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Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies

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ClinicalTrials.gov Identifier: NCT02600351
Recruitment Status : Terminated (Due to lack of feasibility of enrolling participants, the study was terminated early.)
First Posted : November 9, 2015
Results First Posted : April 11, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Interventions Drug: LDV/SOF
Drug: RBV
Enrollment 87
Recruitment Details Participants were enrolled at study sites in the United States (including a site in Puerto Rico), and Canada. The first participant was screened on 11 November 2015. The last study visit occurred on 29 May 2017.
Pre-assignment Details 120 participants were screened.
Arm/Group Title LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants without cirrhosis LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis LDV/SOF (90 mg/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
Period Title: Overall Study
Started 17 17 26 27
Completed 12 17 20 22
Not Completed 5 0 6 5
Reason Not Completed
Lack of Efficacy             3             0             5             2
Lost to Follow-up             1             0             0             0
Randomized but Not Treated             1             0             1             3
Arm/Group Title LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis Total
Hide Arm/Group Description LDV/SOF (90/400 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks in participants without cirrhosis LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis LDV/SOF FDC (90 mg/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis Total of all reporting groups
Overall Number of Baseline Participants 16 17 25 24 82
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who took at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 17 participants 25 participants 24 participants 82 participants
58  (5.7) 57  (5.5) 58  (7.8) 60  (4.5) 59  (6.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 25 participants 24 participants 82 participants
Female
6
  37.5%
4
  23.5%
6
  24.0%
5
  20.8%
21
  25.6%
Male
10
  62.5%
13
  76.5%
19
  76.0%
19
  79.2%
61
  74.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 25 participants 24 participants 82 participants
American Indian Or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.2%
1
   1.2%
Asian
0
   0.0%
1
   5.9%
0
   0.0%
0
   0.0%
1
   1.2%
Black or African American
6
  37.5%
5
  29.4%
6
  24.0%
3
  12.5%
20
  24.4%
Other
0
   0.0%
0
   0.0%
1
   4.0%
1
   4.2%
2
   2.4%
White
10
  62.5%
11
  64.7%
18
  72.0%
19
  79.2%
58
  70.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 25 participants 24 participants 82 participants
Hispanic or Latino
2
  12.5%
3
  17.6%
4
  16.0%
7
  29.2%
16
  19.5%
Not Hispanic or Latino
14
  87.5%
14
  82.4%
21
  84.0%
17
  70.8%
66
  80.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 25 participants 24 participants 82 participants
Canada 1 2 2 7 12
Puerto Rico 1 1 0 1 3
United States 14 14 23 16 67
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 25 participants 24 participants 82 participants
CC
1
   6.3%
2
  11.8%
0
   0.0%
1
   4.2%
4
   4.9%
CT
12
  75.0%
11
  64.7%
16
  64.0%
17
  70.8%
56
  68.3%
TT
3
  18.8%
4
  23.5%
9
  36.0%
6
  25.0%
22
  26.8%
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 16 participants 17 participants 25 participants 24 participants 82 participants
6.5  (0.45) 6.4  (0.48) 6.1  (0.59) 6.0  (0.89) 6.2  (0.67)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 17 participants 25 participants 24 participants 82 participants
< 800,000 IU/mL
1
   6.3%
4
  23.5%
7
  28.0%
8
  33.3%
20
  24.4%
≥ 800,000 IU/mL
15
  93.8%
13
  76.5%
18
  72.0%
16
  66.7%
62
  75.6%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Cessation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, < 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set by Actual Treatment: participants were grouped according to their cirrhotic status and the treatment/duration they actually received.
Arm/Group Title LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
Overall Number of Participants Analyzed 16 17 25 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
81.3
(54.4 to 96.0)
100.0
(80.5 to 100.0)
80.0
(59.3 to 93.2)
91.7
(73.0 to 99.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LDV/SOF 12 Weeks, Without Cirrhosis, LDV/SOF + RBV 12 Weeks, Without Cirrhosis
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments With a 10% non-inferiority margin, a sample size of 90 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 98% for both groups.
Statistical Test of Hypothesis P-Value 0.065
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -18.8
Confidence Interval (2-Sided) 95%
-40.7 to 3.2
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis, LDV/SOF 24 Weeks, With Compensated Cirrhosis
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments With a 10% non-inferiority margin, a sample size of 125 participants per treatment group was required to provide at least 90% power to establish non-inferiority at the 1-sided 0.025 level, assuming the SVR12 rates were 95% for both groups.
