Trial Outcomes & Findings for Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients (NCT NCT01054729)
NCT ID: NCT01054729
Last Updated: 2014-04-17
Results Overview
Adverse events (AEs) occurring during the sofosbuvir treatment period 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
64 participants
Primary outcome timeframe
Baseline to Week 4
Results posted on
2014-04-17
Participant Flow
Subjects were enrolled at a total of 7 study sites in the United States. The first participant was screened on 18 January 2010. The last participant observation was on 25 August 2011.
143 participants were screened and 64 were randomized; 63 participants were treated, and comprise the Safety Analysis Set.
Participant milestones
| Measure |
Sofosbuvir 100 mg+PEG+RBV
Participants received sofosbuvir 100 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
|
Sofosbuvir 200 mg+PEG+RBV
Participants received sofosbuvir 200 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
|
Sofosbuvir 400 mg+PEG+RBV
Participants received sofosbuvir 400 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
|
Placebo+PEG+RBV
Participants received placebo to match sofosbuvir for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
19
|
15
|
14
|
|
Overall Study
Randomized and Treated
|
16
|
18
|
15
|
14
|
|
Overall Study
COMPLETED
|
12
|
14
|
9
|
11
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
6
|
3
|
Reasons for withdrawal
| Measure |
Sofosbuvir 100 mg+PEG+RBV
Participants received sofosbuvir 100 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
|
Sofosbuvir 200 mg+PEG+RBV
Participants received sofosbuvir 200 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
|
Sofosbuvir 400 mg+PEG+RBV
Participants received sofosbuvir 400 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
|
Placebo+PEG+RBV
Participants received placebo to match sofosbuvir for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
|
|---|---|---|---|---|
|
Overall Study
Randomized but Not Treated
|
0
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up, Later Contacted Site
|
0
|
1
|
0
|
0
|
|
Overall Study
Non-responder
|
1
|
0
|
1
|
1
|
|
Overall Study
PEG/RBV Non-responder
|
1
|
0
|
1
|
0
|
|
Overall Study
Personal/Obligations
|
0
|
1
|
0
|
0
|
|
Overall Study
Subject moved
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
Baseline characteristics by cohort
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=18 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
n=14 Participants
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 10.10 • n=99 Participants
|
44.4 years
STANDARD_DEVIATION 8.34 • n=107 Participants
|
44.9 years
STANDARD_DEVIATION 8.43 • n=206 Participants
|
46.6 years
STANDARD_DEVIATION 11.44 • n=7 Participants
|
45.0 years
STANDARD_DEVIATION 9.38 • n=31 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
20 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
43 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
28 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
35 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
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
Black or African American
|
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
|
|
Race/Ethnicity, Customized
White
|
15 participants
n=99 Participants
|
16 participants
n=107 Participants
|
12 participants
n=206 Participants
|
14 participants
n=7 Participants
|
57 participants
n=31 Participants
|
|
Hepatitis C (HCV) RNA
|
6.64 log10 IU/mL
STANDARD_DEVIATION 0.476 • n=99 Participants
|
6.28 log10 IU/mL
STANDARD_DEVIATION 0.813 • n=107 Participants
|
6.49 log10 IU/mL
STANDARD_DEVIATION 0.602 • n=206 Participants
|
6.48 log10 IU/mL
STANDARD_DEVIATION 0.666 • n=7 Participants
|
6.47 log10 IU/mL
STANDARD_DEVIATION 0.655 • n=31 Participants
|
|
HCV RNA Level (IU/mL)
≤ 800,000
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
4 participants
n=7 Participants
|
11 participants
n=31 Participants
|
|
HCV RNA Level (IU/mL)
> 800,000
|
15 participants
n=99 Participants
|
15 participants
n=107 Participants
|
12 participants
n=206 Participants
|
10 participants
n=7 Participants
|
52 participants
n=31 Participants
|
|
Liver Biopsy Fibrosis Score
None or Minimal Fibrosis
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
5 participants
n=206 Participants
|
4 participants
n=7 Participants
|
20 participants
n=31 Participants
|
|
Liver Biopsy Fibrosis Score
Portal Fibrosis
|
11 participants
n=99 Participants
|
10 participants
n=107 Participants
|
9 participants
n=206 Participants
|
9 participants
n=7 Participants
|
39 participants
n=31 Participants
|
|
Liver Biopsy Fibrosis Score
Bridging Fibrosis
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
1 participants
n=206 Participants
|
1 participants
n=7 Participants
|
4 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)
|
69.0 IU/L
STANDARD_DEVIATION 29.69 • n=99 Participants
|
72.6 IU/L
STANDARD_DEVIATION 46.45 • n=107 Participants
|
95.4 IU/L
STANDARD_DEVIATION 75.86 • n=206 Participants
|
70.0 IU/L
STANDARD_DEVIATION 40.73 • n=7 Participants
|
76.2 IU/L
STANDARD_DEVIATION 50.08 • n=31 Participants
|
|
IL28b Genotype
CC
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
4 participants
n=206 Participants
|
4 participants
n=7 Participants
|
