Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection
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| ClinicalTrials.gov Identifier: NCT02378961 |
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Recruitment Status :
Completed
First Posted : March 4, 2015
Results First Posted : September 15, 2017
Last Update Posted : March 3, 2020
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Brief Summary:
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in adults with chronic non genotype 1 hepatitis C virus (HCV) infection.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C Virus Infection | Drug: VOX Drug: SOF/VEL | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 128 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Non-Genotype 1 HCV Infection |
| Actual Study Start Date : | February 16, 2015 |
| Actual Primary Completion Date : | September 21, 2015 |
| Actual Study Completion Date : | January 26, 2016 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Hepatitis C
Drug Information available for:
Sofosbuvir
| Arm | Intervention/treatment |
|---|---|
|
Experimental: VOX+SOF/VEL 6 wk, TN, without cirrhosis
VOX + SOF/VEL for 6 weeks (treatment naive (TN), without cirrhosis)
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Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857 Drug: SOF/VEL 400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
|
Experimental: GS-9857+SOF/VEL 6 wk, TN, with cirrhosis
GS-9857 + SOF/VEL for 6 weeks (treatment naive, with cirrhosis)
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Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857 Drug: SOF/VEL 400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
|
Experimental: VOX+SOF/VEL 8 wk, TN, with cirrhosis
GS-9857 + SOF/VEL for 8 weeks (treatment naive, with cirrhosis)
|
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857 Drug: SOF/VEL 400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
|
Experimental: VOX+SOF/VEL 8 wk,TE, without cirrhosis
GS-9857 + SOF/VEL for 8 weeks (treatment experienced (TE), without cirrhosis)
|
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857 Drug: SOF/VEL 400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
|
Experimental: VOX+SOF/VEL 12 wk, TE, without cirrhosis
VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
|
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857 Drug: SOF/VEL 400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
|
Experimental: GS-9857+SOF/VEL 8 wk, TE, with cirrhosis
GS-9857 + SOF/VEL for 8 weeks (treatment experienced, with cirrhosis)
|
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857 Drug: SOF/VEL 400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
|
Experimental: VOX+SOF/VEL 12 wk, TE, with cirrhosis
VOX + SOF/VEL for 12 weeks (treatment experienced, without cirrhosis)
|
Drug: VOX
100 mg tablet(s) administered orally once daily with food
Other Name: GS-9857 Drug: SOF/VEL 400/100 mg FDC tablet administered orally once daily with food
Other Names:
|
Primary Outcome Measures :
- Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.
- Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event [ Time Frame: Up to 12 Weeks ]
Secondary Outcome Measures :
- Percentage of Participants With Sustained Virologic Response 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.
- Percentage of Participants With HCV RNA < LLOQ on Treatment [ Time Frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) ]
- HCV RNA Change From Baseline [ Time Frame: Baseline through end of treatment (Week 6, Week 8 or Week 12, as applicable) ]
- Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
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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)
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Virologic relapse:
- Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
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Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Individuals with chronic HCV infection
- HCV RNA ≥10^4 IU/mL at screening
- HCV genotypes 2, 3, 4, 5, or 6
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two contraception methods if female of childbearing potential or sexually active male
Key Exclusion Criteria:
- Pregnant or nursing female
- Current or prior history of hepatic decompensation
- Hepatocellular carcinoma (HCC) or other clinically significant malignancy
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378961
Locations
Show 34 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Publications of Results:
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT02378961 |
| Other Study ID Numbers: |
GS-US-367-1169 |
| First Posted: | March 4, 2015 Key Record Dates |
| Results First Posted: | September 15, 2017 |
| Last Update Posted: | March 3, 2020 |
| Last Verified: | October 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | 18 months after study completion |
| Access Criteria: | A secured external environment with username, password, and RSA code. |
| URL: | https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Infections Communicable Diseases Hepatitis C Disease Attributes Pathologic Processes Hepatitis Liver Diseases Digestive System Diseases Blood-Borne Infections |
Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Sofosbuvir Sofosbuvir-velpatasvir drug combination Velpatasvir Antiviral Agents Anti-Infective Agents |