A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Adults
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01783678
Collaborator
(none)
275
24
3
17.9
11.5
0.6
Study Details
Study Description
Brief Summary
This is an Open-label Phase 3 study in adults with chronic genotypes 1, 2, 3, and 4 HCV infection who are co-infected with HIV-1.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
275 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Open-label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Chronic Genotype 1, 2, 3 and 4 Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) Co-infected Subjects
Study Start Date
:
Jan 1, 2013
Actual Primary Completion Date
:
Apr 1, 2014
Actual Study Completion Date
:
Jul 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Genotype 2 treatment-naive Treatment-naive (TN) participants with HIV-1 and genotype 2 HCV coinfection will receive sofosbuvir plus RBV for 12 weeks. |
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
| Experimental: Genotype 2/3 treatment-experienced Treatment-experienced (TE) participants with HIV-1 and genotype 2 or 3 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks. |
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
|
| Experimental: Genotype 1/3/4 treatment-naive Treatment naive (TN) participants with HIV-1 and genotype 1, 3, or 4 HCV co-infection will receive sofosbuvir plus RBV for 24 weeks. |
Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
Other Names:
Drug: RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 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 following the last dose of study drug.
- Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) [Up to 24 weeks]
The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Secondary Outcome Measures
- Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [Posttreatment Weeks 4 and 24]
SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively.
- HCV RNA Change From Baseline at Week 1 [Baseline; Week 1]
- HCV RNA Change From Baseline at Week 2 [Baseline; Week 2]
- HCV RNA Change From Baseline at Week 4 [Baseline; Week 4]
- HCV RNA Change From Baseline at Week 6 [Baseline; Week 6]
- HCV RNA Change From Baseline at Week 8 [Baseline; Week 8]
- Percentage of Participants Experiencing Virologic Failure [Baseline up to Posttreatment Week 24]
On-treatment virologic failure was defined as either: Virologic breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment). Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit."
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 HIV-1 and chronic HCV genotype 1, 2, 3, or 4 co-infection
-
HCV RNA > 10,000 IU/mL at screening
-
HCV treatment history:
-
Treatment-naive for HCV genotypes 1, 2, 3, or 4, or
-
Treatment-experienced for HCV genotypes 2 or 3
-
HIV antiretroviral (ARV) criteria:
-
On a stable, protocol-approved, HIV ARV regimen with undetectable HIV RNA for > 8 weeks prior to screening, or
-
ARV untreated for ≥ 8 weeks prior to screening, with a CD4 T-cell count > 500 cells/mm^3
-
Presence or absence of cirrhosis; a liver biopsy may be required
-
Healthy according to medical history and physical examination with the exception of HCV and HIV diagnosis
-
Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication
Exclusion Criteria:
-
HCV genotype 1 or 4 with previous HCV treatment
-
