1. Anal and Cervical Cytologic Abnormalities among HIV-Infected Women on HAART Remain Prevalent at 12 months in the Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN Study) Erna Milunka Kojic, Susan Cu-Uvin, Lois Conley, Tim Bush, Elizabeth R. Unger, Keith Henry, John Hammer, E. Turner Overton, Teresa Darragh, John T. Brooks The findings and conclusions in this presentation have not been formally disseminated by the Centers for Disease Control and Prevention and should not be construed to represent any agency determination or policy

2. Study to Understand the Natural History of HIV/AIDS in the Era of Effective Therapy (SUN) 5-year prospective observational cohort study 682 adults at 7 clinics in 4 U.S. cities HAART only or no treatment for HIV Monitor complications of treatment and prolonged survival, morbidity and mortality related to HIV infection Testing at baseline and every six months, including anal and cervical HPV typing and cytology Providence Minneapolis St. Louis Denver

3. Demographics (n =53 on HAART) Age, years: mean (range)39 (23-59) Race/Ethnicity: n (%) White, non-Hispanic17 (32) Black, non-Hispanic27 (51) Hispanic6 (11) Other/unknown3 ( 6) Nadir CD4 cell count (cells/µl) 171 Baseline CD4 cell count (cells/µl) 465 Hormonal birth control history32 (60) Smoking, history27 (51) Smoking current22 (42)

4. HPV Prevalence p < 0.001

5. Cytology Prevalence (n =53 on HAART) Cervical cytology N=53 Anal cytology N=53 Baseline cytology Baseline n (%) 12 month n (%) Baseline n (%) 12 month n (%) Normal 38 (72)35 (66) 36 (68) Abnormal 15 (28) 18 (34) 17 (32) 22 women had abnormal cervical cytologies at baseline or 12 months 24 women had abnormal anal cytologies at baseline or 12 months

6. Cytology (n =53 on HAART) Anus 12 months Cervix baseline Cervix 12 months Anus Anus baseline Cervix

7. Cytology Persistence (n =53 on HAART) 12 Month cervical cytology N=53 12 Month anal cytology N=53 Baseline cytology NormalAbnormalNormalAbnormal Normal27/3871%11/3829%26/3574%9/3526% Abnormal8/1553%7/15 47% 10/1856%8/18 44%

8. HPV and Anal Sex Risk for Detection of Prevalent HPV At baseline, history of any anal sex was reported by 36 (40%) women No significant difference between women reporting a history of anal sex compared with women who did not Any HPV detected Self – reported anal sex p-value YesNo Anal HPV+86%89%0.73 Cervical HPV+79%86%0.54

9. Conclusions In HIV-infected women on HAART, HPV infection of the anus and the cervix remains prevalent In this cohort of HIV-infected women on HAART, about one-third had abnormal cytology in the cervix and anus at both baseline and 12 months Almost half of the women with abnormal anal and cervical cytology at baseline remained abnormal at 12 months There is no difference in HPV-related cytologic abnormalities between women who report a history of anal sex and those who do not There is a need to further elucidate the clinical significance of anal HPV infection in HIV infected women

10. SUN Study Sites and Laboratories CDC/ Division of HIV/AIDS Prevention John T. Brooks Lois Conley Tim Bush Cerner Corporation Kathleen Wood Rose Baker Cheryl Lapierre Hennepin County Medical Center (Minneapolis) Keith Henry Ellen Kane Abbott-Northwestern Hospital (Minneapolis) Frank Rhame Jenny Dahlke Brian Goodroad Park-Nicollet Institute (Minneapolis) Hal Martin Meaghan Morton Miriam Hospital (Providence) Charles Carpenter Susan Cu-Uvin Kenneth Mayer Milu Kojic Jennifer Florczyc Washington University School of Medicine (St. Louis) Kristin Mondy E. Turner Overton Lisa Kessels Denver Infectious Disease Consultants (Denver) John Hammer Barbara Widick Cheryl Stewart Sarah Kressy University of Colorado Health Science Center ( Denver) Kenneth Lichtenstein CDC/ Division of Viral and Rickettsial Diseases Elizabeth Unger Ruth Ann Tucker Kara Duncan David Swan

11. END

12. Inclusion Criteria  Documented HIV infection  Age > 18 years  Attended > 2 consecutive visits at clinic in the preceding year  Expected to receive care at clinic for > 2 years  Limited antiretroviral (ARV) exposure:  If < 30 days total prior ARV exposure CD4 100-500  If > 30 days total prior ARV exposure Only received HAART and only since July 1, 1997 CD4 > 100

13. Most Prevalent High-Risk HPV Types in Anus and Cervix at Baseline Percent High-risk HPV types

14. Most Prevalent High-Risk HPV Types in Anus and Cervix at 12 Months Percent High-risk HPV types