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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03036852
Recruitment Status : Completed
First Posted : January 30, 2017
Results First Posted : November 12, 2019
Last Update Posted : March 6, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C
Intervention Drug: SOF/VEL
Enrollment 59
Recruitment Details Participants were enrolled at study sites in Canada, the United Kingdom, Spain, Israel, New Zealand, and Australia. The first participant was screened on 22 March 2017. The last study visit occurred on 07 November 2018.
Pre-assignment Details 78 participants were screened.
Arm/Group Title SOF/VEL
Hide Arm/Group Description Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
Period Title: Overall Study
Started 59
Completed 53
Not Completed 6
Reason Not Completed
Death             2
Lack of Efficacy             2
Adverse Event             1
Lost to Follow-up             1
Arm/Group Title SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate) Total
Hide Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection Total of all reporting groups
Overall Number of Baseline Participants 25 7 16 4 2 5 59
Hide Baseline Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants 59 participants
63  (11.9) 67  (13.5) 55  (8.4) 58  (15.5) 69  (3.5) 52  (13.0) 60  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants 59 participants
Female 10 4 5 1 1 3 24
Male 15 3 11 3 1 2 35
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants 59 participants
Hispanic or Latino 2 0 0 0 0 1 3
Not Hispanic or Latino 23 7 16 4 2 4 56
Unknown or Not Reported 0 0 0 0 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants 59 participants
American Indian or Alaska Native 1 0 1 0 0 0 2
Asian 6 1 7 1 2 1 18
Native Hawaiian or Other Pacific Islander 1 0 1 0 0 0 2
Black or African American 1 2 0 2 0 1 6
White 16 4 7 1 0 3 31
More than one race 0 0 0 0 0 0 0
Unknown or Not Reported 0 0 0 0 0 0 0
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants 59 participants
CC 9 4 6 0 1 3 23
CT 14 1 8 4 1 2 30
TT 2 2 2 0 0 0 6
[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 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants 59 participants
6.0  (0.70) 5.2  (1.04) 6.4  (0.55) 5.6  (1.55) 6.4  (0.27) 4.4  (1.69) 5.8  (1.02)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants 59 participants
< 800,000 IU/mL 12 5 4 2 0 3 26
≥ 800,000 IU/mL 13 2 12 2 2 2 33
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; ie, 15 IU/mL) 12 weeks after stopping the study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set included participants who are enrolled into the study and received at least 1 dose of study drug.
Arm/Group Title SOF/VEL (Total) SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
Overall Number of Participants Analyzed 59 25 7 16 4 2 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.9
(85.9 to 98.9)
92.0
(74.0 to 99.0)
100.0
(59.0 to 100.0)
93.8
(69.8 to 99.8)
100.0
(39.8 to 100.0)
100.0
(15.8 to 100.0)
100.0
(47.8 to 100.0)
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame First dose date up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set included all participants who received at least 1 dose of study drug.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 59
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title SOF/VEL (Total) SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
Overall Number of Participants Analyzed 59 25 7 16 4 2 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.6
(88.3 to 99.6)
96.0
(79.6 to 99.9)
100.0
(59.0 to 100.0)
93.8
(69.8 to 99.8)
100.0
(39.8 to 100.0)
100.0
(15.8 to 100.0)
100.0
(47.8 to 100.0)
4.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
Hide Description SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment.
Time Frame Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title SOF/VEL (Total) SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
Overall Number of Participants Analyzed 59 25 7 16 4 2 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
94.9
(85.9 to 98.9)
92.0
(74.0 to 99.0)
100.0
(59.0 to 100.0)
93.8
(69.8 to 99.8)
100.0
(39.8 to 100.0)
100.0
(15.8 to 100.0)
100.0
(47.8 to 100.0)
5.Secondary Outcome
Title Change From Baseline in HCV RNA
Hide Description [Not Specified]
Time Frame Baseline; Weeks 2, 4, 6, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available date were analyzed.
