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Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection and Child-Pugh Class B Cirrhosis (ASTRAL-4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02201901
Recruitment Status : Completed
First Posted : July 28, 2014
Results First Posted : December 14, 2016
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Interventions Drug: SOF/VEL
Drug: RBV
Enrollment 268
Recruitment Details Participants were enrolled at a total of 47 study sites in the United States. The first participant was screened on 31 July 2014. The last study visit occurred on 25 November 2015.
Pre-assignment Details 438 participants were screened.
Arm/Group Title SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Hide Arm/Group Description SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
Period Title: Overall Study
Started 90 88 90
Completed 75 79 77
Not Completed 15 9 13
Reason Not Completed
Randomized but never treated             0             1             0
Lack of Efficacy             7             1             6
Death             3             3             3
Lost to Follow-up             2             3             2
Withdrew Consent             2             0             2
Adverse Event             1             1             0
Arm/Group Title SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks ((Group 3) Total
Hide Arm/Group Description SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks Total of all reporting groups
Overall Number of Baseline Participants 90 87 90 267
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 90 participants 87 participants 90 participants 267 participants
58  (6.3) 58  (6.9) 58  (5.8) 58  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 87 participants 90 participants 267 participants
Female
33
  36.7%
21
  24.1%
27
  30.0%
81
  30.3%
Male
57
  63.3%
66
  75.9%
63
  70.0%
186
  69.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 90 participants 87 participants 90 participants 267 participants
Hispanic or Latino
13
  14.4%
13
  14.9%
13
  14.4%
39
  14.6%
Not Hispanic or Latino
77
  85.6%
74
  85.1%
77
  85.6%
228
  85.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 87 participants 90 participants 267 participants
Black or African American 6 5 6 17
White 79 79 81 239
Asian 3 0 2 5
American Indian or Alaska Native 0 1 0 1
Native Hawaiian or Pacific Islander 0 1 0 1
Other 2 1 0 3
Not Disclosed 0 0 1 1
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 87 participants 90 participants 267 participants
< 800,000 IU/mL 31 42 45 118
≥ 800,000 IU/mL 59 45 45 149
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log 10 IU/mL
Number Analyzed 90 participants 87 participants 90 participants 267 participants
6.0  (0.54) 5.8  (0.61) 5.9  (0.63) 5.9  (0.60)
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 87 participants 90 participants 267 participants
Genotype 1 68 68 71 207
Genotype 2 4 4 4 12
Genotype 3 14 13 12 39
Genotype 4 4 2 2 8
Genotype 6 0 0 1 1
IL28B   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 90 participants 87 participants 90 participants 267 participants
CC 20 22 20 62
CT 51 46 49 146
TT 19 19 19 57
Missing 0 0 2 2
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS): participants who were randomized into the study and received at least 1 dose of study drug.
Arm/Group Title SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
Overall Number of Participants Analyzed 90 87 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
83.3
(74.0 to 90.4)
94.3
(87.1 to 98.1)
87.8
(79.2 to 93.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SOF/VEL 12 Weeks (Group 1)
Comments A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Binomial test
Comments P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 12 weeks (Group 1) over prespecified rate of 1% .
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection SOF/VEL+RBV 12 Weeks (Group 2)
Comments A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Binomial test
Comments P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL+RBV 12 weeks (Group 2) over prespecified rate of 1%.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection SOF/VEL 24 Weeks (Group 3)
Comments A sample size of 75 participants per treatment group would provide over 99% power to detect 40% improvement in SVR12 rate from the assumed spontaneous rate of 1% or less using a 2-sided exact 1-sample binomial test at significance level of 0.0167.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Binomial test
Comments P-value is from the 2-sided exact 1-sample binomial test for the superiority of SOF/VEL 24 weeks (Group 3) over prespecified rate of 1%.
