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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Co-morbid diseases often present in a substantial proportion of patients with chronic hepatitis C (CHC) and require drugs to treat and control. Grazoprevir/elbavir is metabolized by cytochrome P-450 enzyme of liver. Drug-drug interactions (DDIs) are important issue before commencing direct acting antiviral agents (DAA) treatment for CHC patients. Few studies from Western countries reported that the percentages of DDIs of grazoprevir/elbasvir are limited.In Asia, real-world analysis of DDIs of grazoprevir/elbasvir is lacking and needs to be clarified.
This is a multi-center, retrospective study. Five hospitals in Taiwan and 400 patients Patients treated with grazoprevir/elbasvir during August 2017 to July 2018 are candidates of study subjects. All the required study information will be recorded with detailed chart review.
DDI will be evaluated by HEP Drug Interactions (www.hep-druginteractions.org) assessment of comidications: Category 0: Classification not possible due to lack of information; Category 1: No clinical interaction possible; Category 2: May require dose adjustment/closer monitoring; Category 3: Coadministration not recommended or contraindicated.
The assessment of DDI will be evaluated and recorded according to the suggested categories, the number of patients at risk for a clinically relevant DDI, and the ratio of patients with at least one predicted DDI between medication of grazoprevir/elbasvir will be calculated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug interaction of Elbasvir/Grazoprevir | Patients treated with elbasvir/grazoprevir will be enrolled. DDI will be evaluated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| elbasvir/grazoprevir | Drug | Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the potential drug drug interaction of elbasvir/grazoprevor | the ratio of patients with at least one predicted DDI will be analyzed. | DDI will be assessed before and through the 12 weeks or 16 weeks of elbasvir/grazoprevir treatment |
| Measure | Description | Time Frame |
|---|---|---|
| the comorbid diseases of CHC patients in Taiwan | Comorbid diseases will be recorded and categorized by involved organ systems before elbasvir/grazoprevir treatment. | Comorbid diseases will be assessed before elbasvir/grazoprevir treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients infected with genotype 1 or 4 hepatitis C virus and treated with elbasvir/grazoprevir during August 2017 to July 2018 in Taiwan.
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| Name | Affiliation | Role |
|---|---|---|
| Pin-Nan Cheng, M.D. | National Cheng-Kung University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31594667 | Derived | Liu CJ, Tseng KC, Lo CC, Tseng IH, Cheng PN. Limited drug-drug interaction of elbasvir/grazoprevir for chronic hepatitis C. J Formos Med Assoc. 2020 May;119(5):933-940. doi: 10.1016/j.jfma.2019.09.011. Epub 2019 Oct 5. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2020 | |
| Reset | Jun 8, 2020 | |
| Release | Jun 16, 2020 | |
| Reset | Jul 2, 2020 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 28, 2018 | Oct 10, 2018 | Prot_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2020 | Jun 8, 2020 | |||
| Jun 16, 2020 |
| ID | Term |
|---|---|
| C000611265 | elbasvir-grazoprevir drug combination |
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| Jul 2, 2020 |