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| Name | Class |
|---|---|
| MSD France | INDUSTRY |
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Retrospective Efficacy and Safety Study With Elbasvir (EBR) 50 mg/Grazoprevir (GZR) 100 mg in Hepatitis C Virus (HCV)-infected Patients With Chronic Kidney Disease (CKD) Stage 4-5 During the French Temporary Authorization for Use (ATU) Program: Data From Real-life
Primary objective : Retrospectively collect and describe the real life efficacy (SVR 12)* and safety data of EBR 50 mg/GZR 100 mg based therapy, 12 or 16 weeks dosed in HCV-infected patients with chronic kidney disease. These data are collected following French ATU allocation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elbasvir and Grazoprevir | Drug | Elbasvir 50 mg and grazoprevir 100 mg during the French temporary authorization for use (ATU) program |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Elbasvir (EBR)/Grazoprevir (GZR) | Describe the real life efficacy (Sustained Virologic Response SVR 12) of EBR 50 mg/GZR 100 mg based therapy by assessment of the HCV RNA | 12 weeks after the end of all study therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety during treatment | Assessment of all Adverse Events and laboratory tests collected during treatment | during treatment |
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Inclusion Criteria:
documented chronic (at least 6 months) HCV Genotype1 (GT1) and Genotype 4 (GT4) infection
Mono infected by HCV or co-infected by HCV and HIV
Have an HCV treatment status corresponding to one of the following:
Have CKD defined as:
Subjects with glomerular filtration rate (GFR) ≤30 ml/min who are non-dialysis dependent (NDD) or have been on hemodialysis (HD) for at least 3 months (including subjects awaiting kidney transplant and subjects with failed kidney transplants no longer on immunosuppressant therapy).
Exclusion Criteria:
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CKD subjects with GT1 and GT4 HCV, compensated cirrhotic or non-cirrhotic (i.e all subjects with EBR 50 mg/GZR 100 mg based therapy in ATU allocation) will be included in this retrospective analysis
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| Name | Affiliation | Role |
|---|---|---|
| Laurent ALRIC, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Caen | 14000 | France | |||
| University Hospital Toulouse |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C000611265 | elbasvir-grazoprevir drug combination |
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| Toulouse |
| 31059 |
| France |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |