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Trial record 17 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

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ClinicalTrials.gov Identifier: NCT02738333
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : March 14, 2018
Last Update Posted : November 16, 2018
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
Condition Hepatitis C Virus Infection
Interventions Drug: LDV/SOF
Drug: SOF
Drug: RBV
Enrollment 239
Recruitment Details Participants were enrolled at study sites in Japan. The first participant was screened on 12 April 2016. The last study visit occurred on 11 May 2017.
Pre-assignment Details 266 participants were screened.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Period Title: Overall Study
Started 106 108 25
Completed 104 108 25
Not Completed 2 0 0
Reason Not Completed
Death             1             0             0
Lost to Follow-up             1             0             0
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2) Total
Hide Arm/Group Description LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy Total of all reporting groups
Overall Number of Baseline Participants 106 108 25 239
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who took at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 108 participants 25 participants 239 participants
58  (10.5) 60  (12.3) 74  (7.1) 61  (11.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 108 participants 25 participants 239 participants
Female
54
  50.9%
71
  65.7%
19
  76.0%
144
  60.3%
Male
52
  49.1%
37
  34.3%
6
  24.0%
95
  39.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 108 participants 25 participants 239 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
106
 100.0%
108
 100.0%
25
 100.0%
239
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 108 participants 25 participants 239 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
106
 100.0%
108
 100.0%
25
 100.0%
239
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
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%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 108 participants 25 participants 239 participants
CC
88
  83.0%
86
  79.6%
15
  60.0%
189
  79.1%
CT
17
  16.0%
19
  17.6%
10
  40.0%
46
  19.2%
TT
1
   0.9%
3
   2.8%
0
   0.0%
4
   1.7%
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
HCV RNA (log10 IU/mL)  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 106 participants 108 participants 25 participants 239 participants
6.1  (0.79) 6.1  (0.79) 5.9  (0.72) 6.0  (0.78)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 108 participants 25 participants 239 participants
< 800,000 IU/mL
30
  28.3%
36
  33.3%
10
  40.0%
76
  31.8%
≥ 800,000 IU/mL
76
  71.7%
72
  66.7%
15
  60.0%
163
  68.2%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were randomized and took at least 1 dose of study drug.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 108 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.2
(90.6 to 99.0)
95.4
(89.5 to 98.5)
96.0
(79.6 to 99.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LDV/SOF (Cohort 1), SOF+RBV (Cohort 1)
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments A sample size of 100 participants per treatment group would provide over 90% power to establish non-inferiority in the SVR12 rates between the LDV/SOF group and SOF+RBV group. Sample size was based on the assumptions that the clinically meaningful non-inferiority margin is 10%, both groups have a SVR12 rate of 96%, and the significance level is 0.025 one-sided.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-5.3 to 7.1
Estimation Comments Difference in proportions between treatment groups and associated 95% confidence intervals (CI) are calculated based on stratum-adjusted Mantel-Haenszel proportions.
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 108 25
Measure Type: Number
Unit of Measure: percentage of participants
0.9 1.9 0
3.Secondary Outcome
Title Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 108 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.2
(92.0 to 99.4)
98.1
(93.5 to 99.8)
96.0
(79.6 to 99.9)
4.Secondary Outcome
Title Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Hide Description SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Time Frame Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 108 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.2
(90.6 to 99.0)
95.4
(89.5 to 98.5)
96.0
(79.6 to 99.9)
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 1
Hide Description [Not Specified]
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 108 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.5
(16.7 to 33.8)
31.5
(22.9 to 41.1)
32.0
(14.9 to 53.5)
6.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 2
Hide Description [Not Specified]
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 107 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.6
(64.1 to 81.7)
76.6
(67.5 to 84.3)
76.0
(54.9 to 90.6)
7.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 3
Hide Description [Not Specified]
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 107 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
90.6
(83.3 to 95.4)
90.7
(83.5 to 95.4)
96.0
(79.6 to 99.9)
8.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 4
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 107 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.1
(93.4 to 99.8)
96.3
(90.7 to 99.0)
100.0
(86.3 to 100.0)
9.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 5
Hide Description [Not Specified]
Time Frame Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 105 107 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.1
(93.3 to 99.8)
99.1
(94.9 to 100.0)
100.0
(86.3 to 100.0)
10.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 6
Hide Description [Not Specified]
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 105 107 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
99.0
(94.8 to 100.0)
99.1
(94.9 to 100.0)
100.0
(86.3 to 100.0)
11.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 8
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 105 107 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(96.5 to 100.0)
100.0
(96.6 to 100.0)
100.0
(86.3 to 100.0)
12.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 10
Hide Description [Not Specified]
Time Frame Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 105 107 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(96.5 to 100.0)
100.0
(96.6 to 100.0)
100.0
(86.3 to 100.0)
13.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 12
Hide Description [Not Specified]
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 105 106 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(96.5 to 100.0)
100.0
(96.6 to 100.0)
100.0
(86.3 to 100.0)
14.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 1
Hide Description [Not Specified]
Time Frame Baseline; Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 107 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.18  (0.540) -4.34  (0.602) -4.24  (0.550)
15.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 2
Hide Description [Not Specified]
Time Frame Baseline; Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 107 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.76  (0.759) -4.81  (0.772) -4.64  (0.719)
16.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 3
Hide Description [Not Specified]
Time Frame Baseline; Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 107 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.87  (0.780) -4.89  (0.790) -4.75  (0.714)
17.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 4
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 107 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.89  (0.782) -4.91  (0.794) -4.76  (0.719)
18.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 5
Hide Description [Not Specified]
Time Frame Baseline; Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 105 107 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.91  (0.781) -4.92  (0.794) -4.76  (0.719)
19.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 6
Hide Description [Not Specified]
Time Frame Baseline; Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 105 107 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.91  (0.781) -4.92  (0.793) -4.76  (0.719)
20.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 8
Hide Description [Not Specified]
Time Frame Baseline; Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 105 107 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.92  (0.785) -4.93  (0.794) -4.76  (0.719)
21.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 10
Hide Description [Not Specified]
Time Frame Baseline; Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 105 107 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.92  (0.785) -4.93  (0.794) -4.76  (0.719)
22.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 12
Hide Description [Not Specified]
Time Frame Baseline; Week 12
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Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 105 106 25
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-4.92  (0.785) -4.92  (0.794) -4.76  (0.719)
23.Secondary Outcome
Title Percentage of Participants With Overall Virologic Failure
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Virologic failure was defined as:

