Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01054729
Collaborator
(none)
64
7
4
19
9.1
0.5
Study Details
Study Description
Brief Summary
Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
64 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-center, Double-Blind, Parallel Group, Randomized, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Standard of Care (Pegylated Interferon and Ribavirin) in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1
Study Start Date
:
Jan 1, 2010
Actual Primary Completion Date
:
Apr 1, 2010
Actual Study Completion Date
:
Aug 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sofosbuvir 100 mg+PEG+RBV Participants received sofosbuvir 100 mg (1 x 100 mg tablet) and placebo to match sofosbuvir (3 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) |
Drug: Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
Other Names:
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.
Other Names:
Drug: RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other Names:
|
| Experimental: Sofosbuvir 200 mg+PEG+RBV Participants received sofosbuvir 200 mg (2 x 100 mg tablets) and placebo to match sofosbuvir (2 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) |
Drug: Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
Other Names:
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.
Other Names:
Drug: RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other Names:
|
| Experimental: Sofosbuvir 400 mg+PEG+RBV Participants received sofosbuvir 400 mg (4 x 100 mg tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) |
Drug: Sofosbuvir
Sofosbuvir tablet(s) administered orally once daily
Other Names:
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.
Other Names:
Drug: RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other Names:
|
| Active Comparator: Placebo+PEG+RBV Participants received placebo to match sofosbuvir (4 tablets) for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) |
Drug: Placebo
Placebo to match sofosbuvir administered orally once daily
Drug: PEG
Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.
Other Names:
Drug: RBV
Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period [Baseline to Week 4]
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.
Secondary Outcome Measures
- Change in Circulating HCV RNA at Week 4 [Baseline to Week 4]
- Percentage of Participants With Rapid Virologic Response at Week 4 [Week 4]
Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4.
- 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 [Post-treatment Weeks 12 and 24]
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).
- Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose]
The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir. Cmax is defined as the maximum concentration of drug.
- Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)]
The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir.
- Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose]
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.
- Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)]
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.
- Plasma Pharmacokinetics of GS-331007: Cmax at Day 0 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose]
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.
- Plasma Pharmacokinetics of GS-331007: Cmax at Day 27 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)]
The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir.
- Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose]
The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir).
- Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)]
The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
- Plasma Pharmacokinetics of GS-566500: Cmax at Day 0 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose]
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.
- Plasma Pharmacokinetics of GS-566500: Cmax at Day 27 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)]
The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir.
- Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose]
The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir).
- Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose)]
The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir).
- Percentage of Participants Who Developed Resistance to Sofosbuvir [Baseline to Week 4]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Treatment-naive males and females, 18-65 years of age
-
Genotype 1 HCV infection
-
Negative pregnancy test for females of childbearing age
-
Females of childbearing age and males with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin
Exclusion Criteria:
-
Hepatitis B or HIV infection
-
Pregnant or breast feeding females or male partners of pregnant females
-
Previous interferon or ribavirin-based therapy or investigational anti-HCV agent
-
