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 |
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Recruitment Status :
Completed
First Posted : November 18, 2015
Results First Posted : November 8, 2017
Last Update Posted : March 5, 2019
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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Brief Summary:
The primary objectives of this study are to compare the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed dose combination (FDC) for 8 weeks with that of SOF/VEL FDC for 12 weeks in direct-acting antiviral-naive participants with chronic hepatitis C virus (HCV) infection.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C | Drug: SOF/VEL/VOX Drug: SOF/VEL | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 943 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection |
| Actual Study Start Date : | November 16, 2015 |
| Actual Primary Completion Date : | October 10, 2016 |
| Actual Study Completion Date : | January 11, 2017 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Sofosbuvir
| Arm | Intervention/treatment |
|---|---|
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Experimental: SOF/VEL/VOX
SOF/VEL/VOX tablet for 8 weeks
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Drug: SOF/VEL/VOX
400/100/100 mg tablet administered orally once daily with food
Other Names:
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Active Comparator: SOF/VEL 12 weeks
SOF/VEL tablet for 12 weeks
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Drug: SOF/VEL
400/100 mg tablet administered orally once daily with or without food
Other Names:
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Primary Outcome Measures :
- Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) [ Time Frame: Posttreatment Week 12 ]SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
- Percentage of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event [ Time Frame: Up to 12 weeks ]
Secondary Outcome Measures :
- Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ]SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
- Percentage of Participants With HCV RNA < LLOQ On Treatment [ Time Frame: Weeks 1, 2, 4, 8, and 12 ]
- Change From Baseline in HCV RNA [ Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12 ]
- Percentage of Participants With Virologic Failure [ Time Frame: Up to Posttreatment Week 24 ]
Virologic failure was defined as:
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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:
- Willing and able to provide written informed consent
- HCV RNA ≥ 10^4 IU/mL at screening
- Chronic HCV infection (≥ 6 months)
- HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen
- Use of protocol specified methods of contraception
Key Exclusion Criteria:
- Current or prior history of clinically significant illness that may interfere with participation in the study
- Screening ECG with clinically significant abnormalities
- Laboratory parameters outside the acceptable range at screening
- Pregnant or nursing female
- Chronic liver disease not caused by HCV
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
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): NCT02607800
Locations
Show 93 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Publications of Results:
Jacobson IM, Asselah T, Nahass R, Bhandari BR, Tran A, Hyland RH, et al. A Randomized Phase 3 Trial of Sofosbuvir/Velpatasvir/Voxilaprevir for 8 Weeks Compared to Sofosbuvir/Velpatasvir for 12 Weeks in DAA-Naïve Genotype 1-6 HCV-Infected Patients: The POLARIS-2 Study [Abstract LB-12]. Hepatology AASLD Abstracts 2016;64 (6 (suppl)):1126A.
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT02607800 |
| Other Study ID Numbers: |
GS-US-367-1172 2015-003460-36 ( EudraCT Number ) |
| First Posted: | November 18, 2015 Key Record Dates |
| Results First Posted: | November 8, 2017 |
| Last Update Posted: | March 5, 2019 |
| 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/about/ethics-and-code-of-conduct/policies. |
| 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/about/ethics-and-code-of-conduct/policies |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Gilead Sciences:
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Chronic Hepatitis C Infection |
Additional relevant MeSH terms:
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Infections Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases RNA Virus Infections |
Blood-Borne Infections Communicable Diseases Flaviviridae Infections Sofosbuvir Velpatasvir Antiviral Agents Anti-Infective Agents |