Poor control with HIV ARV regimen requiring a possible dose modification of therapy within 4 weeks of study medication dosing
-
A new AIDS-defining condition diagnosed within 30 days prior to screening
-
Prior use of any other inhibitor of the HCV NS5B polymerase
-
History of any other clinically significant chronic liver disease
-
Evidence of or history of decompensated liver disease
-
Chronic hepatitis B virus (HBV) infection
-
Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
-
Chronic use of immunosuppressive agents or immunomodulatory agents
-
Clinically relevant drug or alcohol abuse within 12 months of screening
-
History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participant's participation for the full duration of the study or not be in the best interest of the participant in the opinion of the investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Darlinghurst | New South Wales | Australia | ||
| 2 | Sydney | New South Wales | Australia | ||
| 3 | Melbourne | Victoria | Australia | ||
| 4 | Parkville | Victoria | Australia | ||
| 5 | Lyon | France | |||
| 6 | Nice | France | |||
| 7 | Paris | France | |||
| 8 | Berlin | Germany | |||
| 9 | Bonn | Germany | |||
| 10 | Duesseldorf | Germany | |||
| 11 | Frankfurt | Germany | |||
| 12 | Hamburg | Germany | |||
| 13 | Würzburg | Germany | |||
| 14 | Bergamo | Italy | |||
| 15 | Milano | Italy | |||
| 16 | Napoli | Italy | |||
| 17 | Rome | Italy | |||
| 18 | Torino | Italy | |||
| 19 | Barcelona | Spain | |||
| 20 | Madrid | Spain | |||
| 21 | Seville | Spain | |||
| 22 | Glasgow | United Kingdom | |||
| 23 | London | United Kingdom | |||
| 24 | Sussex | United Kingdom |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Anuj Gaggar, MD, PhD, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01783678
Other Study ID Numbers:
- GS-US-334-0124
First Posted:
Feb 5, 2013
Last Update Posted:
Apr 30, 2015
Last Verified:
Apr 1, 2015
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at a total of 39 study sites in Australia and Europe. The first participant was screened on 18 January 2013. The last study visit occurred on 10 July 2014. |
|---|---|
| Pre-assignment Detail | 346 participants were screened. |
| Arm/Group Title | Genotype 2 Treatment-naive | Genotype 1 Treatment-naive | Genotype 2 Treatment-experienced | Genotype 3 Treatment-naive | Genotype 3 Treatment-experienced | Genotype 4 Treatment-naive |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| Period Title: Overall Study | ||||||
| STARTED | 19 | 112 | 6 | 58 | 49 | 31 |
| COMPLETED | 17 | 94 | 5 | 50 | 42 | 26 |
| NOT COMPLETED | 2 | 18 | 1 | 8 | 7 | 5 |
Baseline Characteristics
| Arm/Group Title | Genotype 2 Treatment-naive | Genotype 1 Treatment-naive | Genotype 2 Treatment-experienced | Genotype 3 Treatment-naive | Genotype 3 Treatment-experienced | Genotype 4 Treatment-naive | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection | Total of all reporting groups |
| Overall Participants | 19 | 112 | 6 | 57 | 49 | 31 | 274 |
| Age (years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [years] |
55
(8.2)
|
45
(7.6)
|
55
(10.2)
|
47
(5.4)
|
49
(6.2)
|
47
(5.9)
|
47
(7.4)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
4
21.1%
|
12
10.7%
|
0
0%
|
19
33.3%
|
11
22.4%
|
7
22.6%
|
53
19.3%
|
| Male |
15
78.9%
|
100
89.3%
|
6
100%
|
38
66.7%
|
38
77.6%
|
24
77.4%
|
221
80.7%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||||
