Background: Ablation or surgical excision is the typical treatment of anal high-grade squamous intraepithelial lesions (HSIL). Recurrences are common due to the persistence of underlying human papillomavirus (HPV) infection. Additional well-tolerated and effective non-surgical options for HPV-associated anal disease are needed.
Methods: This 3+3 dose escalation Phase I clinical trial evaluated the safety and tolerability of artesunate suppositories in the treatment of patients with biopsy-proven HSIL.
Results: The maximal tolerated dose was 400 mg, administered in 3 cycles. All adverse events associated with the use 200- and 400-mg artesunate suppositories were Grade 1. At the 600-mg dose, patients experienced clinically significant nausea.
Conclusion: Artesunate suppositories are a safe treatment option for anal HSIL.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10723659 | PMC |
| http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0295647 | PLOS |
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