A phase I study of intra-anal artesunate (suppositories) to treat anal high-grade squamous intraepithelial lesions.
Level II
Where this comes from
- Record sourced from PubMed, PMID 38100463.
- Also identified by DOI 10.1371/journal.pone.0295647 and PMC identifier 10723659.
- No licence information is recorded for this record.
- Because redistribution is not established, this page shows the abstract only. Follow the links below for the full text.
Abstract
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. 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. 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. Artesunate suppositories are a safe treatment option for anal HSIL.
Medical subject headings
- Papillomavirus Infections
- Squamous Intraepithelial Lesions
- Anus Neoplasms
- HIV Infections