Arm/Group Title SOF/VEL (Total) SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
Overall Number of Participants Analyzed 59 25 7 16 4 2 5
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 2 Number Analyzed 55 participants 25 participants 6 participants 13 participants 4 participants 2 participants 5 participants
-4.54  (1.017) -4.69  (0.797) -3.78  (0.840) -5.07  (0.493) -4.23  (1.333) -5.29  (0.269) -3.24  (1.668)
Change at Week 4 Number Analyzed 59 participants 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants
-4.69  (1.020) -4.81  (0.704) -4.05  (1.041) -5.20  (0.551) -4.48  (1.547) -5.29  (0.269) -3.26  (1.692)
Change at Week 6 Number Analyzed 59 participants 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants
-4.69  (1.020) -4.81  (0.704) -4.05  (1.041) -5.20  (0.551) -4.48  (1.547) -5.29  (0.269) -3.26  (1.692)
Change at Week 8 Number Analyzed 59 participants 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants
-4.69  (1.020) -4.81  (0.704) -4.05  (1.041) -5.20  (0.551) -4.48  (1.547) -5.29  (0.269) -3.26  (1.692)
Change at Week 12 Number Analyzed 59 participants 25 participants 7 participants 16 participants 4 participants 2 participants 5 participants
-4.69  (1.020) -4.81  (0.704) -4.05  (1.041) -5.20  (0.551) -4.48  (1.547) -5.29  (0.269) -3.26  (1.692)
6.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ on Treatment
Hide Description [Not Specified]
Time Frame Weeks 2, 4, 6, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title SOF/VEL (Total) SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
Overall Number of Participants Analyzed 59 25 7 16 4 2 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
67.8
(54.4 to 79.4)
76.0
(54.9 to 90.6)
85.7
(42.1 to 99.6)
43.8
(19.8 to 70.1)
50.0
(6.8 to 93.2)
100.0
(15.8 to 100.0)
80.0
(28.4 to 99.5)
Week 4
100.0
(93.9 to 100.0)
100.0
(86.3 to 100.0)
100.0
(59.0 to 100.0)
100.0
(79.4 to 100.0)
100.0
(39.8 to 100.0)
100.0
(15.8 to 100.0)
100.0
(47.8 to 100.0)
Week 6
100.0
(93.9 to 100.0)
100.0
(86.3 to 100.0)
100.0
(59.0 to 100.0)
100.0
(79.4 to 100.0)
100.0
(39.8 to 100.0)
100.0
(15.8 to 100.0)
100.0
(47.8 to 100.0)
Week 8
100.0
(93.9 to 100.0)
100.0
(86.3 to 100.0)
100.0
(59.0 to 100.0)
100.0
(79.4 to 100.0)
100.0
(39.8 to 100.0)
100.0
(15.8 to 100.0)
100.0
(47.8 to 100.0)
Week 12
100.0
(93.9 to 100.0)
100.0
(86.3 to 100.0)
100.0
(59.0 to 100.0)
100.0
(79.4 to 100.0)
100.0
(39.8 to 100.0)
100.0
(15.8 to 100.0)
100.0
(47.8 to 100.0)
7.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 to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title SOF/VEL (Total) SOF/VEL (GT-1) SOF/VEL (GT-2) SOF/VEL (GT-3) SOF/VEL (GT-4) SOF/VEL (GT-6) SOF/VEL (Indeterminate)
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 1 (GT-1) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 2 (GT-2) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 3 (GT-3) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 4 (GT-4) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with genotype 6 (GT-6) HCV infection
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks in participants with indeterminate genotype HCV infection
Overall Number of Participants Analyzed 59 25 7 16 4 2 5
Measure Type: Number
Unit of Measure: percentage of participants
3.4 4.0 0 6.3 0 0 0
8.Secondary Outcome
Title Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
Hide Description Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL.
Time Frame First dose date up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Resistance Analysis Population Set included all participants in the Safety Analysis Set with a virologic outcome and at least 1 gene sequenced. All data are reported at a 15% assay cutoff.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 58
Measure Type: Count of Participants
Unit of Measure: Participants
0
9.Secondary Outcome
Title Pharmacokinetic (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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set (all participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value for the corresponding analyte in plasma) with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of SOF.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
2381.9  (567.63)
10.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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of GS-331007 .