17 participants
n=31 Participants
|
|
IL28b Genotype
CT/TT
|
12 participants
n=99 Participants
|
13 participants
n=107 Participants
|
11 participants
n=206 Participants
|
10 participants
n=7 Participants
|
46 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 4Population: Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Adverse events (AEs) occurring during the sofosbuvir treatment period were summarized across the participant population. A participant was counted once if they had a qualifying event.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=18 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
n=14 Participants
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Any AE
|
87.5 percentage of participants
|
83.3 percentage of participants
|
86.7 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Drug-related AE
|
12.5 percentage of participants
|
27.8 percentage of participants
|
33.3 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Grade 3 or higher AE
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
AE leading to drug discontinuation/interruption
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Serious AE
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Safety Analysis Set
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=18 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
n=14 Participants
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Change in Circulating HCV RNA at Week 4
|
-5.323 log10 IU/mL
Standard Deviation 0.6642
|
-5.081 log10 IU/mL
Standard Deviation 0.8068
|
-5.346 log10 IU/mL
Standard Deviation 0.6130
|
-2.8 log10 IU/mL
Standard Deviation 1.6034
|
SECONDARY outcome
Timeframe: Week 4Population: Safety Analysis Set
Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD \[15 IU/mL\]) at Week 4.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=18 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
n=14 Participants
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Rapid Virologic Response at Week 4
|
87.5 percentage of participants
|
94.4 percentage of participants
|
93.3 percentage of participants
|
21.4 percentage of participants
|
SECONDARY outcome
Timeframe: Post-treatment Weeks 12 and 24Population: Safety Analysis Set
SVR at 12 weeks (SVR12) and 24 weeks (SVR24) was defined as HCV RNA \< LOD 12 and 24 weeks after last dose of PEG+RBV, respectively, following completion of 48 weeks of treatment (4 weeks of sofosbuvir or matching placebo and PEG+RBV, followed by an additional 44 weeks of PEG+RBV).
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=18 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
n=14 Participants
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment
SVR12
|
56.3 percentage of participants
|
72.2 percentage of participants
|
86.7 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Sustained Virologic Response (SVR) at 12 and 24 Weeks After Last Dose of PEG+RBV Following Completion of 48 Weeks of Treatment
SVR24
|
56.3 percentage of participants
|
83.3 percentage of participants
|
80.0 percentage of participants
|
42.9 percentage of participants
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdosePopulation: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir. Cmax is defined as the maximum concentration of drug.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=17 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0
|
218.08 ng/mL
Standard Deviation 181.54
|
332.26 ng/mL
Standard Deviation 215.53
|
1257.50 ng/mL
Standard Deviation 736.36
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)Population: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=16 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27
|
253.54 ng/mL
Standard Deviation 171.10
|
475.14 ng/mL
Standard Deviation 358.88
|
1355.65 ng/mL
Standard Deviation 853.85
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdosePopulation: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The AUCinf of sofosbuvir was analyzed at Day 0 (following a single dose of sofosbuvir). AUCinf is defined as the concentration of drug (area under the plasma concentration versus time curve) extrapolated to infinite time.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=17 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0
|
280.19 h*ng/mL
Standard Deviation 199.54
|
585.56 h*ng/mL
Standard Deviation 342.53
|
1867.24 h*ng/mL
Standard Deviation 959.30
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)Population: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The AUCtau of sofosbuvir was analyzed at Day 27 (following continuous dosing of sofosbuvir). AUCtau is defined as the concentration of drug (area under the plasma concentration versus time curve) over the dosing interval.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=16 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27
|
375.70 h*ng/mL
Standard Deviation 203.13
|
732.27 h*ng/mL
Standard Deviation 297.19
|
2011.23 h*ng/mL
Standard Deviation 988.25
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdosePopulation: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The Cmax of GS-331007 was measured at Day 0 following a single dose of sofosbuvir. GS-331007 is the predominant circulating metabolite of sofosbuvir.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=17 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-331007: Cmax at Day 0
