Weekly Epoetin Ups Hemoglobin Levels, QOL in Anemic Patients

February 1, 2002

CHICAGO-Once-a-week dosing of recombinant human erythropoietin (epoetin alfa, Epogen, Procrit) is as effective as thrice-weekly dosing in improving hemoglobin (Hb) levels in HIV-positive patients who are anemic, Howard A. Grossman, MD, said at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC abstract 254).

CHICAGO—Once-a-week dosing of recombinant human erythropoietin (epoetin alfa, Epogen, Procrit) is as effective as thrice-weekly dosing in improving hemoglobin (Hb) levels in HIV-positive patients who are anemic, Howard A. Grossman, MD, said at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC abstract 254).

Despite the overall improvement in the management of individuals infected with HIV through highly active antiretroviral therapy (HAART), anemia continues to be a major problem, said Dr. Grossman, associate attending physician, St. Luke’s-Roosevelt Hospital Center, and assistant clinical professor of medicine, Columbia University College of Physicians and Surgeons.

Even at mild or moderate levels, anemia reduces physical function and undermines individuals’ perceptions of their physical, psychological, and social well being. Yet treatment of anemia, particularly in its milder forms, often is overlooked in HIV-positive individuals, he said

"Anemia has gotten lost in the blur of trying to do antiretroviral therapy. But let’s face it; anemia is one of the main things physicians need to treat, because fatigue is the biggest complaint of HIV patients," he said.

A number of clinical studies have shown that administration of epoetin three times a week can improve the quality of life (QOL), halt progression of AIDS, and improve survival of HIV-positive individuals. In studies involving surgical and cancer patients, reducing the frequency of administration of epoetin to once a week has been effective and well tolerated. Weekly dosing of the medication has not been studied widely in HIV-positive patients, however.

"There are a number of benefits associated with weekly dosing," Dr. Gross-man said. "Once-a-week dosing lends itself to better adherence and the possibility of direct observed dosing in the office. Another important issue is reimbursement. Some insurance companies do not allow physicians to go off label, so it’s important to prove that once-a-week dosing of erythropoietin works for HIV patients."

Study Findings

Findings from an interim analysis of 156 patients indicate that HIV-positive individuals receiving epoetin once a week achieve the same degree of improvement in hemoglobin levels and quality of life assessments as those who take the medication three times weekly.

In this open-label study, HIV-positive patients with a hemoglobin level of 12 g/dL or less were randomized to receive 100 U/kg of epoetin three times a week or 40,000 U once a week for 16 weeks. Hemoglobin levels were assessed at baseline and at 4, 8, 12, and 16 weeks after initiation of treatment with epoetin.

Quality of life scores on the Linear Analog Scale Assessment (LASA) and the Medical Outcomes Study (MOS)-HIV Health Survey were determined at baseline and at weeks 8 and 16.

Improvement in hemoglobin and quality of life was statistically significant over baseline at week 8 (

P

< .05) for patients receiving epoetin once or three times a week. The improvement lasted throughout the 16-week study period, and it was virtually identical for both dosing frequencies.

Baseline hemoglobin was 10.4 g/dL and 10.5 g/dL for the thrice- and once-weekly treatment arms, respectively. At week 8, hemoglobin had risen to 13.1 g/dL and 13.8 g/dL in the two groups. At week 16, hemoglobin was 12.9 g/dL and 13.5 g/dL.

The change in hemoglobin was 2.5 g/dL over baseline in the thrice-weekly group of 76 evaluable patients and 2.8 g/dL in the once-weekly group of 79 evaluable patients.

Quality of Life Scores

Global quality of life scores also improved significantly in both treatment arms by week 8, and the gains were maintained throughout the 16-week study period. There was no difference in quality of life LASA scores (scale of 0 to 100 mm) between the treatment groups at week 16 (see Table). Mean overall LASA was 48 mm and 50 mm at baseline for the thrice- and once-weekly treatment arms, respectively. At week 8, both groups achieved a score of 70 mm, and at week 16, the scores were 70 mm and 69 mm.

The overall change in quality of life LASA was 22 mm for 63 evaluable patients who received epoetin three times a week and 19 mm for 69 patients who received the drug once a week.

Patients in both treatment groups exhibited the same change in scores on the MOS-HIV Health Survey (scale of 0 to 100) at weeks 8 and 16. Scores for quality of life increased 17 points over baseline in both groups when measured at week 8, and they were 13 and 15 points higher for the thrice-weekly group and once-weekly group, respectively, at week 16.

Scores reflecting patients’ perception of their physical and emotional condition rose by 24 points over baseline for the thrice-weekly treatment arm and 20 points for the once-weekly arm at week 8. At week 16, these scores were 15 and 12 points higher, respectively, over baseline.

Raising Awareness

Dr. Grossman pointed out that treating anemia requires a great deal of thought. His hope, based on his research findings, is to raise awareness among practicing physicians about when and how to treat anemia. "I’m trying to get physicians to think about anemia and treat it at an earlier point. If I see a mild anemia, I begin treatment. I don’t think that’s the standard practice right now," he said.