Safety and Efficacy of LDV/SOF Fixed-Dose Combination (FDC) ± Ribavirin in HCV Genotype 1 Subjects
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01726517
Collaborator
(none)
100
1
5
15
6.7
Study Details
Study Description
Brief Summary
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV), administered for 8 or 12 weeks of treatment in participants with chronic genotype 1 hepatitis C virus (HCV) infection who are treatment-naive, and for 12 weeks in participants who had previously received a regimen containing a protease inhibitor for the treatment of HCV.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Open-Label Study of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin in Subjects With Chronic Genotype 1 HCV Infection
Study Start Date
:
Oct 1, 2012
Actual Primary Completion Date
:
Jul 1, 2013
Actual Study Completion Date
:
Jan 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LDV/SOF 8 Weeks (TN) Treatment-naive (TN) participants will be randomized to receive LDV/SOF for 8 weeks. |
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
|
| Experimental: LDV/SOF+RBV 8 Weeks (TN) Treatment-naive participants will be randomized to receive LDV/SOF plus RBV for 8 weeks. |
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
Drug: RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
| Experimental: LDV/SOF 12 Weeks (TN) Treatment-naive participants will be randomized to receive LDV/SOF for 12 weeks. |
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
|
| Experimental: LDV/SOF 12 Weeks (TE) Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) will be randomized to receive LDV/SOF for 12 weeks. |
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
|
| Experimental: LDV/SOF+RBV 12 Weeks (TE) Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) will be randomized to receive LDV/SOF plus RBV for 12 weeks. |
Drug: LDV/SOF
LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
Other Names:
Drug: RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) [Posttreatment Week 12]
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment.
- Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [Baseline to Week 12]
The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized.
Secondary Outcome Measures
- Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24) [Posttreatment Weeks 2, 4, 8, and 24]
SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively.
- Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse [Baseline to Posttreatment Week 24]
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age ≥ 18 years, with chronic genotype 1 HCV infection
-
HCV RNA equal to or greater than 10,000 IU/mL at screening
-
Cirrhosis determination; a liver biopsy may be required
-
Screening laboratory values within defined thresholds
-
Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
-
Pregnant or nursing female or male with pregnant female partner
-
Current or prior history of clinical hepatic decompensation
-
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
-
Chronic use of systemic immunosuppressive agents
-
History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Antonio | Texas | United States | 78215 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Rob Hyland, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01726517
Other Study ID Numbers:
- GS-US-337-0118
First Posted:
Nov 15, 2012
Last Update Posted:
Nov 16, 2018
Last Verified:
Nov 1, 2014
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Gilead Sciences
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at 1 study site in the United States. The first participant was screened on 22 October 2012. The last participant observation was on 13 January 2014. |
|---|---|
| Pre-assignment Detail | 116 participants were screened. |
| Arm/Group Title | LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. |
| Period Title: Overall Study | |||||
| STARTED | 20 | 21 | 19 | 19 | 21 |
| COMPLETED | 20 | 21 | 18 | 19 | 21 |
| NOT COMPLETED | 0 | 0 | 1 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. | Total of all reporting groups |
| Overall Participants | 20 | 21 | 19 | 19 | 21 | 100 |
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
48
(10.7)
|
50
(11.1)
|
46
(11.6)
|
54
(6.6)
|
52
(9.8)
|
50
(10.4)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
6
30%
|
9
42.9%
|
8
42.1%
|
4
21.1%
|
7
33.3%
|
34
34%
|
| Male |
14
70%
|
12
57.1%
|
11
57.9%
|
15
78.9%
|
14
66.7%
|
66
