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

Background Doubts remain about the best treatment for managing premalignant lesions (HSIL) associated with anal cancer. Methods The TREATAIN trial was an open-label, randomized study conducted at Hospital Vall d’Hebron (Spain). Persons with HIV 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, HPV clearance, and HSIL recurrence. EudraCT: 2018-001730-18. ClinicalTrials.gov: NCT04055142. Results Between October 2020 and November 2022, 100 participants were enrolled (36 in the electrocautery arm, 28 in cidofovir arm, and 36 in the sinecatechins arm). Modified intention-to-treat analysis showed a response rate of 69·4% [95% 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=0.189). During the 48-weeks 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=0·811). 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<0·001). Patients were more satisfied with the sinecatechins treatment (5·6 ± 0·4), followed by electrocautery (5·1 ± 0·8), while lower satisfaction was reported with cidofovir treatment (4·77 ± 0·96), p<0.001. Conclusion No statistically significant difference was observed in efficacy between treatments; in contrast, sinecatechins was the most accepted and well-tolerated treatment.