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RESEARCH PRODUCT
12 weeks of interferon-based therapy is feasible in patients with hepatitis C-related cirrhosis and thrombocytopenia: A post hoc analysis of eltrombopag studies.
Piero Luigi AlmasioV. BoccaccioMaria Luisa RussoSavino BrunoEdoardo GianniniParesh Sewpaulsubject
Liver CirrhosisMaleCirrhosisHepacivirusmedicine.disease_causeGastroenterologyBenzoatesSeverity of Illness IndexLiver-related complicationchemistry.chemical_compoundModel for End-Stage Liver DiseaseRisk FactorsAlbumin levelHydrazineMultivariate AnalysiAged 80 and overUnivariate analysisGastroenterologyHepatitis CMiddle AgedHydrazinesTreatment OutcomeFemaleHumanAdultmedicine.medical_specialtyLiver CirrhosiHepatitis C virusEltrombopagAlpha interferonAntiviral AgentsBenzoateInternal medicineAlbuminsRibavirinmedicineHumansLiver-related mortalityAgedAntiviral AgentHepaciviruHepatologybusiness.industryAlbuminRisk FactorRibavirinMELD scoreInterferon-alphaHepatitis C Chronicmedicine.diseaseThrombocytopeniaSurgerychemistryPyrazoleMultivariate AnalysisPyrazolesbusinessdescription
Background: A 24-48-week course of interferon-based therapy poorly tolerated in hepatitis C virus (HCV) cirrhosis patients with thrombocytopenia. Aim of the study was to identify patients at low-risk of liver-related complications over a 12-week course of interferon-based therapy. Methods: We assessed the rate of complications and death during the first 12 weeks of interferon-based therapy in HCV cirrhotics with thrombocytopenia (platelets ≤75×109/L) enrolled in the ENABLE-1 and -2 phase 3 randomised controlled trials. Results: Overall, among 1441 patients, 89 complications (6.9%) and 10 deaths (0.7%) were observed within the first 12 weeks of therapy. At univariate analysis baseline albumin levels and Model for End Stage Liver Disease (MELD) score (≤35. g/L, p<. 0.001, and ≥10, p<. 0.001, respectively) were the only predictors associated with occurrence of complications and death. Of the 1026 patients with serum albumin >35. g/L (71.2%), one patient died (0.1%) and 17 experienced liver-related complications (1.7%). Among 667 patients with serum albumin >35. g/L and MELD score <10, no deaths occurred and 4 experienced liver-related complications (0.6%). Conclusion: Among HCV cirrhotic patients with thrombocytopenia, albumin levels and MELD score can identify patients who may safely receive a 12-week course of interferon-based therapy with a low risk of complications.
year | journal | country | edition | language |
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2015-01-01 | Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver |