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Clinical usage patterns of interferon therapies in the treatment of hepatitis C (HCV)
Author(s) -
Hare C. B.,
Loveland J. J.,
Chu A.,
Gotz V.,
Steffen B. J.,
Morris J. A.
Publication year - 2004
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2003.11.353
Subject(s) - medicine , ribavirin , anemia , gastroenterology , pegylated interferon , hepatitis c , adverse effect , peg ratio , incidence (geometry) , hepatitis c virus , immunology , virus , physics , finance , economics , optics
This study describes “real world” clinical usage patterns and the frequency of select hematologic side effects associated with interferon alfa 2‐b plus ribavirin (REB) and pegylated interferon alfa 2‐b (PEG‐I) plus ribavirin (RBV). Patient demographics, treatment, and adverse event data were collected from a retrospective medical record review of 998 patients with HCV. A total of 551 patients were randomly selected and 447 were provided as an augmented sample in an intent‐to‐treat analysis. Of 998 patients, 330 were initially treated with REB and 345 with PEG‐I + RBV. Risk factors were similar between the two groups except baseline liver disease, which was worse in the REB group, and ethnicity, as there were more African Americans in the REB group. Doses of both PEG‐I + RBV often differed from package insert (PI) recommendations. Rates of anemia (28% REB compared with 29% PEG‐I + RBV) and thrombocytopenia (5% vs. 8%) were similar in both treatment groups. While 92% of patients with anemia and 100% of patients with thrombocytopenia received recommended doses (or lower) of RBV, 71% of patients with anemia and 59% of patients with thrombocytopenia treated with PEG‐I + RBV received RBV doses that were higher than recommended in the PEG‐I PI (1000–1400 mg). In conclusion, the incidence of anemia and thrombocytopenia with PEG‐I + RBV therapy was nearly twice the PI‐reported frequency and was associated with higher doses of RBV prescribed to PEG‐I + RBV treated patients. Clinical Pharmacology & Therapeutics (2004) 75 , P93–P93; doi: 10.1016/j.clpt.2003.11.353