Factors That Improve the Efficacy of Epoetin Alfa for Maintenance of Ribavirin Weight-based Dosing

Patients (pts) with chronic hepatitis C (CHC) treated with ribavirin weight-based dosing (RBV WBD) (>10.6 mg/kg/day) + peginterferon (PEG-IFN) often develop pronounced anemia. Improved compliance (80% or >) results in a higher incidence of anemia and potential need for dose reduction.

During the initial 12 wks of therapy (Rx), dose reduction can result in impaired SVR. Epoetin alfa allows maintenance of RBV WBD.

The aim of this study was to identify factors that may improve the efficacy of epoetin alfa in managing anemia associated with RBV WBD + PEG-IFN in the initial 12 wks of Rx.

Consecutive pts with CHC who were Rx with RBV WBD + PEG-IFN alfa-2a 180 mcg/wk or PEG-IFN alfa-2b 1.5 mcg/kg/wk over a 12-month period were identified. New onset RBV-induced anemia was defined as hemoglobin (Hb) <12 g/dl, >3 g/dl decline in Hb from baseline, or Hb decline >2 g/dl with fatigue.

Pts had a complete blood count (CBC) every wk for the first 12 wks of Rx. Pts with anemia were treated with epoetin alfa 40K units/wk SQ until Hb returned to baseline. Pts with Hb between 10-11 g/dl despite epoetin alfa 40K units/wk SQ were treated with higher doses, 60-80K units/wk SQ until Hb returned to baseline.

Results

56 pts were identified. All pts had baseline Hb >13 g/dl. 4 pts (n=1, suicidal; n=2, platelets <30K; n=1, hyperthyroidism) were excluded due to premature discontinuation of Rx.

52 pts completed initial 12 wks of Rx. 34/52 (65%) pts met the criteria for anemia. 30/52 (58%) were managed with epoetin alfa (3/30 needed a higher doses of epoetin alfa, 60-80K units/wk SQ; 2/30 needed iron supplement). 4/34 (11%) pts with anemia were unable to obtain authorization for epoetin alfa and needed dose reduction. 18/52 (35%) remaining pts did not develop anemia.

Most pts developed anemia between wk 3 and 6 (range, 2-10 wk). Insurance authorization and delivery of epoetin alfa varied from 0 to 21 days. Timing of authorization was dependent on polices of the insurance carrier and the experience of nursing staff.

Late delivery of epoetin alfa lead to RBV dose reduction in 2/30 pts who received epoetin alfa. Weekly CBC facilitated early detection of anemia.

Conclusions

The following factors are crucial in improving the efficacy of epoetin alfa in treating anemia and maintaining RBV WBD:

·         Weekly CBC check;

·         Training of nursing staff to promptly request for epoetin alfa authorization and
      make necessary follow-up calls;

·         Insurance carrier policies;

·         Recognition of pts who may need higher doses of epoetin alfa; and

·         Supplemental iron in pts with low iron and lack of response to epoetin alfa.

05/19/04

Reference
A Ahmed and others. Factors That Improve the Efficacy of Epoetin Alfa for Maintenance of Ribavirin Weight-Based Dosing (RBV WBD). Abstract 1169. Digestive Disease Week. May 15-20, 2004. New Orleans, LA.