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Trial record 3 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Adults With Chronic HCV and HBV Coinfection

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ClinicalTrials.gov Identifier: NCT02613871
Recruitment Status : Completed
First Posted : November 25, 2015
Results First Posted : February 13, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Intervention Drug: LDV/SOF
Enrollment 111
Recruitment Details Participants were enrolled in 14 sites in Taiwan. The first participant was screened on 21 December 2015 and the last visit for primary endpoint analysis was on 04 January 2017.
Pre-assignment Details 135 participants were screened.
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description Ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) 90/400 mg tablet administered orally once daily for 12 weeks
Period Title: Overall Study
Started 111
Completed 0
Not Completed 111
Reason Not Completed
On Study             111
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Baseline Participants 111
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 111 participants
55  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Female
69
  62.2%
Male
42
  37.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian Number Analyzed 111 participants
111
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Not Hispanic or Latino
99
  89.2%
Not Permitted
12
  10.8%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
CC
85
  76.6%
CT
26
  23.4%
[1]
Measure Description: CC and CT alleles are different forms of the IL28b gene.
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 111 participants
5.9  (0.73)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
< 800,000 IU/mL
44
  39.6%
≥ 800,000 IU/mL
67
  60.4%
Cirrhosis status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Absence
93
  83.8%
Presence
18
  16.2%
Fibroscan Score   [1] 
Mean (Standard Deviation)
Unit of measure:  kPa
Number Analyzed 111 participants
9.3  (7.05)
[1]
Measure Description:

FibroScan® is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan® results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:

  • Presence of cirrhosis = FibroScan® result of > 12.5 kPa
  • Absence of cirrhosis = FibroScan® result of ≤ 12.5 kPa
Hepatitis B Virus (HBV) DNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 111 participants
2.1  (0.92)
Plasma HBV DNA  
Mean (Standard Deviation)
Unit of measure:  IU/mL
Number Analyzed 111 participants
9423.1  (69641.90)
HBsAg  
Mean (Standard Deviation)
Unit of measure:  IU/mL
Number Analyzed 111 participants
578.6  (1113.56)
Serum Lysyl oxidase-like 2 (LOXL-2)  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 111 participants
98  (64.4)
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants
Genotype 1
1
   0.9%
Genotype 1a
3
   2.7%
Genotype 1b
64
  57.7%
Genotype 2
43
  38.7%
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 quantification (LLOQ; 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: All enrolled participants who took at least 1 dose of study drug.
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Genotype 1 Number Analyzed 68 participants
100.0
(94.7 to 100.0)
Genotype 2 Number Analyzed 43 participants
100.0
(91.8 to 100.0)
Total Number Analyzed 111 participants
100.0
(96.7 to 100.0)
2.Primary Outcome
Title Percentage of Participants With Any Adverse Event Leading to Permanent Discontinuation of Study Drug
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: All participants who took at least 1 dose of study drug.
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: Percentage of participants
0.0
3.Secondary Outcome
Title Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
100.0
(96.7 to 100.0)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ While on Treatment
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 1
33.3
(24.7 to 42.9)
Week 2
82.0
(73.6 to 88.6)
Week 4
100.0
(96.7 to 100.0)
Week 8
100.0
(96.7 to 100.0)
Week 12
100.0
(96.7 to 100.0)
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Hide Description [Not Specified]
Time Frame Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Outcome Measure Data Not Reported
6.Secondary Outcome
Title HCV RNA Change From Baseline While on Treatment
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 1 -4.14  (0.551)
Week 2 -4.63  (0.702)
Week 4 -4.73  (0.727)
Week 8 -4.73  (0.727)
Week 12 -4.73  (0.727)
7.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