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Up to 24 weeks plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
Overall Number of Participants Analyzed 90 87 90
Measure Type: Number
Unit of Measure: percentage of participants
1.1 16.1 4.4
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide Description SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Time Frame Posttreatment Weeks 4 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
SOF/VEL (400/100mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
Overall Number of Participants Analyzed 90 87 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SVR4
92.2
(84.6 to 96.8)
95.4
(88.6 to 98.7)
90.0
(81.9 to 95.3)
SVR24
83.3
(74.0 to 90.4)
94.3
(87.1 to 98.1)
87.8
(79.2 to 93.7)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
Overall Number of Participants Analyzed 90 87 90
Measure Type: Number
Unit of Measure: percentage of participants
Wk 1(Group 1: N=90; Group 2: N=87; Group 3: N=90) 2.2 14.9 11.1
Wk 2 (Group 1: N=90; Group 2: N=87;Group 3: N=89) 34.4 49.4 39.3
Wk 4 (Group 1: N=90; Group 2: N=87; Group 3: N=89) 81.1 80.5 91.0
Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88) 98.9 97.6 98.9
Wk 8(Group 1: N=89; Group 2: N=84; Group 3: N=87) 98.9 98.8 100.0
Wk 10(Group 1: N=89; Group 2: N=84; Group 3: N=87) 100.0 98.8 100.0
Wk 12(Group 1: N=89; Group 2: N=83; Group 3: N=87) 100.0 98.8 97.7
Wk 16(Group 1: N=0; Group 2: N=0; Group 3: N=86) NA [1]  NA [1]  97.7
Wk 20(Group 1: N=0; Group 2: N=0;Group 3: N=84) NA [1]  NA [1]  100
Wk 24(Group 1: N=0; Group 2: N=0; Group 3: N=84) NA [1]  NA [1]  100
[1]
Treatment for this group was only 12 weeks.
5.Secondary Outcome
Title Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
Overall Number of Participants Analyzed 90 87 90
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Wk 1(Group 1: N=89; Group 2: N=83; Group 3: N=88) -3.51  (0.652) -3.63  (0.691) -3.72  (0.680)
Wk 2(Group 1: N=89; Group 2: N=87; Group 3: N=88) -4.24  (0.677) -4.17  (0.647) -4.38  (0.669)
Wk 4(Group 1: N=88; Group 2: N=86; Group 3: N=88) -4.78  (0.549) -4.58  (0.568) -4.70  (0.613)
Wk 6(Group 1: N=89; Group 2: N=85; Group 3: N=88) -4.87  (0.536) -4.68  (0.607) -4.74  (0.630)
Wk 8(Group 1: N=89; Group 2: N=83; Group 3: N=87) -4.87  (0.536) -4.68  (0.622) -4.76  (0.613)
Wk 10(Group 1: N=89; Group 2: N=84; Group 3, N=87) -4.87  (0.536) -4.67  (0.634) -4.76  (0.613)
Wk 12(Group 1: N=89; Group 2: N=82; Group 3: N=86) -4.87  (0.536) -4.68  (0.624) -4.75  (0.618)
Wk 16 (Group 1: N=0; Group 2: N=0; Group 3: N=85) NA [1]   (NA) NA [1]   (NA) -4.76  (0.617)
Wk 20 (Group 1: N=0; Group 2: N=0; Group 3: N =84) NA [1]   (NA) NA [1]   (NA) -4.77  (0.613)
Wk 24 (Group 1: N=0; Group 2: N=0; Group 3: N =84) NA [1]   (NA) NA [1]   (NA) -4.77  (0.613)
[1]
Treatment for this group was 12 weeks only.
6.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

Virologic failure was defined as

  • On-treatment virologic failure

    • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
    • > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,
    • HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)
  • Relapse

    • HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement
Time Frame Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
Overall Number of Participants Analyzed 90 87 90
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12.2
(6.3 to 20.8)
3.4
(0.7 to 9.7)
8.9
(3.9 to 16.8)
7.Secondary Outcome
Title Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in MELD Score
Hide Description Model for End-Stage Liver Disease (MELD) scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40; higher scores/increased scores indicate greater severity of disease.
