Disclosures 4/27/11! New Developments in HPV Infection 11 for Merck Advisory Board!
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1 New Developments in HPV Infection 11 for 2011 Peter V. Chin-Hong, MD, MAS Division of Infectious Diseases University of California at San Francisco April 28, 2011 AIDS Research Institute Disclosures Merck Advisory Board! Chin-Hong and Palefsky, 2005, ACS atlas 1!
2 Age-Standardized Incidence Rates of Cervical Cancer per 100,000 Katz, I. T. et al. N Engl J Med 2006;354:1110 Goals 1. The review 11 recent advances in knowledge and practice in human papillomavirus infection and disease, and its applicability to primary care! 2. To discuss future trends in the HPV field! Epidemiology! Diagnosis and Screening! Treatment! Prevention! 2!
3 Goals 1. To understand the virology and epidemiology of HPV infection and HPV-associated anogenital disease! 2. To understand diagnostic and screening strategies for HPV associated anogenital disease! 3. To review the potential role of HPV prevention strategies! Epidemiology! Diagnosis and Screening! Treatment! Prevention! Nonenveloped doublestranded DNA virus 1 HPV >100 types identified 2! anogenital 2,3! oncogenic*,2,3 types, including 16, 18, 31, 33, 35, 39, 45, 51, 52, 58! Nononcogenic types include: 6, 11, 40, 42, 43, 44, 54! *High risk; Low risk 1. Howley PM. In: Fields BN, Knipe DM, Howley PM, eds. Philadelphia, Pa: Lippincott-Raven; 1996: Schiffman M, Castle PE. Arch Pathol Lab Med. 2003;127: Wiley DJ, Douglas J, Beutner K, et al. Clin Infect Dis. 2002;35(suppl 2):S210 S Muñoz N, Bosch FX, de Sanjosé S, et al. N Engl J Med. 2003;348: Clifford GM, Smith JS, Aguado T, Franceschi S. Br J Cancer. 2003:89; !
4 Infectious Viral Particles Perinuclear Clearing (Koilocytosis) Episome Basal cell layer *CIN = cervical intraepithelial neoplasia; ICC = invasive cervical cancer 1. Goodman A, Wilbur DC. N Engl J Med. 2003;349: Adapted with permission from the Massachusetts Medical Society. 2. Doorbar J. J Clin Virol. 2005;32(suppl):S7 S Bonnez W. In: Richman DD, Whitley RJ, Hayden FJ, eds. Washington, DC: American Society for Microbiology Press; 2002: !
5 Chin-Hong and Palefsky, 2007, Current Diagnosis and Treatment STDs Courtesy A. Kreuter MD 5!
6 Anal Cancer Incidence San Francisco Cress and Holly, 2003, Prev Med Courtesy Michael Berry, MD Courtesy Michael Berry, MD 6!
7 HPV-related penile neoplasia Penile SIL 2 Scrotal SIL 2 Kuohung et al, IPV 2006! 1! 7!
8 Oropharyngeal cancer Oropharyngeal cancer! Adjusted* Odds Ratio (95% CI)! Lifetime no. vaginal sex partners 26! 3.1 ( )! Lifetime no. oral sex partners 6! 3.4 ( )! Never or rarely use condoms! 2.2 ( )! HPV-16 serology positive! 32.2 ( )! Any oral HPV infection! 12.3 ( )! *Adjusted for age, sex, tobacco use, alcohol use, family history! DʼSouza G et al, 2007, N Engl J Med; 356: ! Oropharyngeal cancer Survival is related to HPV status Ang KK et al, New Engl J Med, 2010 (363): ! US men! 6328! 1818! 2323! Parkin DM, Int J Cancer, 2006! American Cancer Society 2009! 500! 2009 Total 10,969! 8!
9 2009! US men! 6328! 1818! 2323! 500! 2009 Total 10,969! Parkin DM, Int J Cancer, 2006! American Cancer Society 2009! Epidemiology! Diagnosis and Screening! Treatment! Prevention! 9!
