Journal Article

Abacavir Expanded Access Program for Adult Patients Infected with Human Immunodeficiency Virus Type 1

Harold A. Kessler, Judy Johnson, Stephen Follansbee, Michael G. Sension, Donna Mildvan, Gladys E. Sepulveda, Nicholaos C. Bellos and Seth V. Hetherington

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 34, issue 4, pages 535-542
Published in print February 2002 | ISSN: 1058-4838
Published online February 2002 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/338638
Abacavir Expanded Access Program for Adult Patients Infected with Human Immunodeficiency Virus Type 1

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Expanded access programs (EAPs) provide medication to patients with life-threatening, treatment-refractory illnesses before regulatory approval and allow the acquisition of safety information. A 2-part, multisite EAP to evaluate abacavir, a carbocyclic nucleoside reverse-transcriptase inhibitor for use in combination antiretroviral therapy, was conducted. The EAP involved >13,000 adults infected with human immunodeficiency virus type 1 (HIV-1) who no longer responded to commercially available treatment regimens. Part A (open-label trials) examined the efficacy, safety, and tolerance of abacavir, and part B (provision of abacavir through expanded access) assessed only the occurrence of serious adverse events. By month 2 of abacavir-containing treatment, plasma HIV-1 RNA levels decreased by ⩾0.5 log10 in 31.4% of patients, and 5.6% of the patients had HIV-1 RNA levels decrease to <400 copies/mL. Drug-related serious adverse events were reported by 7.7% of patients, the most common of which were nausea, skin rash, diarrhea, malaise or fatigue, and fever. Approximately 4.6% of patients experienced a hypersensitivity reaction that was possibly drug related. Overall, the types and incidences of adverse events reported in the abacavir EAP were similar to those reported in phase 2 and 3 clinical trials evaluating abacavir.

Journal Article.  4839 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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