Efficacy and Safety of PHPV Fusion Factor Vaginal Gel (PHPV®) in Clearing Cervical Persistent High-Risk Human Papillomavirus Infection: A Randomized Controlled Clinical Trial

Lei Yan,1,2 Huan Yin,1,2 Liye Shi,1,2 Bingxue Ding,1,2 Chengniang Liu,1,2 Yong Wang,3 Chun Fu1,2 1Department of Obstetrics and Gynecology, The Second Xiangya Hospital of Central South University, Changsha, Hunan, People’s Republic of China; 2Clinical Research Center for Gynecological Disease in Hunan Province, Changsha, Hunan, People’s Republic of China; 3China Academy of BioMedicine, Shenzhen, Guangdong, People’s Republic of ChinaCorrespondence: Chun Fu, Department of Obstetrics & Gynecology, The Second Xiangya Hospital, Central South University, Changsha, 410011, People’s Republic of China, Tel +8618627315906, Email [email protected]: To evaluate the efficacy and safety of PHPV in the treatment of persistent high-risk papillomavirus (hrHPV) infection of the cervix.Patients and Methods: A randomized controlled trial (RCT) was conducted on patients with persistent hrHPV infection which were randomly assigned in three groups: PHPV, interferon and control. All participants were followed up at baseline, 3 months and 6 months after enrollment. The primary outcome was hrHPV clearance at 6 months post-enrollment. Secondary outcomes included effective rate, HPV E6/E7 mRNA negativity, changes in vaginal microecology and safety. The primary analysis was conducted on the modified intention-to-treat (mITT) population.Results: Of 842 patients screened, 120 were randomly assigned to three groups and 110 were included in the mITT analyses. At 3 months, hrHPV clearance rates were higher in both the PHPV and interferon groups compared with the control group. However, after covariate adjustment, the superiority over no treatment remained robust for PHPV, whereas the interferon vs control comparison showed attenuation. At 6 months, hrHPV clearance was 66.7% in the PHPV group, 45.9% in the interferon group, and 20.6% in the control group. Adjusted analyses showed that PHPV was significantly superior to no treatment (RR 2.81, 95% CI 1.37– 5.79, P=0.005), whereas the interferon vs control comparison did not reach statistical significance (RR 2.08, 95% CI 0.98– 4.44, P=0.058). Similar patterns were observed for effective rate and HPV E6/E7 mRNA negativity, with PHPV demonstrating consistent superiority over no treatment after adjustment. Comparisons between PHPV and interferon did not reach statistical significance for clearance outcomes, although PHPV showed numerically higher efficacy. No serious adverse events were reported.Conclusion: PHPV is an effective and safe non-invasive therapeutic option for persistent hrHPV infection.Clinical Trial Registration: www.chictr.org.cn, ChiCTR2200063608.Keywords: high-risk human papillomavirus, persistent infection, PHPV fusion factor, treatment, clinical trial