Effectiveness of Electrocautery, Topical Cidofovir, and Topical Sinecatechins for the Treatment of Anal High-Grade Squamous Intraepithelial Lesions in Persons With HIV: An Open-Label, Randomized Controlled Trial.

Abstract

Doubts remain about the best treatment for managing premalignant lesions (high-grade squamous intraepithelial lesions [HSIL]) associated with anal cancer. The TREATAIN trial was an open-label, randomized study conducted at Hospital Vall d'Hebron (Spain). Persons with human immunodeficiency virus and anal HSIL were randomly assigned 1:1:1 to receive treatment with electrocautery, topical cidofovir 1% ointment, or topical sinecatechins 10%. The primary outcome was histological resolution of HSIL. Secondary outcomes included adverse events, participant satisfaction, human papillomavirus clearance, and HSIL recurrence. Between October 2020 and November 2022, 100 participants were enrolled (36 in the electrocautery arm, 28 in the cidofovir arm, and 36 in the sinecatechins arm). Modified intention-to-treat analysis showed a response rate of 69.4% (95% confidence interval [CI]: 54.4%-84.5%) of patients in the electrocautery group, 82.1% (95% CI: 67.9%-96.3%) in the cidofovir group, and 61.1% (95% CI: 45.2%-77%) in the sinecatechins group (P = .189). During the 48-week follow-up period, recurrence was observed in 7 participants (28%) in the electrocautery group, 7 (30.4%) in the cidofovir group, and 8 (36.4%) in the sinecatechins group (log-rank test, P = .811). Side effects were reported by 97.2% of patients in the electrocautery group, 85.7% in the cidofovir group, and 33% in the sinecatechins group (P < .001). Patients were more satisfied with the sinecatechins treatment (mean, 5.6 ± 0.4), followed by electrocautery (mean, 5.1 ± 0.8), while lower satisfaction was reported with cidofovir treatment (mean, 4.77 ± 0.96) (P < .001). No statistically significant difference was observed in efficacy between treatments; in contrast, sinecatechins was the most accepted and well-tolerated treatment. Clinical Trials Registration. EudraCT: 2018-001730-18; ClinicalTrials.gov: NCT04055142.