Efficacy of Poly-Gamma-Glutamic Acid in Women with High-Risk Human Papillomavirus-Positive Vaginal Intraepithelial Neoplasia: an Observational Pilot Study.

Poly-gamma-glutamic acid (γ-PGA) is a natural polymer that is synthesized by Bacillus species and has been reported to have antitumor activity. The aim of this study was to investigate the effect of γ-PGA on the treatment of vaginal intraepithelial neoplasia (VAIN). A retrospective observational study on γ-PGA therapy for biopsy-proven VAIN was conducted. The efficacy was assessed by evaluating the results of Pap cytology and the viral load of high-risk HPV at three time points: at enrollment, and at the first and second post-treatment visits. Of 17 patients treated with γ-PGA, only 12 patients who had a high-risk HPV infection were included in the analysis. Histology was VAIN1 in seven patients, VAIN2 in two patients, and VAIN3 in three patients. γ-PGA was administered for newly diagnosed VAIN in five (41.7%) patients and persistent VAIN in seven (58.3%) patients for the mean time of 4.5 months. At the first and second post-treatment visits, cytological regression was observed in five (41.7%) and six (50%) patients, respectively. Regarding the HPV load, the overall response rate was 66.7%, and the mean level was 670.6 ± 292.5 RLU at the first follow-up, which was lower than the initial viral load of 1,494.8 ± 434.5 RLU (p = 0.084). At the second follow-up, the overall response rate was 58.3%, and the mean viral load level was 924.2 ± 493.7 RLU. γ-PGA may be helpful for the cytological regression and reduction of viral load in patients with high-risk HPV-positive VAIN, suggesting that γ-PGA is a promising treatment option for primary or persistent VAIN.