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Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

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ClinicalTrials.gov Identifier: NCT01826981
Recruitment Status : Completed
First Posted : April 9, 2013
Results First Posted : September 16, 2016
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 Chronic Hepatitis C
Interventions Drug: LDV/SOF
Drug: SOF
Drug: RBV
Drug: Peg-IFN
Drug: GS-9669
Drug: VEL
Enrollment 359
Recruitment Details Participants were enrolled at a total of 2 study sites in New Zealand. The first participant was screened on 3 April 2016. The last study visit occurred on 25 May 2015.
Pre-assignment Details 446 participants were screened.
Arm/Group Title Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study. SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and Child Pugh-Turcotte (CPT) B cirrhosis Sofosbuvir (SOF) 400 mg once daily+Velpatasvir (VEL) 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Period Title: Overall Study
Started 19 10 25 26 25 26 25 51 20 27 24 27 26 20 8
Completed 19 9 25 26 18 25 24 40 13 26 22 25 25 15 8
Not Completed 0 1 0 0 7 1 1 11 7 1 2 2 1 5 0
Reason Not Completed
Lack of Efficacy             0             1             0             0             5             0             0             8             7             0             1             0             0             3             0
Lost to Follow-up             0             0             0             0             1             1             0             1             0             1             1             1             1             0             0
Withdrew Consent             0             0             0             0             0             0             1             1             0             0             0             1             0             1             0
Adverse Event             0             0             0             0             1             0             0             0             0             0             0             0             0             0             0
Upper G-I Haemorrhage             0             0             0             0             0             0             0             0             0             0             0             0             0             1             0
Enrolled/Randomized but Not Treated             0             0             0             0             0             0             0             1             0             0             0             0             0             0             0
Arm/Group Title Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) Total
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study. SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection Total of all reporting groups
Overall Number of Baseline Participants 19 10 25 26 25 26 25 50 20 27 24 27 26 20 8 358
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 10 participants 25 participants 26 participants 25 participants 26 participants 25 participants 50 participants 20 participants 27 participants 24 participants 27 participants 26 participants 20 participants 8 participants 358 participants
55  (6.1) 49  (12.5) 56  (5.3) 55  (6.7) 43  (10.2) 48  (9.2) 51  (13.9) 52  (8.2) 56  (5.5) 48  (7.9) 47  (7.9) 50  (10.2) 47  (10.3) 54  (7.0) 53  (6.9) 50.7  (9.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 10 participants 25 participants 26 participants 25 participants 26 participants 25 participants 50 participants 20 participants 27 participants 24 participants 27 participants 26 participants 20 participants 8 participants 358 participants
Female
6
  31.6%
2
  20.0%
10
  40.0%
11
  42.3%
12
  48.0%
15
  57.7%
9
  36.0%
11
  22.0%
3
  15.0%
10
  37.0%
6
  25.0%
10
  37.0%
15
  57.7%
2
  10.0%
2
  25.0%
124
  34.6%
Male
13
  68.4%
8
  80.0%
15
  60.0%
15
  57.7%
13
  52.0%
11
  42.3%
16
  64.0%
39
  78.0%
17
  85.0%
17
  63.0%
18
  75.0%
17
  63.0%
11
  42.3%
18
  90.0%
6
  75.0%
234