History or evidence of medical condition associated with chronic liver disease other than HCV
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Quest Clinical Research | San Francisco | California | United States | 94115 |
| 2 | University of Florida | Gainesville | Florida | United States | 32610 |
| 3 | Orlando Immunology Center | Orlando | Florida | United States | 32803 |
| 4 | Duke University | Durham | North Carolina | United States | 27710 |
| 5 | Alamo Medical Research Center | San Antonio | Texas | United States | 78215 |
| 6 | Virginia Mason Medical Center | Seattle | Washington | United States | 98101 |
| 7 | Fundacion de Investigacion de Diego | Santurce | Puerto Rico | 00909 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Robert H. Hyland, DPhil, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01054729
Other Study ID Numbers:
- P7977-0221
First Posted:
Jan 22, 2010
Last Update Posted:
Apr 17, 2014
Last Verified:
Mar 1, 2014
Keywords provided by Gilead Sciences
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 143 participants were screened and 64 were randomized; 63 participants were treated, and comprise the Safety Analysis Set. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV | Placebo+PEG+RBV |
|---|---|---|---|---|
| Arm/Group Description | Participants received sofosbuvir 100 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) | Participants received sofosbuvir 200 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) | Participants received sofosbuvir 400 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) | Participants received placebo to match sofosbuvir for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48) |
| Period Title: Overall Study | ||||
| STARTED | 16 | 19 | 15 | 14 |
| Randomized and Treated | 16 | 18 | 15 | 14 |
| COMPLETED | 12 | 14 | 9 | 11 |
| NOT COMPLETED | 4 | 5 | 6 | 3 |
Baseline Characteristics
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV | Placebo+PEG+RBV | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks | Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks | Total of all reporting groups |
| Overall Participants | 16 | 18 | 15 | 14 | 63 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
44.4
(10.10)
|
44.4
(8.34)
|
44.9
(8.43)
|
46.6
(11.44)
|
45.0
(9.38)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
5
31.3%
|
8
44.4%
|
4
26.7%
|
3
21.4%
|
20
31.7%
|
| Male |
11
68.8%
|
10
55.6%
|
11
73.3%
|
11
78.6%
|
43
68.3%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
7
43.8%
|
9
50%
|
8
53.3%
|
4
28.6%
|
28
44.4%
|
| Not Hispanic or Latino |
9
56.3%
|
9
50%
|
7
46.7%
|
10
71.4%
|
35
55.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||
| American Indian or Alaska native |
0
0%
|
0
0%
|
1
6.7%
|
0
0%
|
1
1.6%
|
| Black or African American |
1
6.3%
|
2
11.1%
|
2
13.3%
|
0
0%
|
5
7.9%
|
| White |
15
93.8%
|
16
88.9%
|
12
80%
|
14
100%
|
57
90.5%
|
| Hepatitis C (HCV) RNA (log10 IU/mL) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [log10 IU/mL] |
6.64
(0.476)
|
6.28
(0.813)
|
6.49
(0.602)
|
6.48
(0.666)
|
6.47
(0.655)
|
| HCV RNA Level (IU/mL) (participants) [Number] | |||||
| ≤ 800,000 |
1
6.3%
|
3
16.7%
|
3
20%
|
4
28.6%
|
11
17.5%
|
| > 800,000 |
15
93.8%
|
15
83.3%
|
12
80%
|
10
71.4%
|
52
82.5%
|
| Liver Biopsy Fibrosis Score (participants) [Number] | |||||
| None or Minimal Fibrosis |
5
31.3%
|
6
33.3%
|
5
33.3%
|
4
28.6%
|
20
31.7%
|
| Portal Fibrosis |
11
68.8%
|
10
55.6%
|
9
60%
|
9
64.3%
|
39
61.9%
|
| Bridging Fibrosis |
0
0%
|
2
11.1%
|
1
6.7%
|
1
7.1%
|
4
6.3%
|
| Cirrhosis |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Alanine Aminotransferase (ALT) (IU/L) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [IU/L] |
69.0
(29.69)
|
72.6
(46.45)
|
95.4
(75.86)
|
70.0
(40.73)
|
76.2
(50.08)
|
| IL28b Genotype (participants) [Number] | |||||
| CC |
4
25%
|
5
27.8%
|
4
26.7%
|
4
28.6%
|
17
27%
|
| CT/TT |
12
75%
|
13
72.2%
|
11
73.3%
|
10
71.4%
|
46
73%
|
Outcome Measures
| Title | Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period |
|---|---|
| Description | 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. |
| Time Frame | Baseline to Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set: participants were randomized and received at least 1 dose of study drug |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV | Placebo+PEG+RBV |
|---|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks | Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 18 | 15 | 14 |
| Any AE |
87.5
546.9%
|
83.3
462.8%
|
86.7
578%
|
85.7
612.1%
|
| Drug-related AE |
12.5
78.1%
|
27.8
154.4%
|
33.3
222%
|
42.9
306.4%
|
| Grade 3 or higher AE |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| AE leading to drug discontinuation/interruption |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Serious AE |
0.0
0%
|
0.0
0%
|
0.0
0%
|
0.0
0%
|
| Title | Change in Circulating HCV RNA at Week 4 |
