PDF - Preventing Cervical Cancer: Integrating Screening

Impact of the National HPV
Vaccination Program so far
operated by;
Dr Julia Brotherton
Medical Director, NHVPR
Victorian Cytology Service
funded by;
National HPV Vaccination Program
• Australian Government funded from 2007
• 12 - 13 yo girls on an ongoing basis through schools
• 2 year “catch-up” program for 13-18 yo girls through
schools
• 2 year “catch-up” program for 18-26 yo women through
GP’s and community based programs, finished Dec 2009
• 2007-2009 target population ~ 2.4 million
• Quadrivalent vaccine used to date
• National HPV Vaccination Program Register
established
Key components of VPD surveillance
9 Coverage (% of target population vaccinated)
– eg vaccination register, surveys, doses distributed
9 Adverse events following immunisation (safety)
– Passive reporting vs active surveillance
9 Disease monitoring (does the vaccination program
prevent the disease?)
–
–
–
–
Incidence (eg notifications from clinicians, laboratories)
Hospitalisations
Deaths
Type specific for some diseases eg pneumococcal,
meningococcal disease
– ‘Vaccine failures’ (cases of disease that occur in
vaccinated individuals)
National notified coverage Australia
As held at Sept 2011. Excludes consumers who have opted off.
Notified coverage 18-26 yo by State
As held at March 2011. Excludes consumers who have opted off.
Commun Dis Intell 2011;35(2):197–201.
Increase in coverage over time
12-15 year olds
Increase in coverage over time
16 and 17 year olds
HPV vaccine coverage Victoria, 12‐17 year old girls
Equity in screening vs vaccination
• Victoria, Australia
(Barbaro, Brotherton and Gertig, submitted, Med J Aust)
National Cervical Screening Program by
socioeconomic status, Victoria
National HPV Vaccination Program by socioeconomic
status, Victoria
Coverage in Indigenous women
• Indigenous status a voluntary field on
NHVPR
– as at 2011 all school programs reporting
• NT and Qld % Indigenous notifications on
NHVPR close to expected from population
– working to publish State based estimates
• Closing the Gap project – Division of GP
based review of Indigenous coverage
Anticipated early benefits 4vHPV
• HPV infection (16 and 18)1
– Persistent 6 months MITT at 5 years 86%
• Genital warts2 (90%+ 6/11)
– ITT at 3.6 years 62% reduction
• Incident LSIL/HSIL2
– ITT any abnormal Pap at 3.6 years 11% reduction
(NS)
– ITT any CIN2+ at 3.6 years 19% reduction
1. Villa LL et al. Br J Cancer 2006;95:1459-66.
2. Muñoz N et al. J Natl Cancer Inst 2010;102:325–39.
Monitoring vaccine impact in Australia
• Immediate:
– HPV infection – sentinel surveillance model, research studies
– Genital warts – sentinel surveillance model (+ hospital data)
• Short-medium term:
– incident Pap abnormalities – Cervical Screening Registers
– CIN2/3 histopathology - Cervical Screening Registers
– RRP – Australian Paediatric Surveillance Unit
• Long term:
– cervical cancer, other anogenital cancer, oropharyngeal cancer
– Cancer registries
Ref: Brotherton et al: Monitoring the control of human papillomavirus (HPV) infection and
related diseases in Australia: towards a national HPV surveillance strategy. Sexual
Health. 7(3):310-9, 2010 Sep.
HPV prevalence monitoring
• Two studies in progress:
– VACCINE: 1500 Vic women 18-25 recruited via
Facebook. Survey data, verification of HPV vax status
and self collected vaginal swab. (CIA S Garland.
Funding VCA)
– VIP study: post vaccination sentinel site monitoring
WHINURS –
Women Human Papillomavirus genotype prevalence
Indigenous Non-Indigenous Urban Rural Study
Estimate of the prevalence of type
specific genital human papillomavirus
(HPV) infection in sexually active
Australian females prior to vaccine
delivery
POPULATION: Women 18-40 presenting
for a Pap test to Indigenous health
services, Family Planning & Well
Women’s clinics across Australia.
* Garland, Brotherton, Condon et al. BMC Medicine 2011, 9:104
http://www.biomedcentral.com/1741-7015/9/104
VIP- Vaccine Impact in Population
Post-vaccination HPV prevalence monitoring
– 1300 women aged 18-24 presenting to FPA clinics for
Pap test in NSW, VIC and WA.
– Sentinel site model using baseline data from large
sites involved in baseline WHINURS study.
– Survey data from women (demographics, risk factors
including sexual history), verification of HPV vax
status and clinician collected cervical sample.
– Funding C Council and NHMRC
CONFIDENTIAL UNPUBLISHED DATA. NOT FOR
FURTHER CITATION WITHOUT PERMISSION.
Study collaborators
• SN Tabrizi, E Cummings, SM Garland- the
Royal Women’s Hospital- Melbourne
• J Brotherton- Victorian Cytology Service
• R Skinner- Uni of Sydney
• B Liu, J Kaldor- Kirby Institute
• D Bateson (FPNSW)
• K McNamee (FPVIC)
• M Garafelakis (FPWA)
Genital warts sentinel surveillance
Patients
8 public sexual health services
New patients only 2004-2010- first visit to
clinic. N=135,000
No prior history of genital warts.
