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Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

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ClinicalTrials.gov Identifier: NCT03118843
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : April 3, 2019
Last Update Posted : April 3, 2019
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 Hepatitis C Virus Infection
Intervention Drug: SOF/VEL/VOX
Enrollment 31
Recruitment Details Participants were enrolled at study sites in North America, Europe, New Zealand, and Australia. The first participant was screened on 25 April 2017. The last study visit occurred on 19 March 2018.
Pre-assignment Details 38 participants were screened.
Arm/Group Title SOF/VEL/VOX
Hide Arm/Group Description Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
Period Title: Overall Study
Started 31
Completed 31
Not Completed 0
Arm/Group Title SOF/VEL/VOX
Hide Arm/Group Description SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
Safety Analysis Set included all participants who took at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
60  (7.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
8
  25.8%
Male
23
  74.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Hispanic or Latino
2
   6.5%
Not Hispanic or Latino
29
  93.5%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 31 participants
White
25
  80.6%
Black or African American
5
  16.1%
Not Disclosed
1
   3.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
New Zealand
3
   9.7%
Canada
2
   6.5%
United States
20
  64.5%
United Kingdom
1
   3.2%
Australia
2
   6.5%
France
1
   3.2%
Germany
2
   6.5%
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Genotype 1
19
  61.3%
Genotype 2
2
   6.5%
Genotype 3
8
  25.8%
Genotype 4
1
   3.2%
Genotype 5
1
   3.2%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
CC
3
   9.7%
CT
21
  67.7%
TT
7
  22.6%
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
Cirrhosis Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Yes
15
  48.4%
No
16
  51.6%
HCV RNA (log10 IU/mL)  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 31 participants
6.5  (0.56)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
< 800,000 IU/mL
6
  19.4%
≥ 800,000 IU/mL
25
  80.6%
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 quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set included all enrolled participants who took at least 1 dose of study drug.
Arm/Group Title SOF/VEL/VOX
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(88.8 to 100.0)
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Up to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Safety Analysis Set were analyzed.
Arm/Group Title SOF/VEL/VOX
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
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
Participants in the Full Analysis Set were analyzed.
Arm/Group Title SOF/VEL/VOX
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(88.8 to 100.0)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ On Treatment
Hide Description [Not Specified]
Time Frame Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title SOF/VEL/VOX
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 2
51.6
(33.1 to 69.8)
Week 4
96.8
(83.3 to 99.9)
Week 8
100.0
(88.8 to 100.0)
Week 12
100.0
(88.8 to 100.0)
5.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 2 consecutive HCV RNA < LLOQ), 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 Up to Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set were analyzed.
Arm/Group Title SOF/VEL/VOX
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of participants
0
6.Secondary Outcome
Title Change From Baseline in HCV RNA
Hide Description [Not Specified]
Time Frame Baseline; Weeks 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL/VOX
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 2 Number Analyzed 29 participants
-5.16  (0.560)
Change at Week 4 Number Analyzed 30 participants
-5.34  (0.571)
Change at Week 8 Number Analyzed 31 participants
-5.34  (0.563)
Change at Week 12 Number Analyzed 31 participants
-5.34  (0.563)
Time Frame Adverse Events: Up to 12 weeks plus 30 days; All-Cause Mortality: Up to Posttreatment Week 12
Adverse Event Reporting Description Safety Analysis Set included all participants who took at least 1 dose of study drug.
 
Arm/Group Title SOF/VEL/VOX
Hide Arm/Group Description SOF/VEL/VOX (400/100/100 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
All-Cause Mortality
SOF/VEL/VOX
Affected / at Risk (%)
Total   0/31 (0.00%) 
Hide Serious Adverse Events
SOF/VEL/VOX
Affected / at Risk (%)
Total   1/31 (3.23%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1  1/31 (3.23%) 
General disorders   
Asthenia  1  1/31 (3.23%) 
1
Term from vocabulary, MedDRA Version 20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOF/VEL/VOX
Affected / at Risk (%)
Total   17/31 (54.84%) 
Gastrointestinal disorders   
Abdominal distension  1  2/31 (6.45%) 
Abdominal pain  1  2/31 (6.45%) 
Diarrhoea  1  2/31 (6.45%) 
Dyspepsia  1  2/31 (6.45%) 
Nausea  1  5/31 (16.13%) 
General disorders   
Fatigue  1  5/31 (16.13%) 
Pain  1  2/31 (6.45%) 
Infections and infestations   
Pneumonia  1  2/31 (6.45%) 
Upper respiratory tract infection  1  3/31 (9.68%) 
Nervous system disorders   
Headache  1  4/31 (12.90%) 
Psychiatric disorders   
Anxiety  1  2/31 (6.45%) 
Insomnia  1  2/31 (6.45%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  2/31 (6.45%) 
1
Term from vocabulary, MedDRA Version 20.1
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 of Results:
Ruane P, Strasser SJ, Gane EJ, Hyland RH, Shao J, Dvory-Sobol H, et al. Retreatment with Sofosbuvir/Velpatasvir/Voxilaprevir for 12 weeks is safe and effective for patients who have previously received Sofosbuvir/Velpatasvir or Sofosbuvir/Velpatasvir/Voxilaprevir [Abstract LBO-06]. 16th International Symposium on Viral Hepatitis and Liver Diseases (ISVHLD); 2018 14-17 June; Toronto, Canada
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03118843    
Other Study ID Numbers: GS-US-367-4181
2017-000179-98 ( EudraCT Number )
First Submitted: April 13, 2017
First Posted: April 18, 2017
Results First Submitted: March 8, 2019
Results First Posted: April 3, 2019
Last Update Posted: April 3, 2019