Virologic failure is 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), or
  • Relapse (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 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: Percentage of participants
0
8.Secondary Outcome
Title Plasma HBV DNA Change From Baseline While on Treatment and at Posttreatment Weeks 4 and 12
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8, 12, and Posttreatment Weeks 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 1 -0.06  (0.237)
Week 2 0.08  (0.366)
Week 4 0.37  (0.705)
Week 8 0.51  (0.906)
Week 12 0.24  (0.746)
Posttreatment Week 4 0.49  (0.727)
Posttreatment Week 12 0.66  (0.955)
9.Secondary Outcome
Title Plasma HBV DNA Change From Baseline at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Hide Description [Not Specified]
Time Frame Baseline; Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Outcome Measure Data Not Reported
10.Secondary Outcome
Title HBsAg Level Change From Baseline While on Treatment and at Posttreatment Weeks 4 and 12
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8, 12, and Posttreatment Weeks 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 1 -0.14  (0.184)
Week 2 -0.18  (0.181)
Week 4 -0.25  (0.185)
Week 8 -0.41  (0.234)
Week 12 -0.47  (0.266)
Posttreatment Week 4 -0.16  (0.347)
Posttreatment Week 12 -0.01  (0.338)
11.Secondary Outcome
Title HBsAg Level Change From Baseline at Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Hide Description [Not Specified]
Time Frame Baseline; Posttreatment Weeks 24, 36, 48, 60, 72, 84, 96, and 108
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Serum Lysyl Oxidase-like 2 (LOXL-2) Change From Baseline While on Treatment and at Posttreatment Weeks 4 and 12
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8, 12, and Posttreatment Weeks 4 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: pg/mL
Week 1 -2  (29.4)
Week 2 -6  (26.9)
Week 4 -15  (27.8)
Week 8 -18  (33.7)
Week 12 -22  (42.2)
Posttreatment Week 4 -41  (63.1)
Posttreatment Week 12 -33  (45.8)
13.Secondary Outcome
Title Percentage of Participants That Required HBV Therapy During Treatment and up to Posttreatment Week 12
Hide Description [Not Specified]
Time Frame Up to Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: Percentage of participants
1.8
14.Secondary Outcome
Title Percentage of Participants That Required HBV Therapy Up to Posttreatment Week 108
Hide Description [Not Specified]
Time Frame Up to Posttreatment Week 108
Outcome Measure Data Not Reported
15.Secondary Outcome
Title Fibrosis Status as Assessed by Fibroscan® at Posttreatment Week 12
Hide Description

FibroScan® is a non-invasive device that assesses the hardness (or stiffness) of the liver using the technique of transient elastography. FibroScan® results range from 2.5 kPa to 75 kPa with higher scores indicating greater liver stiffness. Per protocol, cirrhosis status was determined as follows:

  • Presence of cirrhosis = FibroScan® result of > 12.5 kPa
  • Absence of cirrhosis = FibroScan® result of ≤ 12.5 kPa
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Mean (Standard Deviation)
Unit of Measure: kPa
8.0  (7.01)
16.Secondary Outcome
Title Fibrosis Status as Assessed by Fibroscan® at Posttreatment Weeks 60 and 108
Hide Description [Not Specified]
Time Frame Posttreatment Weeks 60 and 108
Outcome Measure Data Not Reported
17.Secondary Outcome
Title Percentage of Participants That Develop Hepatocellular Carcinoma (HCC) During Treatment and up to Posttreatment Week 12
Hide Description [Not Specified]
Time Frame Up to Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description:
LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
Overall Number of Participants Analyzed 111
Measure Type: Number
Unit of Measure: Percentage of participants
0
18.Secondary Outcome
Title Percentage of Participants That Develop HCC Up to Posttreatment Week 108
Hide Description [Not Specified]
Time Frame Up to Posttreatment Week 108
Outcome Measure Data Not Reported
Time Frame Up to 12 weeks plus 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title LDV/SOF FDC
Hide Arm/Group Description LDV/SOF 90/400 mg FDC tablet administered orally once daily for 12 weeks
All-Cause Mortality
LDV/SOF FDC
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF FDC
Affected / at Risk (%)
Total   4/111 (3.60%) 
Gastrointestinal disorders   
Duodenal ulcer  1  1/111 (0.90%) 
Injury, poisoning and procedural complications   
Meniscus injury  1  1/111 (0.90%) 
Post procedural haemorrhage  1  1/111 (0.90%) 
Nervous system disorders   
Optic neuritis  1  1/111 (0.90%) 
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 FDC
Affected / at Risk (%)
Total   23/111 (20.72%) 
General disorders   
Fatigue  1  8/111 (7.21%) 
Infections and infestations   
Upper respiratory tract infection  1  9/111 (8.11%) 
Nervous system disorders   
Headache  1  10/111 (9.01%) 
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:
Ledipasvir/sofosbuvir for 12 weeks is safe and effective in patients with chronic hepatitis C and hepatitis B coinfection: A phase 3 study in Taiwan; Journal of Hepatology 2017 vol. 66 | S33-S62, abstract PS-098 [EASL 2017]
Declines in HBsAg Levels Observed during Treatment with Ledipasvir/Sofosbuvir (LDV/SOF) in Patients with Chronic Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Infection; Hepatology, Volume 66, Number 1 (Suppl), abstract 1083 [AASLD 2017]
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02613871     History of Changes
Other Study ID Numbers: GS-US-337-1655
First Submitted: November 23, 2015
First Posted: November 25, 2015
Results First Submitted: January 3, 2018
Results First Posted: February 13, 2018
Last Update Posted: December 11, 2018