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- Title
Does Iatrogenic Scleroderma due to Injection-Site Reaction to Enfuvirtide Impair Absorption of the Drug?
- Authors
Maggi, Paolo; Filotico, Raffaele; Bonora, Stefano; Volpe, Anna; Bellacosa, Chiara; Cinori, Eliana; de Requena, Daniel Gonzalez; D'Avolio, Antonio; Perri, Giovanni Di
- Abstract
BACKGROUND: Chronic iatrogenic scleroderma is a possible obstacle to the absorption of subcutaneously administered drugs. This study correlated the clinical and histopathological pattern of injection-site reactions (ISRs) to the pharmacokinetics of enfuvirtide in patients with HIV. METHODS: Fourteen patients treated with an enfuvirtide-based antiretroviral regimen for a median of 45 weeks were enrolled and their ISRs were evaluated. Twelve patients with evidence of ISRs underwent cutaneous biopsies using a 4-mm punch. The maximum plasma enfuvirtide concentration (Cmax) and the area under the enfuvirtide concentration-time curve (AUC) were assessed using blood sampling. RESULTS: Four different macroscopic patterns of ISR were identified: A no evidence of cutaneous lesions; B transient infiltrative lesions that auto-resolved within 24 hours; C transient nodular lesions that auto-resolved within 715 days; and D stable lesions after more than 30 days. Histological examination showed three morphological patterns: (1) acute urticaria/vasculitis-like pattern, (2) subacute pattern and (3) chronic scleroderma-like pattern. No differences among patients with the various patterns of ISRs were observed, except for a higher Cmax and AUC in patients with pattern 1. CONCLUSIONS: These results confirm that although iatrogenic scleroderma is not related to impaired enfuvirtide absorption, higher Cmax and AUC values are observed in patients with urticaria/vasculitis-like patterns.
- Subjects
SCLERODERMA (Disease); ANTIRETROVIRAL agents; PHARMACOKINETICS; DRUG absorption; HIV-positive persons
- Publication
Clinical Drug Investigation, 2008, Vol 28, Issue 5, p305
- ISSN
1173-2563
- Publication type
Article
- DOI
10.2165/00044011-200828050-00004