  • On-treatment virologic failure:

    • 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
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
  • Virologic relapse:

    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame Up to Posttreatment Week 24
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Full Analysis Set
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks
LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
Overall Number of Participants Analyzed 106 108 25
Measure Type: Number
Unit of Measure: percentage of participants
2.8 3.7 4.0
Time Frame Up to 12 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who took at least 1 dose of study drug
 
Arm/Group Title LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Hide Arm/Group Description LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks SOF 400 mg tablet once daily + RBV capsules (600, 800, or 1000 mg daily based on weight) for 12 weeks LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks in participants who are ineligible for or intolerant to RBV therapy
All-Cause Mortality
LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/106 (0.94%)   0/108 (0.00%)   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/106 (0.94%)   1/108 (0.93%)   1/25 (4.00%) 
Gastrointestinal disorders       
Mallory-Weiss syndrome  1  1/106 (0.94%)  0/108 (0.00%)  0/25 (0.00%) 
Injury, poisoning and procedural complications       
Hip fracture  1  0/106 (0.00%)  1/108 (0.93%)  0/25 (0.00%) 
Nervous system disorders       
Cerebral infarction  1  0/106 (0.00%)  0/108 (0.00%)  1/25 (4.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF (Cohort 1) SOF+RBV (Cohort 1) LDV/SOF (Cohort 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/106 (23.58%)   48/108 (44.44%)   7/25 (28.00%) 
Blood and lymphatic system disorders       
Anaemia  1  0/106 (0.00%)  25/108 (23.15%)  0/25 (0.00%) 
Gastrointestinal disorders       
Stomatitis  1  4/106 (3.77%)  2/108 (1.85%)  2/25 (8.00%) 
General disorders       
Pyrexia  1  0/106 (0.00%)  0/108 (0.00%)  2/25 (8.00%) 
Infections and infestations       
Viral upper respiratory tract infection  1  12/106 (11.32%)  23/108 (21.30%)  1/25 (4.00%) 
Nervous system disorders       
Headache  1  10/106 (9.43%)  9/108 (8.33%)  2/25 (8.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
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
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Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02738333     History of Changes
Other Study ID Numbers: GS-US-337-1903
First Submitted: April 11, 2016
First Posted: April 14, 2016
Results First Submitted: February 12, 2018
Results First Posted: March 14, 2018
Last Update Posted: November 16, 2018