Don t leave the boys behind update on hpv 2011
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Don't leave the boys behind: Update on HPV – 2011. François Boucher MD, FRCPC. Objectives. After this presentation, participants will be able to: Recognize the different manifestations and complications of HPV. Provide appropriate advice on HPV immunization to families of boys and girls.

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Objectives
Objectives

After this presentation, participants will be able to:

  • Recognize the different manifestations and complications of HPV.

  • Provide appropriate advice on HPV immunization to families of boys and girls.

  • Advocate to public health authorities on the merits of universal vaccination for HPV


The human papillomavirus

N = 12

N = 60

The Human papillomavirus

  • DS DNA virus

  • Viral genome is episomal in the host cell

  • > 200 types

  • Classification according to

    • Tropism

      • Cutaneous

      • Mucosal (40 types)

    • Oncogenicity

      • High risk (15)

      • Low risk (12)


Hpv genotypes
HPV genotypes

  • Tissue tropism

    • Cutaneous vs mucosal

  • Association with cancer

    • Oncogenic

    • Non-oncogenic

    • Unknown

  • 15 types known to be associated with cancer

  • HPV-16: 50% of cancers

  • HPV-18: 20%

Neighbor joining phylogenetic tree

of 106 PVs based on CPR region of L1

Park, SB. Lecture Notes in Computer Science. 2003. Vol. 2736.


Cumulative incidence of hpv infection among women sexually active and hpv negative at enrollment
Cumulative incidence of HPV infection among women sexually active and HPV negative at enrollment

Winer RL et al Am J Epidemiol 2003;157:218–226


Estimated life probability of acquiring hpv related morbidity in women
Estimated life-probability of active and HPV negative at enrollmentacquiring HPV & related morbidity in women

  • Genital HPV infection 75%

  • Genital condylomas ≥5%

  • Abnormal routine Pap test ≥35%

  • Invasive cervical cancer

    • Communities with routine Pap-testing <1%

    • Communities without routine Pap-testing ~3%

    • Other ano-genital cancers <1%

    • Anal cancers in men having sex with men ~3%

    • Proportion (~20%) of head/neck cancers <1%


20 active and HPV negative at enrollment

HPV16+

HPV18+

Onc HPV +

15

Onc HPV -

10

5

0

1

2

3

4

5

6

7

8

9

10

11

Cumulative incidence of cervical intraepithelial neoplasia grade 3 and cancer ( ≥ CIN3)over a 10-year period

Cumulative incidence rate (%)

Follow-up time (years)

Khan MJ et al. JNCI 97:1072


Hpv types associated with cervical lesions by grade
HPV types associated active and HPV negative at enrollmentwith cervical lesions by grade

Clinical Virology, 2nd edition, 2002, ASM press


Clinical diagnoses associated with oncogenic hpv
Clinical diagnoses associated active and HPV negative at enrollmentwith oncogenic HPV

  • Cervix

    • Cervical intraepithelial neoplasia: CIN 1-2-3

    • Adenocarcinoma in situ: AIS

  • Vulvovaginal cancers (VIN, VaIN)

    • 25-35% associated with HPV

  • Anal cancers

    • Rare, but increasing in incidence

    • 80-90% HPV

  • Penile cancers

    • 40% HPV

  • Neck/ENT cancers

    • 25-35% associated with HPV


Burden of hpv disease in men
Burden of HPV disease in men active and HPV negative at enrollment

Heterosexual men

  • Prevalence of HPV infection estimated between 25% to 65%

  • HITCH study: 56% positive at study entry

    MSM

  • Overall prevalence is 57%

  • Most common type is HPV 16

  • Infection independently associated with A) Receptive anal intercourse [OR 2] and B) 5+ sexual partners [OR 1.5]

Chin-honget al, J. Infect dis. 2006


Prevalence of genital hpv infection in males
Prevalence of genital HPV infection active and HPV negative at enrollmentin males

Giuliano AR, et al. Cancer Epidemiol Biomarkers. 2008


Hpv infection in males
HPV infection in males active and HPV negative at enrollment


Anogenital warts in men
Anogenital warts in Men active and HPV negative at enrollment

  • Most common HPV manifestation in men

  • Prevalence in Canada (2004):

    • 165.2/100 000 in men

    • 128.4 in women

  • Peak prevalence age

    • 25-29 y.o. in men

    • 220-24 y.o. in women

Kliewer EV et al. Sex Transm Dis 2009;36:380


Anal cancer epidemiology
Anal cancer: epidemiology active and HPV negative at enrollment

  • Uncommon, although increasing in incidence

  • 1.9% of all digestive system cancers; 5260 new cases diagnosed annually (USA)

  • Annual incidence: 2.04 (M) and 2.06 (F) per 100,000; higher in black men (1)