  65.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 10 participants 25 participants 26 participants 25 participants 26 participants 25 participants 50 participants 20 participants 27 participants 24 participants 27 participants 26 participants 20 participants 8 participants 358 participants
White 18 9 22 24 22 23 3 40 17 20 20 20 19 18 3 278
Asian 0 0 1 0 1 1 22 3 1 1 0 1 0 0 1 32
Native Hawaiian or Other Pacific Islander 0 1 2 1 1 1 0 5 2 5 2 3 6 1 4 34
American Indian or Alaska Native 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1
Other 1 0 0 1 1 1 0 2 0 1 2 3 0 1 0 13
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Not Hispanic or Latino Number Analyzed 19 participants 10 participants 25 participants 26 participants 25 participants 26 participants 25 participants 50 participants 20 participants 27 participants 24 participants 27 participants 26 participants 20 participants 8 participants 358 participants
19 10 25 26 25 26 25 50 20 27 24 27 26 20 8 358
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 10 participants 25 participants 26 participants 25 participants 26 participants 25 participants 50 participants 20 participants 27 participants 24 participants 27 participants 26 participants 20 participants 8 participants 358 participants
1b with possible mixed infection with Genotype 4 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1
Genotype 1a 16 0 15 22 0 0 0 0 18 0 0 0 0 9 6 86
Genotype 1a with possible 6 (subtypes c - l) 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1
Genotype 1b 2 0 9 4 0 0 0 0 2 0 0 0 0 0 2 19
Genotype 3 0 0 0 0 1 0 0 3 0 2 1 0 0 0 0 7
Genotype 3a 0 10 0 0 24 25 0 46 0 25 22 27 26 10 0 215
Genotype 3k 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1
Genotype 6 (subtypes c - l) 0 0 0 0 0 0 17 0 0 0 0 0 0 0 0 17
Genotype 6a or 6b 0 0 0 0 0 0 8 0 0 0 0 0 0 0 0 8
Indeterminate genotype. Sequencing indicates GT3a 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1
Indeterminate pattern. Sequencing indicates GT3k 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1
Missing 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1
Cirrhosis Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 10 participants 25 participants 26 participants 25 participants 26 participants 25 participants 50 participants 20 participants 27 participants 24 participants 27 participants 26 participants 20 participants 8 participants 358 participants
No 18 9 7 9 21 20 23 28 0 27 24 27 26 6 6 251
Yes 1 1 18 17 4 6 2 22 20 0 0 0 0 14 2 107
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 19 participants 10 participants 25 participants 26 participants 25 participants 26 participants 25 participants 50 participants 20 participants 27 participants 24 participants 27 participants 26 participants 20 participants 8 participants 358 participants
CC 4 3 6 4 9 15 20 18 7 10 6 15 14 7 7 145
CT 12 5 12 19 10 6 5 27 6 13 15 11 10 7 1 159
TT 3 2 7 3 6 5 0 5 7 4 3 1 2 6 0 54
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
HCV RNA  
Median (Standard Deviation)
Unit of measure:  Log 10 IU/mL
Number Analyzed 19 participants 10 participants 25 participants 26 participants 25 participants 26 participants 25 participants 50 participants 20 participants 27 participants 24 participants 27 participants 26 participants 20 participants 8 participants 358 participants
6.3  (0.51) 6.5  (0.63) 6.5  (0.39) 6.1  (0.69) 6.3  (0.88) 6.3  (0.87) 6.7  (0.67) 6.3  (0.76) 6.0  (0.48) 5.9  (0.86) 6.3  (0.69) 6.0  (0.71) 6.2  (0.92) 6.0  (0.48) 6.0  (10.9) 6.2  (0.76)
HCV RNA Category  
Measure Type: Number
Unit of measure:  IU/mL
Number Analyzed 19 participants 10 participants 25 participants 26 participants 25 participants 26 participants 25 participants 50 participants 20 participants 27 participants 24 participants 27 participants 26 participants 20 participants 8 participants 358 participants
< 800,000 3 1 2 9 9 6 2 15 5 14 10 11 7 6 2 102
>= 800,000 16 9 23 17 16 20 23 35 15 13 14 16 19 14 6 256
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 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 received at least 1 dose of study drug.
