Use of Gardasil in Patients with ASCUS
Gardasil (HPV vaccine) can be administered to individuals with Atypical Squamous Cells of Undetermined Significance (ASCUS), as there are no contraindications for vaccination in this population. The vaccine remains effective for preventing infection with HPV types not already acquired, even in individuals with existing cervical abnormalities.
Understanding ASCUS and HPV Vaccination
- ASCUS represents equivocal cytological findings that may or may not be associated with HPV infection 1
- Approximately 64% of women with ASCUS are HPV positive, with higher rates (81%) in women under 35 years and lower rates (44%) in women over 45 years 2
- Gardasil is a quadrivalent vaccine that protects against HPV types 6,11,16, and 18, which are responsible for approximately 70% of cervical cancers and 90% of genital warts 1, 3
Benefits of HPV Vaccination in ASCUS Patients
- Even with existing ASCUS, vaccination can prevent new infections with vaccine-targeted HPV types not already acquired 1
- The vaccine is most beneficial when administered before exposure to HPV, but may still provide protection against HPV types not yet acquired in individuals with ASCUS 1
- Vaccination does not treat or clear existing HPV infections or associated lesions 1
Management Considerations for ASCUS Patients
Recommended Follow-up for ASCUS
- For patients with ASCUS, management options depend on whether HPV testing is performed 1
- Without HPV testing, follow-up with repeat Pap tests every 4-6 months for 2 years until three consecutive negative smears is recommended 1
- If a second ASCUS occurs during follow-up, colposcopic evaluation should be considered 1
- HPV testing can be used for triage of ASCUS, with colposcopy recommended for HPV-positive patients 1, 4
Risk Stratification
- HPV-negative ASCUS patients have a very low risk (1.4%) of developing CIN3 or worse in subsequent years 5
- HPV-positive ASCUS patients have significantly higher risk (15.2%) of developing CIN3 or worse 5
- Age is an important factor in risk assessment, as HPV positivity decreases with age in women with ASCUS 4
Important Clinical Considerations
- Gardasil is administered as three doses (0,2, and 6 months) intramuscularly 3
- The vaccine is contraindicated in individuals with hypersensitivity to vaccine components, bleeding disorders, or during pregnancy 3
- Vaccination does not replace the need for continued cervical cancer screening according to guidelines 1
- Patients with ASCUS associated with severe inflammation should be evaluated for infectious processes before considering vaccination 1
Pitfalls and Caveats
- HPV vaccination does not treat existing HPV infections or associated lesions; it only prevents new infections with vaccine-targeted types 1
- Vaccine efficacy is significantly lower in individuals with evidence of prior infection with vaccine HPV types 1
- Patients should be counseled that continued cervical cancer screening is necessary even after vaccination 1
- The cost of the vaccine (estimated $300-500 per course) may be prohibitive for some patients 3