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Grand Rounds

HPV Vaccines: Cochrane Reviews Looks at the Evidence with Multi-Year Follow-Up

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BACKGROUND AND PURPOSE:

  • While HPV is common and usually cleared by the immune system, high-risk (hrHPV) types can lead to precancerous lesions
  • Arbyn et al. (Cochrane Reviews, 2018) assessed the efficacy HPV vaccines in protecting against cervical precancer and HPV16/18 infection in adolescent girls and women

METHODS:

  • Database search of RCTs comparing efficacy and safety
  • Participants: Females offered HPV vaccines vs placebo
  • Primary outcomes
    • Precancer associated with vaccine HPV types
    • Precancer irrespective of HPV type
  • Cervical precancer
    • CIN grade 2 and above (CIN2+)
    • CIN grade 3 and above (CIN3+)
    • AIS

RESULTS:

  • 26 trials were included, totaling 73,428 participants
  • 10 trials, with follow-up of 1.3 to 8 years, addressed protection against CIN/AIS
  • Vaccine safety was assessed over a 6-month to 7-year period in 23 studies
  • hrHPV negative at baseline: HPV vaccines reduced CIN2+, CIN3+, AIS associated with HPV16/18 compared with placebo
    • CIN2+: 164 to 2/10,000; Risk Ratio [RR] 0.01; 95% CI, 0 to 0.05 (high certainty evidence)
    • CIN3+: 70 to 0/10,000; RR 0.01; 95% CI, 0.00 to 0.10 (high certainty evidence)
    • AIS: 9 to 0/10,000; RR 0.10; 95% CI, 0.01 to 0.82 (moderate certainty evidence)
  • HPV16/18 negative at baseline:
    • Vaccines also reduced CIN2+, CIN3+, AIS associated with HPV16/18 (high to moderate certainty evidence)
  • Regardless of HPV status at baseline: Vaccines had a similar impact, reducing risk CIN2+, CIN3+, AIS associated with HPV16/18 (high to moderate certainty evidence)
  • There was no difference in adverse events or deaths in women exposed to HPV vaccines, compared to control
  • There was no increased risk for
    • Miscarriage: RR 0.88; 95% CI, 0.68 to 1.14 (high certainty evidence)
    • Elective termination/induced abortion RR 0.90; 95% CI, 0.80 to 1.02 (high certainty evidence)
  • Congenital abnormalities and stillbirths: Uncertain as to whether there is an association (wide CIs, overlapping 1)
    • Effects similar between vaccine and non-vaccine group, but cannot rule out association based on the current review due to study design/sample size

CONCLUSION:

  • Studies were not of sufficient duration nor size to make conclusions of risk for cervical cancer
  • There is high-certainty evidence that HPV vaccines protect against cervical precancer, with the effect highest for lesions associated with HPV16/18
  • Effect is higher for those who are negative for hrHPV or HPV16/18 at baseline compared to unselected HPV status, but effect still present in all cohorts
  • Any deaths that occurred were not associated with the vaccine
  • Long-term effects of the vaccine need to continue to be monitored

Learn More – Primary Sources:

Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors

 

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Related ObG Topics:

Guidance Update: Professional Organizations Align on Cervical Cancer Screening
What to Do with a Normal Pap but Positive HPV, ASC-US, LSIL and ASC-H
ASCCP Releases New Colposcopy Guidance:  A Risk-Based Approach

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