|---|---|
| Description | |
| Time Frame | Baseline to Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV | Placebo+PEG+RBV |
|---|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks | Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 18 | 15 | 14 |
| Mean (Standard Deviation) [log10 IU/mL] |
-5.323
(0.6642)
|
-5.081
(0.8068)
|
-5.346
(0.6130)
|
-2.8
(1.6034)
|
| Title | Percentage of Participants With Rapid Virologic Response at Week 4 |
|---|---|
| Description | Rapid virologic response (RVR) was defined as HCV RNA below the limit of detection (LOD [15 IU/mL]) at Week 4. |
| Time Frame | Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV | Placebo+PEG+RBV |
|---|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks | Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 18 | 15 | 14 |
| Number [percentage of participants] |
87.5
546.9%
|
94.4
524.4%
|
93.3
622%
|
21.4
152.9%
|
| Title | 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 |
|---|---|
| Description | 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). |
| Time Frame | Post-treatment Weeks 12 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV | Placebo+PEG+RBV |
|---|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks | Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 18 | 15 | 14 |
| SVR12 |
56.3
351.9%
|
72.2
401.1%
|
86.7
578%
|
50.0
357.1%
|
| SVR24 |
56.3
351.9%
|
83.3
462.8%
|
80.0
533.3%
|
42.9
306.4%
|
| Title | Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 0 |
|---|---|
| Description | The Cmax of sofosbuvir was measured at Day 0 following a single dose of sofosbuvir. Cmax is defined as the maximum concentration of drug. |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 17 | 15 |
| Mean (Standard Deviation) [ng/mL] |
218.08
(181.54)
|
332.26
(215.53)
|
1257.50
(736.36)
|
| Title | Plasma Pharmacokinetics of Sofosbuvir: Cmax at Day 27 |
|---|---|
| Description | The Cmax of sofosbuvir was measured at Day 27 following continuous dosing of sofosbuvir. |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 16 | 15 |
| Mean (Standard Deviation) [ng/mL] |
253.54
(171.10)
|
475.14
(358.88)
|
1355.65
(853.85)
|
| Title | Plasma Pharmacokinetics of Sofosbuvir: AUCinf at Day 0 |
|---|---|
| Description | 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. |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 17 | 15 |
| Mean (Standard Deviation) [h*ng/mL] |
280.19
(199.54)
|
585.56
(342.53)
|
1867.24
(959.30)
|
| Title | Plasma Pharmacokinetics of Sofosbuvir: AUCtau at Day 27 |
|---|---|
| Description | 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. |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 16 | 15 |
| Mean (Standard Deviation) [h*ng/mL] |
375.70
(203.13)
|
732.27
(297.19)
|
2011.23
(988.25)
|
| Title | Plasma Pharmacokinetics of GS-331007: Cmax at Day 0 |
|---|---|
| Description | 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. |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 17 | 15 |
| Mean (Standard Deviation) [ng/mL] |
197.32
(88.68)
|
357.33
(99.88)
|
662.13
(214.76)
|
| Title | Plasma Pharmacokinetics of GS-331007: Cmax at Day 27 |
|---|---|
| Description | The Cmax of GS-331007 was measured at Day 27 following continuous dosing of sofosbuvir. |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 16 | 15 |
| Mean (Standard Deviation) [ng/mL] |
233.79
(105.02)
|
357.38
(109.91)
|
717.23
(208.62)
|
| Title | Plasma Pharmacokinetics of GS-331007: AUCinf at Day 0 |
|---|---|
| Description | The AUCinf of GS-331007 was analyzed at Day 0 (following a single dose of sofosbuvir). |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 17 | 15 |
| Mean (Standard Deviation) [h*ng/mL] |
2173.18
(852.32)
|
3984.88
(895.69)
|
7559.91
(3065.23)
|
| Title | Plasma Pharmacokinetics of GS-331007: AUCtau at Day 27 |
|---|---|
| Description | The AUCtau of GS-331007 was analyzed at Day 27 (following continuous dosing of sofosbuvir). |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 16 | 15 |
| Mean (Standard Deviation) [h*ng/mL] |
2256.81
(982.40)
|
3389.23
(832.01)
|
7398.99
(2633.70)
|
| Title | Plasma Pharmacokinetics of GS-566500: Cmax at Day 0 |
|---|---|
| Description | 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. |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 17 | 15 |
| Mean (Standard Deviation) [ng/mL] |
69.99
(35.98)
|
145.51
(31.95)
|
293.35
(92.75)
|
| Title | Plasma Pharmacokinetics of GS-566500: Cmax at Day 27 |
|---|---|
| Description | The Cmax of GS-566500 was measured at Day 27 following continuous dosing of sofosbuvir. |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 16 | 15 |
| Mean (Standard Deviation) [ng/mL] |
64.75
(38.51)
|
132.72
(49.33)
|
237.46
(51.66)
|
| Title | Plasma Pharmacokinetics of GS-566500: AUCinf at Day 0 |
|---|---|
