HPV Infection
Conditions
Brief summary
This is a retrospective, multicenter, observational study evaluating real-world HPV-DNA clearance in women with documented persistent high-risk HPV infection lasting at least six months. Clinical data were retrospectively collected from medical records of women managed in routine practice with one of three strategies: AHCC® supplementation alone, nonavalent HPV vaccination alone, or the combination of AHCC® supplementation and nonavalent HPV vaccination. The primary objective is to assess HPV-DNA clearance at 4 and 6 months following treatment initiation.
Detailed description
This retrospective, multicenter, observational study evaluates HPV-DNA clearance in women with documented persistent high-risk HPV infection managed in routine clinical practice. Eligible participants had confirmed HPV-DNA positivity persisting for at least six months and no high-grade cervical lesions. Clinical data were retrospectively collected from medical records from January 2023 to December 2024. Participants were categorized into three exposure groups based on treatments already received as part of standard care: AHCC® supplementation alone, nonavalent HPV vaccination alone, or combined AHCC® supplementation and nonavalent HPV vaccination. No randomization or prospective treatment assignment was performed. The primary outcome is HPV-DNA clearance, defined as conversion from HPV-DNA positive to negative status, assessed at 4 and 6 months after treatment initiation. Secondary outcomes include safety, tolerability, and treatment compliance based on routinely collected clinical data. This study reflects real-world clinical practice and was not designed as a randomized interventional trial.
Interventions
DIETARY_SUPPLEMENTAHCC® (Active Hexose Correlated Compound)
AHCC® supplementation previously prescribed as part of routine clinical care. Information on dosage and duration was retrospectively collected from medical records.
BIOLOGICALGardasil 9®
Nonavalent HPV vaccination previously administered as part of routine clinical care. Vaccination status was retrospectively obtained from medical records.
Sponsors
Liaquat University of Medical & Health Sciences
Università degli Studi dell'Insubria
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female participants aged 18 years or older. * Documented persistent high-risk HPV infection for at least 6 continuous months, confirmed by consecutive HPV-DNA tests. * Absence of high-grade cervical lesions (≤ CIN1). * Availability of complete clinical records with evaluable HPV-DNA testing at baseline and follow-up. * Documented management with AHCC® supplementation alone, nonavalent HPV vaccination alone, or combined AHCC® supplementation and nonavalent HPV vaccination in routine clinical practice. * No prior excisional or ablative treatment of the cervix (including conization or LEEP).
Exclusion criteria
* History of cervical excisional or ablative treatment (including conization or LEEP). * Presence of high-grade cervical lesions (CIN2 or worse) or invasive cervical cancer. * Incomplete clinical documentation or missing HPV follow-up data. * Conditions known to significantly alter immune function, including ongoing immunosuppressive therapy, active autoimmune disease requiring systemic treatment, or documented immunodeficiency, when such information was available in medical records. * Prior systemic antiviral or immunomodulatory therapy specifically aimed at HPV clearance during the observation period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPV-DNA Clearance Rate | 4 months and 6 months | Proportion of participants achieving HPV-DNA negativity, defined as conversion from HPV-DNA positive to negative status based on clinically validated HPV-DNA testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | 4 months and 6 months | Description of adverse events, tolerability, and treatment compliance based on retrospective review of routinely collected clinical records. Adverse events were classified according to CTCAE version 5.0 and analyzed descriptively. |
Countries
Italy
Outcome results
None listed