| Black or African American |
0
0%
|
1
0.9%
|
1
16.7%
|
0
0%
|
0
0%
|
1
3.2%
|
3
1.1%
|
| White |
18
94.7%
|
104
92.9%
|
5
83.3%
|
54
94.7%
|
49
100%
|
29
93.5%
|
259
94.5%
|
| Asian |
0
0%
|
5
4.5%
|
0
0%
|
2
3.5%
|
0
0%
|
0
0%
|
7
2.6%
|
| American Indian/Alaska Native/First Nations |
1
5.3%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.4%
|
| Other |
0
0%
|
1
0.9%
|
0
0%
|
1
1.8%
|
0
0%
|
0
0%
|
2
0.7%
|
| Not Permitted |
0
0%
|
1
0.9%
|
0
0%
|
0
0%
|
0
0%
|
1
3.2%
|
2
0.7%
|
| Race/Ethnicity, Customized (participants) [Number] | |||||||
| Hispanic or Latino |
3
15.8%
|
4
3.6%
|
0
0%
|
3
5.3%
|
5
10.2%
|
1
3.2%
|
16
5.8%
|
| Not Hispanic or Latino |
16
84.2%
|
106
94.6%
|
6
100%
|
54
94.7%
|
44
89.8%
|
29
93.5%
|
255
93.1%
|
| Not Permitted |
0
0%
|
2
1.8%
|
0
0%
|
0
0%
|
0
0%
|
1
3.2%
|
3
1.1%
|
| Cirrhosis Status (participants) [Number] | |||||||
| No |
18
94.7%
|
95
84.8%
|
4
66.7%
|
54
94.7%
|
26
53.1%
|
23
74.2%
|
220
80.3%
|
| Yes |
1
5.3%
|
17
15.2%
|
2
33.3%
|
3
5.3%
|
23
46.9%
|
8
25.8%
|
54
19.7%
|
| IL28b Status (participants) [Number] | |||||||
| CC |
12
63.2%
|
48
42.9%
|
3
50%
|
30
52.6%
|
25
51%
|
9
29%
|
127
46.4%
|
| CT |
5
26.3%
|
45
40.2%
|
1
16.7%
|
21
36.8%
|
20
40.8%
|
14
45.2%
|
106
38.7%
|
| TT |
2
10.5%
|
18
16.1%
|
2
33.3%
|
6
10.5%
|
4
8.2%
|
8
25.8%
|
40
14.6%
|
| Missing |
0
0%
|
1
0.9%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
0.4%
|
| Hepatitis C Virus (HCV) RNA (log10 IU/mL) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [log10 IU/mL] |
6.7
(0.66)
|
6.3
(0.72)
|
6.4
(0.62)
|
6.3
(0.71)
|
6.3
(0.77)
|
5.9
(0.85)
|
6.3
(0.75)
|
| HCV RNA Category (participants) [Number] | |||||||
| < 6 log10 IU/mL |
2
10.5%
|
33
29.5%
|
1
16.7%
|
21
36.8%
|
12
24.5%
|
12
38.7%
|
81
29.6%
|
| ≥ 6 log10 IU/mL |
17
89.5%
|
79
70.5%
|
5
83.3%
|
36
63.2%
|
37
75.5%
|
19
61.3%
|
193
70.4%
|
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 following the last dose of study drug. |
| Time Frame | Posttreatment Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set: participants who were randomized and received at least 1 dose of study drug. 1 participant with genotype 1 HCV infection did not have subtype information available. |
| Arm/Group Title | Genotype 2 Treatment-naive | All Genotype 1 Treatment-naive | Genotype 1a Treatment-naive | Genotype 1b Treatment-naive | Genotype 2 Treatment-experienced | Genotype 3 Treatment-naive | Genotype 3 Treatment-experienced | Genotype 4 Treatment-naive |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| Measure Participants | 19 | 112 | 100 | 11 | 6 | 57 | 49 | 31 |
| Number [percentage of participants] |
89.5
471.1%
|
84.8
75.7%
|
84.0
1400%
|
90.9
159.5%
|
83.3
170%
|
91.2
294.2%
|
85.7
31.3%
|
83.9
NaN
|
| Title | Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s) |
|---|---|
| Description | The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized. |
| Time Frame | Up to 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug |
| Arm/Group Title | Genotype 2 Treatment-naive | Genotype 2/3 Treatment-experienced | Genotype 1/3/4 Treatment-naive |
|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection |
| Measure Participants | 19 | 55 | 200 |
| Number [percentage of participants] |
0
0%
|
1.8
1.6%
|
3.5
58.3%
|
| Title | Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) |
|---|---|
