[WeOrB1303] Frequency, type, severity, and duration of adverse drug events on highly-active antiretroviral therapy (HAART) in a resource-poor setting

14th International AIDS Conference

Barcelona, Spain — July 7-12, 2002

[TITLE:] Frequency, type, severity, and duration of adverse drug events on highly-active antiretroviral therapy (HAART) in a resource-poor setting

[AUTHOR(S):] H. Reuter, T. Kasper, C. Poole, V. Skefile, E. Goemaere¹

Int Conf AIDS. 2002 Jul 7-12;14:Abstract No. WeOrB1303

BACKGROUND: In May 2001, Médecins Sans Frontières began an antiretroviral therapy project in three government-run primary health care centers in Khayelitsha, a poor township of Cape Town, South Africa. Concerns that the population served (primarily poor, sick [median CD4 cell count at baseline of 48] African women, many with anemia and elevated liver functions at baseline) would suffer serious toxicity have been raised by scientists and by politicians, and have been used as a justification for withholding treatment.

METHODS: To date 85 patients have begun HAART, with 15 new enrolling per month (100% African, 67% women). Adverse events were reported to doctors at regular medical consultations and in support groups for people on HAART.

RESULTS: At medical consultations, 45% of patients (38 of 85) reported at least one adverse event (mean number reported: 1.4), while 58% (38 of 65 attending support groups) reported at least one in the support groups (mean 2.9). Laboratory screening detected abnormalities in 48% (41/85; mean 1.6). Most common adverse events reported at clinics were nausea (21% of patients), rash (19%), and headache (12%), while in support groups the most frequently mentioned were rash (27%), headache (24%), and nausea (15%). Most common lab abnormalities were neutropenia (29% of patients) and elevated liver function tests (28%). Of the adverse events reported at clinics, 87% were Grade 1, 13% Gr 2. Of the lab abnormalities, 54% were Gr 1, 21% Gr 2, 17% Gr 3, 8% Gr 4. 8 patients changed therapy for intolerance. 58% of adverse events reported at consultations were mentioned at only one visit; duration of those persisting for multiple visits was a median of one subsequent visit.

Conclusion: Two approaches to reporting adverse events show comparable results. The levels of adverse events seen in a population of sick, poor African women are similar to those seen in other groups and should not be used as a justification to withhold HAART.

Presenting author: Herman Reuter

1Medecins Sans Frontieres, PO Box 27401, Rhine Road, Sea Point, 8055, South Africa.

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