Randomized trial comparing dose reduction and growth factor supplementation for management of hematological side effects in HIV/hepatitis C virus patients receiving pegylated-interferon and ribavirin.

BACKGROUND: Pegylated-interferon (PEG-IFN) and ribavirin (RBV), current standard treatment for hepatitis C virus (HCV) infection, are frequently associated with neutropenia and anemia, leading to high treatment discontinuation rates in HIV/HCV-coinfected patients. Our objective was to compare the effectiveness of intervening with hematologic growth factors versus dose reductions of standard HCV therapy for the management of treatment-induced hematologic disorders. METHODS: Ninety-two HIV/HCV-coinfected, therapy-naive subjects received PEG-IFN alfa-2b 1.5 µg·kg⁻¹·wk⁻¹ and RBV 13 ± 2 mg·kg⁻¹·d⁻¹ for up to 48 weeks. Before treatment initiation, subjects were randomized to subsequently receive growth factors, recombinant human erythropoietin (rHuEPO) and/or granulocyte colony-stimulating factor, or dose reduction (RBV and/or PEG-IFN) for anemia and neutropenia management, respectively. We analyzed the ability of each management strategy to control anemia and neutropenia and the percentage of subjects who achieved a successful treatment outcome according to the different management strategies. RESULTS: During treatment, 43 subjects developed anemia (human erythropoietin, n = 24; dose reduction, n = 19), whereas 25 subjects developed neutropenia (granulocyte colony-stimulating factor, n = 10; dose reduction, n = 15). After the intervention, the increase in both hemoglobin and absolute neutrophil counts did not differ between the 2 side effect management strategies. Sustained response percentages were similar comparing anemic and neutropenic subjects regardless of management strategy (anemia: recombinant human erythropoietin, 29% versus dose reduction, 21%, P = 0.92; neutropenia: granulocyte colony-stimulating factor, 40% versus dose reduction, 20%, P = 0.46). CONCLUSIONS: Growth factor supplementation and dose reduction do not seem to differ as management strategies for anemia and neutropenia in HIV/HCV-coinfected individuals treated with PEG-IFN/RBV.

Smallpox: residual antibody after vaccination.

Of all the microorganisms and toxins, poxviruses (Orthopoxvirus) have the greatest potential for use by terrorists. These viruses can spread rapidly through the environment following initial infection. In 1980, the World Health Organization Eradication Program discontinued vaccination for smallpox and declared that the disease had been eliminated. With the threat of smallpox virus as a bioterrorism weapon, questions have been asked about the persistence of protection (as offered by antibodies) following vaccination with vaccinia virus vaccine. To address this, sera from 204 adults vaccinated as children were tested by enzyme immunoassay (EIA) for the presence of vaccinia virus antibody. Of the 204 individuals whose sera were examined for the presence of vaccinia antibody, 165 (80.9%) had been vaccinated once and 39 (19.1%) had been vaccinated at least twice. Of the 165 sera from individuals vaccinated once, 112 (67.9%) were positive. Of the 39 sera from individuals vaccinated more than once, 31 (79.5%) were positive. The presence of a vaccination scar at the time of blood collection was not determined. Fifty-six nonvaccinated individuals, under 30 years of age, were tested by EIA; four of these (7.1%) were positive for vaccinia virus antibody by EIA. Forty-four EIA-positive and 16 EIA-negative sera were also tested by serum neutralization (SN) as a comparison with the EIA test results; one serum (negative by EIA) was SN positive. No attempt was made to ascertain any demographics other than age (date of birth) and "remembered" times of vaccination.