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Trial record 1 of 4 for:    Hcv polaris
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Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy (POLARIS-2)

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ClinicalTrials.gov Identifier: NCT02607800
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : November 8, 2017
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: SOF/VEL/VOX
Drug: SOF/VEL
Enrollment 943
Recruitment Details Participants were enrolled at study sites in North America, Europe, and, Asia Pacific. The first participant was screened on 16 November 2015. The last study visit occurred on 11 January 2017.
Pre-assignment Details 1116 participants were screened.
Arm/Group Title SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
Hide Arm/Group Description Sofosbuvir/Velpatasvir/Voxilaprevir (Vosevi®; SOF/VEL/VOX) (400/100/100 mg) fixed dose combination (FDC) tablet orally once daily with food for 8 weeks Sofosbuvir/Velpatasvir (Epclusa®; SOF/VEL) (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
Period Title: Overall Study
Started 502 441
Completed 492 430
Not Completed 10 11
Reason Not Completed
Lost to Follow-up             7             10
Withdrew Consent             2             0
Randomized/Enrolled but Not Treated             1             1
Arm/Group Title SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks Total
Hide Arm/Group Description SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 501 440 941
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who took at least 1 dose of the study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 501 participants 440 participants 941 participants
53  (11.1) 52  (11.9) 52  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 501 participants 440 participants 941 participants
Female
246
  49.1%
203
  46.1%
449
  47.7%
Male
255
  50.9%
237
  53.9%
492
  52.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 501 participants 440 participants 941 participants
White
391
  78.0%
365
  83.0%
756
  80.3%
Black or African American
48
   9.6%
47
  10.7%
95
  10.1%
Asian
51
  10.2%
22
   5.0%
73
   7.8%
Other
5
   1.0%
2
   0.5%
7
   0.7%
American Indian or Alaska Native
3
   0.6%
2
   0.5%
5
   0.5%
Native Hawaiian or Pacific Islander
3
   0.6%
2
   0.5%
5
   0.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 501 participants 440 participants 941 participants
Hispanic or Latino
32
   6.4%
52
  11.8%
84
   8.9%
Not Hispanic or Latino
469
  93.6%
388
  88.2%
857
  91.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 501 participants 440 participants 941 participants
New Zealand
13
   2.6%
13
   3.0%
26
   2.8%
Canada
36
   7.2%
24
   5.5%
60
   6.4%
United States
283
  56.5%
269
  61.1%
552
  58.7%
United Kingdom
24
   4.8%
23
   5.2%
47
   5.0%
Australia
13
   2.6%
11
   2.5%
24
   2.6%
France
105
  21.0%
82
  18.6%
187
  19.9%
Germany
27
   5.4%
18
   4.1%
45
   4.8%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 501 participants 440 participants 941 participants
CC
166
  33.1%
136
  30.9%
302
  32.1%
CT
253
  50.5%
245
  55.7%
498
  52.9%
TT
82
  16.4%
59
  13.4%
141
  15.0%
[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 501 participants 440 participants 941 participants
6.1  (0.75) 6.2  (0.66) 6.2  (0.71)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 501 participants 440 participants 941 participants
< 800,000 IU/mL
155
  30.9%
138
  31.4%
293
  31.1%
≥ 800,000 IU/mL
346
  69.1%
302
  68.6%
648
  68.9%
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) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: all randomized/enrolled participants who took at least 1 dose of the study drug
Arm/Group Title SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
Overall Number of Participants Analyzed 501 440
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
95.2
(93.0 to 96.9)
98.2
(96.4 to 99.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SOF/VEL/VOX 8 Weeks, SOF/VEL 12 Weeks
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Noninferiority was demonstrated if the lower bound of the 2-sided 95% confidence interval (CI) for the difference in SVR12 was greater than -5%. If the lower bound of the CI was greater than -5% (ie, the noninferiority null hypothesis was rejected), a 2-sided stratified Cochran-Mantel-Haenszel test was to be used to test for the superiority of SOF/VEL/VOX for 8 weeks over SOF/VEL for 12 weeks at a significance level of 0.05.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-6.0 to -0.4
Estimation Comments Difference in proportions between treatment groups and associated 95% CI were calculated based on stratum-adjusted Mantel-Haenszel proportions.
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinue 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/VOX 8 Weeks SOF/VEL 12 Weeks
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
Overall Number of Participants Analyzed 501 440
Measure Type: Number
Unit of Measure: percentage of participants
0 0.5
3.Secondary Outcome
Title Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide Description SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Time Frame Posttreatment Weeks 4 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) tablet orally once daily with food for 8 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
Overall Number of Participants Analyzed 501 440
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SVR4
96.4
(94.4 to 97.9)
98.9
(97.4 to 99.6)
SVR 24
95.0
(92.7 to 96.7)
98.0
(96.2 to 99.1)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ On Treatment
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 8, and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Percentage of participants in Full Analysis Set with on-treatment data were analyzed.
