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.
Age ≥ 25 years old
Positive HPV DNA test with genotyping 9-24 months prior to Day 0
Positive HPV DNA test with genotyping at Day 0
Pap test: LSIL, ASC-US.
High grade cervical lesions (HSIL)
Ongoing pregnancy, evaluated through a rapid chromatographic immunoassay for qualitative detection of hCG in urine
Ongoing breastfeeding
Primary or secondary immunodepression due to pharmacological treatments
Parallel
Epigallocatechin gallate (EGCG), Folic Acid (FA), Vitamin B12 (B12), and Hyaluronic Acid (HA)
Dietary supplementParticipants will self-administer one oral tablet of the dietary supplement Pervistop daily
Rate of clearance of viral oncoproteins E6 and E7
The percentage of participants showing a negative result for viral E6/E7 mRNA, which are key indicators of HPV DNA integration into the host genome. Analysis will be performed using the Aptima HPV assay, a transcription-mediated amplification (TMA) technique. A negative test result indicates viral clearance or loss of viral integration.
HPV DNA Clearance Rate
The rate of participants who test negative for high-risk HPV DNA using a multiplex PCR kit (Allplex II HPV 28 Detection). A negative result is defined as the absence of detectable high-risk HPV DNA above the analytical limit of detection
Treatment Adherence score
Adherence to the oral supplementation protocol evaluated through the Morisky Medication Adherence Scale (MMAS-4) questionnaire
Quantitative Variation of E6/E7 Levels from baseline to T1
Variation of E6/E7 mRNA levels. Exploratory analysis of quantitative signals generated by the Aptima assay in the form of Relative Luminescent Units (RLU). The RLU value directly corresponds to the amount of target E6/E7 mRNA detected in the sample.
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