| Description | The AUCinf of GS-566500 was analyzed at Day 0 (following a single dose of sofosbuvir). |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, and 12 hours postdose |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 17 | 15 |
| Mean (Standard Deviation) [h*ng/mL] |
266.22
(122.40)
|
645.95
(228.09)
|
1315.94
(618.96)
|
| Title | Plasma Pharmacokinetics of GS-566500: AUCtau at Day 27 |
|---|---|
| Description | The AUCtau of GS-566500 was analyzed at Day 27 (following continuous dosing of sofosbuvir). |
| Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set with available data and who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 16 | 15 |
| Mean (Standard Deviation) [h*ng/mL] |
262.00
(120.64)
|
571.95
(156.59)
|
1072.91
(327.09)
|
| Title | Percentage of Participants Who Developed Resistance to Sofosbuvir |
|---|---|
| Description | |
| Time Frame | Baseline to Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set who received a regimen containing sofosbuvir were analyzed. |
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV |
|---|---|---|---|
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks |
| Measure Participants | 16 | 18 | 15 |
| Number [percentage of participants] |
0.0
0%
|
0.0
0%
|
0.0
0%
|
Adverse Events
| Time Frame | Baseline to Week 48 | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV | Placebo+PEG+RBV | ||||
| Arm/Group Description | Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks | Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks | Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks | ||||
All Cause Mortality |
||||||||
| Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV | Placebo+PEG+RBV | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV | Placebo+PEG+RBV | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/16 (6.3%) | 0/18 (0%) | 3/15 (20%) | 1/14 (7.1%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Pancreatitis acute | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Psychiatric disorders | ||||||||
| Depression | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Vascular disorders | ||||||||
| Peripheral ischaemia | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Sofosbuvir 100 mg+PEG+RBV | Sofosbuvir 200 mg+PEG+RBV | Sofosbuvir 400 mg+PEG+RBV | Placebo+PEG+RBV | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 14/16 (87.5%) | 18/18 (100%) | 13/15 (86.7%) | 13/14 (92.9%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/16 (0%) | 8/18 (44.4%) | 1/15 (6.7%) | 1/14 (7.1%) | ||||
| Neutropenia | 1/16 (6.3%) | 3/18 (16.7%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Ear and labyrinth disorders | ||||||||
| Motion sickness | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
| Vertigo | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Eye disorders | ||||||||
| Blepharitis | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
| Dry eye | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Eye pain | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Presbyopia | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Retinal vasculitis | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Retinitis | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
| Visual acuity reduced | 1/16 (6.3%) | 1/18 (5.6%) | 2/15 (13.3%) | 1/14 (7.1%) | ||||
| Visual impairment | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal discomfort | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Abdominal pain | 1/16 (6.3%) | 0/18 (0%) | 2/15 (13.3%) | 3/14 (21.4%) | ||||
| Abdominal pain upper | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Aphthous stomatitis | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Constipation | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | ||||
| Diarrhoea | 0/16 (0%) | 1/18 (5.6%) | 1/15 (6.7%) | 1/14 (7.1%) | ||||
| Dry mouth | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Dyspepsia | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Flatulence | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Gastrooesophageal reflux disease | 0/16 (0%) | 1/18 (5.6%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Glossodynia | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Haematochezia | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Haemorrhoids | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Nausea | 5/16 (31.3%) | 6/18 (33.3%) | 9/15 (60%) | 6/14 (42.9%) | ||||
| Retching | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Vomiting | 1/16 (6.3%) | 0/18 (0%) | 3/15 (20%) | 0/14 (0%) | ||||
| General disorders | ||||||||
| Asthenia | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
| Chills | 7/16 (43.8%) | 6/18 (33.3%) | 4/15 (26.7%) | 2/14 (14.3%) | ||||
| Fatigue | 7/16 (43.8%) | 8/18 (44.4%) | 9/15 (60%) | 8/14 (57.1%) | ||||
| Injection site erythema | 1/16 (6.3%) | 2/18 (11.1%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Injection site irritation | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Injection site reaction | 1/16 (6.3%) | 1/18 (5.6%) | 1/15 (6.7%) | 2/14 (14.3%) | ||||
