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

N/ACompletedNCT06752083

Liaquat University of Medical & Health Sciences289 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

289

Conditions

HPV Infection

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

HPV-DNA Clearance Rate

Proportion of participants achieving HPV-DNA negativity, defined as conversion from HPV-DNA positive to negative status based on clinically validated HPV-DNA testing.

Time frame: 4 months and 6 months

Secondary Outcomes

Safety and Tolerability

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.