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

Purpose: 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, Conclusion: PHPV is an effective and safe non-invasive therapeutic option for persistent hrHPV infection. Clinical Trial Registration: www.chictr.org.cn, ChiCTR2200063608.