Arm/Group Title Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Overall Number of Participants Analyzed 19 10 25 26 25 26 25 50 20 27 24 27 26 20 8
Measure Type: Number
Unit of Measure: percentage of participants
100 90 100 100 64.0 100 96.0 82.0 65.0 100 87.5 96.3 100.0 75 100
2.Primary Outcome
Title Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)
Hide Description [Not Specified]
Time Frame Up to 24 weeks plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Overall Number of Participants Analyzed 19 10 25 26 25 26 25 50 20 27 24 27 26 20 8
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 4.0 0 4.0 0 0 2.0 0 0 4.2 0 3.8 5.0 0
3.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Hide Description [Not Specified]
Time Frame Weeks 1 and 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Overall Number of Participants Analyzed 19 10 25 26 25 26 25 50 20 27 24 26 26 20 8
Measure Type: Number
Unit of Measure: percentage of participants
Week 1 15.8 30.0 4.0 11.5 20.0 11.5 12.0 12.0 0 33.3 4.2 26.9 19.2 15.0 12.5
Week 2 63.2 50.0 44.0 53.8 64.0 61.5 56.0 52.0 25.0 70.4 66.7 65.4 69.2 45.0 75.0
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Hide Description [Not Specified]
Time Frame Weeks 4, 6, and 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Overall Number of Participants Analyzed 19 10 25 26 24 26 25 50 20 27 23 26 26 20 8
Measure Type: Number
Unit of Measure: percentage of participants
Week 4 100.0 100.0 84.0 92.3 95.8 88.5 96.0 96.0 75.0 96.3 95.7 92.3 96.2 75.0 87.5
Week 6 100.0 100.0 100.0 100.0 100.0 100.0 96.0 100.0 100.0 100.0 100.0 100.0 100.0 90.0 100.0
Week 8 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 100.0 90.0 100.0
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
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 Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Overall Number of Participants Analyzed 19 10 25 26 23 25 24 50 20 20 8
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 100.0 100.0 100.0
6.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
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 Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Overall Number of Participants Analyzed 19 10 25 26 23 24 24 50 20 20 8
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 100.0 100.0 100.0 100.0 100.0 98.0 100.0 100.0 100.0
7.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment
Hide Description [Not Specified]
Time Frame Weeks 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 100.0
Week 20 100.0
Week 24 100.0
8.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)
Hide Description [Not Specified]
Time Frame Posttreatment Weeks 2, 4, 8, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Overall Number of Participants Analyzed 19 10 25 26 24 26 25 50 20 27 23 26 26 20 8
Measure Type: Number
Unit of Measure: percentage of participants
SVR2 100.0 100.0 100.0 100.0 72.0 100.0 100.0 90.0 95.0 100.0 87.5 96.3 100.0 95.0 100.0
SVR4 100.0 100.0 84.0 92.3 95.8 88.5 96.0 96.0 75.0 96.3 95.7 92.3 96.2 75.0 87.5
SVR8 100.0 90.0 100.0 100.0 64.0 100.0 96.0 82.0 65.0 100.0 87.5 96.3 100.0 80.0 100.0
SVR24 100.0 90.0 100.0 100.0 64.0 100.0 96.0 82.0 65.0 100.0 87.5 96.3 100.0 75.0 100.0
9.Secondary Outcome
Title For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)
Hide Description [Not Specified]
Time Frame Posttreatment Weeks 16 and 20
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included the participants who were randomized into Cohort 6 and received at least one dose of study drug.
Arm/Group Title Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
SVR16 100
SVR20 100
10.Secondary Outcome
Title Percentage of Participants With On-treatment Virologic Failure
Hide Description

On-treatment virologic failure was defined as:

  • 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)
Time Frame Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Overall Number of Participants Analyzed 19 10 25 26 25 26 25 50 20 27 24 27 26 20 8
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
11.Secondary Outcome
Title Percentage of Participants Experiencing Viral Relapse
Hide Description Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.
