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, Seth V. Hetherington

Research output: Contribution to journalArticlepeer-review

22 Scopus citations

Abstract

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 anti-retroviral 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.

Original languageEnglish
Pages (from-to)535-542
Number of pages8
JournalClinical Infectious Diseases
Volume34
Issue number4
DOIs
StatePublished - 15 Feb 2002
Externally publishedYes

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