  • HIV-positive MSM have twice the incidence as that of HIV-negative MSM

  • In the HAART era, anal cancer incidence seems to increase (quadrupled compared to pre-HAART era in San Francisco study)(2)

1: Johnson, Cancer 2004

2: Chin-honget al, J. Infect dis. 2006


Anal and cervical cancer incidences compared
Anal and cervical cancer incidences compared active and HPV negative at enrollment

  • Cervical cancer incidence prior to cervical cytology screening: 40-50/100,0001 (1)

  • Cervical cancer currently: 8/100,000

  • Anal cancer among HIV- MSM: up to 37/100,000 (2)

  • Anal cancer among HIV+ MSM: 137/100,000 person-years since 1996 (3)

1: Qualters JR et al. . MMWR 1992, 41:1-152: Daling JR et al. N Engl J Med 1987, 317:973–977

3: D’Souza G et al. J Acquir Immune Defic Syndr. 2008;48(4):491-499


Burden of disease in msm hiv positive
Burden of disease in MSM active and HPV negative at enrollmentHIV-positive


Hpv vaccines

HPV Vaccines active and HPV negative at enrollment


Hpv vaccines1
HPV vaccines active and HPV negative at enrollment

Gardasil™ (Merck)

  • Reassembled VLP protein L1

  • Serotypes 6, 11, 16, 18

  • Schedule: 0, 2 & 6 months

  • Approved: July 2006

    Cervarix™ (GSK)

  • Reassembled VLP protein L1

  • Serotypes 16, 18

  • Schedule: 0, 1 & 6 months

  • Approved: February 2010


Naci recommendations 2007 hpv vaccine
NACI recommendations 2007 active and HPV negative at enrollmentHPV vaccine

  • Females 9-13 years of age, as this is before the onset of sexual intercourse for most females in Canada, and the efficacy would be greatest

  • Females 14-26 years would benefit from the HPV vaccine, even if they are already sexually active, as they may not yet have HPV infection and are very unlikely to have been infected with all four HPV types in the vaccine.

  • Females 14-26 years who have had previous Pap abnormalities, including cervical cancer, or have had genital warts or known HPV infection would still benefit from the HPV vaccine.


Publicly funded provincial hpv vaccination programs
Publicly funded active and HPV negative at enrollmentProvincial HPV vaccination programs

http://www.phac-aspc.gc.ca/im/ptimprog-progimpt/table-1-eng.php


Justification for off label extended schedule
Justification for « off-label » active and HPV negative at enrollmentextended schedule

  • Immune response to vaccine is strongest in younger girls

  • Data from BCCH affiliated Vaccine Evaluation Centre confirms two doses of HPV vaccine are protective due to a strong immune response in girls 9-13 years after two doses given at 0 & 6 months

  • Third dose to ensure sustained protection into sexually active years of life.

  • Girls who are known to have immune system defects associated with solid organ transplant, stem cell transplant, or HIV infection should receive HPV vaccine in the three dose schedule at 0, 2 and 6 months.


  • Hpv vaccine coverage in canada
    HPV vaccine coverage in Canada active and HPV negative at enrollment

    • Current coverage rates in Canada are considered suboptimal

      • Cultural & religious beliefs

      • Public perceptions

      • Vaccine program implementation

    • HPV vaccine uptake (2008-2009)(1):

      • Maritimes: 83%

      • QC: 84-87% (the first year…)

      • ON: 49%

      • AB-MB: 55%

      • BC: 66%

    1: HPV vaccine can still be a tough sell. Times & Transcript, March 4, 2009

    http://timestranscript.canadaeast.com/rss/article/591314


    Population effectiveness
    Population effectiveness active and HPV negative at enrollment

    • Australia public program since 2007

      • 65-75% uptake

      • Incidence of AGW in women and men

      • 36 055 clients of the Melbourne Sexual Health Center, 2004-2008

      • Decreased incidence in women ≈25%/heterosexual men ≈5% per quarter

    • Heterosexual couples study

      • www.mcgill.ca/hitchcohort/

      • 322 couples

      • Decreased incidence of vaccine-type infections 22% vs 7% vaccinated vs unvaccinated

    2009 ISTDR: Abstract OS2.9.02

    EUROGIN 2010 Abstract No SS 4-6


    So, should boys be vaccinated against HPV? active and HPV negative at enrollment


    Cost of immunization programs in canada over the years
    Cost of immunization programs in Canada over the years active and HPV negative at enrollment

    • 1993, boys & girls 0-15 y.o:

      • DPT (5 doses); D2T5 (1 ); OPV (4); Hib (3); MMR (1)

      • $83

    • 2010, boys & girls 0-15 y.o:

      • DTaP-Polio-Hib (4 doses); DTaP-Polio (1); dTaP (1); PneumoC (3); MenC (1); MMR-V (1); MMR (1); HBV/HAV (2); Influenza (6-23 mo) (2 doses "primer" + 1)

