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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

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ClinicalTrials.gov Identifier: NCT01783678
Recruitment Status : Completed
First Posted : February 5, 2013
Results First Posted : April 30, 2015
Last Update Posted : April 30, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Hepatitis C
Human Immunodeficiency Virus
Interventions Drug: Sofosbuvir
Drug: RBV
Enrollment 275
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 Details 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
Hide 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
Reason Not Completed
Randomized but Not Treated             0             0             0             1             0             0
Lack of Efficacy             1             13             1             3             6             5
Lost to Follow-up             0             4             0             2             1             0
Withdrew Consent             1             1             0             2             0             0
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
Hide 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 Number of Baseline Participants 19 112 6 57 49 31 274
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized and received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 112 participants 6 participants 57 participants 49 participants 31 participants 274 participants
55  (8.2) 45  (7.6) 55  (10.2) 47  (5.4) 49  (6.2) 47  (5.9) 47  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 112 participants 6 participants 57 participants 49 participants 31 participants 274 participants
Female
4
  21.1%
12
  10.7%
0
   0.0%
19
  33.3%
11
  22.4%
7
  22.6%
53
  19.3%
Male
15
  78.9%
100
  89.3%
6
 100.0%
38
  66.7%
38
  77.6%
24
  77.4%
221
  80.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 112 participants 6 participants 57 participants 49 participants 31 participants 274 participants
Black or African American 0 1 1 0 0 1 3
White 18 104 5 54 49 29 259
Asian 0 5 0 2 0 0 7
American Indian/Alaska Native/First Nations 1 0 0 0 0 0 1
Other 0 1 0 1 0 0 2
Not Permitted 0 1 0 0 0 1 2
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 112 participants 6 participants 57 participants 49 participants 31 participants 274 participants
Hispanic or Latino 3 4 0 3 5 1 16
Not Hispanic or Latino 16 106 6 54 44 29 255
Not Permitted 0 2 0 0 0 1 3
Cirrhosis Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 112 participants 6 participants 57 participants 49 participants 31 participants 274 participants
No 18 95 4 54 26 23 220
Yes 1 17 2 3 23 8 54
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 112 participants 6 participants 57 participants 49 participants 31 participants 274 participants
CC 12 48 3 30 25 9 127
CT 5 45 1 21 20 14 106
TT 2 18 2 6 4 8 40
Missing 0 1 0 0 0 0 1
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
Hepatitis C Virus (HCV) RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 19 participants 112 participants 6 participants 57 participants 49 participants 31 participants 274 participants
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  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 112 participants 6 participants 57 participants 49 participants 31 participants 274 participants
< 6 log10 IU/mL 2 33 1 21 12 12 81
≥ 6 log10 IU/mL 17 79 5 36 37 19 193
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) at 12 Weeks After Discontinuation of Therapy (SVR12)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 19 112 100 11 6 57 49 31
Measure Type: Number
Unit of Measure: percentage of participants
89.5 84.8 84.0 90.9 83.3 91.2 85.7 83.9
2.Primary Outcome
Title Incidence of Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Hide Description The percentage of participants permanently discontinuing any study drug due to an adverse event was summarized.
Time Frame Up to 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 19 55 200
Measure Type: Number
Unit of Measure: percentage of participants
0 1.8 3.5
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 19 112 100 11 6 57 48 31
Measure Type: Number
Unit of Measure: percentage of participants
SVR4 89.5 87.5 87.0 90.9 83.3 91.2 87.8 90.3
SVR24 89.5 83.0 82.0 90.9 83.3 91.2 83.7 80.6
4.Secondary Outcome
Title HCV RNA Change From Baseline at Week 1
