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Abstract
HEPATIC AND CUTANEOUS TOXICITY ATTRIBUTED TO NEVIRAPINE (NVP)
BENNETT C, JOHNSON S, LYNCH P, LLOYD K, MURPHY R
Background: Reports of NVP-containing PEP regimens and severe skin rashes (n=10), hepatitis (n=11), and fulminant hepatic necrosis (n=1) raise concerns that NVP-associated toxicities are common.
Methods: Data on NVP-associated toxicities (n=1643) from the FDA, phase I studies, and HIV-specialists. Dermatologic (38.2%) and hepato-biliary disorders (22.1%) were the most common side effects.
Results: Hepatitis followed use of NVP-containing PEP regimens (n=15) at a median of 17.5 days, with fevers (n=10), skin rashes (n=6), and eosinophilia (n=6). Among 79 HIV-infected individuals with NVP-associated hepatitis, 89% had > 200 CD4 cells/mm3; 72% of events occurred at < 90 days; and included fulminant hepatic failure (n=16), renal syndromes (n= 26), and toxic epidermal necrolysis (n=5). Three individuals received orthotopic liver transplants and 32 died from hepatitis. Biopsies showed portal eosinophils (n=2), acute hepatic necrosis (n=14), or leucocytoclastic vasculitis of the skin (n=2). Rates of NVP-associated hepatitis were 18% for non-HIV-infected individuals (n=49), 9% for anti-retroviral naïve HIV-infected individuals (mean CD4 =360 cells/mm3 ( n=385)), and 3% for HIV-infected individuals with CD4 < 200 cells/mm3 (n=1125).
Conclusions: NVP should be targeted to persons with CD4s < 200 cells/mm3 and accompanied by liver function monitoring during the first three months of treatment.
The 1st. IAS Conference on HIV Pathogenesis and Treatment
Abstract no.
45
Suggested Citation
"BENNETTC, et al.
HEPATIC AND CUTANEOUS TOXICITY ATTRIBUTED TO NEVIRAPINE (NVP).
Oral Presentation:
The 1st. IAS Conference on HIV Pathogenesis and Treatment
:
Abstract no.
45"
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