
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Sofosbuvir 400 mg (Genotype 1)
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Placebo (Genotype 1)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
Sofosbuvir 400 mg (Genotype 2/3)
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 participants at risk
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=47 participants at risk
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=26 participants at risk
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
n=25 participants at risk
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Eye disorders
Retinal vein occlusion
|
2.1%
1/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
General disorders
Chest pain
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Infections and infestations
Lymphangitis
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Psychiatric disorders
Depression
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
Other adverse events
| Measure |
Sofosbuvir 200 mg (Genotype 1)
n=48 participants at risk
Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 1)
n=47 participants at risk
Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Placebo (Genotype 1)
n=26 participants at risk
Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
|
Sofosbuvir 400 mg (Genotype 2/3)
n=25 participants at risk
Sofosbuvir 400 mg+PEG+RBV for 12 weeks
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
6.4%
3/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Gastrointestinal disorders
Cheilitis
|
8.3%
4/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Blood and lymphatic system disorders
Anaemia
|
22.9%
11/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
17.0%
8/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
26.9%
7/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.0%
3/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.8%
9/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
29.8%
14/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
19.2%
5/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
24.0%
6/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Eye disorders
Eye pain
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
8.0%
2/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Eye disorders
Vision blurred
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
8.5%
4/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Gastrointestinal disorders
Constipation
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Gastrointestinal disorders
Diarrhoea
|
14.6%
7/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
23.4%
11/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Gastrointestinal disorders
Dry mouth
|
4.2%
2/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
8.5%
4/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
6.4%
3/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Gastrointestinal disorders
Nausea
|
35.4%
17/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
44.7%
21/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
34.6%
9/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
48.0%
12/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Gastrointestinal disorders
Vomiting
|
10.4%
5/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
14.9%
7/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
20.0%
5/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
General disorders
Asthenia
|
2.1%
1/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
16.0%
4/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
General disorders
Chest pain
|
2.1%
1/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
General disorders
Chills
|
37.5%
18/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
40.4%
19/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
38.5%
10/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
36.0%
9/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
General disorders
Fatigue
|
66.7%
32/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
68.1%
32/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
61.5%
16/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
36.0%
9/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
General disorders
Injection site reaction
|
14.6%
7/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
8.5%
4/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
General disorders
Pyrexia
|
25.0%
12/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
21.3%
10/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
16.0%
4/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
General disorders
Irritability
|
16.7%
8/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
14.9%
7/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
19.2%
5/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.0%
3/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
General disorders
Malaise
|
10.4%
5/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
6.4%
3/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
General disorders
Pain
|
29.2%
14/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
25.5%
12/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
30.8%
8/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
16.0%
4/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Infections and infestations
Oral herpes
|
4.2%
2/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.3%
2/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Infections and infestations
Sinusitis
|
12.5%
6/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.3%
2/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.3%
2/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Infections and infestations
Urinary tract infection
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.3%
2/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.4%
5/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.8%
6/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
15.4%
4/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.0%
3/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.4%
5/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
10.6%
5/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
19.2%
5/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
32.0%
8/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.3%
2/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
19.2%
5/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.0%
3/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
6/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
23.4%
11/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
23.1%
6/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
20.0%
5/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.1%
1/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
6.4%
3/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
8.0%
2/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Nervous system disorders
Dizziness
|
12.5%
6/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
10.6%
5/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
11.5%
3/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
20.0%
5/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Nervous system disorders
Dysgeusia
|
8.3%
4/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
10.6%
5/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
8.0%
2/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Nervous system disorders
Headache
|
35.4%
17/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
42.6%
20/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
57.7%
15/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
44.0%
11/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Nervous system disorders
Hyperaesthesia
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.0%
3/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Psychiatric disorders
Affect lability
|
2.1%
1/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Psychiatric disorders
Anxiety
|
8.3%
4/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
14.9%
7/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
11.5%
3/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Psychiatric disorders
Depression
|
14.6%
7/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
10.6%
5/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
11.5%
3/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
8.0%
2/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Psychiatric disorders
Insomnia
|
18.8%
9/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
31.9%
15/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
34.6%
9/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
16.0%
4/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Psychiatric disorders
Mood Swings
|
4.2%
2/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Psychiatric disorders
Sleep disorder
|
10.4%
5/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
8/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.8%
6/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
11.5%
3/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
16.0%
4/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.5%
6/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
10.6%
5/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
15.4%
4/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
8.0%
2/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
10.6%
5/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.0%
3/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.4%
5/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.3%
2/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
6/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.3%
2/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.2%
2/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
8.5%
4/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.4%
5/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
10.6%
5/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
4.2%
2/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.4%
5/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
14.9%
7/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
11.5%
3/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.0%
1/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
7.7%
2/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
8.0%
2/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
8/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
10.6%
5/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
11.5%
3/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.0%
3/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
6.2%
3/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
4.3%
2/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
29.2%
14/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
31.9%
15/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
15.4%
4/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.0%
3/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Vascular disorders
Hot flush
|
2.1%
1/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
2.1%
1/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
3.8%
1/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.0%
3/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
|
Vascular disorders
Hypertension
|
2.1%
1/48 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
6.4%
3/47 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
0.00%
0/26 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
12.0%
3/25 • Baseline to last dose or sofosbovir/placebo plus 30 days
|
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