| Description | SVR4 and SVR24 were defined as HCV RNA < the lower limit of quantitation (LLOQ) 4 weeks and 24 weeks following the last dose of study drug, respectively. |
| Time Frame | Posttreatment Weeks 4 and 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available. |
| Arm/Group Title | Genotype 2 Treatment-naive | All Genotype 1 Treatment-naive | Genotype 1a Treatment-naive | Genotype 1b Treatment-naive | Genotype 2 Treatment-experienced | Genotype 3 Treatment-naive | Genotype 3 Treatment-experienced | Genotype 4 Treatment-naive |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| Measure Participants | 19 | 112 | 100 | 11 | 6 | 57 | 48 | 31 |
| SVR4 |
89.5
471.1%
|
87.5
78.1%
|
87.0
1450%
|
90.9
159.5%
|
83.3
170%
|
91.2
294.2%
|
87.8
32%
|
90.3
NaN
|
| SVR24 |
89.5
471.1%
|
83.0
74.1%
|
82.0
1366.7%
|
90.9
159.5%
|
83.3
170%
|
91.2
294.2%
|
83.7
30.5%
|
80.6
NaN
|
| Title | HCV RNA Change From Baseline at Week 1 |
|---|---|
| Description | |
| Time Frame | Baseline; Week 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available. |
| Arm/Group Title | Genotype 2 Treatment-naive | All Genotype 1 Treatment-naive | Genotype 1a Treatment-naive | Genotype 1b Treatment-naive | Genotype 2 Treatment-experienced | Genotype 3 Treatment-naive | Genotype 3 Treatment-experienced | Genotype 4 Treatment-naive |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| Measure Participants | 19 | 112 | 100 | 11 | 6 | 54 | 48 | 31 |
| Mean (Standard Deviation) [log10 IU/mL] |
-4.72
(0.573)
|
-4.54
(0.776)
|
-4.57
(0.777)
|
-4.35
(0.752)
|
-4.34
(0.575)
|
-4.41
(0.498)
|
-4.33
(0.667)
|
-4.21
(0.665)
|
| Title | HCV RNA Change From Baseline at Week 2 |
|---|---|
| Description | |
| Time Frame | Baseline; Week 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available. |
| Arm/Group Title | Genotype 2 Treatment-naive | All Genotype 1 Treatment-naive | Genotype 1a Treatment-naive | Genotype 1b Treatment-naive | Genotype 2 Treatment-experienced | Genotype 3 Treatment-naive | Genotype 3 Treatment-experienced | Genotype 4 Treatment-naive |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| Measure Participants | 19 | 111 | 99 | 11 | 6 | 55 | 47 | 30 |
| Mean (Standard Deviation) [log10 IU/mL] |
-5.29
(0.681)
|
-4.92
(0.717)
|
-4.97
(0.674)
|
-4.55
(0.928)
|
-4.98
(0.633)
|
-4.86
(0.677)
|
-4.89
(0.776)
|
-4.52
(0.843)
|
| Title | HCV RNA Change From Baseline at Week 4 |
|---|---|
| Description | |
| Time Frame | Baseline; Week 4 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available. |
| Arm/Group Title | Genotype 2 Treatment-naive | All Genotype 1 Treatment-naive | Genotype 1a Treatment-naive | Genotype 1b Treatment-naive | Genotype 2 Treatment-experienced | Genotype 3 Treatment-naive | Genotype 3 Treatment-experienced | Genotype 4 Treatment-naive |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| Measure Participants | 19 | 109 | 97 | 11 | 6 | 57 | 49 | 31 |
| Mean (Standard Deviation) [log10 IU/mL] |
-5.33
(0.655)
|
-4.95
(0.720)
|
-5.01
(0.674)
|
-4.55
(0.928)
|
-5.05
(0.618)
|
-4.89
(0.708)
|
-4.84
(0.895)
|
-4.57
(0.846)
|
| Title | HCV RNA Change From Baseline at Week 6 |
|---|---|
| Description | |
| Time Frame | Baseline; Week 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available. |
