Does iatrogenic scleroderma due to injection-site reaction to enfuvirtide impair absorption of the drug?

Clinical Drug Investigation
Paolo MaggiGiovanni Di Perri

Abstract

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. 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. 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 7-15 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. ...Continue Reading

References

Mar 15, 2003·The New England Journal of Medicine·Jacob P LalezariUNKNOWN TORO 1 Study Group
May 30, 2003·The New England Journal of Medicine·Adriano LazzarinUNKNOWN TORO 2 Study Group
Sep 6, 2003·Journal of Clinical Virology : the Official Publication of the Pan American Society for Clinical Virology·Jacob P LalezariTosca Kinchelow
Feb 27, 2004·The Journal of Antimicrobial Chemotherapy·Paolo MaggiRaffaele Filotico
Nov 11, 2005·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Benoit TrottierMiklos P Salgo
Jan 19, 2006·Therapeutic Drug Monitoring·Antonio D'AvolioGiovanni Di Perri

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