Hide Description [Not Specified]
Time Frame Baseline; Week 1
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 19 112 100 11 6 54 48 31
Mean (Standard Deviation)
Unit of Measure: 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)
5.Secondary Outcome
Title HCV RNA Change From Baseline at Week 2
Hide Description [Not Specified]
Time Frame Baseline; Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 19 111 99 11 6 55 47 30
Mean (Standard Deviation)
Unit of Measure: 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)
6.Secondary Outcome
Title HCV RNA Change From Baseline at Week 4
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 19 109 97 11 6 57 49 31
Mean (Standard Deviation)
Unit of Measure: 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)
7.Secondary Outcome
Title HCV RNA Change From Baseline at Week 6
Hide Description [Not Specified]
Time Frame Baseline; Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 19 109 97 11 6 57 49 31
Mean (Standard Deviation)
Unit of Measure: 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)
8.Secondary Outcome
Title HCV RNA Change From Baseline at Week 8
Hide Description [Not Specified]
Time Frame Baseline; Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 19 109 97 11 6 56 49 31
Mean (Standard Deviation)
Unit of Measure: 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)
9.Secondary Outcome
Title Percentage of Participants Experiencing Virologic Failure
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 19 112 100 11 6 57 49 31
Measure Type: Number
Unit of Measure: percentage of participants
On-Treatment Virologic Failure 0 0 0 0 0 0 2.0 0
Virologic Relapse 5.3 12.5 13.0 9.1 16.7 7.0 12.5 16.1
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
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Genotype 2 Treatment-naive Genotype 2/3 Treatment-experienced Genotype 1/3/4 Treatment-naive
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   5/55 (9.09%)   10/200 (5.00%) 
Blood and lymphatic system disorders       
Anaemia  1  0/19 (0.00%)  1/55 (1.82%)  1/200 (0.50%) 
Thrombocytopenia  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Cardiac disorders       
Supraventricular tachycardia  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
General disorders       
Pyrexia  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Hepatobiliary disorders       
Bile duct stone  1  0/19 (0.00%)  1/55 (1.82%)  0/200 (0.00%) 
Cholecystitis  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Infections and infestations       
Atypical pneumonia  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Gastroenteritis  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Tooth abscess  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Musculoskeletal and connective tissue disorders       
Rhabdomyolysis  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatic cancer  1  0/19 (0.00%)  1/55 (1.82%)  0/200 (0.00%) 
Nervous system disorders       
Headache  1  0/19 (0.00%)  1/55 (1.82%)  0/200 (0.00%) 
Psychiatric disorders       
Alcoholism  1  0/19 (0.00%)  1/55 (1.82%)  0/200 (0.00%) 
Drug abuse  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Mania  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Psychotic disorder  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Renal and urinary disorders       
Renal failure acute  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Skin and subcutaneous tissue disorders       
Petechiae  1  0/19 (0.00%)  0/55 (0.00%)  1/200 (0.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Genotype 2 Treatment-naive Genotype 2/3 Treatment-experienced Genotype 1/3/4 Treatment-naive
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/19 (89.47%)   45/55 (81.82%)   166/200 (83.00%) 
Blood and lymphatic system disorders       
Anaemia  1  1/19 (5.26%)  3/55 (5.45%)  16/200 (8.00%) 
Cardiac disorders       
Tachycardia  1  1/19 (5.26%)  2/55 (3.64%)  1/200 (0.50%) 
Ear and labyrinth disorders       
Ear discomfort  1  1/19 (5.26%)  0/55 (0.00%)  0/200 (0.00%) 
Gastrointestinal disorders       
Nausea  1  3/19 (15.79%)  4/55 (7.27%)  32/200 (16.00%) 
Diarrhoea  1  1/19 (5.26%)  5/55 (9.09%)  24/200 (12.00%) 
Vomiting  1  0/19 (0.00%)  1/55 (1.82%)  13/200 (6.50%) 
Abdominal pain  1  1/19 (5.26%)  3/55 (5.45%)  9/200 (4.50%) 
Abdominal pain upper  1  3/19 (15.79%)  1/55 (1.82%)  9/200 (4.50%) 
