WASHINGTON — Treatment with 1 dose of epoetin alfa every other week maintained a normal hemoglobin level and was associated with a significant boost in quality of life among 292 HIV-infected patients who were anemic when they began treatment.
“Many physicians don't treat HIV-infected patients who have anemia until their hemoglobin level falls to 8 g/dL, and many physicians also think that anemia doesn't occur in HIV-infected patients who are treated with highly active antiretroviral therapy,” Patricia Salvato, M.D., said in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. Physicians also avoid using epoetin alfa because it is expensive, and they believe that their patients would prefer not to get regular subcutaneous injections.
But these results showed that maintaining a normal hemoglobin level in HIV-infected patients can have a significant impact on quality of life that “may translate into clinically meaningful improvements in functional capacity,” said Dr. Salvato, an infectious diseases physician in Houston.
The study was funded by Ortho Biotech, which markets a formulation of epoetin alfa (Procrit).
Of 292 patients who were infected with HIV and had been on a stable antiretroviral treatment regimen for at least 4 weeks, all patients had a hemoglobin level of 12 g/dL or less; the median level for patients in the study was 11.1 g/dL.
Each patient received a subcutaneous dose of 40,000 units of epoetin alfa once a week until their hemoglobin level reached the target level of at least 13 g/dL; 237 patients (81%) reached the target level. Once at this level, patients went on a maintenance regimen of 40,000 units every other week, and they were followed on this regimen for 24 weeks. Patients whose hemoglobin level dropped to 11 g/dL or less were switched back to weekly dosages until their hemoglobin again rose to at least 13 g/dL. If a patient's hemoglobin level rose to 14 g/dL or higher, treatment was stopped until the level fell below 14 g/dL.
Quality of life for each patient was measured at baseline and then at 2-week intervals using a linear analog scale. Patients also were assessed with the Medical Outcomes Study HIV Health Survey scores for physical and mental health. Complete outcome scores were collected for 208 patients.
Patients had an average hemoglobin increase of 2.6 g/dL. Compared with baseline measurements, overall quality of life scores increased by an average of 15 mm (29%) by the time patients entered the maintenance phase, and by 19 mm (37%) after 24 weeks of maintenance treatment, Dr. Salvato reported at the conference, sponsored by the American Society for Microbiology. The quality of life improvements involved both energy and activity level.
The Medical Outcomes Study HIV Health Survey scores rose by an average of 6 points (14%) for the mental-health assessment by the time patients entered the maintenance phase, and this increase was maintained through the end of the 24-week follow-up. The physical health summary score rose by an average of 4 points (10%) when patients entered maintenance, and this increase also was maintained for 24 weeks.
Adverse events that were judged related to epoetin alfa occurred in 6% of treated patients, and none were serious.