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in percentages
Estimated Value -11.7
Confidence Interval (2-Sided) 95%
-32.1 to 8.8
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Discontinued From Study Treatment for an Adverse Event
Hide Description [Not Specified]
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
Overall Number of Participants Analyzed 16 17 25 24
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0
3.Secondary Outcome
Title Percentage of Participants With HCV RNA < the Lower Limit of Quantitation (LLOQ) at 4 and 24 Weeks Posttreatment
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 by Actual Treatment
Arm/Group Title LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
LDV/SOF (90 mg/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
Overall Number of Participants Analyzed 16 17 25 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SVR4
93.8
(69.8 to 99.8)
100.0
(80.5 to 100.0)
88.0
(68.8 to 97.5)
95.8
(78.9 to 99.9)
SVR24
81.3
(54.4 to 96.0)
100.0
(80.5 to 100.0)
80.0
(59.3 to 93.2)
91.7
(73.0 to 99.0)
4.Secondary Outcome
Title Percentage of Participants With Viral Breakthrough
Hide Description Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment.
Time Frame Up to 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set by Actual Treatment
Arm/Group Title LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
Overall Number of Participants Analyzed 16 17 25 24
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 0
5.Secondary Outcome
Title Percentage of Participants With Viral Relapse
Hide Description Viral relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA <LLOQ at last on-treatment visit.
Time Frame Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set by Actual Treatment
Arm/Group Title LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
Overall Number of Participants Analyzed 16 17 25 24
Measure Type: Number
Unit of Measure: percentage of participants
18.8 0 20.0 8.3
6.Secondary Outcome
Title Number of Participants With Emerging Resistance
Hide Description The full-length NS3, NS5A, and NS5B coding regions were deep sequenced at pretreatment (baseline) for all participants included in the Full Analysis Set, and at posttreatment for all participants who relapsed.
Time Frame Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set by Actual Treatment who have pre-existing NS5B, NS5A, and NS3/4A resistance-associated variants (RAVs) at baseline and who experienced virologic failure were analyzed. There were no participants with pre-existing RAVs who experienced virologic failure in the LDV/SOF+RBV 12 weeks, without cirrhosis group.
Arm/Group Title LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis
LDV/SOF FDC (90/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis
LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
Overall Number of Participants Analyzed 3 0 5 2
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
5
 100.0%
2
 100.0%
Time Frame Up to 24 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Hide Arm/Group Description LDV/SOF (90/400 mg) FDC tablet orally once daily for 12 weeks in participants without cirrhosis LDV/SOF (90/400 mg) FDC tablet orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks in participants without cirrhosis LDV/SOF FDC (90 mg/400 mg) tablet orally once daily + RBV (1000 or 1200 mg/day divided twice daily) for 12 weeks in participants with compensated cirrhosis LDV/SOF (90/400 mg) FDC tablet orally once daily for 24 weeks in participants with compensated cirrhosis
All-Cause Mortality
LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%)   0/25 (0.00%)   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/17 (0.00%)   0/25 (0.00%)   1/24 (4.17%) 
Gastrointestinal disorders         
Gastrointestinal haemorrhage  1  0/16 (0.00%)  0/17 (0.00%)  0/25 (0.00%)  1/24 (4.17%) 
Upper gastrointestinal haemorrhage  1  0/16 (0.00%)  0/17 (0.00%)  0/25 (0.00%)  1/24 (4.17%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, Without Cirrhosis LDV/SOF + RBV 12 Weeks, With Compensated Cirrhosis LDV/SOF 24 Weeks, With Compensated Cirrhosis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/16 (68.75%)   14/17 (82.35%)   19/25 (76.00%)   15/24 (62.50%) 
Eye disorders         
Angle closure glaucoma  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Dry eye  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Gastrointestinal disorders         
Abdominal distension  1  0/16 (0.00%)  0/17 (0.00%)  1/25 (4.00%)  2/24 (8.33%) 
Cheilitis  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Diarrhoea  1  1/16 (6.25%)  1/17 (5.88%)  1/25 (4.00%)  2/24 (8.33%) 
Dry mouth  1  0/16 (0.00%)  2/17 (11.76%)  0/25 (0.00%)  0/24 (0.00%) 
Dyspepsia  1  0/16 (0.00%)  0/17 (0.00%)  2/25 (8.00%)  0/24 (0.00%) 
Haematochezia  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Nausea  1  2/16 (12.50%)  1/17 (5.88%)  3/25 (12.00%)  3/24 (12.50%) 
Vomiting  1  3/16 (18.75%)  1/17 (5.88%)  1/25 (4.00%)  1/24 (4.17%) 