Constipation  1  0/19 (0.00%)  0/55 (0.00%)  10/200 (5.00%) 
Gastrooesophageal reflux disease  1  0/19 (0.00%)  0/55 (0.00%)  10/200 (5.00%) 
Abdominal tenderness  1  1/19 (5.26%)  0/55 (0.00%)  1/200 (0.50%) 
Gastrointestinal pain  1  1/19 (5.26%)  0/55 (0.00%)  1/200 (0.50%) 
Tongue ulceration  1  1/19 (5.26%)  0/55 (0.00%)  0/200 (0.00%) 
General disorders       
Fatigue  1  5/19 (26.32%)  11/55 (20.00%)  40/200 (20.00%) 
Asthenia  1  1/19 (5.26%)  11/55 (20.00%)  32/200 (16.00%) 
Pyrexia  1  0/19 (0.00%)  3/55 (5.45%)  5/200 (2.50%) 
Influenza like illness  1  1/19 (5.26%)  0/55 (0.00%)  4/200 (2.00%) 
Malaise  1  1/19 (5.26%)  0/55 (0.00%)  2/200 (1.00%) 
Hepatobiliary disorders       
Jaundice  1  1/19 (5.26%)  1/55 (1.82%)  5/200 (2.50%) 
Hyperbilirubinaemia  1  1/19 (5.26%)  0/55 (0.00%)  2/200 (1.00%) 
Infections and infestations       
Nasopharyngitis  1  3/19 (15.79%)  5/55 (9.09%)  11/200 (5.50%) 
Upper respiratory tract infection  1  1/19 (5.26%)  2/55 (3.64%)  13/200 (6.50%) 
Rhinitis  1  1/19 (5.26%)  0/55 (0.00%)  8/200 (4.00%) 
Sinusitis  1  1/19 (5.26%)  1/55 (1.82%)  7/200 (3.50%) 
Bronchitis  1  1/19 (5.26%)  0/55 (0.00%)  7/200 (3.50%) 
Influenza  1  0/19 (0.00%)  3/55 (5.45%)  4/200 (2.00%) 
Pharyngitis  1  1/19 (5.26%)  0/55 (0.00%)  3/200 (1.50%) 
Ear infection  1  1/19 (5.26%)  0/55 (0.00%)  1/200 (0.50%) 
Localised infection  1  1/19 (5.26%)  0/55 (0.00%)  1/200 (0.50%) 
Otitis media  1  1/19 (5.26%)  0/55 (0.00%)  1/200 (0.50%) 
Subcutaneous abscess  1  1/19 (5.26%)  0/55 (0.00%)  0/200 (0.00%) 
Urethritis gonococcal  1  1/19 (5.26%)  0/55 (0.00%)  0/200 (0.00%) 
Investigations       
Haemoglobin decreased  1  1/19 (5.26%)  0/55 (0.00%)  3/200 (1.50%) 
Metabolism and nutrition disorders       
Decreased appetite  1  1/19 (5.26%)  2/55 (3.64%)  17/200 (8.50%) 
Hyperphagia  1  0/19 (0.00%)  3/55 (5.45%)  1/200 (0.50%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  1/19 (5.26%)  6/55 (10.91%)  11/200 (5.50%) 
Back pain  1  1/19 (5.26%)  2/55 (3.64%)  13/200 (6.50%) 
Arthralgia  1  1/19 (5.26%)  2/55 (3.64%)  11/200 (5.50%) 
Intervertebral disc protrusion  1  1/19 (5.26%)  0/55 (0.00%)  2/200 (1.00%) 
Musculoskeletal chest pain  1  1/19 (5.26%)  0/55 (0.00%)  2/200 (1.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Seborrhoeic keratosis  1  1/19 (5.26%)  0/55 (0.00%)  0/200 (0.00%) 
Nervous system disorders       
Headache  1  1/19 (5.26%)  7/55 (12.73%)  35/200 (17.50%) 
Lethargy  1  1/19 (5.26%)  1/55 (1.82%)  15/200 (7.50%) 
Dizziness  1  0/19 (0.00%)  5/55 (9.09%)  9/200 (4.50%) 
Psychiatric disorders       
Insomnia  1  3/19 (15.79%)  5/55 (9.09%)  36/200 (18.00%) 
Irritability  1  1/19 (5.26%)  6/55 (10.91%)  20/200 (10.00%) 
Anxiety  1  0/19 (0.00%)  3/55 (5.45%)  15/200 (7.50%) 
Sleep disorder  1  1/19 (5.26%)  1/55 (1.82%)  13/200 (6.50%) 
Depression  1  0/19 (0.00%)  5/55 (9.09%)  9/200 (4.50%) 
Depressed mood  1  2/19 (10.53%)  0/55 (0.00%)  4/200 (2.00%) 
Mood swings  1  1/19 (5.26%)  1/55 (1.82%)  2/200 (1.00%) 
Stress  1  1/19 (5.26%)  1/55 (1.82%)  1/200 (0.50%) 
Abnormal dreams  1  1/19 (5.26%)  0/55 (0.00%)  1/200 (0.50%) 
Claustrophobia  1  1/19 (5.26%)  0/55 (0.00%)  0/200 (0.00%) 
Renal and urinary disorders       
Chromaturia  1  0/19 (0.00%)  3/55 (5.45%)  1/200 (0.50%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/19 (0.00%)  6/55 (10.91%)  17/200 (8.50%) 
Dyspnoea  1  2/19 (10.53%)  8/55 (14.55%)  10/200 (5.00%) 
Dyspnoea exertional  1  2/19 (10.53%)  5/55 (9.09%)  11/200 (5.50%) 
Oropharyngeal discomfort  1  1/19 (5.26%)  0/55 (0.00%)  1/200 (0.50%) 
Dysphonia  1  1/19 (5.26%)  0/55 (0.00%)  0/200 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  0/19 (0.00%)  5/55 (9.09%)  16/200 (8.00%) 
Rash  1  2/19 (10.53%)  3/55 (5.45%)  15/200 (7.50%) 
Dry skin  1  1/19 (5.26%)  2/55 (3.64%)  9/200 (4.50%) 
Alopecia  1  0/19 (0.00%)  3/55 (5.45%)  5/200 (2.50%) 
Dermatitis  1  2/19 (10.53%)  1/55 (1.82%)  4/200 (2.00%) 
Hyperhidrosis  1  1/19 (5.26%)  0/55 (0.00%)  2/200 (1.00%) 
Urticaria  1  1/19 (5.26%)  0/55 (0.00%)  1/200 (0.50%) 
Hair texture abnormal  1  1/19 (5.26%)  0/55 (0.00%)  0/200 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01783678     History of Changes
Other Study ID Numbers: GS-US-334-0124
First Submitted: January 31, 2013
First Posted: February 5, 2013
Results First Submitted: April 15, 2015
Results First Posted: April 30, 2015
Last Update Posted: April 30, 2015