Arm/Group Title SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
Overall Number of Participants Analyzed 501 440
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 1 Number Analyzed 501 participants 440 participants
24.8
(21.0 to 28.8)
22.7
(18.9 to 26.9)
Week 2 Number Analyzed 501 participants 439 participants
65.9
(61.5 to 70.0)
61.3
(56.5 to 65.9)
Week 4 Number Analyzed 501 participants 439 participants
92.4
(89.7 to 94.6)
92.0
(89.1 to 94.4)
Week 8 Number Analyzed 500 participants 439 participants
99.2
(98.0 to 99.8)
99.8
(98.7 to 100.0)
Week 12 Number Analyzed 0 participants 439 participants
99.8
(98.7 to 100.0)
5.Secondary Outcome
Title Change From Baseline in HCV RNA
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 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 8 Weeks SOF/VEL 12 Weeks
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
Overall Number of Participants Analyzed 501 440
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 1 Number Analyzed 491 participants 433 participants
-4.23  (0.689) -4.24  (0.679)
Week 2 Number Analyzed 496 participants 436 participants
-4.75  (0.747) -4.77  (0.646)
Week 4 Number Analyzed 501 participants 437 participants
-4.95  (0.750) -4.99  (0.656)
Week 8 Number Analyzed 496 participants 439 participants
-4.99  (0.754) -5.03  (0.655)
Week 12 Number Analyzed 0 participants 438 participants
-5.03  (0.656)
6.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 Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks
SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
Overall Number of Participants Analyzed 501 440
Measure Type: Number
Unit of Measure: percentage of participants
4.2 0.7
Time Frame Up to 12 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
Hide Arm/Group Description SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 8 weeks SOF/VEL (400/100 mg) FDC tablet orally once daily with or without food for 12 weeks
All-Cause Mortality
SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   0/501 (0.00%)   0/440 (0.00%) 
Hide Serious Adverse Events
SOF/VEL/VOX 8 Weeks SOF/VEL 12 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   15/501 (2.99%)   7/440 (1.59%) 
Cardiac disorders     
Acute myocardial infarction  1  1/501 (0.20%)  0/440 (0.00%) 
Angina pectoris  1  0/501 (0.00%)  1/440 (0.23%) 
Atrial fibrillation  1  1/501 (0.20%)  0/440 (0.00%) 
Gastrointestinal disorders     
Small intestinal obstruction  1  1/501 (0.20%)  0/440 (0.00%) 
General disorders     
Chest pain  1  1/501 (0.20%)  0/440 (0.00%) 
Hepatobiliary disorders     
Biliary colic  1  1/501 (0.20%)  0/440 (0.00%) 
Cholelithiasis  1  1/501 (0.20%)  0/440 (0.00%) 
Infections and infestations     
Clostridium difficile colitis  1  0/501 (0.00%)  1/440 (0.23%) 
Perineal abscess  1  1/501 (0.20%)  0/440 (0.00%) 
Pneumonia  1  0/501 (0.00%)  1/440 (0.23%) 
Pyelonephritis  1  1/501 (0.20%)  1/440 (0.23%) 
Injury, poisoning and procedural complications     
Multiple fractures  1  0/501 (0.00%)  1/440 (0.23%) 
Road traffic accident  1  0/501 (0.00%)  1/440 (0.23%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  1/501 (0.20%)  0/440 (0.00%) 
Flank pain  1  0/501 (0.00%)  1/440 (0.23%) 
Musculoskeletal chest pain  1  1/501 (0.20%)  0/440 (0.00%) 
Myositis  1  0/501 (0.00%)  1/440 (0.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer  1  1/501 (0.20%)  0/440 (0.00%) 
Lung adenocarcinoma metastatic  1  1/501 (0.20%)  0/440 (0.00%) 
Nervous system disorders     
Cerebral haemorrhage  1  1/501 (0.20%)  0/440 (0.00%) 
Psychiatric disorders     
Alcohol withdrawal syndrome  1  0/501 (0.00%)  1/440 (0.23%) 
Depression  1  0/501 (0.00%)  1/440 (0.23%) 
Suicide attempt  1  0/501 (0.00%)  1/440 (0.23%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/501 (0.20%)  0/440 (0.00%) 
Vascular disorders     
Peripheral artery occlusion  1  1/501 (0.20%)  0/440 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
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 8 Weeks SOF/VEL 12 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   280/501 (55.89%)   213/440 (48.41%) 
Gastrointestinal disorders     
Diarrhoea  1  88/501 (17.56%)  32/440 (7.27%) 
Nausea  1  80/501 (15.97%)  40/440 (9.09%) 
General disorders     
Asthenia  1  32/501 (6.39%)  27/440 (6.14%) 
Fatigue  1  106/501 (21.16%)  91/440 (20.68%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  19/501 (3.79%)  24/440 (5.45%) 
Nervous system disorders     
Headache  1  134/501 (26.75%)  99/440 (22.50%) 
Psychiatric disorders     
Insomnia  1  26/501 (5.19%)  21/440 (4.77%) 
1
Term from vocabulary, MedDRA 19.0
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: Clinical Trial Disclosures
Organization: Gilead Sciences
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02607800    
Other Study ID Numbers: GS-US-367-1172
2015-003460-36 ( EudraCT Number )
First Submitted: November 16, 2015
First Posted: November 18, 2015
Results First Submitted: October 10, 2017
Results First Posted: November 8, 2017
Last Update Posted: March 5, 2019