Effectiveness and safety of REBACIN as a non-invasive intervention for persistent high-risk human papillomavirus infection: A real-world prospective multicenter cohort study

Fei Chen ,Sheng Wang,Yifan Cheng ,Lin Yang ,Jianyang Ma ,Jianming Ying ,Yuxiu Liu ,Xuefeng Wang ,Yongtao Yang ,Lin Li ,Guonan Zhang ,Tian Xia ,Chun-Fa Zhang ,Xiaomei Wang ,Xu Zhang ,Su Zhou ,Qi Sun ,Guiyu Wang ,Rongrong Xie ,Youzhong Zhang ,Yiwei Ling ,Lei Wei ,Quanxin Qu ,Di Wu ,J.y Chen ,Jie Guo ,Dongping Du ,Ying Zhang ,Jinghe Lang

doi:10.1016/j.ygyno.2023.09.004

Abstract

BackgroundWe previously reported that REBACIN effectively eliminates persistent high-risk human papillomavirus (hrHPV) infection. Here, we conducted a prospective multicenter cohort study to evaluate the safety and effectiveness of REBACIN, taking into account factors such as specific hrHPV subtype and patient's age. MethodsAccording to inclusion/exclusion criteria and participant willingness, 3252 patients were divided into REBACIN group while 249 patients into control group. Patients in REBACIN group received one course treatment of intravaginal administration of REBACIN while no treatment in control group. After drug withdrawal, participants in both groups were followed up. ResultsThe clearance rate of persistent hrHPV infection in REBACIN group was 60.64%, compared to 20.08% in control group. Specifically, the clearance rates for single-type infection of HPV16 or HPV18 were 70.62% and 69.23%, respectively, which was higher than that of HPV52 (59.04%) or HPV58 (62.64%). In addition, the single, double, and triple/triple+ infections had a clearance rate of 65.70%, 53.31%, and 38.30%, respectively. Moreover, 1635 patients under 40 years old had a clearance rate of 65.14%, while it was 55.08% for 1447 patients over 40 years old. No serious adverse effects were found. ConclusionThis study confirmed that REBACIN can effectively and safely eliminate persistent hrHPV infection, which the clearance rate of HPV16/18 is higher than that of HPV52/58, the clearance rate of single-type infection is higher than that of multiple-type infections, and the clearance rate in young patients is higher than that in elder patients, providing a guidance for REBACIN application in clearing hrHPV persistent infection in real-world settings. Clinical trial registrationChinese Clinical Trial RegistryRegistration Number: ChiCTR1800015617http://www.chictr.org.cn/showproj.aspx?proj=26529Date of Registration: 2018-04-11

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