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Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease (ESRD)

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ClinicalTrials.gov Identifier: NCT03036839
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : December 9, 2019
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Intervention Drug: LDV/SOF
Enrollment 95
Recruitment Details Participants were enrolled at study sites in Taiwan, Italy, Germany, the United States, and Belgium. The first participant was screened on 27 June 2017. The last study visit occurred on 14 February 2019.
Pre-assignment Details 124 participants were screened.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description Treatment-naive genotype 1 participants without cirrhosis received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily orally with or without food for 8 weeks. Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Period Title: Overall Study
Started 45 31 19
Completed 42 31 14
Not Completed 3 0 5
Reason Not Completed
Adverse Event             0             0             1
Death             3             0             3
Withdrew Consent             0             0             1
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks Total
Hide Arm/Group Description Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks. Total of all reporting groups
Overall Number of Baseline Participants 45 31 19 95
Hide Baseline Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants 31 participants 19 participants 95 participants
60  (12.0) 59  (10.1) 65  (7.1) 61  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 31 participants 19 participants 95 participants
Female 16 19 4 39
Male 29 12 15 56
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 31 participants 19 participants 95 participants
Hispanic or Latino 0 0 2 2
Not Hispanic or Latino 45 31 17 93
Unknown or Not Reported 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 31 participants 19 participants 95 participants
American Indian or Alaska Native 0 0 0 0
Asian 21 29 11 61
Native Hawaiian or Other Pacific Islander 1 0 0 1
Black or African American 3 0 2 5
White 20 2 6 28
More than one race 0 0 0 0
Unknown or Not Reported 0 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 31 participants 19 participants 95 participants
Belgium 3 0 0 3
United States 4 0 4 8
Taiwan 21 29 10 60
Italy 9 2 5 16
Germany 8 0 0 8
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 31 participants 19 participants 95 participants
CC 24 24 9 57
CT 12 5 9 26
TT 9 2 1 12
[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 45 participants 31 participants 19 participants 95 participants
5.8  (0.80) 5.9  (0.95) 5.9  (0.63) 5.8  (0.82)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 31 participants 19 participants 95 participants
< 800,000 IU/mL 24 14 10 48
≥ 800,000 IU/mL 21 17 9 47
Cirrhosis Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 31 participants 19 participants 95 participants
Yes 0 0 19 19
No 45 31 0 76
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 31 participants 19 participants 95 participants
Genotype 1 45 8 15 68
Genotype 2 0 19 2 21
Genotype 4 0 0 2 2
Genotype 5 0 1 0 1
Genotype 6 0 2 0 2
Indeterminate 0 1 0 1
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 hepatitis C virus ribonucleic acid (HCV RNA) < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment. The exact 95% confidence interval (CI) for the percentage within treatment group was based on the Clopper-Pearson method.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included participants who were enrolled into the study and received at least 1 dose of study drug. Participants were grouped within the Full Analysis Set by genotype and treatment group to which they were enrolled.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 45 31 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.3
(81.7 to 98.6)
100.0
(88.8 to 100.0)
84.2
(60.4 to 96.6)
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame First dose date up to Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 45 31 19
Measure Type: Number
Unit of Measure: percentage of participants
0 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 (ie, 15 IU/mL) at 4 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 45 31 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.8
(88.2 to 99.9)
100.0
(88.8 to 100.0)
84.2
(60.4 to 96.6)
4.Secondary Outcome
Title Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Hide Description SVR24 was defined as HCV RNA < LLOQ (ie, 15 IU/mL) at 24 weeks after stopping study treatment. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.
Time Frame Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 45 31 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.3
(81.7 to 98.6)
100.0
(88.8 to 100.0)
84.2
(60.4 to 96.6)
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ on Treatment
Hide Description The total number of participants with HCV RNA < LLOQ was the sum of the number of participants with HCV RNA "< LLOQ detected" plus the number of participants with HCV RNA "< LLOQ target not detected (TND)". LLOQ was 15 IU/mL. The exact 95% CI for the percentage within treatment group was based on the Clopper-Pearson method.
