Topical trichloroacetic acid versus electrocautery for treatment of anal intraepithelial neoplasia in people living...

To compare efficacy and safety of topical trichloroacetic acid (TCA) versus electrocautery (ECA) for the treatment of human papillomavirus (HPV)-associated anal intraepithelial neoplasia (AIN) in people living with HIV (PLWH).

The TECAIN-study was a prospective, multicentre, randomised (1:1 block-randomisation), open-label, non-inferiority trial in PLWH with histologically confirmed AIN recruited from seven German proctological units. The primary endpoint (PE) was therapeutic success defined as a combination of complete clinical response evaluated by high-resolution-anoscopy and histological AIN-clearance/regression four weeks after the end-of-treatment (4-weeks-follow-up, 4WFU). Secondary endpoints were assessed at 4WFU and 24WFU. Efficacy was analysed in the intention-to-treat-population as primary analysis with a non-inferiority margin of -12%.

Of 659 PLWH screened with HRA, 257 patients with AIN were randomised. Therapeutic outcome was assessed in 233 PLWH (TCA n = 118, ECA n = 115). The PE was reached in 62 patients of the TCA-group (52.5%) versus 71 patients of the ECA-group (61.7%) (difference in proportion - 9.2%, 95%CI -21.8% to 3.5%). While non-inferiority of TCA could not be shown for the PE at 4WFU, TCA was non-inferior to ECA at 24WFU (therapeutic success 50.8% vs. 48.7% (difference 2.2%, 95%CI -10.7% to 15.0%)). Adverse events occurred in 67.8% in both groups at 4WFU (mostly mild or moderate). Severe treatment-related pain was significantly less frequent in the TCA-group (4.2%) compared to the ECA-group (14.8%). HPV-findings did not differ between treatment groups between baseline and follow-up visits.

TCA is an effective, well-tolerated and less complex alternative to ECA for the treatment of AIN in PLWH.