HPV Disease

This interventional, single-center, open-label randomized clinical study evaluates the efficacy of an oral dietary supplement (Pervistop®) in women with persistent Human Papillomavirus (HPV) infection. The supplement is a combination of four natural molecules: Epigallocatechin gallate (EGCG), folic acid (FA), vitamin B12 (B12), and hyaluronic acid (HA).The primary objective is to describe the effect of this association on HPV DNA integration into the host genome by measuring the clearance rate of viral oncoproteins E6 and E7. A total of 42 women aged 25 or older with persistent HPV infection and low-grade cervical lesions will be randomized 1:1 into two groups. The treated group will receive one tablet of Pervistop® daily for six months, while the control group will follow standard clinical practice. The study aims to determine if this nutritional intervention can counteract viral persistence.

The majority of low-grade pre-invasive lesions of cervix (low-grade squamous intraepithelial lesions, LSIL).will regress spontaneously over 2 years and immediate treatment may not be necessary. According to the Hong Kong College of Obstetricians and Gynaecologists (HKCOG), if a low-grade lesion is confirmed by colposcopy and biopsy, the patient can be observed and followed up with HPV testing or co-testing at 12 months, irrespective of age. This randomized controlled study is to determine whether high-intensity focused ultrasound (HIFU) treatment of low-grade pre-invasive lesions of cervix, can cause regression of these lesions in more patients within a specific time when compared to observation as a standard management according to HKCOG Guidelines. All eligible patients will be randomized in a 1:1 ratio into 2 groups: high-intensity focused ultrasound (HIFU) or Observation group. Background information of the patients such as age, parity, body mass index, smoking status and the presence of chronic medical disease will be collected. All patients with cervical HR-HPV status will be tested. Patients randomized into HIFU group will receive HIFU treatment within 2 weeks after randomization. Those randomized into Observation group will have no intervention. All patients will attend follow-up at 6 and 12 months after randomization, during which cervical smear for cytology (with cytopathologists blinded to the treatment group) and HR-HPV testing will be performed. The rate of cytological LSIL regression and HR-HPV clearance rates at 6 and 12 months in both groups will be analyzed. Patients will be referred back to colposcopy clinic for repeat colposcopy if needed according to HKCOG Guidelines. At the 12-month follow-up visit, if referral to repeat colposcopy is not needed, patients will be referred back to their primary care physicians, Department of Health Family Health Service, Family Planning Association or other primary care centres for follow-up cervical smears.

This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).