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DELAYED RECOVERY OF PEGYLATED INTERFERON AND RIBAVIRIN INDUCED ANEMIA
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Helen Azzam, (Furqaan Ahmed, Brent Peterson, Deborah Rovner, Nicole Taylor, Ira M Jacobson), from the Weill Medical College of Cornell University, New York, NY reported on a study at AASLD (Oct 2003) that found full recovery from treatment induced reduced hemoglobin (anemia) can take a period of time after stopping HCV IFN/RBV therapy. Although many recover within 4 weeks after IFN/RBV therapy ends, some take 12 weeks, and a smaller percentage of patients may take 24 weeks to recover. A small percentage of patients in this study did not fully recover at the 24 week time after therapy. Recovery was measured as a return to hemoglobin values within 1 gm of the value before therapy started.
There is little published data on the recovery of anemia in patients with chronic hepatitis C who are treated with pegylated interferon and ribavirin. The aim of this study is to evaluate the time course of the development and recovery of pegylated interferon and ribavirin induced anemia.
This report provides data on 78 patients enrolled from one center in two U.S. multi-center studies, one in treatment-naïve patients and one in prior treatment failures. Patients were treated with three different regimens- peginterferon alfa-2b 1.5 µg/kg/week and weight-based ribavirin (800-1400 mg) daily, peginterferon alfa-2b 1.5 µg/kg/week and fixed-dose ribavirin (800 mg) daily, and peginterferon alfa-2b 1.0 µg/kg/week and weight-based ribavirin (1000-1200 mg) daily. Anemia was defined as a hemoglobin fall below 10 gm/dl.
All 78 patients had a decrease in hemoglobin (Hb) while on therapy. The mean maximum fall in Hb was 3.7 gm/dl. Sixteen (20.5%) patients became anemic with a Hb fall below 10gm/dl, and the mean time of occurrence of anemia was 122 days. Of the 16 patients who became anemic, all had follow-up data to at least 12 weeks post therapy.
When Hb recovery was defined as a return of Hb to within 1.0 gm of baseline, 38 (49%) patients in the overall group recovered by follow-up week 4, 28 (36%) patients by follow-up week 12, 7 (9%) patients by follow-up week 24 and 4 (5%) patients did not recover by follow-up week 24.
Of the patients with a fall in Hb below 10 gm during therapy, 9 patients recovered by follow-up week 4, 2 patients by follow-up week 12, one patient by follow-up week 24, and four patients did not recover by follow-up week 24.
Comparisons were made between those anemic patients who did recover to baseline Hb levels and those who did not. There were no differences between these two groups with respect to mean age, gender, race, genotype, degree of fibrosis on liver biopsy, or pegylated interferon or ribavirin dose at initiation of therapy. All anemic patients underwent ribavirin dose reduction.
Two of the anemic patients were iron deficient (defined as iron and ferritin levels below the normal range ± a low MCV). Investigation of the gastrointestinal lumen was negative in one patient with iron deficiency anemia; the other patient had an AVM in the small intestine that was thought to be the source of gastrointestinal blood loss.
Of those anemic patients in whom the Hb recovered, 74% (5/7) received erythropoietin compared with only 44% (4/9) of those who did not recover. There were four sustained responders in the recovery group, and five in the non-recovery group.
The authors concluded:
1) Recovery of hemoglobin to baseline levels may take longer in patients who have been treated with pegylated interferon and ribavirin than what has been reported for patients treated with standard interferon and ribavirin.
2) In patients treated with pegylated interferon and ribavirin, return to baseline Hb levels does not occur in all patients by follow-up weeks 12 or 24.
3) In patients in whom the anemia does recover, it may take up to 12 weeks after treatment is discontinued, to do so.
4) Erythropoietin use may facilitate recovery from anemia.
5) Further studies on anemia recovery after treatment with pegylated interferon and ribavirin are warranted.
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