What is the role of Gardasil 9 (Human Papillomavirus 9-valent vaccine) in treating a patient with genital warts caused by Human Papillomavirus (HPV)?

Gardasil 9 in Patients with Genital Warts

Gardasil 9 is not a treatment for existing genital warts but serves as a preventive measure against future HPV infections with types not yet acquired. 1 The vaccine has no therapeutic effect on existing HPV infections or lesions, including genital warts.

Role of Gardasil 9 in Patients with Genital Warts

Prevention vs. Treatment

• Gardasil 9 is purely preventive, not therapeutic 1
• Protects against HPV types 6 and 11 (which cause ~90% of genital warts) and seven high-risk oncogenic types (16,18,31,33,45,52, and 58) 1
• Cannot clear existing HPV infections or treat existing genital warts 1

Benefits for Patients with Existing Genital Warts

• May prevent infection with other HPV types not yet acquired 1
• May reduce risk of future genital warts caused by different HPV strains
• Provides protection against HPV-related cancers (cervical, anal, oropharyngeal, vaginal, vulvar, and penile) 1

Evidence on Recurrence Prevention

• Meta-analysis data suggests HPV vaccination does not prevent recurrence of anogenital warts in patients who have already been treated for them 2
• The overall effect estimate for recurrence prevention was 1.02 (0.75-1.38), showing no significant benefit 2

Management of Genital Warts

Appropriate treatment for existing genital warts includes:

1. Topical treatments:

   • Imiquimod (including newer 3.75% formulation) 3
   • Podofilox
   • Sinecatechins 1

2. Provider-administered treatments:

   • Cryotherapy
   • Trichloroacetic acid
   • Surgical removal
   • Laser therapy
   • Electrocautery 3, 1

Vaccination Recommendations

Age-Based Recommendations

• Ages 9-14: 2-dose schedule (0,6-12 months) 1
• Ages 15-26: 3-dose schedule (0,1-2,6 months) 1
• Ages 27-45: Shared clinical decision-making recommended 1
• Over 45: Not authorized 1

Special Populations

• Men who have sex with men (MSM): Recommended through age 26 3, 1
• Immunocompromised individuals: Recommended through age 26 3, 1
• People living with HIV/AIDS: Recommended through age 26 3

Important Considerations

Patient Education Points

• Genital warts have a high recurrence rate (approximately 30%), whether clearance occurs spontaneously or following treatment 3
• HPV can be transmitted even when no visible warts are present 1
• Condoms may reduce but not eliminate transmission risk 3, 1
• Patients should inform current sexual partners about genital warts 1

Public Health Impact

• Population-level studies have shown decreases in genital wart diagnoses following HPV vaccination programs:
  • 35% decrease among females under 21 years 4
  • 19% decrease among males under 21 years 4
  • Reductions in genital warts have been observed even with bivalent HPV vaccine programs 5

Practical Approach for Clinicians

1. Treat existing genital warts using appropriate therapies
2. Consider HPV vaccination status and offer Gardasil 9 if not previously vaccinated
3. Explain that vaccination will not treat current warts but may prevent future HPV infections
4. Provide appropriate counseling about HPV transmission, safer sex practices, and the importance of partner notification
5. Consider screening for other sexually transmitted infections

Pitfalls to Avoid

• Do not present Gardasil 9 as a treatment for existing genital warts
• Do not assume vaccination will prevent recurrence of treated warts
• Do not neglect appropriate treatment of existing warts while focusing on vaccination
• Do not overlook the need for cervical cancer screening in women, regardless of vaccination status 1