TY - JOUR
T1 - Hepatic decompensation/serious adverse events in post-liver transplantation recipients on sofosbuvir for recurrent hepatitis C virus
AU - Patel, Neal
AU - Bichoupan, Kian
AU - Ku, Lawrence
AU - Yalamanchili, Rachana
AU - Harty, Alyson
AU - Gardenier, Donald
AU - Ng, Michel
AU - Motamed, David
AU - Khaitova, Viktoriya
AU - Bach, Nancy
AU - Chang, Charissa
AU - Grewal, Priya
AU - Bansal, Meena
AU - Agarwal, Ritu
AU - Liu, Lawrence
AU - Im, Gene
AU - Leong, Jennifer
AU - Kim-Schluger, Leona
AU - Odin, Joseph
AU - Ahmad, Jawad
AU - Friedman, Scott
AU - DIeterich, Douglas
AU - Schiano, Thomas
AU - Perumalswami, Ponni
AU - Branch, Andrea
N1 - Publisher Copyright:
© The Author(s) 2016.
PY - 2016/3/7
Y1 - 2016/3/7
N2 - 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/dL, 95%CI: 0.40-0.88, P < 0.01), estimated glomerular filtration rate (OR = 0.95 per mL/min per 1.73 m2, 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, 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.
AB - 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/dL, 95%CI: 0.40-0.88, P < 0.01), estimated glomerular filtration rate (OR = 0.95 per mL/min per 1.73 m2, 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, 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.
KW - Anemia
KW - Hepatic decompensation
KW - Hepatitis C virus
KW - Liver transplant
KW - Ribavirin
KW - Serious adverse event
KW - Sofosbuvir
UR - http://www.scopus.com/inward/record.url?scp=84959881577&partnerID=8YFLogxK
U2 - 10.3748/wjg.v22.i9.2844
DO - 10.3748/wjg.v22.i9.2844
M3 - Article
C2 - 26973423
AN - SCOPUS:84959881577
SN - 1007-9327
VL - 22
SP - 2844
EP - 2854
JO - World Journal of Gastroenterology
JF - World Journal of Gastroenterology
IS - 9
ER -