Reducing HPV Viral Burden in Men: A Synergistic Approach Using Pidotimod and Prophylactic Vaccination

Area of Science:

• Immunology
• Virology
• Public Health

Background:

• Persistent high-risk human papillomavirus (HPV) genotypes pose a significant oncogenic risk.
• Current prophylactic HPV vaccines are effective but their impact on existing infections is under investigation.
• Exploring adjunctive therapies to enhance HPV clearance is crucial for public health.

Purpose of the Study:

• To evaluate the efficacy of adjunctive Pidotimod therapy with the nonavalent HPV vaccine in reducing persistent HPV genotypes and promoting clearance in men.
• To assess the impact of Pidotimod on HPV strain burden in HIV-negative men with existing HPV infections.

Main Methods:

• A retrospective pilot study involving 23 HIV-negative men with anal and/or genital HPV infections.
• Participants received either the nonavalent HPV vaccine alone (control) or the vaccine plus oral Pidotimod.
• HPV genotyping was performed at baseline and 12 months using real-time PCR.

Main Results:

• The Pidotimod + vaccine group showed a higher HPV-negative conversion rate (62.5%) compared to the control group (28.6%), though not statistically significant (p=0.19).
• The Pidotimod group demonstrated a significantly greater reduction in the number of persistent HPV genotypes at 12 months (p=0.008).
• Pre-exposure prophylaxis (PrEP) use was associated with significantly lower HPV clearance rates (p<0.01).

Conclusions:

• Adjunctive Pidotimod therapy shows a promising trend in reducing HPV strain burden when combined with the nonavalent HPV vaccine in men.
• This immunomodulatory strategy may be beneficial for managing multiple and persistent HPV infections, including in high-risk groups like PrEP users.
• Larger prospective studies are warranted to confirm these findings and establish the role of Pidotimod in HPV management.