Do Antioxidants Ameliorate Ribavirin Related Anemia in HCV Patients
Clifford A Brass, Schering Lab, Oncology Biotech, Kenilworth, NJ; E Piken, South Bay Gastroenterology, Torrance, CA
Based on a large increase in efficacy, combination therapy with inteferon a-2b plus ribavirin has become the standard of care for the treatment of chronic HCV. However, this therapy causes ribavirin induced hemolysis, which leads to a 3 gm drop in hemoglobin necessitating dose reductions in about 15% of patients. Although the exact mechanism of this hemolysis has not been defined, a leading hypothesis is that the accumulation of ribavirin in the red cell leads to an overwhelming oxidative stress. Aim: Therefore, we conducted a pilot study to see if the concurrent use of over the counter antioxidants would ameliorate the anemia seen with interferon/ribavirin therapy. Methods: Twelve consecutive treatment naive patients with chronic HCV were treated with 1,200 mg of ribavirin in 2 divided doses each day (1,000 mg if BW<75 kg) plus 3 MU interferon a-2b SQ TiW. These patients were also given over the counter preparations of vitamin C (1,000 mg) and vitamin E (800 IU) daily (AO). Controls (C) consited of 14 matched relapse patients from the same clinic who received 1,000 mg of ribavirin daily plus 3 MU interferon a-2b SQ TiW. Hemoglobin was measured pre-therapy, and at weeks, 2 4, 8, and 12. Results: Patient demographics were similar in the two groups (M/F: 9/3 in AO, 11/3 C; race C/A/H/AA= 8/2/2/0 and 11/0/2/AA). Two patients in the AO group were cirrhotic vs 1 pt in the C group. There were fewer genotype 1 patients (44%) in the AO group than the C group (77%). Hemoglobin values are shown in the table: By week 4 all the C patients had a >1 gm drop in HgB with 9/13 patients experiencing a >2 gm drop in HbB. In contrast, 7/12 and 4/12 patients in the AO group had 1 or 2 gm drops in HgB at that time. Of note, 3 patients in the control group required DR of ribavirin, but no one in the AO required DR in the 1st 4 months of therapy. Conclusions: The concomitant use of antioxidants appears to markedly delay the severity of anemia during the 1st several weeks of ribavirin/interferon a-2b therapy, when compared to both historical controls, and relapse patients within the same clinic. This effect is almost lost by week 12 of therapy. This pilot data suggests that alternative antioxidant regimens should be studied for their potential benefit in limiting ribavirin related anemia during ribavirin/interferon a-2b therapy in HCV patients.
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