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John T. Brooks 1 , Pragna Patel 1 , Erna Milu Kojic 2 ,

Anal Human Papillomavirus Infection in HIV-Infected Men Who Have Sex With Men (MSM) and Men Who Have Sex with Women (MSW) in the SUN Study. John T. Brooks 1 , Pragna Patel 1 , Erna Milu Kojic 2 , Lois Conley 1 , Tim Bush 1 , Elizabeth Unger 1 ,

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John T. Brooks 1 , Pragna Patel 1 , Erna Milu Kojic 2 ,

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  1. Anal Human Papillomavirus Infection in HIV-Infected Men Who Have Sex With Men (MSM) and Men Who Have Sex with Women (MSW) in the SUN Study John T. Brooks1, Pragna Patel1, Erna Milu Kojic2, Lois Conley1, Tim Bush1, Elizabeth Unger1, Teresa Darragh3, Keith Henry4, John Hammer5, Turner Overton6, Joel Palefsky3, Susan Cu-Uvin1 1. CDC, Atlanta GA 2. The Miriam Hospital, Providence RI 3. UCSF School of Medicine, San Francisco CA 4. Hennepin County Medical Center, Minneapolis MN 5. Rose Medical Center, Denver CO 6. Washington University School of Medicine, St. Louis MO

  2. Background • Anal cancer incidence increased among HIV-infected men • Anal human papillomavirus (HPV) infection • Immunosuppression • Need for effective anal cancer screening algorithms • Considerable interest in “anal Pap smear” evaluation • Existing data inadequate to inform guidelines • No randomized controlled clinical trials

  3. Objectives 1) Describe prevalence of anal HPV within a contemporary cohort of HIV-infected men • Men who have sex with men (MSM) • Men who have sex with women (MSW) • 2) Describe the utility of anal HPV testing to detect the presence of anal cytopathology in these men anal cytology  high resolution anoscopy HPV screening 

  4. Methods – Study Population • The “SUN” Study*: - Closed prospective observational cohort study 700 adults - Natural history of HIV disease in the contemporary era Minneapolis Providence St. Louis Denver * Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy

  5. Methods – Study Population • Inclusion • eitherARV-naïve with CD4 cell count 100-500 cells/µL • orHAART-experienced with CD4 cell count >100 cells/µL • Enrolled 2004 – 2006 • Sexuality (i.e., MSM vs. MSW) defined based on self report on an audio-computer assisted self-interview

  6. Methods – Baseline Examination • Clinicians collected two Dacron® anal swabs at enrollment: • HPV screening • Roche Linear Assay  37 types – CDC (E. Unger) • Categorized as high-risk and low-risk types • Cytopathological examination • Bethesda system – UCSF (T. Darragh)

  7. Results - Characteristics at Time of Specimen Collection * IQR = interquartile range (25th to 75th percentile), † n = 503, ‡ n = 497

  8. MSW (N = 97) MSM (N = 410) Prevalence of Anal HPV by Type among 507 Enrolled Males Median number of types (IQR) 6 (3-8) 2 (2-4) 3 (2-5) 1 (1-2) 2 (1-3) 1 (0-2)

  9. Association of Anal HPV with Cytopathological Abnormalities, MSM (N = 375) • * Atypical cells of undetermined significance (ASCUS) • Low-grade squamous intraepithelial lesion (LSIL) • High-grade squamous intraepithelial lesion (HSIL) • **RR = unadjusted relative risk, † 95% CI = 95% confidence interval

  10. Association of Anal HPV with Cytopathological Abnormalities, MSW (N = 89) * ASCUS, LSIL or HSIL, **RR = unadjusted relative risk, † 95% CI = 95% confidence interval

  11. Test Characteristics of Anal HPV Detection For Any Abnormal Anal Cytology (N = 464) MSM (N = 375) MSW (N = 89) Any abnormal cytology Any abnormal cytology + - + - 42% falsely positive 68% falsely positive 210 149 17 36 + + Any HPV Any HPV 52% abnormal 19% abnormal 4% no further work-up 40% no further work-up 2* 14 0 36 - - * both ASCUS

  12. Limitations • We did not include severely immunosuppressed patients • We did not conduct simultaneous anoscopy and biopsies to assess correlation of cytology and histology • We did not examine negative predictive value of anal HPV testing for absence of abnormal anal histology

  13. Conclusions • Anal HPV was highly prevalent among men in this contemporary cohort of HIV-infected patients • Anal HPV prevalence was significantly greater among MSM than among MSW • The absence of HPV (“negative test”) was highly predictive of the absence of anal cytopathology

  14. Recommendations • As anal cancer screening algorithms are developed, the high negative predictive value of HPV testing for the absence of cytopathology we observed deserves further consideration as an initial screening step to exclude men from the need for high resolution anoscopy, especially among groups of men with low to moderate prevalence of anal HPV infection • Need randomized controlled study to examine utility of anal cytological screening for detecting abnormal histology and reducing anal cancer morbidity and mortality

  15. SUN Study Sites and STI Laboratories • Miriam Hospital (Providence) • Charles Carpenter, Susan Cu-Uvin, Kenneth Mayer, • Milu Kojic, Jennifer Florczyk, Sara Metzler, • Patricia D’Aiello • Washington University School of Medicine (St. Louis) • E. Turner Overton, Lisa Kessels, Mariea Snell, • Dorothea Dedeaux-Turner, Sara Hubert, • Kenneth Griffie • Denver Infectious Disease Consultants (Denver) • John Hammer, Barbara Widick, Tara Kennedy, • Billy Thomas • University of Colorado Health Science Center ( Denver) • Kenneth Lichtenstein, Cheryl Stewart • CDC/ Division of STD Prevention • John Papp, Carol Farshy   CDC/ Division of HIV/AIDS Prevention John T. Brooks, Pragna Patel, Lois Conley, Tim Bush Cerner Corporation Kathleen Wood, Rose Baker, Cheryl Akridge Hennepin County Medical Center (Minneapolis) Keith Henry , Jason Baker, Eddie Gunderson, Miki Olson, John Hall Abbott-Northwestern Hospital (Minneapolis) Frank Rhame, Mark Olson, Eve Austad Park-Nicollet Institute (Minneapolis) Hal Martin, Meaghan Morton, Cheri Murch Emory University Angie Caliendo

  16. Comparison of Testing Characteristics * From the present study † U.S. Preventive Services Task Force. Screening for Cervical Cancer: Recommendations and Rationale. AHRQ Publication No. 03-515A. January 2003. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/3rduspstf/cervcan/cervcanrr.htm

  17. MSM, high-risk types MSM, low-risk types Non-MSM, high-risk types Non-MSM, low-risk types

  18. Prevalence of Anal HPV by Type among 507 Enrolled Males, 2004-2006 49% no HPV 16 or 18 83% no HPV 16 or 18

  19. Prevalence of Anal HPV by CD4 Cell Count among 507 Enrolled Males MSW (N = 96) MSM (N = 407) (n = 24) (n = 195) (n = 198) (n =11) (n = 51) (n = 34) CD4 cell count (cells/µL) P-value for trend: 0.448 P-value for trend: 0.189

  20. Table 1. Characteristics of the 507 Enrolled Male Participants, the SUN Study, 2004-2006 (N = 507) * IQR = interquartile range (25th to 75th percentile), † n = 503, ‡ n = 497

  21. Table 2. Prevalence of Anal Human Papillomavirus Infection among Male Participants, the SUN Study, 2004-2006 (N = 507)

  22. Methods - Statistical • Univariate associations • Chi-square or Fisher’s exact test  categorical variables • Wilcoxon rank sum test  continuous variables

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