Time Frame Baseline 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 SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
Overall Number of Participants Analyzed 69 75 69
Measure Type: Number
Unit of Measure: percentage of participants
Decrease (Improvement) 55.1 49.3 50.7
No Change 20.3 25.3 21.7
Increase (Worsening) 24.6 25.3 27.5
8.Secondary Outcome
Title Percentage of Participants With a Decrease, No Change, or Increase Between Baseline and Posttreatment Week 24 in Child-Pugh-Turcotte (CPT) Score
Hide Description CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15; higher scores/increased scores indicate greater severity of disease.
Time Frame Baseline 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 SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
Overall Number of Participants Analyzed 69 75 69
Measure Type: Number
Unit of Measure: percentage of participants
Decrease (Improvement) 44.9 53.3 63.8
No Change 43.5 37.3 27.5
Increase (Worsening) 11.6 9.3 8.7
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Hide Arm/Group Description SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
All-Cause Mortality
SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/90 (18.89%)   14/87 (16.09%)   16/90 (17.78%) 
Blood and lymphatic system disorders       
Anaemia  1  1/90 (1.11%)  1/87 (1.15%)  0/90 (0.00%) 
Iron deficiency anaemia  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Cardiac disorders       
Acute myocardial infarction  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Atrial fibrillation  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Myocardial infarction  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Endocrine disorders       
Adrenal insufficiency  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Gastrointestinal disorders       
Ascites  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Colitis  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Duodenal ulcer perforation  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Gastric ulcer  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Gastric varices haemorrhage  1  1/90 (1.11%)  0/87 (0.00%)  1/90 (1.11%) 
Gastrointestinal haemorrhage  1  3/90 (3.33%)  0/87 (0.00%)  0/90 (0.00%) 
Haematemesis  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Ileus  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Incarcerated umbilical hernia  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Mallory-Weiss syndrome  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Nausea  1  2/90 (2.22%)  0/87 (0.00%)  0/90 (0.00%) 
Rectal haemorrhage  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Small intestinal obstruction  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Upper gastrointestinal haemorrhage  1  1/90 (1.11%)  0/87 (0.00%)  1/90 (1.11%) 
Vomiting  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
General disorders       
Hernia  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Hepatobiliary disorders       
Hepatorenal syndrome  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Hyperbilirubinaemia  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Jaundice  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Portal vein thrombosis  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Infections and infestations       
Bacteraemia  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Bone abscess  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Cellulitis  1  1/90 (1.11%)  1/87 (1.15%)  0/90 (0.00%) 
Device related infection  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Escherichia infection  1  0/90 (0.00%)  1/87 (1.15%)  1/90 (1.11%) 
Infectious colitis  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Localised infection  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Osteomyelitis  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Peritonitis  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Pneumonia  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Sepsis  1  1/90 (1.11%)  3/87 (3.45%)  1/90 (1.11%) 
Urinary tract infection  1  0/90 (0.00%)  2/87 (2.30%)  0/90 (0.00%) 
Injury, poisoning and procedural complications       
Fall  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Head injury  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Hip fracture  1  0/90 (0.00%)  1/87 (1.15%)  1/90 (1.11%) 
