Abacavir expanded access program for adult patients infected with human immunodeficiency virus type 1.
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 > or =0.5 log(10) 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.
Kessler
Harold A
HA
Rush Presbyterian St. Luke's Medical Center, Section of Infectious Diseases, Chicago, IL, USA.
Johnson
Judy
J
Follansbee
Stephen
S
Sension
Michael G
MG
Mildvan
Donna
D
Sepulveda
Gladys E
GE
Bellos
Nicholaos C
NC
Hetherington
Seth V
SV
D000328:Adult; D019380:Anti-HIV Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015224:Dideoxynucleosides / Q000009:adverse effects / Q000627:therapeutic use*; D004342:Drug Hypersensitivity; D004359:Drug Therapy, Combination; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality; D015497:HIV-1; D006297:Health Services Accessibility; D006801:Humans; D008297:Male; D016896:Treatment Outcome; D000099227:Abacavir
D019380:Anti-HIV Agents; D015224:Dideoxynucleosides; D000099227:Abacavir