Time Frame Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)
Hide Arm/Group Description:
Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
Overall Number of Participants Analyzed 19 10 25 26 24 26 25 50 20 27 23 26 26 20 8
Measure Type: Number
Unit of Measure: percentage of participants
0 10.0 0 0 33.3 0 4.0 16.3 35.0 0 8.7 0 0 15.0 0
Time Frame Up to 24 Weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study. SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
All-Cause Mortality
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Hide Serious Adverse Events
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/10 (0.00%)   1/25 (4.00%)   0/26 (0.00%)   4/25 (16.00%)   0/26 (0.00%)   1/25 (4.00%)   1/50 (2.00%)   2/20 (10.00%)   3/20 (15.00%)   0/8 (0.00%)   1/27 (3.70%)   0/24 (0.00%)   0/27 (0.00%)   0/26 (0.00%) 
Cardiac disorders                               
Angina pectoris  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Pericardial effusion  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Eye disorders                               
Choroidal effusion  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Lens dislocation  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Gastrointestinal disorders                               
Abdominal pain  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Abdominal pain upper  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Diverticular perforation  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Haemorrhoidal haemorrhage  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Hepatobiliary disorders                               
Hepatic cirrhosis  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Infections and infestations                               
Lower respiratory tract infection  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Urinary tract infection  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                               
Hepatocellular carcinoma  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Squamous cell carcinoma of the tongue  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Nervous system disorders                               
Encephalopathy  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Seizure  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Psychiatric disorders                               
Agitation  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Renal and urinary disorders                               
Acute kidney injury  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Vascular disorders                               
Shock haemorrhagic  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 18.0.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment) Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment) Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease) Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN) Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN) Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN) Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE) Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B) Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment) Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection) Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic) Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/19 (89.47%)   10/10 (100.00%)   24/25 (96.00%)   24/26 (92.31%)   24/25 (96.00%)   23/26 (88.46%)   21/25 (84.00%)   43/50 (86.00%)   19/20 (95.00%)   17/20 (85.00%)   6/8 (75.00%)   18/27 (66.67%)   18/24 (75.00%)   22/27 (81.48%)   21/26 (80.77%) 
Blood and lymphatic system disorders                               
Anaemia  1  1/19 (5.26%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/26 (0.00%) 
Haemolytic anaemia  1  3/19 (15.79%)  0/10 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  0/25 (0.00%)  4/26 (15.38%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  2/24 (8.33%)  0/27 (0.00%)  1/26 (3.85%) 
Lymphadenopathy  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  0/27 (0.00%)  1/26 (3.85%) 
Ear and labyrinth disorders                               
Tinnitus  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Eye disorders                               
Eye irritation  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Eye pruritus  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Eyelid thickening  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Eyelids pruritus  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Gastrointestinal disorders                               
Abdominal pain  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  1/27 (3.70%)  2/26 (7.69%) 
Abdominal pain lower  1  0/19 (0.00%)  2/10 (20.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Abdominal pain upper  1  0/19 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  2/26 (7.69%)  1/25 (4.00%)  0/26 (0.00%)  1/25 (4.00%)  1/50 (2.00%)  2/20 (10.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/26 (3.85%) 