| Arm/Group Title | Genotype 2 Treatment-naive | All Genotype 1 Treatment-naive | Genotype 1a Treatment-naive | Genotype 1b Treatment-naive | Genotype 2 Treatment-experienced | Genotype 3 Treatment-naive | Genotype 3 Treatment-experienced | Genotype 4 Treatment-naive |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| Measure Participants | 19 | 109 | 97 | 11 | 6 | 57 | 49 | 31 |
| Mean (Standard Deviation) [log10 IU/mL] |
-5.33
(0.655)
|
-4.95
(0.718)
|
-5.01
(0.672)
|
-4.55
(0.928)
|
-5.05
(0.618)
|
-4.89
(0.710)
|
-4.91
(0.789)
|
-4.57
(0.846)
|
| Title | HCV RNA Change From Baseline at Week 8 |
|---|---|
| Description | |
| Time Frame | Baseline; Week 8 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Full Analysis Set with available data were analyzed. 1 participant with genotype 1 HCV infection did not have subtype information available. |
| Arm/Group Title | Genotype 2 Treatment-naive | All Genotype 1 Treatment-naive | Genotype 1a Treatment-naive | Genotype 1b Treatment-naive | Genotype 2 Treatment-experienced | Genotype 3 Treatment-naive | Genotype 3 Treatment-experienced | Genotype 4 Treatment-naive |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| Measure Participants | 19 | 109 | 97 | 11 | 6 | 56 | 49 | 31 |
| Mean (Standard Deviation) [log10 IU/mL] |
-5.33
(0.655)
|
-4.95
(0.722)
|
-5.01
(0.676)
|
-4.55
(0.928)
|
-5.05
(0.618)
|
-4.88
(0.708)
|
-4.86
(0.876)
|
-4.57
(0.846)
|
| Title | Percentage of Participants Experiencing Virologic Failure |
|---|---|
| Description | On-treatment virologic failure was defined as either: Virologic breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or Nonresponse (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment). Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period, having achieved HCV RNA < LLOQ at last on-treatment visit." |
| Time Frame | Baseline up to Posttreatment Week 24 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set. 1 participant with genotype 1 HCV infection did not have subtype information available. |
| Arm/Group Title | Genotype 2 Treatment-naive | All Genotype 1 Treatment-naive | Genotype 1a Treatment-naive | Genotype 1b Treatment-naive | Genotype 2 Treatment-experienced | Genotype 3 Treatment-naive | Genotype 3 Treatment-experienced | Genotype 4 Treatment-naive |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group) | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection |
| Measure Participants | 19 | 112 | 100 | 11 | 6 | 57 | 49 | 31 |
| On-Treatment Virologic Failure |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
2.0
0.7%
|
0
NaN
|
| Virologic Relapse |
5.3
27.9%
|
12.5
11.2%
|
13.0
216.7%
|
9.1
16%
|
16.7
34.1%
|
7.0
22.6%
|
12.5
4.6%
|
16.1
NaN
|
Adverse Events
| Time Frame | Up to 24 weeks plus 30 days | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug | |||||
| Arm/Group Title | Genotype 2 Treatment-naive | Genotype 2/3 Treatment-experienced | Genotype 1/3/4 Treatment-naive | |||
| Arm/Group Description | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection | SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection | |||
All Cause Mortality |
||||||
| Genotype 2 Treatment-naive | Genotype 2/3 Treatment-experienced | Genotype 1/3/4 Treatment-naive | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Genotype 2 Treatment-naive | Genotype 2/3 Treatment-experienced | Genotype 1/3/4 Treatment-naive | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/19 (0%) | 5/55 (9.1%) | 10/200 (5%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/19 (0%) | 1/55 (1.8%) | 1/200 (0.5%) | |||
