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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection

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ClinicalTrials.gov Identifier: NCT02487030
Recruitment Status : Completed
First Posted : July 1, 2015
Results First Posted : December 14, 2017
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 255
Recruitment Details Participants were enrolled in 4 sites in Egypt. The first participant was screened on 07 September 2015 and the last study visit was on 04 February 2017.
Pre-assignment Details 289 participants were screened.
Arm/Group Title LDV/SOF 8 wk TN (Cohort 1, Group 1) LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2) LDV/SOF 12 wk TN (Cohort 1, Group 3) LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) LDV/SOF 12 wk TE (Cohort 3, Group 1) LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
Hide Arm/Group Description Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed dose combination (FDC) tablet administered orally once daily for 8 weeks (wk) in treatment-naive (TN) participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily + Ribavirin (RBV) tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily in treatment-experienced (TE) participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were in enrolled into Cohort 2.
Period Title: Overall Study
Started 43 42 43 42 36 38 11
Completed 41 38 41 40 34 37 11
Not Completed 2 4 2 2 2 1 0
Reason Not Completed
Lack of Efficacy             2             4             1             0             1             0             0
Lost to Follow-up             0             0             1             1             0             1             0
Adverse Event             0             0             0             1             0             0             0
Death             0             0             0             0             1             0             0
Arm/Group Title LDV/SOF 8 wk TN (Cohort 1, Group 1) LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2) LDV/SOF 12 wk TN (Cohort 1, Group 3) LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) LDV/SOF 12 wk TE (Cohort 3, Group 1) LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2) Total
Hide Arm/Group Description LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2. Total of all reporting groups
Overall Number of Baseline Participants 43 42 43 42 36 38 11 255
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized or enrolled and received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 42 participants 43 participants 42 participants 36 participants 38 participants 11 participants 255 participants
53  (13.9) 49  (12.2) 49  (13.0) 46  (12.1) 49  (11.8) 51  (10.1) 48  (16.3) 50.0  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 43 participants 42 participants 36 participants 38 participants 11 participants 255 participants
Female
18
  41.9%
20
  47.6%
21
  48.8%
20
  47.6%
4
  11.1%
13
  34.2%
3
  27.3%
99
  38.8%
Male
25
  58.1%
22
  52.4%
22
  51.2%
22
  52.4%
32
  88.9%
25
  65.8%
8
  72.7%
156
  61.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Number Analyzed 43 participants 42 participants 43 participants 42 participants 36 participants 38 participants 11 participants 255 participants
43
 100.0%
42
 100.0%
43
 100.0%
42
 100.0%
36
 100.0%
38
 100.0%
11
 100.0%
255
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Not Hispanic or Latino Number Analyzed 43 participants 42 participants 43 participants 42 participants 36 participants 38 participants 11 participants 255 participants
43
 100.0%
42
 100.0%
43
 100.0%
42
 100.0%
36
 100.0%
38
 100.0%
11
 100.0%
255
 100.0%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 43 participants 42 participants 36 participants 38 participants 11 participants 255 participants
CC
12
  27.9%
5
  11.9%
11
  25.6%
9
  21.4%
8
  22.2%
8
  21.1%
0
   0.0%
53
  20.8%
CT
28
  65.1%
26
  61.9%
26
  60.5%
25
  59.5%
24
  66.7%
21
  55.3%
8
  72.7%
158
  62.0%
TT
3
   7.0%
11
  26.2%
6
  14.0%
8
  19.0%
7
  19.4%
9
  23.7%
3
  27.3%
47
  18.4%
[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 43 participants 42 participants 43 participants 42 participants 36 participants 38 participants 11 participants 255 participants
6.0  (0.64) 5.6  (0.63) 5.7  (0.69) 5.8  (0.66) 5.8  (1.10) 5.8  (1.04) 6.2  (0.59) 5.8  (0.79)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 42 participants 43 participants 42 participants 36 participants 38 participants 11 participants 255 participants
< 800,000 IU/mL
17
  39.5%
26
  61.9%
25
  58.1%
28
  66.7%
16
  44.4%
17
  44.7%
5
  45.5%
134
  52.5%
≥ 800,000 IU/mL
26
  60.5%
16
  38.1%
18
  41.9%
14
  33.3%
20
  55.6%
21
  55.3%
6
  54.5%
121
  47.5%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 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
Full Analysis Set: all randomized or enrolled participants who had genotype 4 HCV infection and who took at least 1 dose of study drug.
Arm/Group Title LDV/SOF 8 wk TN (Cohort 1, Group 1) LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2) LDV/SOF 12 wk TN (Cohort 1, Group 3) LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) LDV/SOF 12 wk TE (Cohort 3, Group 1) LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
Overall Number of Participants Analyzed 43 42 43 42 36 38 11
Measure Type: Number
Number (99% Confidence Interval)
Unit of Measure: percentage of participants
95.3
(84.2 to 99.4)
90.5
(77.4 to 97.3)
97.7
(87.7 to 99.9)
97.6
(87.4 to 99.9)
94.4
(81.3 to 99.3)
100.0
(90.7 to 100.0)
100.0
(71.5 to 100.0)
2.Primary Outcome
Title Percentage of Participants Who Discontinued LDV/SOF Drug Due to an Adverse Event (AE)
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis Set
Arm/Group Title LDV/SOF 8 Weeks LDV/SOF + RBV 8 Weeks LDV/SOF 12 Weeks LDV/SOF + RBV 12 Weeks
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
Overall Number of Participants Analyzed 43 42 79 91
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0 1.1
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 4 and 24 weeks after 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 LDV/SOF 8 wk TN (Cohort 1, Group 1) LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2) LDV/SOF 12 wk TN (Cohort 1, Group 3) LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) LDV/SOF 12 wk TE (Cohort 3, Group 1) LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
Overall Number of Participants Analyzed 43 42 43 42 36 38 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SVR4
95.3
(84.2 to 99.4)
95.2
(83.8 to 99.4)
97.7
(87.7 to 99.9)
97.6
(87.4 to 99.9)
100.0
(90.3 to 100.0)
100.0
(90.7 to 100.0)
100.0
(71.5 to 100.0)
SVR24
95.3
(84.2 to 99.4)
90.5
(77.4 to 97.3)
97.7
(87.7 to 99.9)
97.6
(87.4 to 99.9)
94.4
(81.3 to 99.3)
100.0
(90.7 to 100.0)
100.0
(71.5 to 100.0)
4.Secondary Outcome
Title Percentage of Participants With Overall Virologic Failure
Hide Description