Aphthous stomatitis  1  0/19 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  1/26 (3.85%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Ascites  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Constipation  1  0/19 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  2/26 (7.69%)  3/25 (12.00%)  2/26 (7.69%)  1/25 (4.00%)  1/50 (2.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Dental caries  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Diarrhoea  1  1/19 (5.26%)  0/10 (0.00%)  2/25 (8.00%)  4/26 (15.38%)  2/25 (8.00%)  0/26 (0.00%)  4/25 (16.00%)  4/50 (8.00%)  0/20 (0.00%)  2/20 (10.00%)  0/8 (0.00%)  2/27 (7.41%)  2/24 (8.33%)  4/27 (14.81%)  1/26 (3.85%) 
Dry mouth  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  2/26 (7.69%)  1/25 (4.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Dyspepsia  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  2/26 (7.69%) 
Faeces discoloured  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Flatulence  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Gastric ulcer  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Gastrooesophageal reflux disease  1  0/19 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  1/26 (3.85%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  2/50 (4.00%)  0/20 (0.00%)  2/20 (10.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Gingival pain  1  0/19 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Haemorrhoids  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Lip dry  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Melaena  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Mouth ulceration  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Nausea  1  4/19 (21.05%)  3/10 (30.00%)  7/25 (28.00%)  11/26 (42.31%)  9/25 (36.00%)  4/26 (15.38%)  0/25 (0.00%)  5/50 (10.00%)  3/20 (15.00%)  1/20 (5.00%)  0/8 (0.00%)  4/27 (14.81%)  1/24 (4.17%)  4/27 (14.81%)  3/26 (11.54%) 
Toothache  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  1/25 (4.00%)  1/26 (3.85%)  2/25 (8.00%)  0/50 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  1/27 (3.70%)  0/26 (0.00%) 
Vomiting  1  1/19 (5.26%)  1/10 (10.00%)  1/25 (4.00%)  3/26 (11.54%)  3/25 (12.00%)  1/26 (3.85%)  0/25 (0.00%)  1/50 (2.00%)  2/20 (10.00%)  2/20 (10.00%)  0/8 (0.00%)  0/27 (0.00%)  4/24 (16.67%)  2/27 (7.41%)  0/26 (0.00%) 
General disorders                               
Catheter site bruise  1  0/19 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Chest discomfort  1  1/19 (5.26%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Chills  1  0/19 (0.00%)  3/10 (30.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Fatigue  1  6/19 (31.58%)  3/10 (30.00%)  5/25 (20.00%)  9/26 (34.62%)  5/25 (20.00%)  2/26 (7.69%)  6/25 (24.00%)  13/50 (26.00%)  4/20 (20.00%)  4/20 (20.00%)  2/8 (25.00%)  5/27 (18.52%)  3/24 (12.50%)  4/27 (14.81%)  7/26 (26.92%) 
Temperature intolerance  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Tenderness  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Ulcer  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Vessel puncture site phlebitis  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Hepatobiliary disorders                               
Portal vein thrombosis  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Infections and infestations                               
Cellulitis  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Conjunctivitis  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Fungal skin infection  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Furuncle  1  1/19 (5.26%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  0/27 (0.00%)  1/26 (3.85%) 
Gastroenteritis  1  0/19 (0.00%)  2/10 (20.00%)  0/25 (0.00%)  0/26 (0.00%)  2/25 (8.00%)  3/26 (11.54%)  0/25 (0.00%)  2/50 (4.00%)  2/20 (10.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Influenza  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Lower respiratory tract infection  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  2/25 (8.00%)  2/26 (7.69%)  0/25 (0.00%)  2/50 (4.00%)  0/20 (0.00%)  6/20 (30.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  0/26 (0.00%) 
Oral herpes  1  2/19 (10.53%)  0/10 (0.00%)  3/25 (12.00%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Pertussis  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Rhinitis  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Sinusitis  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  2/26 (7.69%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Tooth abscess  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/26 (0.00%) 
Upper respiratory tract infection  1  4/19 (21.05%)  1/10 (10.00%)  8/25 (32.00%)  5/26 (19.23%)  9/25 (36.00%)  9/26 (34.62%)  6/25 (24.00%)  9/50 (18.00%)  8/20 (40.00%)  6/20 (30.00%)  2/8 (25.00%)  1/27 (3.70%)  3/24 (12.50%)  3/27 (11.11%)  4/26 (15.38%) 
Urinary tract infection  1  1/19 (5.26%)  0/10 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  2/25 (8.00%)  0/50 (0.00%)  1/20 (5.00%)  2/20 (10.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  2/27 (7.41%)  0/26 (0.00%) 
Viral infection  1  0/19 (0.00%)  0/10 (0.00%)  4/25 (16.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/25 (8.00%)  1/50 (2.00%)  0/20 (0.00%)  1/20 (5.00%)  5/8 (62.50%)  0/27 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  0/26 (0.00%) 
Vulvovaginal candidiasis  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Injury, poisoning and procedural complications                               
Arthropod bite  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  0/26 (0.00%) 
