HIV-infected men and women. Joel Palefsky, M.D. University of California, San Francisco

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1 Anal cytology and anal cancer in HIV-infected men and women. Joel Palefsky, M.D. University of California, San Francisco April 10, 2010

2 Disclosures Merck and Co: Research grant support, advisory boards

3 Cervical Squamo-columnar Transformation Zone Active transformation zone Original squamocolumnar junction Active squamocolumnar junction Columnar epithelium External os Cervical cleft opening

4

5 From condyloma to cancer Bethesda Classification Cervical Intraepithelial Neoplasia Normal Low-grade squamous intra-epithelial ith l lesion* Flat CIN 1 CIN 2 condyloma High-grade squamous intra-epithelial ith l lesion CIN 3 Invasive cancer Histology of the Squamous Cervical Epithelium basal layer basal membrane Associated HPV Types (Relative Frequency) negative or other HPV types HPV 6, 11, 42, 43, 44 HPV 31, 33, 35, 52, 58 HPV 16 HPV 18, 45, 56 90% 80% 70% 60% 50% 40% 30% 20% 10% The prevalence of high-risk oncogenic HPVs increases with the severity of the lesion * LSIL also includes ASCUS (atypical squamous cells of unknown significance) Modified from Bonnez W. Papillomavirus. In: Richman RD et al eds. Clinical Virology. 2nd ed. Washington, DC: American Society for Microbiology; 2002:

6 The incidence of HPV-related cancers is increasing Age-adjusted Incidence Rate of Primary, malignant Anal cancer by Gender and Year of diagnosis Rate per Age-adjus sted Incidence 100, Male Female Year of Diagnosis Parkin DM et al, CA Cancer J Clin 2005; Chaturvedi A et al, 2008

7 Recent reports of incidence in anal cancer since introduction of ART Piketty C, Selinger-Leneman H, Grabaret S, et al. AIDS. 2008;22: /100,000 person-years among HIV+ MSM since 1999 D Souza G, Wiley D, Li X, et al. J Acquir Immune Defic Syndr. 2008;48(4): /100,000 person-years among HIV+ MSM since 1996 Patel P, Hanson H, Sullivan S, et al. Ann Intern Med. 2008; 10(148): /100,000 person-years among HIV+ MSM since 2000 Engels EA, Biggar, RJ et al. Int J Cancer 2008; 123: /100,000 person-years among HIV+ men and women since 1996

8 Progression of HGAIN to anal cancer

9 Percent with anal HPV infection HIV- HIV+ HIV+ HIV+ CD4> <200

10 Anal HPV infection by age group in sexually active HIV-negative MSM Perc cent HPV HPV HR 0 <

11 HPV infection Low-grade CIN High-grade CIN Cervical cancer Schiffman, MH. J Natl Cancer Inst. 1992; 84:394-98

12 Percent with abnormal anal cytology HIV- HIV+ HIV+ HIV+ CD4> <200

13 Prevalence of anal cytologic abnormalities by age among sexually active HIV-negative MSM Perc cent ASIL HSIL 5 0 <

14 Population-based data Chin-Hong et al Ann Int Med 2008; 149; 300-6

15 Anal and cervical HPV infection in HIV-positive women Anal Cervical HIV- HIV+ CD4 >500 HIV+ CD HIV+ CD4 <200

16 Cervical vs anal HPV types

17 AIN in HIV+ and HIV- women ( N= 655) AIN (16%) was more common among HIV- positive women than HIV- women (4%) p<.001 CIN (16%) was more common than among HIV-positive women than HIV- women (5%) p=.003 Hessol N and Palefsky J AIDS 2009; 23:59-70.

18 The cervical cancer model Anal and cervical cancer are biologically similar The incidence of cervical cancer has declined largely due to screening and treatment of high-grade grade CIN HGAIN is a true anal cancer precursor

19 Progression of HGAIN to cancer Classic Bowen s: 5-10% progression (Rickert RR et al. CA 1977; 27:160-6) 6) 8 of 72 (11%) immunosuppressed patients progressed from HGAIN to cancer over 42 months (Watson et al, ANZ J Surg. Aug 2006;76(8):715-17) ) 22 patients with HGAIN progressed to cancer over an average of 52 months from time of first diagnosis (Berry et al, submitted)

20 Reasons for lack of routine screening Lack of data on the optimal screening strategy Paucity of clinicians trained in high resolution anoscopy, biopsy and treatment of AIN Paucity of data on efficacy of treatment for HGAIN Paucity of cost-effectiveness data No data yet that treatment of HGAIN reduces the incidence id of anal cancer

21 Recommendations of the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the HIV Medicine i Association of the Infectious Diseases Society of America (HIVMA/IDSA).anal cytology screening of HIVseropositive MSM and of women may be useful preventive measures. However, studies of screening and treatment t t programs for AIN 2 or 3 need to be implemented before definitive recommendations for anal cytology screening can be made.

