Telaprevir

1
Reactions 1459 - 6 Jul 2013 S Telaprevir Acute pancreatitis: case report A 61-year-old man developed acute pancreatitis while receiving telaprevir [Telavic]. The man was admitted in June 2012, and started telaprevir 2250 mg/day [route not stated], peginterferon-α-2b and ribavirin for chronic hepatitis C virus (HCV) infection; he was also receiving allopurinol for hyperuricaemia. After starting treatment, he developed an intermittent fever thought to be a side effect of peginterferon-α-2b, and he received loxoprofen as needed. On day 3 of treatment, tests revealed minor increases in AST, ALT, creatinine and uric acid levels. The dose of allopurinol was increased for hyperuricaemia with good control, whilst AST and ALT levels improved without treatment. On day 5 of hospitalisation, tests revealed a creatinine level of 1.51 mg/dL suggesting renal dysfunction. On day 6 of hospitalisation, the man’s telaprevir dosage was decreased to 1500 mg/day. On day 8, his creatinine level improved to 1.42 mg/dL. On day 9, his telaprevir dose was increased to 2250mg. On day 10, tests revealed a creatinine level of 2.04 mg/dL, and his telaprevir dose was reduced to 1500 mg/day. He was discharged on day 15 with HCV-RNA below the detectable level. On day 17, he experienced pain in the cardiac area, and he presented with worsening of abdominal pain the following day. CT scan revealed an enlarged pancreas, while tests revealed a serum amylase level of 2905 IU/L. He was diagnosed with grade 2 acute pancreatitis and admitted. Telaprevir and ribavirin were discontinued, and he received gabexate, meropenem and hydration. The following day ribavirin was restarted after alleviation of abdominal pain and a decrease in his serum amylase level. His acute pancreatitis improved and he was discharged on day 32. On day 43, his HCV-RNA was positive, and he restarted telaprevir 1500 mg/day on day 49. His serum amylase level increased from 139 IU/L to 224 IU/L, and the telaprevir dosage was decreased to 1000 mg/day on day 52. On day 59, he presented with abdominal pain and a serum amylase level of 6134 IU/L. He was diagnosed with recurrence of acute pancreatitis and admitted. Following treatment, his abdominal pain and amylase level improved, and he was discharged on day 78. Triple antiviral therapy was discontinued. He subsequently had a temporary deterioration in pancreatitis; however, acute pancreatitis had not recurred at last follow-up. Author comment: Our case involved the onset of pancreatitis during administration of telaprevir, alleviation following suspension, and recurrence with re-administration, and since other pancreatitis causes, including other drugs (peginterferon/ribavirin) were not observed, it would be classified as definite telaprevir-induced pancreatitis according to the Ministry of Health, Labour and Welfare Individual Disease Response Manual for Serious Adverse Reactions: Acute Pancreatitis (drug-induced pancreatitis). Matsushita M, et al. A case of acute pancreatitis induced by telaprevir in the anti- HCV treatment with peginterferon and ribavirin. Kanzo 54: 340-346, No. 5, 2013. Available from: URL: http://dx.doi.org/10.2957/kanzo.54.340 [Japanese; summarised from a translation] - Japan 803089221 1 Reactions 6 Jul 2013 No. 1459 0114-9954/10/1459-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Transcript of Telaprevir

Reactions 1459 - 6 Jul 2013

STelaprevir

Acute pancreatitis: case reportA 61-year-old man developed acute pancreatitis while

receiving telaprevir [Telavic].The man was admitted in June 2012, and started telaprevir

2250 mg/day [route not stated], peginterferon-α-2b andribavirin for chronic hepatitis C virus (HCV) infection; he wasalso receiving allopurinol for hyperuricaemia. After startingtreatment, he developed an intermittent fever thought to be aside effect of peginterferon-α-2b, and he received loxoprofenas needed. On day 3 of treatment, tests revealed minorincreases in AST, ALT, creatinine and uric acid levels. The doseof allopurinol was increased for hyperuricaemia with goodcontrol, whilst AST and ALT levels improved withouttreatment. On day 5 of hospitalisation, tests revealed acreatinine level of 1.51 mg/dL suggesting renal dysfunction.

On day 6 of hospitalisation, the man’s telaprevir dosage wasdecreased to 1500 mg/day. On day 8, his creatinine levelimproved to 1.42 mg/dL. On day 9, his telaprevir dose wasincreased to 2250mg. On day 10, tests revealed a creatininelevel of 2.04 mg/dL, and his telaprevir dose was reduced to1500 mg/day. He was discharged on day 15 with HCV-RNAbelow the detectable level. On day 17, he experienced pain inthe cardiac area, and he presented with worsening ofabdominal pain the following day. CT scan revealed anenlarged pancreas, while tests revealed a serum amylase levelof 2905 IU/L. He was diagnosed with grade 2 acutepancreatitis and admitted. Telaprevir and ribavirin werediscontinued, and he received gabexate, meropenem andhydration. The following day ribavirin was restarted afteralleviation of abdominal pain and a decrease in his serumamylase level. His acute pancreatitis improved and he wasdischarged on day 32. On day 43, his HCV-RNA was positive,and he restarted telaprevir 1500 mg/day on day 49. His serumamylase level increased from 139 IU/L to 224 IU/L, and thetelaprevir dosage was decreased to 1000 mg/day on day 52.On day 59, he presented with abdominal pain and a serumamylase level of 6134 IU/L. He was diagnosed with recurrenceof acute pancreatitis and admitted. Following treatment, hisabdominal pain and amylase level improved, and he wasdischarged on day 78. Triple antiviral therapy wasdiscontinued. He subsequently had a temporary deteriorationin pancreatitis; however, acute pancreatitis had not recurred atlast follow-up.

Author comment: Our case involved the onset ofpancreatitis during administration of telaprevir, alleviationfollowing suspension, and recurrence with re-administration,and since other pancreatitis causes, including other drugs(peginterferon/ribavirin) were not observed, it would beclassified as definite telaprevir-induced pancreatitis accordingto the Ministry of Health, Labour and Welfare IndividualDisease Response Manual for Serious Adverse Reactions:Acute Pancreatitis (drug-induced pancreatitis).Matsushita M, et al. A case of acute pancreatitis induced by telaprevir in the anti-HCV treatment with peginterferon and ribavirin. Kanzo 54: 340-346, No. 5, 2013.Available from: URL: http://dx.doi.org/10.2957/kanzo.54.340 [Japanese;summarised from a translation] - Japan 803089221

1

Reactions 6 Jul 2013 No. 14590114-9954/10/1459-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved