Recombinant human erythropoietin in an Italian cohort of anaemic HIV- infected patients taking zidovudine

Twenty-one HIV-infected patients were enrolled in an open trial to assess the safety and efficacy of recombinant human erythropoietin (r-HuEPO) in treating zidovudine (AZT)-related anaemia. Eleven patients successfully completed the 6-month study, achieving mean increases of 3.4 g/dL in haemoglobin and of 10.1 percentage points in haematocrit. The only side effect that was possibly related to treatment was transient headache, reported by 2 patients. For the 10 patients who failed to complete the trial, treatment was discontinued in 6 cases due to development of opportunistic infections [Pneumocystis carinii pneumonia (PCP) in 3 cases, neuromeningeal cryptococcosis in 1, Escherichia coli in 1, and neural toxoplasmosis in 1]; 3 failed to respond to treatment (2 with baseline erythropoietin levels <500 U/L and 1 with baseline erythropoietin of more than 2900 U/L); and 1 patient developed a psychosis, for which she had been treated many times since adolescence. In contrast to other studies reported in the literature, the baseline erythropoietin levels of our patients were lower (<100 U/L in 15 cases and <500 U/L in all but one case), and there was no correlation between haemoglobin at enrollment and the baseline erythropoietin level. Nevertheless, this study demonstrates the excellent tolerance of r-HuEPO and its effectiveness in treating HIV/AZT-related anaemia.