|
197.32 ng/mL
Standard Deviation 88.68
|
357.33 ng/mL
Standard Deviation 99.88
|
662.13 ng/mL
Standard Deviation 214.76
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)Population: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=16 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-331007: Cmax at Day 27
|
233.79 ng/mL
Standard Deviation 105.02
|
357.38 ng/mL
Standard Deviation 109.91
|
717.23 ng/mL
Standard Deviation 208.62
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdosePopulation: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=17 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0
|
2173.18 h*ng/mL
Standard Deviation 852.32
|
3984.88 h*ng/mL
Standard Deviation 895.69
|
7559.91 h*ng/mL
Standard Deviation 3065.23
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)Population: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=16 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27
|
2256.81 h*ng/mL
Standard Deviation 982.40
|
3389.23 h*ng/mL
Standard Deviation 832.01
|
7398.99 h*ng/mL
Standard Deviation 2633.70
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdosePopulation: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The Cmax of GS-566500 was measured at Day 0 following a single dose of sofosbuvir. GS-566500 is one of the major metabolites of sofosbuvir.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=17 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-566500: Cmax at Day 0
|
69.99 ng/mL
Standard Deviation 35.98
|
145.51 ng/mL
Standard Deviation 31.95
|
293.35 ng/mL
Standard Deviation 92.75
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)Population: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=16 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-566500: Cmax at Day 27
|
64.75 ng/mL
Standard Deviation 38.51
|
132.72 ng/mL
Standard Deviation 49.33
|
237.46 ng/mL
Standard Deviation 51.66
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdosePopulation: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=17 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0
|
266.22 h*ng/mL
Standard Deviation 122.40
|
645.95 h*ng/mL
Standard Deviation 228.09
|
1315.94 h*ng/mL
Standard Deviation 618.96
|
—
|
SECONDARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)Population: Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed.
The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=16 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27
|
262.00 h*ng/mL
Standard Deviation 120.64
|
571.95 h*ng/mL
Standard Deviation 156.59
|
1072.91 h*ng/mL
Standard Deviation 327.09
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 4Population: Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed.
Outcome measures
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 Participants
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=18 Participants
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 Participants
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 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 100 mg+PEG+RBV
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Sofosbuvir 200 mg+PEG+RBV
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Sofosbuvir 400 mg+PEG+RBV
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo+PEG+RBV
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 participants at risk
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=18 participants at risk
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 participants at risk
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
n=14 participants at risk
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Vascular disorders
Peripheral ischaemia
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
Other adverse events
| Measure |
Sofosbuvir 100 mg+PEG+RBV
n=16 participants at risk
Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 200 mg+PEG+RBV
n=18 participants at risk
Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
|
Sofosbuvir 400 mg+PEG+RBV
n=15 participants at risk
Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
|
Placebo+PEG+RBV
n=14 participants at risk
Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/16 • Baseline to Week 48
|
44.4%
8/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
1/16 • Baseline to Week 48
|
16.7%
3/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Ear and labyrinth disorders
Motion sickness
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Eye disorders
Blepharitis
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Eye disorders
Dry eye
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Eye disorders
Eye pain
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Eye disorders
Presbyopia
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Eye disorders
Retinal vasculitis
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Eye disorders
Retinitis
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Eye disorders
Visual acuity reduced
|
6.2%
1/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
13.3%
2/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Eye disorders
Visual impairment
