Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection
NCT ID: NCT05092074
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-10-01
2023-02-28
Brief Summary
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Detailed Description
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Despite the efficacy and safety are excellent in patients receiving DAAs for HCV, about 1%-5% of these patients fail to successfully clear virus by DAA treatment. Retreating patients who fail to respond to DAAs with more potent DAAs would be of paramount importance for treating physicians and patients. Even since 2017, an estimated of 110,000 to 120,000 viremic patients in Taiwan have received governmental reimbursement with DAA treatment. Based on a recent report from National Hepatitis C Program (NHCP) office, about 2% of subjects in Taiwan have virologic failures to DAA treatment, which implies that about 2,200 to 2,400 HCV-infected patients remain viremic with the currently approved first-line DAA therapies. Furthermore, the majority of them have been treated with HCV non-structural 5A (NS5A)-based DAA regimens. Sofosbuvir/velpatasvir/voxilaprevir, a pangenotypic DAA regimen, serves as a rescue therapy for HCV patients who do not respond to first-line DAA treatment. The phase 3 POLARIS-1 trial which retreated HCV patients who failed to respond to NS5A-containing DAAs with SOF/VEL/VOX for 12 weeks revealed that the SVR12 rate was 96%. Among patients without cirrhosis and with compensated cirrhosis, the SVR12 rates were 99% and 93%, respectively. In addition, the phase 3 POLARIS-4 trial which retreated HCV genotype 1a and 3 patients who failed to respond to non-NS5A-containing DAAs with SOF/VEL/VOC for 12 weeks in HCV revealed that the SVR12 rates were 98% and 94%, respectively. Because all patients enrolled in the POLARIS-1 and POLARIS-4 trials who failed to prior genotype-specific DAA regimens, data regarding the effectiveness and safety of SOF/VEL/VOX for patients who failed to prior pangenotypic DAA regimens remain elusive. Two small-scale real-world studies assessing the performance of SOF/VEL/VOX for 12 weeks in patients who failed to pangenotypic SOF/VEL or glecaprevir/pibrentasvir (GLE/PIB) revealed that SVR12 rates were 100% and 94%. Nonetheless, two real-world studies in Western countries showed that the SVR12 rates of SOF/VEL/VOX for 12 weeks ranged from 95%-96% for HCV patients who failed to prior DAA therapies.
Based on the approval of governmental reimbursement of SOF/VEL/VOX retreatment for HCV genotype 1-6 patients who fail to prior NS5A-containing DAA regimens and HCV genotype 1a and 3 patients who fail to prior non-NS5A-containing DAA regimen on September 1, 2021 in Taiwan, the investigators aim to conduct a multicenter observational study to assess the real-world effectiveness and safety of SOF/VEL/VOX for 12 weeks in these patients to provide a powerful evidence to optimize the clinical practice in Taiwan.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Vosevi 400/100/100 Oral Tablet
Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX, Vosevi) 400/100/100 oral tablet: 1 table per os per day for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 20 years
* Patients with any HCV genotype (genotype 1-6 or indeterminate genotype) who failed to NS5A-containing DAA regimen or patients with HCV genotype 1a or 3 who failed to non-NS5A-containing DAA regimen
Exclusion Criteria
* Patients who receive concomitant medications which are contraindicated for SOF/VEL/VOX, and who decline to stop or switch contraindicated concomitant medications
* Patients who receive therapeutic vaccination or other investigational agents for HCV
20 Years
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chen-Hua Liu, MD
Role: STUDY_DIRECTOR
National Taiwan University Hospital
Locations
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China Medical University Beigang Hospital
Beigang, , Taiwan
Changhua Christian Hospital
Changhua, , Taiwan
Ditmanson Medical Foundation Chiayi Christian Hospital
Chiayi City, , Taiwan
St. Martin De Porres Hospital
Chiayi City, , Taiwan
Yang Ming Hospital
Chiayi City, , Taiwan
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Dalin, , Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Douliu, , Taiwan
Chi-Mei Medical Center, Liouying
Liuying, , Taiwan
Fu Jen Catholic University Hospital
New Taipei City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ke-Jhang Huang, MD
Role: primary
Wei-Wen Su, MD
Role: primary
Chi-Yi Chen, MD
Role: primary
Ching-Chu Lo, MD
Role: primary
Chia-Sheng Huang, MD
Role: primary
Kuo-Chih Tseng, MD, PhD
Role: primary
Yu-Jen Fang, MD
Role: primary
Jyh-Jou Chen, MD
Role: primary
Chi-Yang Chang, MD
Role: primary
Cheng-Yuan Peng, MD, PhD
Role: primary
Ming-Chang Tsai, MD
Role: primary
Sheng-Shun Yang, MD, PhD
Role: primary
Chen-Hua Liu, MD, PhD
Role: primary
Wei-Yu Kao, MD
Role: primary
Yu-Lueng Shih, MD, PhD
Role: primary
Other Identifiers
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202109016RIND
Identifier Type: -
Identifier Source: org_study_id