NEW YORK (Reuters Health) Dec 01 - Anemia that develops in patients infected with hepatitis C virus (HCV) during treatment with peginterferon-alfa and ribavirin (PEG-IFN/RBV) may be a good sign, new research hints.
In a large study, researchers found that patients who developed anemia were more likely to achieve sustained virologic response (SVR) than those who did not, despite decreased RBV dosing following a decline in hemoglobin levels. In addition, the virologic relapse rate wasn't increased in patients who cut back on RBV dose.
These data "firmly underscore the recommendation for RBV dose reduction as the primary strategy for management of treatment-related anemia," write Dr. Mark S. Sulkowski, of Johns Hopkins University School of Medicine in Baltimore, and colleagues in the November 10th issue of Gastroenterology.
They also found that the use of erythropoiesis-stimulating agents (ESAs) minimized discontinuation of treatment in patients with early-onset anemia, leading to higher SVR rates in this subgroup.
Anemia is seen in up to 30% of treated HCV patients and often leads to RBV dose reduction and/or discontinuation of treatment, Dr. Sulkowski and colleagues note in their report.
However, because lower SVR rates have been reported in patients who cut back on RBV, "many clinicians and patients prefer to avoid this strategy and instead use ESAs (off-label) to improve anemia-related symptoms while maintaining RBV dose," the investigators note.
Nonetheless, "considerable uncertainty exists regarding the role of adjuvant ESAs during HCV treatment," they point out.
Dr. Sulkowski's team evaluated the relationship between treatment-related anemia, ESA use, and treatment outcomes in 3,023 treatment-naive patients with HCV genotype 1. All were treated for up to 48 weeks with a standard PEG-IFN/RBV regimen. ESAs were allowed for patients with hemoglobin levels less than 10 g/dL after RBV dose reduction.
Anemia occurred in 28.6% of study patients. Most of these patients lowered their RBV dose and 51.9% were given an ESA.
"Unexpectedly," the investigators say, the SVR rate was significantly higher in anemic patients than nonanemic patients (difference, +12% for anemic patients).
Moreover, SVR rates were associated with the magnitude of hemoglobin decrease. SVR rates were 43.7% in patients with an absolute hemoglobin decline greater than 3 grams per deciliter compared with 29.9% in those with a maximum decline of 3 grams per deciliter.
Patients with early-onset anemia (after 8 weeks or less of treatment) had significantly higher SVR rates with ESA use than those with later onset anemia. Those with early-onset anemia were also less apt to discontinue treatment due to adverse events (12.6% vs. 30.1%; P < 0.001).
ESAs didn't affect SVR or discontinuation rates among patients with late-onset anemia, suggesting that these patients are "not likely to benefit from adjuvant ESAs," the authors note.
The finding that RBV dose reduction wasn't associated with lower SVR rates is important, they say. "ESAs should not be used solely to avoid RBV dose reduction in anemic patients."
"Prospective, randomized controlled trials are needed to define the optimal role of adjuvant ESAs during HCV treatment regimens that include PEG-IFN/RBV," they conclude.
Gastroenterology. Posted November 10, 2010. Abstract
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