Virologic failure was defined as

  • On-treatment virologic failure

    • confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment (ie, breakthrough),
    • confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment (ie, rebound),
    • 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 LDV/SOF 8 wk TN (Cohort 1, Group 1) LDV/SOF + RBV 8 wk TN (Cohort 1, Group 2) LDV/SOF 12 wk TN (Cohort 1, Group 3) LDV/SOF + RBV 12 wk TN (Cohort 1, Group 4) LDV/SOF 12 wk TE (Cohort 3, Group 1) LDV/SOF + RBV 12 wk TE (Cohort 3, Group 2) LDV/SOF + RBV 12 wk SOF or LDV/SOF Experienced (Cohort 2)
Hide Arm/Group Description:
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TN participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily in TE participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in TE participants
LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 12 weeks in SOF or LDV/SOF experienced participants. Participants who completed treatment in Study GS-US-334-0138 with SOF+RBV for 12 or 24 weeks or those who participated in Cohort 1 of this study with LDV/SOF ± RBV for 8 weeks and did not achieve SVR12 were enrolled into Cohort 2.
Overall Number of Participants Analyzed 43 42 43 42 36 38 11
Measure Type: Number
Unit of Measure: percentage of participants
4.7 9.5 2.3 0.0 2.8 0.0 0.0
Time Frame Up to 12 weeks + 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LDV/SOF 8 Weeks LDV/SOF + RBV 8 Weeks LDV/SOF 12 Weeks LDV/SOF + RBV 12 Weeks
Hide Arm/Group Description LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 8 weeks LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks LDV/SOF (90/400 mg) FDC tablet administered orally once daily for 12 weeks LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) for 8 weeks
All-Cause Mortality
LDV/SOF 8 Weeks LDV/SOF + RBV 8 Weeks LDV/SOF 12 Weeks LDV/SOF + RBV 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF 8 Weeks LDV/SOF + RBV 8 Weeks LDV/SOF 12 Weeks LDV/SOF + RBV 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/42 (0.00%)   0/79 (0.00%)   3/91 (3.30%) 
General disorders         
Chest Pain  1  0/43 (0.00%)  0/42 (0.00%)  0/79 (0.00%)  1/91 (1.10%) 
Injury, poisoning and procedural complications         
Road traffic accident  1  0/43 (0.00%)  0/42 (0.00%)  0/79 (0.00%)  2/91 (2.20%) 
Vascular disorders         
Peripheral vascular disorder  1  0/43 (0.00%)  0/42 (0.00%)  0/79 (0.00%)  1/91 (1.10%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF 8 Weeks LDV/SOF + RBV 8 Weeks LDV/SOF 12 Weeks LDV/SOF + RBV 12 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/43 (25.58%)   15/42 (35.71%)   23/79 (29.11%)   41/91 (45.05%) 
Blood and lymphatic system disorders         
Anaemia  1  0/43 (0.00%)  2/42 (4.76%)  0/79 (0.00%)  7/91 (7.69%) 
Gastrointestinal disorders         
Abdominal pain upper  1  0/43 (0.00%)  2/42 (4.76%)  0/79 (0.00%)  6/91 (6.59%) 
Constipation  1  0/43 (0.00%)  3/42 (7.14%)  0/79 (0.00%)  3/91 (3.30%) 
Dyspepsia  1  3/43 (6.98%)  1/42 (2.38%)  5/79 (6.33%)  6/91 (6.59%) 
General disorders         
Fatigue  1  4/43 (9.30%)  5/42 (11.90%)  8/79 (10.13%)  14/91 (15.38%) 
Pyrexia  1  1/43 (2.33%)  1/42 (2.38%)  1/79 (1.27%)  5/91 (5.49%) 
Infections and infestations         
Bronchitis  1  3/43 (6.98%)  1/42 (2.38%)  3/79 (3.80%)  2/91 (2.20%) 
Nervous system disorders         
Headache  1  4/43 (9.30%)  13/42 (30.95%)  13/79 (16.46%)  20/91 (21.98%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.1)
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
Publications of Results:
Shiha G, Waked I, Soliman R, Abdelrazek W, Hassany M, Fouad R, et al. Ledipasvir/sofosbuvir for 8 or 12 weeks with or without ribavirin in HCV genotype 4 patients in Egypt. [Abstract OP158]. Asian Pacific Association for the Study of the Liver (APASL); 2017 15-19 February; Shanghai, China
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02487030     History of Changes
Other Study ID Numbers: GS-US-337-1643
First Submitted: June 27, 2015
First Posted: July 1, 2015
Results First Submitted: November 9, 2017
Results First Posted: December 14, 2017
Last Update Posted: November 16, 2018