The effect of local photodynamic therapy with 5-aminolevulinic acid in the treatment of vaginal intraepithelial lesions with high-risk HPV infection

Background: Recent data has shown increased rate of vaginal intraepithelial neoplasia (VAIN) in younger in-dividuals. Traditional VAIN treatments exert adverse effects on the anatomy and functions of the vagina. Topical 5-aminolevulinic acid photodynamic therapy (ALA-PDT) is a novel, non-invasive targeted therapy for intra-epithelial lesions. Here, we aimed to investigate the efficacy and safety of ALA-PDT in VAIN with high-risk HPV (HR-HPV) infection. Methods: This study enrolled a total of 82 HR-HPV-positive women diagnosed with VAIN, who were receiving ALA-PDT. The effect of ALA-PDT was evaluated using HPV genotyping and Thinprep cytologic test (TCT). Be-sides, colposcopy directed biopsies were performed in all patients at 3-month follow-up, and in patients with positive HR-HPV and/or abnormal TCT results during the follow-up period. Results: Our data showed that the HPV clearance rate was 53.7% (44/82) at 6-month follow-up and 67.1% (55/ 82) at 12-month follow-up. Patients with HPV16/18 combined with other HR-HPV (HPV16/18 & other HR-HPV) infection, those with a history of hysterectomy and/or older age were had significantly lower HPV clearance rate. Besides, the lesion complete remission (CR) rate was 90.2% (74/82). These results show that HPV16/18 & other HR-HPV infection was associated with significantly lower CR rates. Throughout the follow-up, 2 cases had persistent lesions (2.4%), 6 cases had partial remission (7.3%), 2 cases recurred (2.7%) but none of the patients had disease progression. Conclusions: Taken together, our data showed that ALA-PDT is an effective, safe, and alternative treatment for VAIN patients with HR-HPV infection. However, the ALA-PDT efficacy was relatively poor in patients with older age, HPV16/18 & other HR-HPV infection and/or those with a history of hysterectomy.