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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

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ClinicalTrials.gov Identifier: NCT02671500
Recruitment Status : Completed
First Posted : February 2, 2016
Results First Posted : January 8, 2019
Last Update Posted : January 8, 2019
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: SOF/VEL
Enrollment 375
Recruitment Details Participants were enrolled at study sites in Asia. The first participant was screened on 19 April 2016. The last study visit occurred on 27 March 2018.
Pre-assignment Details 437 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 375
Completed 361
Not Completed 14
Reason Not Completed
Lack of Efficacy             12
Lost to Follow-up             2
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 Baseline Participants 375
Hide Baseline Analysis Population Description
Safety Analysis Set included participants who were enrolled into the study and received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 375 participants
45  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants
Female
178
  47.5%
Male
197
  52.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
374
  99.7%
Unknown or Not Reported
1
   0.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants
American Indian or Alaska Native
0
   0.0%
Asian
375
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants
Vietnam
36
   9.6%
Singapore
22
   5.9%
China
264
  70.4%
Malaysia
12
   3.2%
Thailand
41
  10.9%
HCV genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants
Genotype 1
129
  34.4%
Genotype 2
64
  17.1%
Genotype 3
84
  22.4%
Genotype 6
98
  26.1%
IL28b Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants
CC
320
  85.3%
CT
53
  14.1%
TT
2
   0.5%
HCV RNA (log10 international units per milliliter [IU/mL])  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 375 participants
6.2  (0.86)
HCV RNA Category   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 375 participants
< 800,000 IU/mL
116
  30.9%
≥ 800,000 IU/mL
259
  69.1%
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
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 participants who were enrolled into the study and received at least 1 dose of study drug.
Arm/Group Title SOF/VEL (Overall) SOF/VEL (China - Region 1) SOF/VEL (Southeast Asia - Region 2)
Hide Arm/Group Description:
All participants received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
All participants in China received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
All participants in Southeast Asia (Malaysia, Singapore, Thailand, and Vietnam) received SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
Overall Number of Participants Analyzed 375 264 111
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
96.5
(94.1 to 98.1)
96.2
(93.1 to 98.2)
97.3
(92.3 to 99.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SOF/VEL (China - Region 1)
Comments A sample size of 260 participants in Region 1 would provide more than 80% power to detect an improvement of at least 6 percentage points in SVR12 rate from the performance goal of 85% by using a two-sided exact one-sample binomial test at the significance level of 0.05.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method 2-sided 1 sample exact binomial test
Comments [Not Specified]
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 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title SOF/VEL
Hide Arm/Group Description:
SOF/VEL (400/100 mg) fixed-dose combination (FDC) tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 375
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
Full Analysis Set
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 375
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
97.1
(94.8 to 98.5)
4.Secondary Outcome
Title Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24)
Hide Description SVR 24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Time Frame Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
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 375
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.5
(94.1 to 98.1)
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ On Treatment
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 6, 8, 10, 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
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 375
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
Week 1 Number Analyzed 375 participants
27.7
(23.3 to 32.6)
Week 2 Number Analyzed 374 participants
73.8
(69.0 to 78.2)
Week 4 Number Analyzed 374 participants
95.5
(92.8 to 97.3)
Week 6 Number Analyzed 374 participants
99.7
(98.5 to 100.0)
Week 8 Number Analyzed 374 participants
100.0
(99.0 to 100.0)
Week 10 Number Analyzed 374 participants
100.0
(99.0 to 100.0)
Week 12 Number Analyzed 374 participants
100.0
(99.0 to 100.0)
6.Secondary Outcome
Title Change From Baseline in HCV RNA
Hide Description [Not Specified]
Time Frame Baseline and up to Week 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
Hide Arm/Group Description:
SOF/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks
Overall Number of Participants Analyzed 374
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Change at Week 1 Number Analyzed 369 participants
-4.38  (0.705)
Change at Week 2 Number Analyzed 371 participants
-4.89  (0.822)
Change at Week 4 Number Analyzed 374 participants
-5.02  (0.849)
Change at Week 6 Number Analyzed 374 participants
-5.03  (0.857)
Change at Week 8 Number Analyzed 374 participants
-5.03  (0.857)
Change at Week 10 Number Analyzed 374 participants
-5.03  (0.857)
Change at Week 12 Number Analyzed 374 participants
-5.03  (0.857)
7.Secondary Outcome
Title Percentage of Participants With Overall Virologic Failure
Hide Description Virologic failure was defined as: (1) 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) or (2) 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 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
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 375
Measure Type: Number
Unit of Measure: percentage of participants
3.2
Time Frame Up to 12 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set included participants who were enrolled into the study and received at least 1 dose of study drug.
 
Arm/Group Title SOL/VEL
Hide Arm/Group Description SOL/VEL (400/100 mg) FDC tablet orally once daily for 12 weeks.
All-Cause Mortality
SOL/VEL
Affected / at Risk (%)
Total   0/375 (0.00%) 
Hide Serious Adverse Events
SOL/VEL
Affected / at Risk (%)
Total   3/375 (0.80%) 
Infections and infestations   
Diabetic foot infection  1  1/375 (0.27%) 
Pneumonia  1  1/375 (0.27%) 
Injury, poisoning and procedural complications   
Ligament rupture  1  1/375 (0.27%) 
1
Term from vocabulary, MedDRA (20.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOL/VEL
Affected / at Risk (%)
Total   36/375 (9.60%) 
Infections and infestations   
Upper respiratory tract infection  1  36/375 (9.60%) 
1
Term from vocabulary, MedDRA (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:
Lim SG, Rosmawati M, Phuong L, Hoi PT, McNabb BL, Lu S, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in a Genotype 1-6 HCV Infected Population from Singapore, Malaysia, Thailand, and Vietnam: Results from a Phase 3, Clinical Trial [Abstract 1094]. Hepatology 2017; 66 (1 Suppl): 586A.
Wei L, Xie Q, Huang Y, Wu S, Xu M, Tang H, et al. Safety and Efficacy of Sofosbuvir/Velpatasvir in Genotype 1-6 HCV-Infected Patients in China: Results from a Phase 3 Clinical Trial. [Abstract 637]. Hepatology 2018; 68 (1 Suppl): 379A.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02671500    
Other Study ID Numbers: GS-US-342-1518
First Submitted: January 29, 2016
First Posted: February 2, 2016
Results First Submitted: December 20, 2018
Results First Posted: January 8, 2019
Last Update Posted: January 8, 2019