[133] IMPROVING QUALITY OF LIFE IN ANAEMIC, HIV-INFECTED PATIENTS DURING THE HIGHLY ACTIVE ANTIRETROVIRAL THERAPY ERA

5th International Workshop on Adverse Drug Reactions and Lipodystrophy in HIV

8–11 July 2003, Le Meridien Montparnasse, Paris, France

IMPROVING QUALITY OF LIFE IN ANAEMIC, HIV-INFECTED PATIENTS DURING THE HIGHLY ACTIVE ANTIRETROVIRAL THERAPY ERA

Antiviral Therapy 2003; 8:L87 (abstract 133)

H Grossman¹ and GJ Leitz²
¹Columbia University, New York, NY, USA; and ²Ortho Biotech Products, L.P., Bridgewater, NJ, USA

BACKGROUND: Anaemia contributes to fatigue and decreased quality of life (QOL) in HIV-infected patients. QOL has come to the forefront of HIV side-effect management due to the increasing number of antiretrovirals and their associated adverse effects. In addition, highly active antiretroviral therapy (HAART) has dramatically improved survival times in HIV, and QOL during this period is being more closely scrutinized by patients and caregivers.

OBJECTIVE: Two separate clinical trials were conducted to determine if epoetin α treatment for anaemia in HIV-infected patients can correct haemoglobin and improve QOL.

METHODS: Two community-based, open-label, multicentre clinical trials (CS1 and CS2) separately measured haemoglobin and QOL, using the Linear Analogue Scale Assessment (LASA) and the Medical Outcomes Study-HIV (MOS-HIV). LASA is a 0–100 mm scale, with 100 indicating better health. MOS-HIV measures ten dimensions of health and is scored from 0–100 points, with 100 indicating better health. CS1 randomized patients to receive epoetin α 40,000 U once weekly or epoetin α 100 U/kg thrice weekly. CS2 evaluated epoetin α 40,000 U once weekly. CS1 and CS2 had similar patient populations; there were no statistically significant differences in baseline demographics and results between the two groups in CS1. Thus, once-weekly data will be presented.

RESULTS: Mean final haemoglobin increases were 2.9 g/dl and 2.4 g/dl in CS1 and CS2, respectively (P<0.001). LASA energy increased 25 mm in CS1 and 37 mm in CS2; LASA activity increased 21 mm in both trials; and LASA overall QOL increased 19 and 20 mm in CS1 and CS2, respectively (P<0.05 for all LASA changes; all changes baseline to final). In CS1, the role function, energy/fatigue, and physical function domains of the MOS-HIV showed greatest improvement, with increases of 18, 18 and 16 points (P<0.0001), respectively. In CS2, the energy/fatigue, physical function, and social function domains showed greatest improvement, with increases of 17, 14, and 13 points (P<0.05), respectively. In CS1 there was a similar increase in QOL, even though patients entered with a higher haemoglobin than in CS2.

CONCLUSIONS: Correcting anaemia with epoetin α in HIV-infected patients resulted in improved energy and activity levels, as well as improved overall QOL.

Presenting author: H Grossman

2003-07-08
133

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