| Thrombocytopenia | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Cardiac disorders | ||||||
| Supraventricular tachycardia | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| General disorders | ||||||
| Pyrexia | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Hepatobiliary disorders | ||||||
| Bile duct stone | 0/19 (0%) | 1/55 (1.8%) | 0/200 (0%) | |||
| Cholecystitis | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Infections and infestations | ||||||
| Atypical pneumonia | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Gastroenteritis | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Tooth abscess | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Rhabdomyolysis | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Hepatic cancer | 0/19 (0%) | 1/55 (1.8%) | 0/200 (0%) | |||
| Nervous system disorders | ||||||
| Headache | 0/19 (0%) | 1/55 (1.8%) | 0/200 (0%) | |||
| Psychiatric disorders | ||||||
| Alcoholism | 0/19 (0%) | 1/55 (1.8%) | 0/200 (0%) | |||
| Drug abuse | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Mania | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Psychotic disorder | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Renal and urinary disorders | ||||||
| Renal failure acute | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Petechiae | 0/19 (0%) | 0/55 (0%) | 1/200 (0.5%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Genotype 2 Treatment-naive | Genotype 2/3 Treatment-experienced | Genotype 1/3/4 Treatment-naive | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/19 (89.5%) | 45/55 (81.8%) | 166/200 (83%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 1/19 (5.3%) | 3/55 (5.5%) | 16/200 (8%) | |||
| Cardiac disorders | ||||||
| Tachycardia | 1/19 (5.3%) | 2/55 (3.6%) | 1/200 (0.5%) | |||
| Ear and labyrinth disorders | ||||||
| Ear discomfort | 1/19 (5.3%) | 0/55 (0%) | 0/200 (0%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 3/19 (15.8%) | 4/55 (7.3%) | 32/200 (16%) | |||
| Diarrhoea | 1/19 (5.3%) | 5/55 (9.1%) | 24/200 (12%) | |||
| Vomiting | 0/19 (0%) | 1/55 (1.8%) | 13/200 (6.5%) | |||
| Abdominal pain | 1/19 (5.3%) | 3/55 (5.5%) | 9/200 (4.5%) | |||
| Abdominal pain upper | 3/19 (15.8%) | 1/55 (1.8%) | 9/200 (4.5%) | |||
| Constipation | 0/19 (0%) | 0/55 (0%) | 10/200 (5%) | |||
| Gastrooesophageal reflux disease | 0/19 (0%) | 0/55 (0%) | 10/200 (5%) | |||
| Abdominal tenderness | 1/19 (5.3%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Gastrointestinal pain | 1/19 (5.3%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Tongue ulceration | 1/19 (5.3%) | 0/55 (0%) | 0/200 (0%) | |||
| General disorders | ||||||
| Fatigue | 5/19 (26.3%) | 11/55 (20%) | 40/200 (20%) | |||
| Asthenia | 1/19 (5.3%) | 11/55 (20%) | 32/200 (16%) | |||
| Pyrexia | 0/19 (0%) | 3/55 (5.5%) | 5/200 (2.5%) | |||
| Influenza like illness | 1/19 (5.3%) | 0/55 (0%) | 4/200 (2%) | |||
| Malaise | 1/19 (5.3%) | 0/55 (0%) | 2/200 (1%) | |||
| Hepatobiliary disorders | ||||||
| Jaundice | 1/19 (5.3%) | 1/55 (1.8%) | 5/200 (2.5%) | |||
| Hyperbilirubinaemia | 1/19 (5.3%) | 0/55 (0%) | 2/200 (1%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 3/19 (15.8%) | 5/55 (9.1%) | 11/200 (5.5%) | |||
| Upper respiratory tract infection | 1/19 (5.3%) | 2/55 (3.6%) | 13/200 (6.5%) | |||
| Rhinitis | 1/19 (5.3%) | 0/55 (0%) | 8/200 (4%) | |||
| Sinusitis | 1/19 (5.3%) | 1/55 (1.8%) | 7/200 (3.5%) | |||