10 Cervical Cytology Classification The 2001 Bethesda System Normal 1 ASCUS2 LSIL3 HSIL 3 Two types of atypical squamous cells (ASC) 4! Atypical squamous cells of undetermined significance (ASCUS)! Atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesions (ASC-H)! Squamous intraepithelial lesions (SIL) 4! Low-grade SIL (LSIL): Mild dysplasia, cervical intraepithelial neoplasia 1 (CIN 1)! High-grade SIL (HSIL): Moderate and severe dysplasia, CIN 2/3, carcinoma in situ (CIS)! 1. Spitzer M, Johnson C. Philadelphia, Pa: WB Saunders Company; 2002: Apgar BS, Zoschnick L. Am Fam Physician. 2003;68: Cannistra SA, Niloff JM. N Engl J Med. 1996;334: Solomon D, Davey D, Kurman R, et al, for the Forum Group Members and the Bethesda 2001 Workshop. JAMA. 2002;287: Chin-Hong and Palefsky, 2005, ACS atlas Chin-Hong and Palefsky, 2005, ACS atlas 10!
11 Chin-Hong and Palefsky, 2005, ACS atlas Chin-Hong and Palefsky, 2005, ACS atlas 11!
12 Histological Classification Cervical Intraepithelial Neoplasia Cervical intraepithelial neoplasia (CIN) 1! CIN 1: Mild dysplasia; includes condyloma (anogenital warts)! CIN 2: Moderate dysplasia! CIN 3: Severe dysplasia; includes CIS! CIN 1! Histology of squamous cervical epithelium 1! Basal cell Basal membrane Normal! CIN 1! (condyloma)! CIN 1! (mild dysplasia)! CIN 2 (moderate dysplasia)! CIN 3! (severe dysplasia/cis)! Invasive Cancer! CIN caused by HPV can clear without treatment. 2! 1. Bonnez W. In: Richman DD, Whitley RJ, Hayden FJ, eds. Washington, DC: American Society for Microbiology Press; 2002: Ostor AG. Int J Gynecol Pathol. 1993;12: Chin-Hong and Palefsky, 2005, ACS atlas FIG 3b Chin-Hong and Klausner, 2008, MLO 12!
13 2! HPV Testing To Reduce Cervical Cancer in Resource-limited settings 132,000 women in 497 villages in rural India! Cluster randomized trial! Outcome (per 100,000) HPV Testing Cytologic Testing VIA Control Cervical cancer incidence Death rate Sankaranarayanan et al, New Engl J Med, 2009 Apr 2, 360! Chin-Hong and Klausner, 2008, MLO 13!
14 Anal Cancer The incidence of anal cancer is increasing in men and women Anal cancer is more common in gay men than is cervical cancer in women HPV-associated anal intraepithelial neoplasia (AIN) are precursors of anal cancer Previous work has shown a high prevalence of AIN and HPV infection in HIV-positive men and women, gay men, women at high risk for HIV, women with CIN and transplant recipients Out Magazine, December 2005 Anal cancer screening Anal Cytology Screening Normal ASCUS LSIL HSIL Repeat in 12 months (HIV+) Repeat in 2-3 years (HIV-) High-resolution Anoscopy with Biopsy No Lesion Seen AIN I AIN II or III Follow every 6 months Treat Chin-Hong and Palefsky, 2002, CID 14!
15 Epidemiology! Diagnosis and Screening! Treatment! Prevention! Treatment Options External high-grade disease (AIN 2/3) Aldara (5% Imiquimod) possibly! Liquid Nitrogen or Trichloroacetic acid! LASER or cauterization! Internal high-grade disease (AIN 2/3) Trichloroacetic acid! LASER! Infrared Coagulation! Intraoperative excision with cauterization! Vaccines! Chin-Hong and Palefsky, 2002, CID 3! 15!
