824 
Epoetin-Alfa administered Once Weekly Improves Anemia in HIV/HCV Co-infected Patients Treated with Interferon/Ribavirin Therapy: A Prospective, Randomized Study
D Dieterich*1, M Sulkowski2, E Bini3, N Bräu4, C Newman5, D Alvarez6, E DeJesus7, P Bowers8, G Leitz9, and the HIV/HCV Co-infection Study Group
1Mt Sinai Med. Ctr., New York, NY, USA; 2Johns Hopkins Univ., Baltimore, MD, USA; 3New York VA Med. Ctr., NY, USA; 4Bronx VA Med. Ctr., NY, USA; 5Med. Coll. of Georgia, Augusta, GA, USA; 6Drexel Univ. Coll. of Med., Philadelphia, PA, USA; 7IDC Res. Initiative, Altamonte Springs, FL, USA; 8Johnson & Johnson Pharm. Res. and Devt., Raritan, NJ, USA; and 9Ortho Biotech Products, L.P., Bridgewater, NJ, USA
Background: Anemia is the
most common hematologic disorder in HIV-infected patients. Combination IFN/RBV therapy for chronic HCV infection is known to
induce anemia as well; therefore, co-infected patients may be at higher risk
for developing anemia. It has been demonstrated that anemia in HIV and HCV
mono-infected patients can be treated with epoetin-a (EPO) therapy. This is the first prospective, randomized study
to evaluate the effect of EPO in anemic HIV/HCV co-infected patients.
Methods: An open-label, randomized, parallel
group study was conducted in 52 anemic HIV/HCV-co-infected patients receiving
IFN/RBV. Patients who had Hb
≤12 g/dL or who experienced an Hb decrease of at least 2 g/dL from the
start of IFN/RBV therapy were
randomized to receive either EPO 40,000 IU subcutaneously once per week or no
EPO (standard of care) for 16 weeks. The primary objective of this study was to
evaluate the Hb response between EPO and standard of care groups at week 16.
Results: An interim analysis was conducted in 41
patients (n = 22 [EPO], n = 19 [standard of care]). Baseline
characteristics were similar between the 2 groups: mean age, 46.4 years; 83% men;
mean weight, 80.1 kg; 10% no ARV; 90% on HAART; 54% on AZT-containing regimen;
mean CD4+, 404.1 cells/µL [range 51 to 1062]. The mean
duration from start of IFN/RBV
therapy to randomization was 12 weeks. The mean change in Hb from baseline to
week 16 was 2.8±0.3 g/dL in the EPO
group vs 0.4±0.3 g/dL in the standard
of care group (p <0.001; table). AZT patients receiving EPO had a
similar Hb response compared with non-AZT patients receiving EPO. Serious
adverse effects occurred in 1 EPO patient (constipation) and 2 standard of care
patients (substernal chest pain, psychosis). A total of 5 (23%) EPO patients
and 7 (37%) standard of care patients dropped out within 16 weeks due to: IFN/RBV
discontinuation (5 EPO, 3 standard of care), patient request (3 standard of
care), lost to follow-up (1 standard of care).
Conclusions: Anemic
HIV/HCV co-infected patients receiving IFN/RBV
therapy demonstrated significant increases in Hb at week 16 with EPO compared
with standard of care. Similar Hb increases have been demonstrated in HIV and
HCV mono-infected patients treated with EPO.
|
Mean Hb (g/dL)
|
EPO
|
SOC
|
|
All
patients
|
(n = 22)
|
(n = 19)
|
|
Start of IFN/RBV
therapy
|
14.6±0.4
|
14.6±0.4
|
|
Baseline
|
11.0±0.3
|
11.6±0.3
|
|
Week 16
|
13.9±0.4
|
12.0±0.3
|
|
AZT
patients
|
(n = 13)
|
(n = 9)
|
|
Baseline
|
10.7±0.4
|
10.8±0.4
|
|
Week 16
|
13.7±0.5
|
11.3±0.3
|
|
Non-AZT
patients
|
(n = 9)
|
(n = 10)
|
|
Baseline
|
11.6±0.6
|
12.4±0.4
|
|
Week 16
|
14.2±0.8
|
12.6±0.5
|
Keywords: epoetin alfa; anemia; hemoglobin