Chest crushing  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/8 (12.50%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Contusion  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Fall  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Ligament sprain  1  1/19 (5.26%)  0/10 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/26 (3.85%) 
Limb injury  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Muscle strain  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  2/25 (8.00%)  2/26 (7.69%)  0/25 (0.00%)  1/50 (2.00%)  1/20 (5.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  2/27 (7.41%)  0/26 (0.00%) 
Musculoskeletal injury  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Rib fracture  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Skin abrasion  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Thermal burn  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/26 (0.00%) 
Investigations                               
Weight decreased  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  1/27 (3.70%)  1/24 (4.17%)  0/27 (0.00%)  0/26 (0.00%) 
Metabolism and nutrition disorders                               
Decreased appetite  1  1/19 (5.26%)  2/10 (20.00%)  0/25 (0.00%)  3/26 (11.54%)  1/25 (4.00%)  1/26 (3.85%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  1/27 (3.70%)  2/24 (8.33%)  2/27 (7.41%)  0/26 (0.00%) 
Hypokalaemia  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Increased appetite  1  0/19 (0.00%)  0/10 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Musculoskeletal and connective tissue disorders                               
Arthralgia  1  2/19 (10.53%)  3/10 (30.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  0/25 (0.00%)  1/50 (2.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  1/26 (3.85%) 
Back pain  1  1/19 (5.26%)  0/10 (0.00%)  2/25 (8.00%)  2/26 (7.69%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  2/50 (4.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  2/27 (7.41%)  1/24 (4.17%)  0/27 (0.00%)  3/26 (11.54%) 
Muscle spasms  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Muscle twitching  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Musculoskeletal chest pain  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  1/26 (3.85%)  1/25 (4.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Musculoskeletal discomfort  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Musculoskeletal pain  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Myalgia  1  1/19 (5.26%)  2/10 (20.00%)  2/25 (8.00%)  4/26 (15.38%)  1/25 (4.00%)  1/26 (3.85%)  2/25 (8.00%)  1/50 (2.00%)  1/20 (5.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  1/27 (3.70%)  0/26 (0.00%) 
Pain in extremity  1  1/19 (5.26%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  2/25 (8.00%)  0/26 (0.00%)  1/25 (4.00%)  1/50 (2.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Rotator cuff syndrome  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Nervous system disorders                               
Amnesia  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Balance disorder  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/26 (0.00%) 
Cognitive disorder  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/25 (8.00%)  1/26 (3.85%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Disturbance in attention  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  4/50 (8.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  0/26 (0.00%) 
Dizziness  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  2/50 (4.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Dysgeusia  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  2/50 (4.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  0/26 (0.00%) 
Headache  1  5/19 (26.32%)  2/10 (20.00%)  10/25 (40.00%)  9/26 (34.62%)  10/25 (40.00%)  8/26 (30.77%)  2/25 (8.00%)  13/50 (26.00%)  4/20 (20.00%)  3/20 (15.00%)  0/8 (0.00%)  6/27 (22.22%)  5/24 (20.83%)  3/27 (11.11%)  4/26 (15.38%) 
Hypersomnia  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Hypoaesthesia  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Lethargy  1  1/19 (5.26%)  1/10 (10.00%)  4/25 (16.00%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  3/50 (6.00%)  2/20 (10.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  3/27 (11.11%)  3/26 (11.54%) 
Memory impairment  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/26 (0.00%) 
Migraine  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Paraesthesia  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  1/25 (4.00%)  1/26 (3.85%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Presyncope  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  2/50 (4.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  2/24 (8.33%)  1/27 (3.70%)  1/26 (3.85%) 
Somnolence  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  2/25 (8.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Syncope  1  2/19 (10.53%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/26 (3.85%) 
Psychiatric disorders                               
Affect lability  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Anxiety  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  1/26 (3.85%)  3/25 (12.00%)  1/26 (3.85%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Depression  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  2/25 (8.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/8 (12.50%)  1/27 (3.70%)  1/24 (4.17%)  1/27 (3.70%)  1/26 (3.85%) 