| Bronchitis | 1/19 (5.3%) | 0/55 (0%) | 7/200 (3.5%) | |||
| Influenza | 0/19 (0%) | 3/55 (5.5%) | 4/200 (2%) | |||
| Pharyngitis | 1/19 (5.3%) | 0/55 (0%) | 3/200 (1.5%) | |||
| Ear infection | 1/19 (5.3%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Localised infection | 1/19 (5.3%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Otitis media | 1/19 (5.3%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Subcutaneous abscess | 1/19 (5.3%) | 0/55 (0%) | 0/200 (0%) | |||
| Urethritis gonococcal | 1/19 (5.3%) | 0/55 (0%) | 0/200 (0%) | |||
| Investigations | ||||||
| Haemoglobin decreased | 1/19 (5.3%) | 0/55 (0%) | 3/200 (1.5%) | |||
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 1/19 (5.3%) | 2/55 (3.6%) | 17/200 (8.5%) | |||
| Hyperphagia | 0/19 (0%) | 3/55 (5.5%) | 1/200 (0.5%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Myalgia | 1/19 (5.3%) | 6/55 (10.9%) | 11/200 (5.5%) | |||
| Back pain | 1/19 (5.3%) | 2/55 (3.6%) | 13/200 (6.5%) | |||
| Arthralgia | 1/19 (5.3%) | 2/55 (3.6%) | 11/200 (5.5%) | |||
| Intervertebral disc protrusion | 1/19 (5.3%) | 0/55 (0%) | 2/200 (1%) | |||
| Musculoskeletal chest pain | 1/19 (5.3%) | 0/55 (0%) | 2/200 (1%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Seborrhoeic keratosis | 1/19 (5.3%) | 0/55 (0%) | 0/200 (0%) | |||
| Nervous system disorders | ||||||
| Headache | 1/19 (5.3%) | 7/55 (12.7%) | 35/200 (17.5%) | |||
| Lethargy | 1/19 (5.3%) | 1/55 (1.8%) | 15/200 (7.5%) | |||
| Dizziness | 0/19 (0%) | 5/55 (9.1%) | 9/200 (4.5%) | |||
| Psychiatric disorders | ||||||
| Insomnia | 3/19 (15.8%) | 5/55 (9.1%) | 36/200 (18%) | |||
| Irritability | 1/19 (5.3%) | 6/55 (10.9%) | 20/200 (10%) | |||
| Anxiety | 0/19 (0%) | 3/55 (5.5%) | 15/200 (7.5%) | |||
| Sleep disorder | 1/19 (5.3%) | 1/55 (1.8%) | 13/200 (6.5%) | |||
| Depression | 0/19 (0%) | 5/55 (9.1%) | 9/200 (4.5%) | |||
| Depressed mood | 2/19 (10.5%) | 0/55 (0%) | 4/200 (2%) | |||
| Mood swings | 1/19 (5.3%) | 1/55 (1.8%) | 2/200 (1%) | |||
| Stress | 1/19 (5.3%) | 1/55 (1.8%) | 1/200 (0.5%) | |||
| Abnormal dreams | 1/19 (5.3%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Claustrophobia | 1/19 (5.3%) | 0/55 (0%) | 0/200 (0%) | |||
| Renal and urinary disorders | ||||||
| Chromaturia | 0/19 (0%) | 3/55 (5.5%) | 1/200 (0.5%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 0/19 (0%) | 6/55 (10.9%) | 17/200 (8.5%) | |||
| Dyspnoea | 2/19 (10.5%) | 8/55 (14.5%) | 10/200 (5%) | |||
| Dyspnoea exertional | 2/19 (10.5%) | 5/55 (9.1%) | 11/200 (5.5%) | |||
| Oropharyngeal discomfort | 1/19 (5.3%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Dysphonia | 1/19 (5.3%) | 0/55 (0%) | 0/200 (0%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 0/19 (0%) | 5/55 (9.1%) | 16/200 (8%) | |||
| Rash | 2/19 (10.5%) | 3/55 (5.5%) | 15/200 (7.5%) | |||
| Dry skin | 1/19 (5.3%) | 2/55 (3.6%) | 9/200 (4.5%) | |||
| Alopecia | 0/19 (0%) | 3/55 (5.5%) | 5/200 (2.5%) | |||
| Dermatitis | 2/19 (10.5%) | 1/55 (1.8%) | 4/200 (2%) | |||
| Hyperhidrosis | 1/19 (5.3%) | 0/55 (0%) | 2/200 (1%) | |||
| Urticaria | 1/19 (5.3%) | 0/55 (0%) | 1/200 (0.5%) | |||
| Hair texture abnormal | 1/19 (5.3%) | 0/55 (0%) | 0/200 (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:
NCT01783678
Other Study ID Numbers:
- GS-US-334-0124
First Posted:
Feb 5, 2013
Last Update Posted:
Apr 30, 2015
Last Verified:
Apr 1, 2015