REBACIN® can remove high-risk Human Papillomavirus (HPV) persistent infection efficiently as an effective non-invasive treatment: a multicenter prospective study.

OBJECTIVE

To evaluate the efficacy of REBACIN® as a non-invasive treatment for persistent high-risk HPV (HR-HPV) clearance compared with interferon and no treatment, identify optimal cutoff values for HPV E6/E7 mRNA/DNA assays, analyze clinical predictors, and validate REBACIN® as a safe alternative to invasive interventions for cervical cancer prevention.

METHODS

According to the predefined inclusion and exclusion criteria, eligible patients were randomly selected and enrolled after obtaining their informed consent. Patients were allocated to three groups: the REBACIN group (received a course of intravaginal REBACIN administration), the recombinant human interferon α-2b group (received recombinant human interferon α-2b treatment), and the control group (received no treatment). After drug discontinuation, follow-up was conducted for all participants across the three groups.

RESULTS

In the HPV E6/E7 mRNA and HPV-DNA testing cohorts, the clearance rates in the REBACIN® group were 54.9% and 64.0%, respectively. The optimal cutoff value of baseline HPV E6/E7 mRNA for predicting viral clearance in the REBACIN® group was 15.47 RLUs. After adjusting for confounders, patients in the REBACIN® group tested via HPV-DNA who were ≥ 50 years old [OR 0.34, 95% CI 0.14-0.81], had multiple infections [OR 0.36, 95% CI 0.17-0.76], or were HPV52-positive [OR 0.26, 95% CI 0.12-0.58] showed significantly lower viral clearance probabilities.

CONCLUSION

This study suggests that REBACIN® may represent a non-invasive treatment option, providing a new option for the clinical treatment of persistent HR-HPV infections to prevent cervical cancer.