NHS Cervical Screening Programme Introducing HPV Triage

Human Papilloma Virus (HPV)

There are over 100 subtypes of HPV. Most do not cause significant disease.

The high risk HPV subtypes are 16, 18, 31 & 33 – types 16 & 18 are found in 70% of cervical cancers. Non oncogenic types are 6 & 11, which cause visible genital warts.

Transient HPV is common especially in women under 35 years.

It persists in 20-30% of women putting them at increased risk of developing cervical cancer.

Women or their partners may have had HPV for many years without knowing it.

There is no reliable treatment to clear the virus.

HPV Sentinel Sites Triage Presentation

HPV testing for women with first Borderline Nuclear Change (BNC) or mild dyskaryosis test result

Six cytology centres will soon become ‘sentinel sites’ for introducing HPV Triage into the cervical screening programme. MAVARIC is a randomised trial set up in August 2005 to compare two automated screening technologies with manual screening. Women registered in the MAVARIC Trial already receive HPV triage. After 16th April 2007 all samples will be tested for HPV if the cytology result is first BNC or mild dyskaryosis.

HPV Sentinel Sites Triage Presentation

Pilot Studies

Studies showed that: HPV testing is acceptable to women because it reduces the number of early repeat tests that need to be done and speeds up referral to colposcopy where indicated.

46% of women with (first) BNC changes were HPV positive.

83% of women with (first) mild dyskaryosis were HPV positive.

Women who are high risk HPV negative are unlikely to develop cervical cancer.

HPV testing will result in some additional colposcopy referrals.

Rana et al (2004) reported that in the long-term, 40% of women with BNC test results are eventually referred to colposcopy.

HPV Sentinel Sites Triage Presentation

What is HPV Triage?

All cervical samples with first BNC or mild dyskaryosis test result will be tested for HPV to distinguish between women who need referral to colposcopy and women who can be safely returned to routine recall.

Women who test positive for HPV will be referred to colposcopy. Women who are HPV negative will be returned to routine recall.

HPV Sentinel Sites Triage Presentation

HPV Sentinel Sites Triage Presentation

Test of Cure Protocol (Follow up of treated CIN)

HPV testing will be used following treatment for CIN.

Women who are cytology negative and HPV negative will proceed to a three year recall period – avoiding the need for 10 years of annual tests.

Untreated CIN1 will be followed up at colposcopists discretion.

Women who are cytology +ve or HPV +ve at 6 months post treatment will be colposcoped.

HPV Sentinel Sites Triage Presentation

The Screening Programme with HPV Triage

The screening programme with HPV Triage will follow the current procedure. The PCT will send an HPV information leaflet with the invitation letter to all women.

The usual procedure for obtaining informed consent for cervical screening will include HPV testing should it be indicated by the test result.

The original LBC sample will be used if HPV testing is indicated, no other sample is necessary.

HPV test results will be included in the cytology report along with appropriate management recommendations.

HPV Sentinel Sites Triage Presentation

The Screening Programme with HPV Triage

(continued) Women will receive their cytology (and HPV) result in a letter from the PCT.

The subsequent procedure for each type of recommended action (routine recall, repeat test, or refer to colposcopy) will remain as currently set out in the practice guidelines.

Women under 25 are excluded from the protocol as routine screening does not commence until age 25.

HPV testing will apply whether women attend their GP practice, GUM or a Family Planning Clinic.

HPV Sentinel Sites Triage Presentation

Other Considerations

Local call and re-call computer software has been amended to incorporate HPV results.

New result letters have been written to include HPV test result if performed.

HPV Sentinel Sites Triage Presentation

Guidance on Explaining HPV Triage to Women

We cannot know when an individual woman became infected.

We cannot know from whom this infection was transmitted.

High risk HPV does not cause genital warts and wart associated types do not cause CIN.

HPV infection cannot be treated, only CIN.

HPV vaccination will help prevent HPV infection/CIN in the future.

HPV Sentinel Sites Triage Presentation