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
230989.2  (81453.30)
11.Secondary Outcome
Title PK Parameter: AUCtau of VEL
Hide Description AUCtau is defined as the population PK derived area under the concentration verses 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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state AUCtau of VEL.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
4279.4  (2198.77)
12.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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis set with available data were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of SOF.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: ng/mL
1041.0  (176.96)
13.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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of GS-331007.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: ng/mL
9776.2  (3433.16)
14.Secondary Outcome
Title PK Parameter: Cmax of VEL
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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Cmax of VEL.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: ng/mL
226.9  (92.80)
15.Secondary Outcome
Title PK Parameter: Ctau of VEL
Hide Description Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.
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 Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the PK Analysis Set were analyzed. Population PK analyses of all sparse and intensive PK data were utilized to estimate steady-state Ctau of VEL.
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: ng/mL
137.2  (95.91)
Time Frame Adverse Events: First dose date up to Week 12 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.
 
Arm/Group Title SOF/VEL
Hide Arm/Group Description SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
All-Cause Mortality
SOF/VEL
Affected / at Risk (%)
Total   2/59 (3.39%) 
Hide Serious Adverse Events
SOF/VEL
Affected / at Risk (%)
Total   11/59 (18.64%) 
Cardiac disorders   
Atrial fibrillation † 1  1/59 (1.69%) 
Cardiac failure congestive † 1  1/59 (1.69%) 
Infections and infestations   
Cellulitis † 1  1/59 (1.69%) 
Device related infection † 1  1/59 (1.69%) 
Lower respiratory tract infection viral † 1  1/59 (1.69%) 
Pneumonia † 1  1/59 (1.69%) 
Streptococcal bacteraemia † 1  1/59 (1.69%) 
Injury, poisoning and procedural complications   
Post procedural haemorrhage † 1  1/59 (1.69%) 
Post procedural swelling † 1  1/59 (1.69%) 
Pubis fracture † 1  1/59 (1.69%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neurilemmoma benign † 1  1/59 (1.69%) 
Psychiatric disorders   
Anxiety † 1  1/59 (1.69%) 
Depression † 1  1/59 (1.69%) 
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%
SOF/VEL
Affected / at Risk (%)
Total   33/59 (55.93%) 
Gastrointestinal disorders   
Constipation † 1  4/59 (6.78%) 
Diarrhoea † 1  3/59 (5.08%) 
Dyspepsia † 1  3/59 (5.08%) 
Gastrooesophageal reflux disease † 1  3/59 (5.08%) 
Nausea † 1  8/59 (13.56%) 
Vomiting † 1  8/59 (13.56%) 
General disorders   
Fatigue † 1  8/59 (13.56%) 
Metabolism and nutrition disorders   
Decreased appetite † 1  3/59 (5.08%) 
Musculoskeletal and connective tissue disorders   
Arthralgia † 1  4/59 (6.78%) 
Muscle spasms † 1  3/59 (5.08%) 
Nervous system disorders   
Dizziness † 1  5/59 (8.47%) 
Headache † 1  10/59 (16.95%) 
Psychiatric disorders   
Insomnia † 1  6/59 (10.17%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  5/59 (8.47%) 
1
Term from vocabulary, MedDRA 21.1
†
Indicates events were collected by systematic assessment
[Not Specified]
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:
Borgia SM, Dearden J, Lurie Y, Shafran SD, Brown A, Hyland RH, et al. Sofosbuvir/Velpatasvir for 12 Weeks Is Safe and Effective in Patients Undergoing Dialysis. American Association for the Study of Liver Diseases (AASLD); 2018 09-13 November; San Francisco, CA.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03036852    
Other Study ID Numbers: GS-US-342-4062
2016-003625-42 ( EudraCT Number )
First Submitted: January 27, 2017
First Posted: January 30, 2017
Results First Submitted: August 12, 2019
Results First Posted: November 12, 2019
Last Update Posted: March 6, 2020