General disorders         
Chills  1  0/16 (0.00%)  2/17 (11.76%)  0/25 (0.00%)  2/24 (8.33%) 
Fatigue  1  2/16 (12.50%)  6/17 (35.29%)  7/25 (28.00%)  4/24 (16.67%) 
Influenza like illness  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Infections and infestations         
Candida infection  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Gastroenteritis  1  1/16 (6.25%)  0/17 (0.00%)  0/25 (0.00%)  0/24 (0.00%) 
Hordeolum  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Upper respiratory tract infection  1  1/16 (6.25%)  0/17 (0.00%)  2/25 (8.00%)  1/24 (4.17%) 
Viral upper respiratory tract infection  1  0/16 (0.00%)  0/17 (0.00%)  2/25 (8.00%)  1/24 (4.17%) 
Investigations         
Blood creatine phosphokinase increased  1  0/16 (0.00%)  2/17 (11.76%)  0/25 (0.00%)  1/24 (4.17%) 
Blood pressure diastolic increased  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Metabolism and nutrition disorders         
Gout  1  1/16 (6.25%)  0/17 (0.00%)  0/25 (0.00%)  0/24 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  1/24 (4.17%) 
Back pain  1  0/16 (0.00%)  0/17 (0.00%)  2/25 (8.00%)  1/24 (4.17%) 
Joint swelling  1  1/16 (6.25%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Muscle spasms  1  0/16 (0.00%)  0/17 (0.00%)  4/25 (16.00%)  0/24 (0.00%) 
Myalgia  1  1/16 (6.25%)  1/17 (5.88%)  0/25 (0.00%)  1/24 (4.17%) 
Tendonitis  1  1/16 (6.25%)  0/17 (0.00%)  0/25 (0.00%)  1/24 (4.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Skin papilloma  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Nervous system disorders         
Dizziness  1  0/16 (0.00%)  1/17 (5.88%)  1/25 (4.00%)  0/24 (0.00%) 
Dysgeusia  1  0/16 (0.00%)  1/17 (5.88%)  2/25 (8.00%)  0/24 (0.00%) 
Headache  1  5/16 (31.25%)  2/17 (11.76%)  9/25 (36.00%)  7/24 (29.17%) 
Hypoaesthesia  1  0/16 (0.00%)  2/17 (11.76%)  0/25 (0.00%)  0/24 (0.00%) 
Migraine  1  1/16 (6.25%)  0/17 (0.00%)  0/25 (0.00%)  0/24 (0.00%) 
Restless legs syndrome  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  1/24 (4.17%) 
Somnolence  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Psychiatric disorders         
Affect lability  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Insomnia  1  1/16 (6.25%)  5/17 (29.41%)  3/25 (12.00%)  3/24 (12.50%) 
Irritability  1  1/16 (6.25%)  1/17 (5.88%)  1/25 (4.00%)  2/24 (8.33%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/16 (0.00%)  3/17 (17.65%)  2/25 (8.00%)  0/24 (0.00%) 
Dyspnoea  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  1/24 (4.17%) 
Dyspnoea exertional  1  0/16 (0.00%)  1/17 (5.88%)  1/25 (4.00%)  0/24 (0.00%) 
Nasal congestion  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Skin and subcutaneous tissue disorders         
Dry skin  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Eczema  1  1/16 (6.25%)  0/17 (0.00%)  0/25 (0.00%)  0/24 (0.00%) 
Pruritus  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
Pruritus generalised  1  0/16 (0.00%)  1/17 (5.88%)  1/25 (4.00%)  0/24 (0.00%) 
Rash  1  1/16 (6.25%)  2/17 (11.76%)  5/25 (20.00%)  2/24 (8.33%) 
Rash macular  1  1/16 (6.25%)  0/17 (0.00%)  0/25 (0.00%)  0/24 (0.00%) 
Skin irritation  1  0/16 (0.00%)  1/17 (5.88%)  0/25 (0.00%)  0/24 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Due to lack of feasibility of enrolling participants, the study was terminated early. Although, the non-inferiority tests were performed, the actual sample size was inadequate compared to the planned enrollment of 430 participants.
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: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Publications of Results:
Tam E, Brown RS, Satapathy S, Shen X, Camus G, Copans A, et al. Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF), with or without Ribavirin (RBV), for Treatment of HCV-mono and HIV/HCV Co-infected Patients Who Have Failed Prior Treatment with Non-NS5A, SOF-based Therapies [Poster THU-265]. The International Liver Congress™ 2017: European Association for the Study of the Liver (EASL); 2017 19-23 April; Amsterdam, the Netherlands.
Tam E, Mantry PS, Satapathy SK, Ghali P, Shen X, Han LL, et al. A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF), with or without Ribavirin (RBV), in HCV Infected Subjects Who Have Failed Prior Treatment with Non-NS5A, SOF-based Therapies (RESCUE) [Poster PP0217]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China.
Tam E, Brown RS, Satapathy S, Camus G, Copans A, Rossaro L, et al. Ledipasvir/Sofosbuvir ± Ribavirin in HCV and HIV/HCV Prior SOF-based Virologic Failures (RESCUE and ACTG A5348 Studies) [Poster 568LB]. Conference on Retroviruses and Opportunistic Infections (CROI); 2017 13-16 February; Seattle, WA.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02600351     History of Changes
Other Study ID Numbers: GS-US-337-1746
First Submitted: November 5, 2015
First Posted: November 9, 2015
Results First Submitted: March 13, 2018
Results First Posted: April 11, 2018
Last Update Posted: November 16, 2018