Categories
‘Eligible age’ <26 years old in July 2007, or
‘older’.
Men who have sex with men (MSM) last 12m.
Heterosexual men – sex with women only last
12m.
‘Non-resident’ – arrived in the current or
previous calendar year. ‘Resident’ – arrived
earlier or born in Australia.
Statistics
Chi-square test for trend within two periods before and during the qHPV vaccination
program.
Donovan B, et al. Lancet Inf Dis 2011
Updated data presented courtesy of B Donovan
Proportion with genital warts in women, by
half-year, 2004-2010
Women> 26 years of age (2007)
Pre-vaccine period
Vaccine period
Women<=26 years of age (2007)
Pre-vaccine period
Vaccine period
p-trend=0.96
p-trend=0.06
p-trend=0.84
-25%
-73%
p-trend<0.001
Donovan B, et al. Lancet Inf Dis 2011
Updated data presented courtesy of B Donovan
Proportion with genital warts in men, by halfyear, 2004-2010
By gender of sexual partner
By age group <> 26 years,
heterosexual men
p-trend=0.22
p-trend<0.001
-35%
-44%
p-trend=0.02
p-trend<0.001
Pre-vaccine period
-25%
Vaccine period
Pre-vaccine period
Vaccine period
Donovan B, et al. Lancet Inf Dis 2011
Updated data presented courtesy of B Donovan
Almost 90% decline in genital warts in
women and HSM < 21 years since July 2007
Adjusted OR pre and post July
2007(no. of sex partners)
Non residents excluded
Read T R H et al. Sex Transm Infect
doi:10.1136/sextrans-2011-050234
©2011 by BMJ Publishing Group Ltd
Females <21 Pre 1.11 (0.9-1.4)
Post 0.44 (0.3-0.6)
MSW <21
Pre 1.32 (0.9-1.9)
Post 0.42(0.3-0.6)
Victorian post vaccination incidence analysis • AIM: To determine if there has been any change in the incidence of screen detected
cervical abnormalities since the 4vHPV vaccination program
•METHODS: VCCR data 2000 – 2009
•LGA=LSIL +poss LSIL cytology
•HGA=AIS/CIN2+ histopathology. Cervical cancer results are not presented.
•Incident defined as a woman’s first LGA or HGA diagnosis, or
• an abnormality that occurred at least 2 years after a previous abnormality, with
at least two negative tests in the intervening period. A woman’s first HGA
diagnosis was also “incident” if it followed an LGA diagnosis, regardless of the
intervening period.
• Analysis by quarters and age group. Poisson piecewise regression used for
comparing changes in trends
Low Grade Cytology: smoothed curves
¾ No apparent effect after HPV vaccination
J Brotherton
et al.
The Lancet
2011; 377:
2085–92.
AIS/CIN2+ histopathology: smoothed curves
Victoria 2003‐2009 by age group
¾ Apparent decline in youngest age groups
¾ Significant post vax women <18 years Incidence Rate Ratio per quarter 0.87, p=0.01
¾ Difference in pre/post IRR per quarter 1.14, p=0.05
J Brotherton
et al.
The Lancet
2011; 377:
2085–92.
Trends in prevalent abnormalities
Source: VCCR as at Sept 2011
National trends
Role of data linkage
• Individual level data needed to accurately assess vaccine
effectiveness and impact on screening participation
• Linkage to CSRs and cancer registers
• Linkage fields: name, address, DOB, Medicare no (or health
care identifier in future)
• Revised NCSP indicators will report screening outcomes
and participation by vaccination status
• Initial de-identified research based linkage
• Eventual ongoing linkage with CSRs holding vaccination
status…or a National Cervical Cancer Prevention Register?
Type specific CIN/cancer monitoring
• Needed to assess what HPV types are causing
high grade cervical disease (and cancers) over
time.
• VACCINE study is HPV typing 500 CIN3 lesions
from vaccine age eligible Victorian women using
laser capture microdissection technique –
prospective specimens from VCS and RWH lab
included.
• Cancers not yet routinely typed
Australian Paediatric Surveillance Unit- Recurrent
Respiratory Papillomatosis Surveillance
• All paediatricians and
paediatric ENT
surgeons complete
monthly report cards
• If seen any RRP<15
years sent survey and
opportunity for lesion
HPV typing
• Commenced October
2011
Acknowledgements
•
•
•
VIP investigators (CIA Sepehr Tabrizi,
CIB Julia Brotherton, CIC Rachel
Skinner, AIs Deborah Bateson, Kathleen
McNamee, Maria Garefalakis, John
Kaldor, Suzanne Garland.) Special
thanks to Bette Liu and Eleanor
Cummins for rapid work on the interim
analysis!
Basil Donovan and Kit Fairley
Dorota Gertig, Marion Saville, Genevieve
Chappell and Bianca Barbaro
The National HPV Vaccination Program Register
is owned by the Commonwealth Department of
Health and Ageing and operated by the Victorian
Cytology Service www.hpvregister.org.au
Contact details: Julia Brotherton
[email protected]