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

• Published in: Clinical infectious diseases Vol. 34; no. 4; pp. 535 - 542
• Main Authors: Kessler, Harold A., Johnson, Judy, Follansbee, Stephen, Sension, Michael G., Mildvan, Donna, Sepulveda, Gladys E., Bellos, Nicholaos C., Hetherington, Seth V.
• Format: Journal Article
• Language: English
• Published: Chicago, IL The University of Chicago Press 15-02-2002; University of Chicago Press
• Subjects: Adult; AIDS; Anti-HIV Agents - adverse effects; Anti-HIV Agents - therapeutic use; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antiretrovirals; Antiviral agents; Antivirals; Biological and medical sciences; Dideoxynucleosides - adverse effects; Dideoxynucleosides - therapeutic use; Drug Hypersensitivity; Drug Therapy, Combination; Employee assistance programs; Exanthema; Female; Health Services Accessibility; HIV; HIV 1; HIV Infections - drug therapy; HIV Infections - mortality; HIV/AIDS; Human viral diseases; Humans; Hypersensitive response; Infectious diseases; Male; Medical sciences; Nausea; Pharmacology. Drug treatments; RNA; Treatment Outcome; Viral diseases; Viral diseases of the lymphoid tissue and the blood. Aids; Purine nucleoside; Demography; Accessibility; HIV-1 virus; Toxicity; Reverse transcriptase inhibitor; Secondary effect; Adult; Antiviral; Human; Immunopathology; Sanitary program; Treatment efficiency; Retroviridae; Enzyme inhibitor; AIDS; Immune deficiency; Lentivirus; Care; Infection; Virus; Chemotherapy; Treatment; International organization; Viral disease; Abacavir; Human immunodeficiency virus; Nucleosidic analog
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1086/338638

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.