Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus

Autor: Douglas T. Dieterich, Rachana Yalamanchili, Michel Ng, Ritu Agarwal, Neal Patel, Donald Gardenier, Meena B. Bansal, Jawad Ahmad, Viktoriya Khaitova, Thomas D. Schiano, Priya Grewal, Lawrence Ku, Scott L. Friedman, Kian Bichoupan, Charissa Chang, Andrea D. Branch, Joseph A. Odin, Jennifer Leong, Gene Im, David Motamed, Leona Kim-Schluger, Ponni V. Perumalswami, Nancy Bach, Lawrence Liu, Alyson Harty
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Male
Time Factors
Sofosbuvir
Hepacivirus
medicine.medical_treatment
Kaplan-Meier Estimate
Liver transplantation
medicine.disease_cause
Gastroenterology
chemistry.chemical_compound
0302 clinical medicine
Recurrence
Risk Factors
Odds Ratio
Medicine
030212 general & internal medicine
biology
virus diseases
Anemia
General Medicine
Hepatitis C
Middle Aged
Treatment Outcome
030211 gastroenterology & hepatology
Drug Therapy
Combination
Female
medicine.drug
Adult
medicine.medical_specialty
Hepatitis C virus
Observational Study
Antiviral Agents
End Stage Liver Disease
03 medical and health sciences
Internal medicine
Ribavirin
Humans
Adverse effect
Aged
business.industry
medicine.disease
biology.organism_classification
digestive system diseases
Surgery
Liver Transplantation
Transplantation
Logistic Models
chemistry
Multivariate Analysis
Virus Activation
business
Liver Failure
Popis: To determine the safety profile of new hepatitis C virus (HCV) treatments in liver transplant (LT) recipients with recurrent HCV infection.Forty-two patients were identified with recurrent HCV infection that underwent LT at least 12 mo prior to initiating treatment with a Sofosbuvir-based regimen during December 2013-June 2014. Cases were patients who experienced hepatic decompensation and/or serious adverse events (SAE) during or within one month of completing treatment. Controls had no evidence of hepatic decompensation and/or SAE. HIV-infected patients were excluded. Cumulative incidence of decompensation/SAE was calculated using the Kaplan Meier method. Exact logistic regression analysis was used to identify factors associated with the composite outcome.Median age of the 42 patients was 60 years [Interquartile Range (IQR): 56-65 years], 33% (14/42) were female, 21% (9/42) were Hispanic, and 9% (4/42) were Black. The median time from transplant to treatment initiation was 5.4 years (IQR: 2.1-8.8 years). Thirteen patients experienced one or more episodes of hepatic decompensation and/or SAE. Anemia requiring transfusion, the most common event, occurred in 62% (8/13) patients, while 54% (7/13) decompensated. The cumulative incidence of hepatic decompensation/SAE was 31% (95%CI: 16%-41%). Risk factors for decompensation/SAE included lower pre-treatment hemoglobin (OR = 0.61 per g/dL, 95%CI: 0.40-0.88, P0.01), estimated glomerular filtration rate (OR = 0.95 per mL/min per 1.73 m(2), 95%CI: 0.90-0.99, P = 0.01), and higher baseline serum total bilirubin (OR = 2.43 per mg/dL, 95%CI: 1.17-8.65, P0.01). The sustained virological response rate for the cohort of 42 patients was 45%, while it was 31% for cases.Sofosbuvir/ribavirin will continue to be used in the post-transplant population, including those with HCV genotypes 2 and 3. Management of anemia remains an important clinical challenge.
Databáze: OpenAIRE
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