Time Frame Weeks 2, 4, 6, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 45 31 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2 Number Analyzed 45 participants 31 participants 19 participants
84.4
(70.5 to 93.5)
90.3
(74.2 to 98.0)
84.2
(60.4 to 96.6)
Week 4 Number Analyzed 44 participants 31 participants 19 participants
100.0
(92.0 to 100.0)
100.0
(88.8 to 100.0)
100.0
(82.4 to 100.0)
Week 6 Number Analyzed 44 participants 31 participants 19 participants
100.0
(92.0 to 100.0)
100.0
(88.8 to 100.0)
94.7
(74.0 to 99.9)
Week 8 Number Analyzed 44 participants 31 participants 18 participants
100.0
(92.0 to 100.0)
100.0
(88.8 to 100.0)
100.0
(81.5 to 100.0)
Week 12 Number Analyzed 0 participants 31 participants 17 participants
100.0
(88.8 to 100.0)
100.0
(80.5 to 100.0)
Week 16 Number Analyzed 0 participants 0 participants 17 participants
100.0
(80.5 to 100.0)
Week 20 Number Analyzed 0 participants 0 participants 17 participants
100.0
(80.5 to 100.0)
Week 24 Number Analyzed 0 participants 0 participants 16 participants
100.0
(79.4 to 100.0)
6.Secondary Outcome
Title HCV RNA
Hide Description [Not Specified]
Time Frame Weeks 2, 4, 6, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 44 31 19
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 2 Number Analyzed 42 participants 31 participants 19 participants
1.17  (0.107) 1.22  (0.261) 1.18  (0.098)
Week 4 Number Analyzed 44 participants 31 participants 19 participants
1.15  (0.000) 1.15  (0.000) 1.15  (0.000)
Week 6 Number Analyzed 44 participants 31 participants 18 participants
1.15  (0.000) 1.15  (0.000) 1.15  (0.000)
Week 8 Number Analyzed 44 participants 31 participants 18 participants
1.15  (0.000) 1.15  (0.000) 1.15  (0.000)
Week 12 Number Analyzed 0 participants 31 participants 17 participants
1.15  (0.000) 1.15  (0.000)
Week 16 Number Analyzed 0 participants 0 participants 17 participants
1.15  (0.000)
Week 20 Number Analyzed 0 participants 0 participants 17 participants
1.15  (0.000)
Week 24 Number Analyzed 0 participants 0 participants 16 participants
1.15  (0.000)
7.Secondary Outcome
Title Change From Baseline in HCV RNA
Hide Description [Not Specified]
Time Frame Weeks 2, 4, 6, 8, 12, 16, 20, 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 44 31 19
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 2 Number Analyzed 42 participants 31 participants 19 participants
-4.63  (0.799) -4.71  (0.894) -4.67  (0.631)
Change at Week 4 Number Analyzed 44 participants 31 participants 19 participants
-4.61  (0.805) -4.79  (0.950) -4.71  (0.631)
Change at Week 6 Number Analyzed 44 participants 31 participants 18 participants
-4.61  (0.805) -4.79  (0.950) -4.81  (0.474)
Change at Week 8 Number Analyzed 44 participants 31 participants 18 participants
-4.61  (0.805) -4.79  (0.950) -4.81  (0.474)
Change at Week 12 Number Analyzed 0 participants 31 participants 17 participants
-4.79  (0.950) -4.79  (0.480)
Change at Week 16 Number Analyzed 0 participants 0 participants 17 participants
-4.79  (0.480)
Change at Week 20 Number Analyzed 0 participants 0 participants 17 participants
-4.79  (0.480)
Change at Week 24 Number Analyzed 0 participants 0 participants 16 participants
-4.75  (0.466)
8.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

Virologic failure was defined as:

  • On-treatment virologic failure:

    • 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)
  • Virologic relapse:

    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame Baseline up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 45 31 19
Measure Type: Number
Unit of Measure: percentage of participants
0 0 0
9.Secondary Outcome
Title Percentage of Participants Who Developed Resistance to LDV and SOF
Hide Description [Not Specified]
Time Frame Baseline up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The Resistance Analysis Population was defined as all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. As no participant had a relapse in this study, this outcome could not be analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Pharmacokinetics (PK) Parameter: AUCtau of LDV
Hide Description AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Time Frame Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Analysis Set included all participants who took at least 1 dose of the study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 44 31 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
11923.9  (6319.41) 13632.7  (4648.74) 13542.5  (6322.88)
11.Secondary Outcome
Title PK Parameter: AUCtau of SOF
Hide Description AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Time Frame Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 24 23 12
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
2435.4  (452.83) 2296.6  (583.30) 2838.2  (438.93)
12.Secondary Outcome
Title PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
Hide Description AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Time Frame Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 44 31 19
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
234980.1  (67648.52) 269050.3  (93600.65) 280829.5  (93618.16)
13.Secondary Outcome
Title PK Parameter: Cmax of LDV
Hide Description Cmax is defined as the population PK derived maximum concentration of the drug.
Time Frame Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 44 31 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
544.2  (271.72) 618.4  (204.87) 607.0  (267.38)
14.Secondary Outcome
Title PK Parameter: Cmax of SOF
Hide Description Cmax is defined as the population PK derived maximum concentration of the drug.
Time Frame Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set with available data were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 24 23 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
1059.8  (251.74) 1005.8  (204.54) 1052.5  (295.06)
15.Secondary Outcome
Title PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
Hide Description Cmax is defined as the population PK derived maximum concentration of the drug.
Time Frame Sparse PK Samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Weeks 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=2))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set were analyzed.
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description:
Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks.
Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks.
Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
Overall Number of Participants Analyzed 44 31 19
Mean (Standard Deviation)
Unit of Measure: ng/mL
9956.3  (2846.07) 11392.7  (3938.33) 11882.4  (3951.04)
Time Frame Adverse Events: First dose date up to Week 24 plus 30 days; All-Cause Mortality: First dose date up to Posttreatment Week 24
Adverse Event Reporting Description The Safety Analysis Set included all participants who received at least 1 dose of study drug. Participants were grouped within the Safety Analysis Set according to the treatment they actually received.
 
Arm/Group Title LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Hide Arm/Group Description Treatment-naive genotype 1 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 8 weeks. Treatment-experienced genotype 1 participants and treatment-naive or treatment-experienced genotype 2 (Taiwan only), 4, 5, and 6 participants without cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 12 weeks. Participants with compensated cirrhosis received LDV/SOF (90/400 mg) FDC tablet once daily orally with or without food for 24 weeks.
All-Cause Mortality
LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/45 (6.67%)   0/31 (0.00%)   3/19 (15.79%) 
Hide Serious Adverse Events
LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/45 (8.89%)   2/31 (6.45%)   6/19 (31.58%) 
Blood and lymphatic system disorders       
Anaemia  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Cardiac disorders       
Cardiac arrest  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Cardiac valve disease  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Gastrointestinal disorders       
Duodenal ulcer haemorrhage  1  1/45 (2.22%)  0/31 (0.00%)  0/19 (0.00%) 
Haematochezia  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Haemorrhagic erosive gastritis  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Melaena  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
General disorders       
Death  1  1/45 (2.22%)  0/31 (0.00%)  1/19 (5.26%) 
Hepatobiliary disorders       
Hepatitis acute  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Infections and infestations       
Infection  1  1/45 (2.22%)  0/31 (0.00%)  0/19 (0.00%) 
Osteomyelitis  1  1/45 (2.22%)  0/31 (0.00%)  0/19 (0.00%) 
Peritonitis  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Sepsis  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  1/45 (2.22%)  0/31 (0.00%)  0/19 (0.00%) 
Arteriovenous fistula site complication  1  0/45 (0.00%)  1/31 (3.23%)  0/19 (0.00%) 
Arteriovenous fistula thrombosis  1  0/45 (0.00%)  1/31 (3.23%)  0/19 (0.00%) 
Femur fracture  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Overdose  1  1/45 (2.22%)  0/31 (0.00%)  0/19 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hepatocellular carcinoma  1  0/45 (0.00%)  1/31 (3.23%)  0/19 (0.00%) 
Psychiatric disorders       
Mental status changes  1  1/45 (2.22%)  0/31 (0.00%)  0/19 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary embolism  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF for 8 Weeks LDV/SOF for 12 Weeks LDV/SOF for 24 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/45 (51.11%)   28/31 (90.32%)   15/19 (78.95%) 
Cardiac disorders       
Atrial fibrillation  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Cardiac valve disease  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Myocardial ischaemia  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Palpitations  1  0/45 (0.00%)  1/31 (3.23%)  1/19 (5.26%) 