| Irritability | 1/16 (6.3%) | 0/18 (0%) | 1/15 (6.7%) | 2/14 (14.3%) | ||||
| Non-cardiac chest pain | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Pain | 1/16 (6.3%) | 2/18 (11.1%) | 1/15 (6.7%) | 3/14 (21.4%) | ||||
| Pyrexia | 2/16 (12.5%) | 1/18 (5.6%) | 1/15 (6.7%) | 1/14 (7.1%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Cellulitis | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
| Gastroenteritis viral | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Impetigo | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Sinusitis | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | ||||
| Upper respiratory tract infection | 1/16 (6.3%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Urinary tract infection | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Contusion | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Investigations | ||||||||
| Weight increased | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 3/16 (18.8%) | 1/18 (5.6%) | 3/15 (20%) | 1/14 (7.1%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 7/16 (43.8%) | 2/18 (11.1%) | 3/15 (20%) | 0/14 (0%) | ||||
| Arthritis | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Back pain | 0/16 (0%) | 0/18 (0%) | 2/15 (13.3%) | 1/14 (7.1%) | ||||
| Muscle fatigue | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Muscle spasms | 0/16 (0%) | 0/18 (0%) | 2/15 (13.3%) | 0/14 (0%) | ||||
| Musculoskeletal stiffness | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Myalgia | 4/16 (25%) | 1/18 (5.6%) | 2/15 (13.3%) | 1/14 (7.1%) | ||||
| Pain in extremity | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Synovial cyst | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Melanocytic naevus | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Nervous system disorders | ||||||||
| Balance disorder | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
| Disturbance in attention | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Dizziness | 2/16 (12.5%) | 1/18 (5.6%) | 3/15 (20%) | 2/14 (14.3%) | ||||
| Headache | 4/16 (25%) | 6/18 (33.3%) | 5/15 (33.3%) | 2/14 (14.3%) | ||||
| Paraesthesia | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Sinus headache | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Psychiatric disorders | ||||||||
| Affect lability | 1/16 (6.3%) | 2/18 (11.1%) | 1/15 (6.7%) | 2/14 (14.3%) | ||||
| Anxiety | 2/16 (12.5%) | 1/18 (5.6%) | 3/15 (20%) | 0/14 (0%) | ||||
| Daydreaming | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Depression | 1/16 (6.3%) | 2/18 (11.1%) | 2/15 (13.3%) | 0/14 (0%) | ||||
| Insomnia | 5/16 (31.3%) | 3/18 (16.7%) | 3/15 (20%) | 2/14 (14.3%) | ||||
| Mood swings | 0/16 (0%) | 1/18 (5.6%) | 1/15 (6.7%) | 1/14 (7.1%) | ||||
| Renal and urinary disorders | ||||||||
| Dysuria | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Reproductive system and breast disorders | ||||||||
| Sexual dysfunction | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 0/16 (0%) | 1/18 (5.6%) | 2/15 (13.3%) | 0/14 (0%) | ||||
| Dyspnoea | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Dyspnoea exertional | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | ||||
| Epistaxis | 0/16 (0%) | 2/18 (11.1%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Nasal congestion | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Oropharyngeal pain | 0/16 (0%) | 3/18 (16.7%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Pleuritic pain | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
| Rhinorrhoea | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Dermatitis | 3/16 (18.8%) | 2/18 (11.1%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Dry skin | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Erythema | 1/16 (6.3%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Hair texture abnormal | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 1/14 (7.1%) | ||||
| Night sweats | 0/16 (0%) | 0/18 (0%) | 0/15 (0%) | 1/14 (7.1%) | ||||
| Photosensitivity reaction | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Pruritus | 3/16 (18.8%) | 3/18 (16.7%) | 5/15 (33.3%) | 1/14 (7.1%) | ||||
| Psoriasis | 0/16 (0%) | 0/18 (0%) | 1/15 (6.7%) | 0/14 (0%) | ||||
| Rash | 0/16 (0%) | 2/18 (11.1%) | 0/15 (0%) | 2/14 (14.3%) | ||||
| Skin lesion | 0/16 (0%) | 1/18 (5.6%) | 0/15 (0%) | 0/14 (0%) | ||||
| Vascular disorders | ||||||||
| Flushing | 1/16 (6.3%) | 0/18 (0%) | 0/15 (0%) | 0/14 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
| Name/Title | Clinical Trial Disclosures |
|---|---|
| Organization | Gilead Sciences, Inc. |
| Phone | |
| ClinicalTrialDisclosures@gilead.com |
Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01054729
Other Study ID Numbers:
- P7977-0221
First Posted:
Jan 22, 2010
Last Update Posted:
Apr 17, 2014
Last Verified:
Mar 1, 2014