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Abdominal pain
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
13.3%
2/15 • Baseline to Week 48
|
21.4%
3/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Nausea
|
31.2%
5/16 • Baseline to Week 48
|
33.3%
6/18 • Baseline to Week 48
|
60.0%
9/15 • Baseline to Week 48
|
42.9%
6/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
20.0%
3/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
General disorders
Asthenia
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
General disorders
Chills
|
43.8%
7/16 • Baseline to Week 48
|
33.3%
6/18 • Baseline to Week 48
|
26.7%
4/15 • Baseline to Week 48
|
14.3%
2/14 • Baseline to Week 48
|
|
General disorders
Fatigue
|
43.8%
7/16 • Baseline to Week 48
|
44.4%
8/18 • Baseline to Week 48
|
60.0%
9/15 • Baseline to Week 48
|
57.1%
8/14 • Baseline to Week 48
|
|
General disorders
Injection site erythema
|
6.2%
1/16 • Baseline to Week 48
|
11.1%
2/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
General disorders
Injection site irritation
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
General disorders
Injection site reaction
|
6.2%
1/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
14.3%
2/14 • Baseline to Week 48
|
|
General disorders
Irritability
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
14.3%
2/14 • Baseline to Week 48
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
General disorders
Pain
|
6.2%
1/16 • Baseline to Week 48
|
11.1%
2/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
21.4%
3/14 • Baseline to Week 48
|
|
General disorders
Pyrexia
|
12.5%
2/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Infections and infestations
Bronchitis
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Infections and infestations
Cellulitis
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Infections and infestations
Gastroenteritis viral
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Infections and infestations
Impetigo
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Infections and infestations
Urinary tract infection
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Investigations
Weight increased
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
3/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
20.0%
3/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
43.8%
7/16 • Baseline to Week 48
|
11.1%
2/18 • Baseline to Week 48
|
20.0%
3/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
13.3%
2/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
13.3%
2/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
4/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
13.3%
2/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Nervous system disorders
Balance disorder
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Nervous system disorders
Dizziness
|
12.5%
2/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
20.0%
3/15 • Baseline to Week 48
|
14.3%
2/14 • Baseline to Week 48
|
|
Nervous system disorders
Headache
|
25.0%
4/16 • Baseline to Week 48
|
33.3%
6/18 • Baseline to Week 48
|
33.3%
5/15 • Baseline to Week 48
|
14.3%
2/14 • Baseline to Week 48
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Psychiatric disorders
Affect lability
|
6.2%
1/16 • Baseline to Week 48
|
11.1%
2/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
14.3%
2/14 • Baseline to Week 48
|
|
Psychiatric disorders
Anxiety
|
12.5%
2/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
20.0%
3/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Psychiatric disorders
Daydreaming
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Psychiatric disorders
Depression
|
6.2%
1/16 • Baseline to Week 48
|
11.1%
2/18 • Baseline to Week 48
|
13.3%
2/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Psychiatric disorders
Insomnia
|
31.2%
5/16 • Baseline to Week 48
|
16.7%
3/18 • Baseline to Week 48
|
20.0%
3/15 • Baseline to Week 48
|
14.3%
2/14 • Baseline to Week 48
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Reproductive system and breast disorders
Sexual dysfunction
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
13.3%
2/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • Baseline to Week 48
|
11.1%
2/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • Baseline to Week 48
|
16.7%
3/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
18.8%
3/16 • Baseline to Week 48
|
11.1%
2/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.2%
1/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.8%
3/16 • Baseline to Week 48
|
16.7%
3/18 • Baseline to Week 48
|
33.3%
5/15 • Baseline to Week 48
|
7.1%
1/14 • Baseline to Week 48
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
6.7%
1/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • Baseline to Week 48
|
11.1%
2/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
14.3%
2/14 • Baseline to Week 48
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/16 • Baseline to Week 48
|
5.6%
1/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
|
Vascular disorders
Flushing
|
6.2%
1/16 • Baseline to Week 48
|
0.00%
0/18 • Baseline to Week 48
|
0.00%
0/15 • Baseline to Week 48
|
0.00%
0/14 • Baseline to Week 48
|
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