22 Lack of data on the optimal screening strategy Anal cytology has similar performance characteristics ti to cervical cytology

23 Anal cytology and histology correlation Anal histopathology Anal cytology* Normal Atypical AIN 1 AIN 2 or 3 Insufficient Total (%) Normal (32%) ASCUS (3%) LSIL (35%) HSIL (28%) Insufficient (1%) Total (%) 5 (5%) 2 (2%) 26 (26%) 69 (68%) 0 (0%) 102

24 Paucity of clinicians trained in high resolution anoscopy, biopsy and treatment of AIN ASCCP and other courses More and more clinicians being trained U.S., Canada, Australia, U.K., France, Germany and others

25 Paucity of data on efficacy of treatment for HGAIN Early in natural history- increased ease of treating small lesions 85% TCA Singh JC 2009; JAIDS, 52(4): Mid-natural history- local vs. surgical removal Infra-red red coagulation 65% free of disease after median of 413 days Goldstone SE et al, Dis Colon Rectum. 2006; 49: Late in natural a history- monitoring to detect early development of cancer

26 Early detection of anal cancer: superficially invasive squamous cell carcinoma of the anus (SISCCA) 19 patients treated with local excision No patients died of SCCA 5 of 19 (26%) developed recurrent cancer 2 required RAC No patients required a colostomy 17 of 19 (89%) developed recurrent HGD Careful follow-up is essential Berry, Jay and Palefsky,unpublished data

27 Paucity of cost-effectiveness data Anal cytology screening ($/QALY): Anal pap screening +HIV* -HIV** Every year $16,600 $34,800 Every 2 years $13,000 $15,100 *Goldie et al. JAMA. 1999; 281: **Goldie et al. Am J Med. 2000; 108:

28 Until this is sorted out. What to do in the meantime?

29 The anal cancer screening test Digital rectal exam

30 Anal cytology screening for AIN

31 Who should be screened? All HIV+ MSM with good prognosis? All HIV+ men regardless of sexual orientation All HIV- MSM over the age of 40? Women with high-grade grade vulvar lesions or cancer? All HIV+ women?? All men and women with perianal condyloma?m Men and women with ih transplant-associated associated immunosuppression

32 Before setting up screening Ability to perform cytology Ability to perform HRA and anal biopsies Ability to read cytology and biopsies Ability to perform office-based treatment

33 Before setting up screening Surgeons who understand d AIN to whom you can refer patients as needed

34 Until the definitive studies are done All of the evidence combined suggests that we should be treating HGAIN Proven carcinogenic potential, rising rates of anal cancer, proven prevention in the cervix If feasible, screen and treat t Monitor for progression to anal cancer among those who cannot be treated If screening not feasible, annual DRE

35 Protocol 020 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 i l/ i l intraepithelial ith l 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*

36 Efficacy against persistent anal infection in MSM Per-protocol population Endpoint HPV 6/11/16/18 HPV 6 HPV 11 n #of Cases GARDASIL (N=299) PY At Risk IR per 100 PY at Risk n # of Cases Placebo (N=299) PY at Risk IR per 100 PY at Risk HPV HPV N = Number of subjects randomized to the respective vaccination group who received at least 1 injection. n = Number of subjects who have at least one follow-up visit after Month 7. Efficacy (%) (95% CI) 94.9 (80.4, 99.4) 92.1 (47.2, 99.8) 100 (-15.5, 100) 93.8 (60.0, 99.9) 100 (51.5, 100)

37 Efficacy against HPV 6/11/16/18- related AIN and anal cancer in MSM Per protocol population Quadrivalent HPV vaccine (N=299) Placebo (N=299) HPV 6/11/16/18 related AIN and anal cancer By lesion type AIN 1 n Cases Rate n Cases Rate Efficacy y( (%) Condyloma acuminata Non-acuminate AIN 2 or worse CI (39.6 to 93.3) (16.3 to 93.4) (8.2 to 100) (-33.5 to 90.8) (8.8 to 95.4) AIN (-16.9 to 97.5) AIN 3 Anal cancer NA ( to 96.4) NA Palefsky J, for the Male Quadrivalent HPV Vaccine Efficacy Trial Team. Quadrivalent HPV vaccine efficacy against anal intraepithelial neoplasia in men having sex with men. Presented at: EUROGIN 2010 Congress; February 17-20, 2010; Monte Carlo, Monaco. Abstract SS 19-2.

38 Summary HIV-positive men and women are at unacceptably high risk of anal cancer Screening and treatment t t of HGAIN should be considered in high-risk populations to reduce the risk of progression to cancer HPV vaccines may also reduce the incidence of anal cancer in the future

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