      • $408

      • …excluding HPV vaccine…

      • ≈50% conjugated pneumococcal vaccine


    Cost of immunization programs in the usa
    Cost of immunization programs in the USA active and HPV negative at enrollment

    • 2010, boys & girls 0-15 y.o:

      • 30 doses against 16 diseases (excluding Influenza)

      • $1450 for males, $1800 for females

      • HPV & meningo ≈ 25%


    Vaccine efficacy in men
    Vaccine efficacy in men active and HPV negative at enrollment

    Giuliano et al., NEJM 2011; 364(5):401


    Prevention of hpv 6 11 16 18 infection in men
    Prevention of HPV 6/11/16/18 active and HPV negative at enrollmentinfection in men

    • 4065 males, aged 16-26 years

    • Per protocol efficacy:

      • 90.4% reduction in the incidence of HPV 6/11/16/18-related EGL

      • 89.4% reduction in condyloma/warts (6/11)

      • 85.6% reduction of persistent HPV 6/11/16/18 infection

    Giuliano et al., NEJM 2011; 364(5):401


    Prevention of anal intraepithelial neoplasia ain and anal cancer in msm
    Prevention of active and HPV negative at enrollmentanal intraepithelial neoplasia (AIN) and anal cancer in MSM

    • 602/4065 males, aged 16-26 years

    • Per protocol efficacy:

      • 77.5% reduction in the incidence of HPV 6/11/16/18-related AIN and anal cancer

      • 74.9% reduction in high-grade AIN

      • 94.9% reduction of persistent HPV 6/11/16/18 infection

    Giuliano et al., NEJM 2011; 364(5):401


    Cost effectiveness of hpv vaccination
    Cost-effectiveness of HPV vaccination active and HPV negative at enrollment

    • Vaccination of 12-year-old girls is cost-effective

      • Consistent across models

      • Estimates not sensitive to uncertainty in natural history and epidemiology of HPV

    • More uncertainty, less precision in cost-effectiveness estimates for:

      • Vaccination of adult women

      • Vaccination of males

    Kim JJ. NEJM, October 19, 2011

    Chesson H. ACIP, October 10, 2010


    Male hpv vaccination
    Male HPV vaccination active and HPV negative at enrollment

    • Estimates of cost-effectiveness of male vaccination vary

      • Within one model when key assumptions are changed

      • Across different models due to differences in model structure and/or assumptions

    • Cost-effectiveness of male vaccination depends on health outcomes included

      • Most favorable scenario is when all potential health outcomes are included

    Chesson H. ACIP, October 10, 2010


    Male hpv vaccination1
    Male HPV vaccination active and HPV negative at enrollment

    • Cost-effectiveness of male vaccination depends on vaccine coverage of females

      • Most favorable scenario for male vaccination is when coverage of females is low (1)

      • Male vaccination estimated to cost $26,000 (2) to $62,000 (3) per QALY when female coverage ≤ 50%

    1: Brisson M, et al. J Infect Dis. 2011:204 (3): 372

    2: Elbasha EH, Dasbach EJ. Vaccine 2010; 28(42): 6858

    2: Kim JJ, Goldie SJ. BMJ 2009; 339:b3884


    Male hpv vaccination2
    Male HPV vaccination active and HPV negative at enrollment

    • Improving vaccine coverage of females may be more cost-effective than male vaccination

      Even if outreach costs are incurred to increase coverage

    • HPV vaccination of MSM is likely to be a cost-effective intervention for the prevention of genital warts and anal cancer

      Kim (2010) found cost per QALY $15,000-$38,000 over range of assumptions about age at vaccination and prior exposure to HPV

    Kim JJ. Lancet Infectious Diseases, 2010; 10(12):845 - 852


    Hpv immunization programs current issues
    HPV Immunization programs: active and HPV negative at enrollmentCurrent issues

    • Duration of protection in women

      • At least five years, probably longer

      • Assess need for recall immunization

    • Duration of protection in males

      • Unknown

    • Importance of cross-protection among serotypes

    • Different population models are currently being evaluated for efectiveness & cost-benefit

    • Should vaccine valency be increased? If so, which types should be included?


    Should pediatricians recommend hpv vaccination for boys
    Should pediatricians recommend HPV vaccination for boys? active and HPV negative at enrollment

    • Pro:

      • Safe, efficient and effective vaccine

      • Individual protection against AGW and cancers

      • Decreased burden of disease & transmission (evidence of herd immunity)

      • Principle of equity

      • Parents may ask for it…

    • Con:

      • Vaccine still very expensive

      • Cost-effectiveness still in doubt

      • Acceptance will be a challenge

      • Parents may oppose it…

    http://tinyurl.com/3apx7hh


    Merci

    Merci! active and HPV negative at enrollment

    François Boucher MD, FRCPC


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