16 Therapeutic HPV vaccine to prevent progression of vulvar intraepithelial neoplasia 22 women with HPV-16 VIN 3! Phase II study! Postvaccination improvement Symptomatic outcome N(%) Partial response N(%) Complete response N(%) 3 months 11 (50) 7 (35) 5 (25) 12 months 12 (63) 6 (32) 9 (47) *vaccine against HPV-16 oncoproteins E6 and E7! 20/22 received 3 or 4 doses! Kenter GG et al, New Engl J Med, 2009 Nov 5, 361:1838! Regression of VIN 3 after receving therapeutic HPV vaccine Kenter GG et al, New Engl J Med, 2009 Nov 5, 361:1838! 4! 16!
17 New York Times 8/29/06 17!
18 Epidemiology! Diagnosis and Screening! Treatment! Prevention! Empty viral capsid (VLP) Elicits immune response in host Transcription Capsid proteins Translation Eukaryotic Cell 18!
19 1. Berzofsky JA, et al. J Clin Invest. 2004;114: Kirnbauer R, et al. Proc Natl Acad Sci USA. 1992;89: Modis Y, et al. EMBO J. 2002;21: Quadrivalent vaccine 100% Efficacious Against HPV 16- and 18-Related CIN 2/3 and AIS PPE-Combined Population; subjects were naïve to HPV Types 6, 11, 16, and/or 18 Combined Analysis The efficacy of the quadrivalent vaccine against HPV 16-, and 18-related VIN 2/3 or VaIN 2/3 was 100%. 5! 19!
20 Bivalent vaccine 100% Efficacious Against HPV 16- and 18-Related CIN 2/3 and AIS (6.4 years) PPE-Combined Population; subjects were naïve to HPV Types 16, and/or 18 Combined Analysis Romanowski B et al, Lancet, 2009 Dec 12; 374: ! Quadrivalent vaccine Efficacious Against HPV 16/18-Related Infection and Disease among women aged years old PPE-Combined Population; subjects were naïve to HPV Types 6, 11, 16, and/or 18 Combined Analysis Munoz N et al, Lancet, 2009 Jun 6; 373: !
21 X! 7! Objectives Primary! Safety Efficacy: Combined incidence of HPV 6/11/16/18 related external genital lesions: Main study: HM + MSM External genital warts Penile/perianal/perineal intraepithelial neoplasia (PIN) Penile, perianal, or perineal cancer Sub-study: MSM Anal intraepithelial neoplasia (AIN) Anal Cancer Immunogenicity Geometric mean titers, seroconversion Secondary! Efficacy:! Incidence of persistent HPV 6/11/16/18 infection*! Incidence of HPV 6/11/16/18 DNA detection at one or more visits! *HPV DNA detection in anogenital specimens from >2 consecutive visits >6 months apart (± 1 month visit windows) or! HPV 6/11/16/18-related disease with positivity to the same type at adjacent visit.! 21!
22 Study design Randomized (1:1), double-blind, placebo-controlled 3 doses of quadrivalent vaccine or placebo at 0, 2, and 6 months Planned 36 month follow-up (mean 30.1 months in current analysis) Enrolled subjects: 3463 heterosexual men (HM) years old 602 men having sex with men (MSM) years old Key Inclusion/Exclusion Criteria No evidence of genital lesions No history of genital warts Lifetime sexual partners: Heterosexual males: 1-5 MSM: <5; identify themselves as MSM and engaged in oral sex or receptive/insertive anal sex with another man within the last year Methodology Swabs: For HPV DNA testing Penile Scrotal Perineal/perianal Intra-anal (MSM only) Pap smear: For cytology Intra-anal (MSM only) Biopsies: For histology and HPV DNA testing External genital Intra-anal (MSM only) 22!
