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Chronic hepatitis C virus (HCV) infection, an important cause of morbidity and mortality worldwide, is a significant problem in kidney transplant recipients (KTRs) given its high prevalence in patients undergoing hemodialysis. Interferon based regimens were cornerstone of treatment of HCV infection in the past; however, due to their low efficacy and high rates of adverse effects, they have been abandoned in the new era of direct acting antivirals (DAAs). Several studies demonstrated the efficacy and safety of DAAs, yet data regarding clinical practice of these agents in KTRs is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of DAAs in KTRs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group | Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals. |
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| Measure | Description | Time Frame |
|---|---|---|
| SVR12 | Undetectable levels of HCV RNA for 12 weeks after the end of treatment with direct acting antivirals. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Stable Graft Function | Stability of serum creatinine and proteinuria levels of kidney transplant recipients during and after the treatment with direct acting antivirals. | 6-12 months |
| Stable Serum Trough Levels of Immunosuppressive Agents |
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Inclusion Criteria:
Exclusion Criteria:
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Kidney transplant recipients with chronic HCV infection who were treated using direct acting antivirals.
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| Name | Affiliation | Role |
|---|---|---|
| Safak Mirioglu, MD | Department of Internal Medicine, Istanbul Faculty of Medicine | Principal Investigator |
| Halil Yazici, MD | Department of Internal Medicine, Istanbul Faculty of Medicine | Study Chair |
| Sabahattin Kaymakoglu, MD | Department of Internal Medicine, Istanbul Faculty of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27842383 | Background | Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, Yun C, Massetto B, Brainard DM, McHutchison JG, Bourliere M, Peck-Radosavljevic M, Manns M, Pol S. Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. Ann Intern Med. 2017 Jan 17;166(2):109-117. doi: 10.7326/M16-1205. Epub 2016 Nov 15. |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Stability of serum trough levels of calcineurin and mTOR inhibitors during the treatment with direct acting antivirals.
| 6 months |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |