Efficacy of Lentinula Edodes-Derived Supplement (AHCC®) in Promoting Negativity of Persistent HPV Infection

Liaquat University of Medical & Health Sciences

Status: Completed

Conditions: HPV Infection

Treatments: Biological: Gardasil 9®; Dietary Supplement: AHCC® (Active Hexose Correlated Compound)

Study type: Observational

Funder types: Other

Identifiers

NCT06752083

117_22.112024_Papion®

Details and patient eligibility

About

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.

Full 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.

Enrollment: 289 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

289 participants in 3 patient groups

Unvaccinated with AHCC® Supplement

Description:

Women previously managed in routine clinical practice with AHCC® supplementation alone for persistent HPV infection. Participants had not received HPV vaccination prior to treatment. Clinical data were retrospectively collected from medical records to evaluate HPV-DNA clearance following this real-world management strategy.

Treatment:

Dietary Supplement: AHCC® (Active Hexose Correlated Compound)

Vaccinated with AHCC® Supplement

Description:

Women previously managed in routine clinical practice with combined AHCC® supplementation and nonavalent HPV vaccination for persistent HPV infection. Treatments were prescribed as part of standard care. Clinical data were retrospectively collected to assess HPV-DNA clearance following combined real-world exposure.

Treatment:

Biological: Gardasil 9®

Dietary Supplement: AHCC® (Active Hexose Correlated Compound)

Vaccinated Only

Description:

Women previously managed in routine clinical practice with nonavalent HPV vaccination alone for persistent HPV infection. No AHCC® supplementation was used. Clinical data were retrospectively collected to assess HPV-DNA clearance following vaccination as standard care.

Treatment:

Biological: Gardasil 9®