Journal Article

Cutaneous injection site reactions to long-term therapy with enfuvirtide

Paolo Maggi, Nicoletta Ladisa, Eliana Cinori, Andrea Altobella, Giuseppe Pastore and Raffaele Filotico

in Journal of Antimicrobial Chemotherapy

Published on behalf of British Society for Antimicrobial Chemotherapy

Volume 53, issue 4, pages 678-681
Published in print April 2004 | ISSN: 0305-7453
Published online April 2004 | e-ISSN: 1460-2091 | DOI:
Cutaneous injection site reactions to long-term therapy with enfuvirtide

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Objective: Enfuvirtide is the first of a new class of antiretroviral agents. The drug is safe and well tolerated; injection site reactions are the most common adverse events. The aim of this study was the clinical and histopathological evaluation of injection site reactions in patients treated for 80 weeks.

Materials and methods: Six patients were evaluated. Five of them underwent cutaneous biopsies using a 4 mm punch. Sections were stained with haematoxylin–eosin, periodic acid-Schiff stain and Verhoeff’s stain. Moreover, immunohistochemical studies were carried out using CD20, CD45Ro and CD34 antibodies.

Results: Four different macroscopic patterns were presented: (a) no evidence of cutaneous lesions; (b) transient infiltrative lesions which auto-resolved within 24 h; (c) transient nodular lesions which auto-resolved within 7–15 days; and (d) stable lesions after more than 30 days with a scleroderma-like aspect. Histological examination showed three patterns: (1) an acute urticaria/vasculitis-like pattern with inflammation of the fat tissue; (2) a sub-acute pattern with an initial dermal sclerosis; (3) a chronic scleroderma-like pattern with connective tissue disposed around the adnexa, whose structure was intact. The immunohistochemical study evidenced a prevalence of T lymphocytes and a moderate neoangiogenesis.

Conclusions: In our experience, after a rather long period of treatment, cutaneous reactions comprised a variety of features largely independent of the virological and immunological outcome. The adnexa was unaltered in all patients, this indicating a tendency to a possible regression of the sclerotic lesions. Therefore, patients should be encouraged to rotate the sites of injection thus permitting the tissues to regenerate.

Keywords: Keywords: antiretroviral therapy, HIV-1 fusion inhibitors, peptide inhibitors

Journal Article.  1983 words. 

Subjects: Medical Oncology ; Critical Care

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