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Virologic response and haematologic toxicity of boceprevir‐ and telaprevir‐containing regimens in actual clinical settings
Author(s) -
Butt A. A.,
Yan P.,
Shaikh O. S.,
Freiberg M. S.,
Lo Re V.,
Justice A. C.,
Sherman K. E.
Publication year - 2015
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.12375
Subject(s) - boceprevir , telaprevir , medicine , neutropenia , ribavirin , gastroenterology , regimen , tolerability , adverse effect , sofosbuvir , hepatitis c virus , cohort , pegylated interferon , immunology , toxicity , virus
Summary Effectiveness, safety and tolerability of boceprevir ( BOC ) and telaprevir ( TPV ) in actual clinical settings remain unknown. We determined rates of sustained virologic response ( SVR ) and haematologic adverse effects among persons treated with BOC ‐ or TPV ‐containing regimens, compared with pegylated interferon/ribavirin ( PEG / RBV ). Using an established cohort of hepatitis C virus ( HCV )‐infected persons, Electronically Retrieved Cohort of HCV Infected Veterans ( ERCHIVES ), we identified those treated with a BOC ‐ or TPV ‐containing regimen and HCV genotype 1‐infected controls treated with PEG / RBV . We excluded those with HIV coinfection and missing HCV RNA values to determine SVR . Primary endpoints were SVR (undetectable HCV RNA ≥12 weeks after treatment completion) and haematologic toxicity (grade 3/4 anaemia, neutropenia and thrombocytopenia). We evaluated 2288 persons on BOC ‐, 409 on TPV ‐containing regimen and 6308 on PEG / RBV . Among these groups, respectively, 31%, 43% and 9% were treatment‐experienced; 17%, 37% and 14% had baseline cirrhosis; 63%, 54% and 48% were genotype 1a. SVR rates among noncirrhotics were as follows: treatment naïve: 65% ( BOC ), 67% ( TPV ) and 31% ( PEG / RBV ); treatment experienced: 57% ( BOC ), 54% ( TPV ) and 13% ( PEG / RBV ); ( P‐ value not significant for BOC vs TPV ; P < 0.0001 for BOC or TPV vs PEG / RBV ). Haematologic toxicities among BOC ‐, TPV ‐ and PEG / RBV ‐treated groups were as follows: grade 3/4 anaemia 7%, 11% and 3%; grade 4 thrombocytopenia 2.2%, 5.4% and 1.7%; grade 4 neutropenia 8.2%, 5.6% and 3.4%. SVR rates are higher and closer to those reported in pivotal clinical trials among BOC ‐ and TPV ‐treated persons compared with PEG / RBV ‐treated persons. Haematologic adverse events are frequent, but severe toxicity is uncommon.