23 Number of subjects enrolled by country Taiwan Sweden Spain South Africa Philippines Portugal Peru Norway Netherlands Mexico Germany Finland Croatia Costa Rica Canada Brazil Australia USA HM Number of subjects enrolled MSM HM = heterosexual men; MSM = men having sex with men.! Quadrivalent vaccine Efficacious Against HPV 6/11/16/18-Related Disease among men aged years old PPE-Combined Population; subjects were naïve to HPV Types 6, 11, 16, and/or 18 Giuliano AR et al, New Engl J Med, 2011 (564)5:401 EGL=Extragenital lesions! Giuliano AR et al, New Engl J Med, 2011 (564)5:401 23!
24 Efficacy against external genital lesions (EGL) Per-protocol population! Endpoint GARDASIL (n = 1,397) Cases Inc. per 100 PY Cases Placebo (n = 1,408) Inc. per 100 PY % Efficacy 95% CI p-value All subjects , 98.1 <0.001 n = number of subjects randomized who received at least one injection and have follow-up after month 7; PY = person years; CI = confidence interval.! EGLs include external genital warts, penile/perianal/perineal intraepithelial neoplasia (PIN), penile, perianal, or perineal cancer;! case counting began after month 7.! Efficacy against external genital lesions (EGL) Per-protocol population! Severity GARDASIL (n = 1,397) Cases Inc. per 100 PY Cases Placebo (n = 1,408) Inc. per 100 PY % Efficacy 95% CI Condyloma 3* , 97.9 PIN PIN 2/ Penile/perineal/ perianal cancer *Two cases related to HPV 6 alone, and one case related to HPV 6/11/35! n = number of subjects randomized who received at least one injection and have follow-up after month 7 PY = person years; CI = confidence interval.! PIN = penile/perianal/perineal intraepithelial neoplasia; case counting began after month 7.! Efficacy against HPV 6/11/16/18-related persistent infection and DNA detection Per-protocol population! Endpoint Persistent infection* DNA detection** GARDASIL (n = 1,390) Cases Inc. per 100 PY Cases Placebo (n = 1,400) Inc. per 100 PY % Efficacy 95% CI p-value , 92.2 < , 55.6 <0.001 *PERSISTENT INFECTION HPV DNA detection in anogenital specimens from >2 consecutive visits >6 months apart! (± 1 month visit windows) or HPV 6/11/16/18-related disease with positivity to the same! type at adjacent visit! **DNA DETECTION! HPV DNA detection in anogenital specimens from >1 visit! n = number of subjects randomized who received at least one injection and have follow-up after month 7; PY = person years;! CI = confidence interval.! 24!
25 Conclusions GARDASIL was highly efficacious in reducing the incidence of external genital lesions in men aged years! GARDASIL was generally well tolerated.! In young men aged years, GARDASIL was effective in reducing anogenital:! Persistent HPV 6/11/16/18 infection and! HPV 6/11/16/18 DNA detection in at least one visit! Decisions on male vaccine implementation strategies will require further consideration by policy makers! Efficacy and safety are critical! Other criteria used by policy makers may include: burden of disease and epidemiology, health economic modeling and program feasibility! 8! Quadrivalent vaccine efficacious against HPV 6/11/16/18-related anal precancer lesions among MSM aged years old PPE-Combined Population; subjects were naïve to HPV Types 6, 11, 16, and/or 18 Palefsky et al, New Engl J Med, 2011 in press 25!
26 9! Safety and immunogenicity in HIV-infected children 7-12 year old HIV-infected boys and girls! Characteristics *GARDASIL (n = 90) % Ab response 28 weeks *Placebo (n = 36) % Ab response 28 weeks HPV <5 HPV <5 HPV <5 HPV <5 *Similar CD4%, log10 plasma HIV RNA at baseline! Vaccine administered at weeks 0, 8, 24! Moscicki AB et al, IPV 2009! 10! 26!
