The Body Covers: The XIV International AIDS Conference
Once-Weekly Epoetin Alfa Corrects Hemoglobin as Effectively as Thrice Weekly
July 11, 2002
As the use of highly active antiretroviral therapy (HAART) has improved the overall health of patients with HIV, anemia has been perceived as a less important clinical issue. However, anemia remains a common and quite real problem for patients, particularly those with advanced disease who are least able to cope with additional physical setbacks. Anemia also has a detrimental impact on the progression of HIV disease. An inverse relationship exists between anemia and survival among patients with HIV. Recently, it has been shown that HIV-positive patients who recovered from anemia had a significantly longer survival time compared to those who remained anemic.1
Recombinant Human Erythropoietin (epoetin alpha, Procrit) is both biologically and immunologically indistinguishable from naturally occurring erythropoietin. Epoetin alfa (Procrit) stimulates the production of new red blood cells in the bone marrow.
The safety and efficacy of epoetin alfa (Procrit) have been well established in a variety of clinical trials, and over the past decade, it has been used in over one million patients in the United States.
The thrice-weekly dosing schedule in anemic HIV-positive patients receiving zidovudine (AZT) has been shown to correct the anemia, decrease blood transfusion requirements, and improve quality of life. Once-weekly epoetin alpha (Procrit) has been shown to be similar to thrice-weekly dosing in increasing hemoglobin and improving quality of life in cancer patients receiving chemotherapy.
The present study compared the effect of QW (once-weekly) versus TIW (thrice-weekly) administration of epoetin alpha (Procrit) on hemoglobin levels and quality of life (QOL) in HIV-positive patients receiving stable antiretroviral therapy. The study was done to see if the more convenient once-weekly dosing schedule was as effective as the thrice-weekly schedule.
The present study is similar in design to a study done by the CHAMPS study group and presented at the 39th annual meeting of the Infectious Diseases Society of America in October 2001.2 Michael Saag, M.D., et al. in the CHAMPS study showed that once-weekly dosing for 16 weeks increased hemoglobin by at least one g/dL in 75 percent of patients with a mean rise in hemoglobin of 2.7 g/dL.
The once-weekly epoetin alpha (Procrit) dosing schedule was found to be efficacious in HIV-positive patients on antiretroviral therapy with or without AZT and across all races. Epoetin alpha (Procrit) increased hemoglobin levels independent of baseline CD4+ cell count, viral load, and change in CD4+ cell count, indicating its effects are independent of these parameters. As the hemoglobin increased, quality of life improved proportionately in a statistically significant fashion. The maximum increase in quality of life parameters occurred when the hemoglobin level was increased to 10-12 g/dL.
Results of Present Study
In the present study, Dr. Grossman and colleagues report a preliminary analysis of their final data results of 269 anemic (hemoglobin less than 12 g/dL) HIV-positive patients on stable antiretroviral therapy randomized to receive epoetin alpha (Procrit) either once-weekly (40,000 units) or thrice-weekly (100 units/kg).
Improvement in hemoglobin levels and quality of life was found to be similar and highly significant for both dosing regimens with no statistically significant differences noted between the two groups. This randomized prospective open-label study provided a direct comparison of therapeutic efficacy and tolerability of once-weekly versus thrice-weekly administration of epoetin alpha (Procrit) in anemic HIV-positive patients.
The mean increase in hemoglobin was 2.5 g/dL in the TIW group and 2.8 g/dL in the QW group. In both groups, the hemoglobin continued to rise until week 12 and was maintained for the duration of the study (16 weeks). Overall, the quality of life improved significantly in both treatment groups by week eight and was maintained, again, for the duration of the study. These results clearly indicate that, as in the CHAMPS study, the more convenient once-weekly dosing schedule is equally effective as thrice-weekly in increasing hemoglobin levels and improving quality of life. Both once-weekly and thrice-weekly administration of epoetin alpha (Procrit) were found to be equally safe and well tolerated.
Taken together, these two studies in HIV-positive anemic patients, coupled with similar findings in anemic cancer patients receiving chemotherapy, indicate that the convenient once-weekly dosing of epoetin alpha (Procrit) is comparable to thrice-weekly dosing in:
in patients with HIV, regardless of AZT use, CD4+ cell count, or plasma viral load.
The importance of this study for both physicians and patients is that it provides compelling evidence of the efficacy and safety of the more convenient once-weekly dosing schedule. Further, the study suggests that the effect is seen independent of the use of AZT or prognostic markers, such as CD4+ cell count or plasma viral load.
Despite important advances in antiretroviral therapy (HAART), anemia remains a common and significant problem for many HIV-infected people. Anemia has a deleterious effect on both functional capacity and quality of life, and has been associated with shortened survival (increased mortality). Not only is HIV-associated anemia an important contributor to morbidity and mortality, recent reports indicate that recovering from anemia is associated with improved quality of life and survival. Despite this, the majority of AIDS-treating physicians tend to view fatigue, a primary marker for anemia, as one of the least significant consequences of HIV infection and its treatment. This is particularly startling given the importance people living with HIV place on the symptoms of anemia.3
This study, along with the Anemia in HIV Working Group Consensus Statement, are a call to action for HIV-treating physicians and people living with HIV to be more aware of the decrement in quality of life caused by HIV-associated anemia and the benefits of treating even mild to moderate anemia in the setting of HIV disease. Monitoring for anemia at regular intervals as HIV disease progresses or as therapy changes, and maintaining normal hemoglobin levels are essential for optimal care. The normal range of hemoglobin for men is 14-18 g/dL and, for women, 12-16 g/dL.
Epoetin alpha (Procrit) is a highly effective and safe treatment for chronic HIV-associated anemia. It has been shown to reduce transfusion requirements, improve quality of life, and enhance the ability to perform daily activities. The current study conclusively demonstrates that the once-weekly dosing schedule, while offering significant advantages in terms of convenience, is equally safe and effective as the previously recommended three-times-per-week dosing regimen.
Dosing convenience is firmly linked to adherence and consequently, this more convenient, equally efficacious regimen can be expected to improve compliance. Medication regimens for patients with HIV disease are frequently complex and rigorous. Any improvement in dosing convenience would be warmly welcomed by both prescribing physicians and people living with HIV.
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