Acceptability of Intravaginal Artesunate as Adjuvant Therapy for Cervical Precancer and Persistent Human Papillomavirus: Data From a Phase 2 Placebo-Controlled Trial [ID 269]

INTRODUCTION: Women living with human immunodeficiency virus (WLWH) have increased rates of persistent infection with human papillomavirus (HPV) and six times the lifetime risk of cervical cancer compared to HIV-negative women. Innovative therapies are needed to reduce cervical precancer recurrence rates, driven by HPV persistence, among WLWH. Adjuvant intravaginal cytotoxic treatments may improve the success rates of precancer treatment with thermal ablation, the most common treatment method for cervical precancer in low- and middle-income countries (LMICs). Determining the acceptability of intravaginal treatments for HPV or cervical precancer among women in LMICs will guide product development. METHODS: This phase 2 double-blind randomized placebo-controlled trial is recruiting HPV-positive women who have undergone thermal ablation treatment in western Kenya. A minimum of 4 weeks following ablation, women are randomized (2:1) to intravaginal artesunate (200 mg) or placebo. Women self-administer the pessaries, alternating treatment weeks with safety visits. Following a 6-week dosing period, we administer a questionnaire to assess product acceptability. RESULTS: In this ongoing trial, as of August 4, 2025, 101 women have been randomized to artesunate or placebo. Of the 89 participants who have completed the dosing phase, 90% reported having a good experience while using the pessary. Although 33% of participants reported feeling overwhelmed with initial use, an overwhelming majority (95.5%) felt more comfortable by the end of the dosing period. All participants were willing to use the pessary again if required for treatment. CONCLUSIONS/IMPLICATIONS: Women in western Kenya have thus far found intravaginal pessaries acceptable as adjuvant therapy for cervical precancer.