Ear and labyrinth disorders       
Vertigo  1  0/45 (0.00%)  1/31 (3.23%)  1/19 (5.26%) 
Eye disorders       
Cataract  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Conjunctival hyperaemia  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Glaucoma  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Gastrointestinal disorders       
Abdominal distension  1  0/45 (0.00%)  2/31 (6.45%)  0/19 (0.00%) 
Constipation  1  1/45 (2.22%)  4/31 (12.90%)  1/19 (5.26%) 
Diarrhoea  1  2/45 (4.44%)  2/31 (6.45%)  0/19 (0.00%) 
Gastrooesophageal reflux disease  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Hyperchlorhydria  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Large intestine polyp  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Nausea  1  4/45 (8.89%)  1/31 (3.23%)  1/19 (5.26%) 
Vomiting  1  4/45 (8.89%)  1/31 (3.23%)  1/19 (5.26%) 
General disorders       
Asthenia  1  1/45 (2.22%)  0/31 (0.00%)  4/19 (21.05%) 
Chest discomfort  1  0/45 (0.00%)  1/31 (3.23%)  1/19 (5.26%) 
Chest pain  1  0/45 (0.00%)  1/31 (3.23%)  1/19 (5.26%) 
Fatigue  1  3/45 (6.67%)  2/31 (6.45%)  2/19 (10.53%) 
Influenza like illness  1  1/45 (2.22%)  0/31 (0.00%)  1/19 (5.26%) 
Oedema peripheral  1  0/45 (0.00%)  1/31 (3.23%)  1/19 (5.26%) 
Pyrexia  1  1/45 (2.22%)  1/31 (3.23%)  1/19 (5.26%) 
Tenderness  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Infections and infestations       
Cellulitis  1  0/45 (0.00%)  2/31 (6.45%)  0/19 (0.00%) 
Clostridial infection  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Nasopharyngitis  1  3/45 (6.67%)  7/31 (22.58%)  1/19 (5.26%) 
Peritonitis bacterial  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Pseudomonas infection  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Shunt infection  1  1/45 (2.22%)  0/31 (0.00%)  1/19 (5.26%) 
Upper respiratory tract infection  1  2/45 (4.44%)  3/31 (9.68%)  0/19 (0.00%) 
Injury, poisoning and procedural complications       
Concussion  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Contusion  1  1/45 (2.22%)  2/31 (6.45%)  3/19 (15.79%) 
Fall  1  0/45 (0.00%)  3/31 (9.68%)  1/19 (5.26%) 
Ligament sprain  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Limb injury  1  0/45 (0.00%)  1/31 (3.23%)  2/19 (10.53%) 
Muscle strain  1  1/45 (2.22%)  0/31 (0.00%)  1/19 (5.26%) 
Shunt occlusion  1  3/45 (6.67%)  0/31 (0.00%)  1/19 (5.26%) 
Shunt stenosis  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/45 (0.00%)  1/31 (3.23%)  1/19 (5.26%) 
Hyperkalaemia  1  1/45 (2.22%)  0/31 (0.00%)  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  2/45 (4.44%)  1/31 (3.23%)  1/19 (5.26%) 
Arthritis  1  0/45 (0.00%)  2/31 (6.45%)  0/19 (0.00%) 
Muscle spasms  1  1/45 (2.22%)  7/31 (22.58%)  4/19 (21.05%) 
Musculoskeletal chest pain  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Musculoskeletal pain  1  0/45 (0.00%)  1/31 (3.23%)  1/19 (5.26%) 
Myalgia  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Pain in extremity  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Nervous system disorders       
Dizziness  1  2/45 (4.44%)  4/31 (12.90%)  1/19 (5.26%) 
Headache  1  3/45 (6.67%)  3/31 (9.68%)  2/19 (10.53%) 
Hypoaesthesia  1  1/45 (2.22%)  0/31 (0.00%)  1/19 (5.26%) 
Psychiatric disorders       
Insomnia  1  1/45 (2.22%)  4/31 (12.90%)  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/45 (6.67%)  3/31 (9.68%)  0/19 (0.00%) 
Dyspnoea  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Skin and subcutaneous tissue disorders       
Ecchymosis  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Pruritus  1  1/45 (2.22%)  3/31 (9.68%)  3/19 (15.79%) 
Rash  1  0/45 (0.00%)  1/31 (3.23%)  1/19 (5.26%) 
Rash papular  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Skin exfoliation  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
Vascular disorders       
Hypertension  1  0/45 (0.00%)  1/31 (3.23%)  1/19 (5.26%) 
Hypotension  1  0/45 (0.00%)  0/31 (0.00%)  1/19 (5.26%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
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:
Chuang W-L, Hu T-H, Buggisch P, et al. Ledipasvir/sofosbuvir for 8, 12, or 24 weeks is safe and effective in patients undergoing dialysis. J Hepatol 2019;70 (Suppl 1S):e225.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03036839    
Other Study ID Numbers: GS-US-337-4063
2016-003489-25 ( EudraCT Number )
First Submitted: January 27, 2017
First Posted: January 30, 2017
Results First Submitted: November 15, 2019
Results First Posted: December 9, 2019
Last Update Posted: March 2, 2020