Study Demonstrates Safety of Erythropoiesis-stimulating Agents to Manage Ribavirin-related
Anemia in Hepatitis C Patients By
Liz Highleyman  | erythropoiesis-stimulating
agents (ESAs) |  | |
Red
Blood Cells |
Hemolytic
anemia is a common treatment-limiting side effect of ribavirin
used in combination with pegylated interferon for chronic
hepatitis C. But an adequate dose of ribavirin helps prevent HCV relapse after
completion of therapy, leading physicians to use erythropoiesis-stimulating agents
(ESAs) such as Procrit to increase red blood cell production. In
November 2006, the U.S. Food and Drug Administration (FDA) issued a warning regarding
an increased
risk for serious cardiovascular complications associated in patients receiving
ESAs More recently, the agency warned that these
drugs were associated with more rapid tumor growth and increased risk of death
in people with certain types of cancer.
Noting that clinical data in other
patient populations has demonstrate increased rates of cardiovascular events,
thrombosis (clotting), malignancy, and death among ESA recipients, Canadian researchers
sought to determine whether these complications were also increased in hepatitis
C patients using ESAs to manage ribavirin-induced anemia during hepatitis C treatment.
As
reported in the July 15, 2008 issue of Clinical Infectious Diseases, the
investigators identified all recipients of combination
interferon/ribavirin therapy at the Ottawa Hospital Viral Hepatitis Clinic
between October 2003 and October 2006. During this period, patients initiated
174 total courses of anti-HCV therapy.
Predictors of ESA use were assessed using regression analysis, and adverse events
during and after treatment were evaluated. Results
•
Predictors of ESA use included older age, lower body weight, lower baseline hemoglobin
level, and infection with HCV genotypes
1 or 4.
•
88% of ESA recipients achieved targeted hemoglobin levels of > 110 g/L.
•
The sustained virological response (SVR) rate
was higher in ESA recipients compared with non-recipients (54% vs 45%, respectively),
but the difference did not reach statistical significance.
•
In the period following HCV treatment, no patients experienced myocardial infarction,
deep vein thrombosis, or pulmonary embolism.
•
The frequencies of stroke and cancer events were low overall.
•
Rates of adverse events appeared to be similar in the 2 groups.
Based
on these findings, the study authors concluded that "ESA use is not associated
with increased risk of cardiovascular events, malignancy, thrombosis, or death
in HCV-infected patients during receipt of HCV
therapy or in the period after completion." "Given
the inherent differences in patient populations, practitioners should exercise
caution when extrapolating the results of studies of other diseases to HCV infection,"
they added. "Our efficacy and safety analysis suggests against the withholding
of ESAs in the management of anemia induced by HCV treatment."
Department
of Internal Medicine and Division of Infectious Diseases, Ottawa Health Research
Institute Methods Centre, Ottawa Hospital, University of Ottawa, Ottawa, Ontario,
Canada; Damos, Hamilton, Ontario, Canada.
7/29/08
Reference
CT
Costiniuk, F Camacho, and CL Cooper. Erythropoiesis-stimulating agent use for
anemia induced by interferon-ribavirin treatment in patients with hepatitis c
virus infection is not associated with increased rates of cardiovascular disease,
thrombosis, malignancy, or death. Clinical Infectious Diseases 47(2): 198-202.
July 15, 2008. (Abstract)
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