66%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||
| Hispanic or Latino |
3
15%
|
12
57.1%
|
9
47.4%
|
6
31.6%
|
10
47.6%
|
40
40%
|
| Not Hispanic or Latino |
17
85%
|
9
42.9%
|
10
52.6%
|
13
68.4%
|
11
52.4%
|
60
60%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
1
5.3%
|
0
0%
|
1
1%
|
| Asian |
1
5%
|
0
0%
|
1
5.3%
|
0
0%
|
0
0%
|
2
2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
4
20%
|
0
0%
|
1
5.3%
|
2
10.5%
|
2
9.5%
|
9
9%
|
| White |
15
75%
|
21
100%
|
17
89.5%
|
16
84.2%
|
19
90.5%
|
88
88%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Hepatitis C Virus (HCV) Genotype (participants) [Number] | ||||||
| 1a |
17
85%
|
19
90.5%
|
17
89.5%
|
18
94.7%
|
16
76.2%
|
87
87%
|
| 1b |
3
15%
|
2
9.5%
|
2
10.5%
|
1
5.3%
|
5
23.8%
|
13
13%
|
| IL28b Status (participants) [Number] | ||||||
| CC |
4
20%
|
7
33.3%
|
1
5.3%
|
2
10.5%
|
1
4.8%
|
15
15%
|
| CT |
12
60%
|
11
52.4%
|
14
73.7%
|
13
68.4%
|
11
52.4%
|
61
61%
|
| TT |
4
20%
|
3
14.3%
|
4
21.1%
|
4
21.1%
|
9
42.9%
|
24
24%
|
| HCV RNA (log10 IU/mL) (log10 IU/mL) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [log10 IU/mL] |
6.1
(0.82)
|
6.0
(0.84)
|
6.1
(0.79)
|
6.3
(0.49)
|
6.2
(0.42)
|
6.1
(0.69)
|
| HCV RNA Category (participants) [Number] | ||||||
| < 800,000 IU/mL |
9
45%
|
7
33.3%
|
7
36.8%
|
4
21.1%
|
5
23.8%
|
32
32%
|
| ≥ 800,000 IU/mL |
11
55%
|
14
66.7%
|
12
63.2%
|
15
78.9%
|
16
76.2%
|
68
68%
|
| Prior HCV Treatment and Response (participants) [Number] | ||||||
| Non-responder to PI boceprevir |
0
0%
|
0
0%
|
0
0%
|
9
47.4%
|
9
42.9%
|
18
18%
|
| Relapse/Breakthrough to PI boceprevir |
0
0%
|
0
0%
|
0
0%
|
2
10.5%
|
2
9.5%
|
4
4%
|
| Non-responder to PI telaprevir |
0
0%
|
0
0%
|
0
0%
|
3
15.8%
|
6
28.6%
|
9
9%
|
| Relapse/Breakthrough to PI telaprevir |
0
0%
|
0
0%
|
0
0%
|
5
26.3%
|
4
19%
|
9
9%
|
| Cirrhosis (participants) [Number] | ||||||
| No |
20
100%
|
21
100%
|
19
100%
|
8
42.1%
|
10
47.6%
|
78
78%
|
| Yes |
0
0%
|
0
0%
|
0
0%
|
11
57.9%
|
11
52.4%
|
22
22%
|
Outcome Measures
| Title | Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12) |
|---|---|
| Description | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after stopping study treatment. |
| Time Frame | Posttreatment Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: participants were randomized and received at least 1 dose of study drug |
| Arm/Group Title | LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. |
| Measure Participants | 20 | 21 | 19 | 19 | 21 |
| Number [percentage of participants] |
95.0
475%
|
100.0
476.2%
|
94.7
498.4%
|
94.7
498.4%
|
100.0
476.2%
|
| Title | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
|---|---|
| Description | The number of participants experiencing an adverse event leading to permanent discontinuation of study drug(s) was summarized. |
| Time Frame | Baseline to Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set |
| Arm/Group Title | LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. |
| Measure Participants | 20 | 21 | 19 | 19 | 21 |
| Number [participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Percentage of Participants With SVR at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR24) |
|---|---|
| Description | SVR2, SVR4, SVR8, and SVR24 was defined as HCV RNA < LLOQ at 2, 4, 8, and 24 weeks following the last dose of study drug, respectively. |
| Time Frame | Posttreatment Weeks 2, 4, 8, and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. |
| Measure Participants | 20 | 21 | 19 | 19 | 21 |
| SVR2 |
100.0
500%
|
100.0
476.2%
|
100.0
526.3%
|
94.7
498.4%
|
100.0
476.2%
|
| SVR4 |
100.0
500%
|
100.0
476.2%
|
100.0
526.3%
|
94.7
498.4%
|
100.0
476.2%
|
| SVR8 |
95.0
475%
|
100.0
476.2%
|
100.0
526.3%
|
94.7
498.4%
|
100.0
476.2%
|
| SVR24 |
95.0
475%
|
100.0
476.2%
|
94.7
498.4%
|
94.7
498.4%
|
100.0
476.2%
|
| Title | Percentage of Participants Experiencing Viral Breakthrough or Viral Relapse |
|---|---|
| Description | Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values. Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement. |
| Time Frame | Baseline to Posttreatment Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) |
|---|---|---|---|---|---|
| Arm/Group Description | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. |
| Measure Participants | 20 | 21 | 19 | 19 | 21 |
| Viral breakthrough |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Viral relapse |
5.0
25%
|
0
0%
|
0
0%
|
5.3
27.9%
|
0
0%
|
Adverse Events