Insomnia  1  7/19 (36.84%)  2/10 (20.00%)  7/25 (28.00%)  1/26 (3.85%)  3/25 (12.00%)  3/26 (11.54%)  0/25 (0.00%)  10/50 (20.00%)  3/20 (15.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  3/24 (12.50%)  6/27 (22.22%)  2/26 (7.69%) 
Irritability  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  1/25 (4.00%)  2/26 (7.69%)  0/25 (0.00%)  4/50 (8.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  1/27 (3.70%)  2/26 (7.69%) 
Mood swings  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  2/26 (7.69%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Panic attack  1  2/19 (10.53%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Tearfulness  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/26 (3.85%) 
Renal and urinary disorders                               
Chromaturia  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  1/50 (2.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/26 (0.00%) 
Lower urinary tract symptoms  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Renal colic  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Reproductive system and breast disorders                               
Breast pain  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Menopausal symptoms  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Respiratory, thoracic and mediastinal disorders                               
Asthma  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  2/26 (7.69%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  1/50 (2.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Cough  1  3/19 (15.79%)  2/10 (20.00%)  3/25 (12.00%)  0/26 (0.00%)  3/25 (12.00%)  0/26 (0.00%)  0/25 (0.00%)  2/50 (4.00%)  1/20 (5.00%)  1/20 (5.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  0/27 (0.00%)  1/26 (3.85%) 
Dyspnoea  1  1/19 (5.26%)  0/10 (0.00%)  3/25 (12.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/50 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  1/24 (4.17%)  0/27 (0.00%)  0/26 (0.00%) 
Dyspnoea exertional  1  1/19 (5.26%)  1/10 (10.00%)  5/25 (20.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  4/50 (8.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Oropharyngeal pain  1  1/19 (5.26%)  1/10 (10.00%)  1/25 (4.00%)  1/26 (3.85%)  1/25 (4.00%)  0/26 (0.00%)  2/25 (8.00%)  4/50 (8.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  1/27 (3.70%)  0/24 (0.00%)  0/27 (0.00%)  1/26 (3.85%) 
Pleuritic pain  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  1/50 (2.00%)  1/20 (5.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Pulmonary oedema  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Rhinorrhoea  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/8 (12.50%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Sneezing  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/8 (12.50%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Skin and subcutaneous tissue disorders                               
Alopecia  1  0/19 (0.00%)  1/10 (10.00%)  2/25 (8.00%)  1/26 (3.85%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/50 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/8 (0.00%)  1/27 (3.70%)  1/24 (4.17%)  0/27 (0.00%)  1/26 (3.85%) 
Dermal cyst  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  1/26 (3.85%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Dermatitis  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Dry skin  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  2/50 (4.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/26 (3.85%) 
Dyshidrotic eczema  1  0/19 (0.00%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Hyperhidrosis  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  3/50 (6.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Pruritus  1  1/19 (5.26%)  0/10 (0.00%)  3/25 (12.00%)  0/26 (0.00%)  0/25 (0.00%)  2/26 (7.69%)  1/25 (4.00%)  3/50 (6.00%)  1/20 (5.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  3/26 (11.54%) 
Rash  1  4/19 (21.05%)  2/10 (20.00%)  0/25 (0.00%)  2/26 (7.69%)  1/25 (4.00%)  1/26 (3.85%)  2/25 (8.00%)  7/50 (14.00%)  1/20 (5.00%)  3/20 (15.00%)  0/8 (0.00%)  0/27 (0.00%)  3/24 (12.50%)  2/27 (7.41%)  4/26 (15.38%) 
Rash macular  1  0/19 (0.00%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Skin discomfort  1  1/19 (5.26%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Skin lesion  1  1/19 (5.26%)  0/10 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  1/27 (3.70%)  0/26 (0.00%) 
Skin ulcer  1  0/19 (0.00%)  0/10 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  0/26 (0.00%) 
Vascular disorders                               
Hypertension  1  1/19 (5.26%)  1/10 (10.00%)  0/25 (0.00%)  0/26 (0.00%)  1/25 (4.00%)  0/26 (0.00%)  0/25 (0.00%)  0/50 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/8 (0.00%)  0/27 (0.00%)  0/24 (0.00%)  0/27 (0.00%)  1/26 (3.85%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 18.0.
There were no limitations affecting the analysis or results.
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01826981    
Other Study ID Numbers: GS-US-337-0122
First Submitted: April 1, 2013
First Posted: April 9, 2013
Results First Submitted: July 28, 2016
Results First Posted: September 16, 2016
Last Update Posted: November 16, 2018