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AIM: To determine the safety profile of new hepatitis C virus(HCV) treatments in liver transplant(LT) recipients with recurrent HCV infection.METHODS: 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. HIVinfected 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. RESULTS: 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/d L, 95%CI: 0.40-0.88, P < 0.01), estimated glomerular filtration rate(OR = 0.95 per m L/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/d L, 95%CI: 1.17-8.65, P < 0.01). The sustained virological response rate for the cohort of 42 patients was 45%, while it was 31% for cases.CONCLUSION: 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.
AIM: To determine the safety profile of new hepatitis C virus (HCV) treatments in liver transplant (LT) recipients with recurrent HCV infection. METHODS: 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 finishing treatment. Controls had no evidence of hepatic decompensation and / or SAE . 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. RESULTS: 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 initiatio 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 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 / 95% CI: 0.40-0.88, P <0.01), estimated glomerular filtration rate (OR = 0.95 per m L / min per 1.73 m 2, 95% CI: 0.90-0.99, P = 0.01) The sustained virological response rate for the cohort of 42 patients was 45%, while it was 31% for cases. CONCLUSION: 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.