| Time Frame | Baseline to Week 12 plus 30 days | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) | |||||
| Arm/Group Description | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks. | Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks. | Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks. | |||||
All Cause Mortality |
||||||||||
| LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 1/21 (4.8%) | 1/19 (5.3%) | 1/19 (5.3%) | 1/21 (4.8%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/20 (0%) | 0/21 (0%) | 0/19 (0%) | 0/19 (0%) | 1/21 (4.8%) | |||||
| Gastrointestinal disorders | ||||||||||
| Peptic ulcer | 0/20 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/19 (0%) | 0/21 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Spinal compression fracture | 0/20 (0%) | 0/21 (0%) | 0/19 (0%) | 1/19 (5.3%) | 0/21 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Delirium | 0/20 (0%) | 1/21 (4.8%) | 0/19 (0%) | 0/19 (0%) | 0/21 (0%) | |||||
| Suicidal ideation | 0/20 (0%) | 0/21 (0%) | 0/19 (0%) | 0/19 (0%) | 1/21 (4.8%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| LDV/SOF 8 Weeks (TN) | LDV/SOF+RBV 8 Weeks (TN) | LDV/SOF 12 Weeks (TN) | LDV/SOF 12 Weeks (TE) | LDV/SOF+RBV 12 Weeks (TE) | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/20 (45%) | 12/21 (57.1%) | 8/19 (42.1%) | 7/19 (36.8%) | 12/21 (57.1%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| Anaemia | 0/20 (0%) | 2/21 (9.5%) | 0/19 (0%) | 0/19 (0%) | 6/21 (28.6%) | |||||
| Gastrointestinal disorders | ||||||||||
| Nausea | 2/20 (10%) | 2/21 (9.5%) | 1/19 (5.3%) | 0/19 (0%) | 4/21 (19%) | |||||
| Abdominal pain | 1/20 (5%) | 1/21 (4.8%) | 1/19 (5.3%) | 0/19 (0%) | 1/21 (4.8%) | |||||
| Diarrhoea | 2/20 (10%) | 0/21 (0%) | 0/19 (0%) | 0/19 (0%) | 0/21 (0%) | |||||
| Vomiting | 0/20 (0%) | 2/21 (9.5%) | 0/19 (0%) | 0/19 (0%) | 0/21 (0%) | |||||
| Abdominal distension | 1/20 (5%) | 0/21 (0%) | 0/19 (0%) | 0/19 (0%) | 0/21 (0%) | |||||
| Cheilitis | 0/20 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/19 (0%) | 0/21 (0%) | |||||
| Constipation | 1/20 (5%) | 0/21 (0%) | 0/19 (0%) | 0/19 (0%) | 0/21 (0%) | |||||
| Parotid gland enlargement | 1/20 (5%) | 0/21 (0%) | 0/19 (0%) | 0/19 (0%) | 0/21 (0%) | |||||
| Peptic ulcer | 0/20 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/19 (0%) | 0/21 (0%) | |||||
| General disorders | ||||||||||
| Fatigue | 0/20 (0%) | 1/21 (4.8%) | 1/19 (5.3%) | 0/19 (0%) | 0/21 (0%) | |||||
| Infections and infestations | ||||||||||
| Upper respiratory tract infection | 2/20 (10%) | 0/21 (0%) | 1/19 (5.3%) | 1/19 (5.3%) | 4/21 (19%) | |||||
| Bronchitis | 1/20 (5%) | 1/21 (4.8%) | 0/19 (0%) | 1/19 (5.3%) | 1/21 (4.8%) | |||||
| Influenza | 2/20 (10%) | 0/21 (0%) | 0/19 (0%) | 0/19 (0%) | 0/21 (0%) | |||||
| Urinary tract infection | 0/20 (0%) | 2/21 (9.5%) | 0/19 (0%) | 0/19 (0%) | 0/21 (0%) | |||||
| Latent tuberculosis | 0/20 (0%) | 0/21 (0%) | 0/19 (0%) | 1/19 (5.3%) | 0/21 (0%) | |||||
| Pharyngitis | 0/20 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/19 (0%) | 0/21 (0%) | |||||
| Pneumonia | 0/20 (0%) | 0/21 (0%) | 0/19 (0%) | 1/19 (5.3%) | 0/21 (0%) | |||||
| Investigations | ||||||||||
| Blood pressure increased | 0/20 (0%) | 0/21 (0%) | 1/19 (5.3%) | 0/19 (0%) | 0/21 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Decreased appetite | 0/20 (0%) | 2/21 (9.5%) | 0/19 (0%) | 1/19 (5.3%) | 0/21 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Back pain | 1/20 (5%) | 1/21 (4.8%) | 1/19 (5.3%) | 1/19 (5.3%) | 0/21 (0%) | |||||
| Muscle spasms | 1/20 (5%) | 0/21 (0%) | 0/19 (0%) | 0/19 (0%) | 2/21 (9.5%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 2/20 (10%) | 3/21 (14.3%) | 0/19 (0%) | 1/19 (5.3%) | 1/21 (4.8%) | |||||
| Tremor | 0/20 (0%) | 0/21 (0%) | 0/19 (0%) | 1/19 (5.3%) | 0/21 (0%) | |||||
| Psychiatric disorders | ||||||||||
| Insomnia | 0/20 (0%) | 2/21 (9.5%) | 0/19 (0%) | 0/19 (0%) | 0/21 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Cough | 0/20 (0%) | 2/21 (9.5%) | 0/19 (0%) | 0/19 (0%) | 0/21 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Dermatitis | 1/20 (5%) | 0/21 (0%) | 0/19 (0%) | 0/19 (0%) | 2/21 (9.5%) | |||||
| Pruritus | 0/20 (0%) | 0/21 (0%) | 0/19 (0%) | 1/19 (5.3%) | 0/21 (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:
NCT01726517
Other Study ID Numbers:
- GS-US-337-0118
First Posted:
Nov 15, 2012
Last Update Posted:
Nov 16, 2018
Last Verified:
Nov 1, 2014