27 Male circumcision Outcomes in women Male factors! Cervical cancer! in monogamous female partners if male partner circumcised! Adjusted Odds Ratio (95% CI)! Lifetime no. sex partners 6! 0.42 ( )! Sex with sex workers! 0.53 ( )! Castellsague et al, 2002, New Engl J Med; 346:15! Male circumcision Outcomes in men HPV infection! in circumcised men! Adjusted Odds Ratio (95% CI)! Glans/corona of penis! 0.51 ( )! Penile shaft! 0.59 ( )! All penile sites! 0.53 ( )! Hernandez et al, 2008, JID: 197! Castellsague et al, 2007, IPV! Male circumcision Outcomes in men Tobian AR et al, 2009, New Engl J Med; 360:1298! 27!
28 Impact of condom use Anal HPV, LSIL and HSIL Unadjusted incidence densities P<0.001! P=0.035! P=0.54! HPV: human papillomavirus; LSIL: low-grade squamous intraepithelial lesions;! HSIL: high-grade squamous intraepithelial lesions.! Incident anal HPV predictors Multivariable analysis Variable Multivariable OR 95% CI P Age No. sexual partners 1, Proportion times <0.001 condoms not used Ecstasy use Poppers use OR Odds Ratio; CI Confidence Interval; 1 previous 6 months; 2 per increase in 10 partners! 28!
29 HPV Prevention in women Vaccines! Male circumcision! Male condoms! HAART! X!!!! Chin-Hong PV, JID 2008! Vaccines! HPV Prevention in men Male circumcision! Male condoms! HAART! X!!!! Chin-Hong PV, JID 2008! Courtesy Michael Berry 29!
30 Courtesy Karen Smith-McCune, MD 11! Predictors of HIV Seroconversion Multivariable analysis Variable Multivariable 1 HR 95% CI P Some college Anal HPV by PCR, 3 types Unprotected anal sex 2, Methamphetamine use <0.001 Depression HR Hazard Ratio; CI Confidence Interval; 1 Also adjusted for no. sexual partners, race, other STIs, alcohol use; 2 Previous 6 months; 3 Partner HIV status unknown Chin-Hong PV et al, AIDS 2009:23! 30!
31 Risk of HIV Seroconversion *P<0.05 By HPV status * * Atypical squamous cells on cytology also independently predicted HIV seroconversion (HR 2.8, 95% CI ) in a separate model Chin-Hong PV et al, AIDS 2009:23! CD68 (macrophages) in AIN3 Courtesy Dr. Sharof Tugizov GR Stratum granulosum; SP stratum spinosum; BL Basal Cells Future Epidemiology: males, transmission, new populations (including immunocompromised patients)! Diagnosis and Screening: low cost methods, periodicity of screening! Treatment: vaccines! Prevention: more vaccines (more types, new populations), cost-effectiveness! 31!
32 Goals 1. The review 11 recent advances in knowledge and practice in human papillomavirus infection and disease, and its applicability to primary care! 2. To discuss future trends in the HPV field! Epidemiology! Diagnosis and Screening! Treatment! Prevention! Acknowledgements UCSF Joel Palefsky Maria da Costa Tere Darragh Eric Vittiinghoff Jeff Klausner UCLA Tom Coates San Francisco DPH Susan Buchbinder Grant Colfax Tony Buckman Fenway Community Health (Boston) Ken Mayer Daniel Cohen David Pantalone Arnel Montenegro Denver DPH Frank Judson Ken Miller Dave Ward New York Blood Center Beryl Koblin Louise Austin SCHARP (Seattle) Marla Husnic Eileen Hess Lynette Browne Abt (Boston) Dana Benet Maria Madison Funding: UARP, UCSF GCRC, NIH-HPTN, K23 career mentored award, CYTYC corporation 32!
33 Special Thank You Prof. Dr. Alexander Kreuter! Prof. Dr. Norman Brockmeyer! Judith Coenenberg! 33!
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