Joint dislocation  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Radius fracture  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Rib fracture  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Splenic rupture  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Tibia fracture  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Traumatic haemothorax  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Metabolism and nutrition disorders       
Hyperkalaemia  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Hyponatraemia  1  1/90 (1.11%)  2/87 (2.30%)  0/90 (0.00%) 
Musculoskeletal and connective tissue disorders       
Rhabdomyolysis  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Diffuse large B-cell lymphoma  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Hepatocellular carcinoma  1  0/90 (0.00%)  0/87 (0.00%)  3/90 (3.33%) 
Nervous system disorders       
Cerebrovascular accident  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Hepatic encephalopathy  1  2/90 (2.22%)  2/87 (2.30%)  1/90 (1.11%) 
Seizure  1  1/90 (1.11%)  1/87 (1.15%)  0/90 (0.00%) 
Syncope  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Psychiatric disorders       
Depression  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Mental status changes  1  1/90 (1.11%)  0/87 (0.00%)  0/90 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Hypoxia  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Pleural effusion  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Pulmonary hypertension  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Respiratory failure  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Skin and subcutaneous tissue disorders       
Skin ulcer  1  0/90 (0.00%)  1/87 (1.15%)  0/90 (0.00%) 
Vascular disorders       
Hypotension  1  0/90 (0.00%)  0/87 (0.00%)  1/90 (1.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOF/VEL 12 Weeks (Group 1) SOF/VEL+RBV 12 Weeks (Group 2) SOF/VEL 24 Weeks (Group 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   65/90 (72.22%)   74/87 (85.06%)   61/90 (67.78%) 
Blood and lymphatic system disorders       
Anaemia  1  4/90 (4.44%)  26/87 (29.89%)  3/90 (3.33%) 
Gastrointestinal disorders       
Abdominal discomfort  1  1/90 (1.11%)  5/87 (5.75%)  3/90 (3.33%) 
Abdominal pain  1  7/90 (7.78%)  6/87 (6.90%)  4/90 (4.44%) 
Ascites  1  5/90 (5.56%)  4/87 (4.60%)  0/90 (0.00%) 
Constipation  1  6/90 (6.67%)  3/87 (3.45%)  6/90 (6.67%) 
Diarrhoea  1  6/90 (6.67%)  18/87 (20.69%)  7/90 (7.78%) 
Gastrooesophageal reflux disease  1  2/90 (2.22%)  2/87 (2.30%)  8/90 (8.89%) 
Nausea  1  20/90 (22.22%)  22/87 (25.29%)  18/90 (20.00%) 
Vomiting  1  7/90 (7.78%)  5/87 (5.75%)  6/90 (6.67%) 
General disorders       
Fatigue  1  23/90 (25.56%)  34/87 (39.08%)  21/90 (23.33%) 
Oedema peripheral  1  7/90 (7.78%)  6/87 (6.90%)  7/90 (7.78%) 
Pyrexia  1  6/90 (6.67%)  4/87 (4.60%)  3/90 (3.33%) 
Infections and infestations       
Nasopharyngitis  1  2/90 (2.22%)  3/87 (3.45%)  8/90 (8.89%) 
Upper respiratory tract infection  1  3/90 (3.33%)  2/87 (2.30%)  8/90 (8.89%) 
Metabolism and nutrition disorders       
Decreased appetite  1  4/90 (4.44%)  2/87 (2.30%)  5/90 (5.56%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  7/90 (7.78%)  3/87 (3.45%)  2/90 (2.22%) 
Back pain  1  6/90 (6.67%)  1/87 (1.15%)  4/90 (4.44%) 
Muscle spasms  1  3/90 (3.33%)  10/87 (11.49%)  4/90 (4.44%) 
Nervous system disorders       
Headache  1  23/90 (25.56%)  18/87 (20.69%)  17/90 (18.89%) 
Psychiatric disorders       
Insomnia  1  9/90 (10.00%)  12/87 (13.79%)  9/90 (10.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  2/90 (2.22%)  9/87 (10.34%)  0/90 (0.00%) 
Dyspnoea  1  4/90 (4.44%)  8/87 (9.20%)  2/90 (2.22%) 
Skin and subcutaneous tissue disorders       
Pruritus  1  10/90 (11.11%)  4/87 (4.60%)  4/90 (4.44%) 
Rash  1  6/90 (6.67%)  5/87 (5.75%)  7/90 (7.78%) 
Vascular disorders       
Hypertension  1  3/90 (3.33%)  5/87 (5.75%)  0/90 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 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
EMail: ClinicalTrialDisclosures@gilead.com
Other Publications:
Charlton MR, O'Leary JG, Bzowej NH, Muir AJ, Korenblat KM, Fenkel JM, et al. Sofosbuvir/Velapatasvir Fixed Dose Combination for the Treatment of HCV in Patients with Decompensated Liver Disease: The Phase 3 ASTRAL-4 Study. Hepatology 2015; 62 (6): 1387A-1388A.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02201901    
Other Study ID Numbers: GS-US-342-1137
First Submitted: July 24, 2014
First Posted: July 28, 2014
Results First Submitted: August 24, 2016
Results First Posted: December 14, 2016
Last Update Posted: November 15, 2018