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Say Yes to the Test!

Say Yes to the Test!. Jeffrey L. Lennox, MD Professor of Medicine Emory University School of Medicine Atlanta, GA. From JL Lennox, MD, and KA Workowski , MD, at Atlanta, GA: April 10, 2013, IAS-USA. A Brief History of the Cervical Pap Smear.

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Say Yes to the Test!

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  1. Say Yes to the Test! Jeffrey L. Lennox, MDProfessor of MedicineEmory University School of MedicineAtlanta, GA From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  2. A Brief History of the Cervical Pap Smear • 1928 – Papanicolaou presents methods and case reports. Received press attention, but little interest from medical establishment. • 1941 – Papanicolaou publishes additional data. • 1955 – First large study completed. • Late 50’s–60’s – Refinements, training of cytologists. • 1984 – 82% reduction in cervical cancer mortality compared to 1940’s. From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  3. In the 30 years after the description of the Pap smear, but before its acceptance, cervical cancer was the #1 cause of cancer mortality in women From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  4. Why Did the Medical Establishment Reject Cervical Pap Smears? • New test, no proof of efficacy and benefit • Insufficient training and expertise of pathologists • Additional costs to screen • Wide variability in results between labs • Bias against women, particularly with regards to STIs From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  5. Anal Pap Smear Among HIV-Infected Men: 27 years since first description • 1986 – “Association Between Anorectal Dysplasia, HPV and HIV in Homosexual Men”* • Obtained rectal Paps from 61 men, 39 re-examined 6-12 months later • 31% HIV+ • Findings: • 24/61(39%) had dysplasia • Dysplasia associations – history of anal warts, frequent receptive anal sex, HIV+ • Persistent dysplasia more common in HIV+ From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  6. Incidence of Anal Cancer in HIV-Infected Persons During HAART Era 34,189 HIV-infected patients from 13 North American cohorts 131-159 per 100,000 person-years, 31-59% higher than the peak for cervical cancer! Silverberg MJ, ClinInfDis2012, 54(7):1023-34 From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  7. Are all HIV-infected men equally at risk? • Cross sectional study of 200 MSM and 123 MSW, all HIV-infected, who had anoscopy performed.1 • Dysplasia present: 21% MSM, 7% MSW • Military cohort- median anal cancer age 42 years.2 • Persons with HIV >15 years had 12x higher rate than those <5 years (p<0.01) 1. Abramowitz L, AIDS 2007, 21(11): 1457-65. 2. Crum-Cianflone and Marconi, AIDS, Feb 2010 From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  8. How Well does the Anal Pap do When Compared to Biopsy? Chiao EY,JAIDS 2006;43:223-233 From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  9. Cost Effectiveness of Anal Cytology Screening in MSM Goldie SJ. JAMA 1999, 281(19):1822-1829 From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  10. Cost Effectiveness of Other Common Interventions Anal Pap Goldie SJ. JNCI 2004;96:604-615 From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  11. Cost Effectiveness of HRA Only vs. Pap for Screening - Methods • 401 HIV+ MSM had HRA, Pap, and HPV digene assay done at same visit. • 98/401 (24%) had AIN 2/3 based on biopsy during HRA. • For sensitivity and specificity the HRA biopsy was assumed to be gold standard. Lam JMC, AIDS 2011, 25: 635-42 From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  12. Cost Effectiveness of HRA Only vs. Pap - Results Conclusion: Direct HRA is the most cost effective Insert figure Pap > ASCUS: HRA HPV+ : HRA HRA From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  13. Random Biopsy Increases HGSIL Diagnostic Rate of HRA • 372 patients had HRA with directed and random biopsies done at same visit • 124 patients with HSIL, 11 (9%) diagnosed by random biopsy Silvera R, CROI 2013, #142 From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  14. New York State Guidelines • Clinicians should obtain anal cytology at baseline and annually in the following HIV-infected populations: • Men who have sex with men • Any patient with a history of anogenitalcondylomas • Women with abnormal cervical and/or vulvar histology From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  15. My Conclusions – • For those with HIV of >5 years duration, use direct HRA if available for MSM and other high risk people • Use Pap as second choice, followed by HRA • When performing HRA do 1-3 random biopsies From JL Lennox, MD, and KA Workowski, MD, at Atlanta, GA: April 10, 2013, IAS-USA.

  16. Anal Cancer Prevention 1st! Kimberly A. Workowski, MDProfessor of MedicineEmory University School of MedicineAtlanta, GA

  17. Natural History of HPV Infection • HPV persistence is a prerequisite for abnormal anogenital cytology • Most infections self limited • Limited data on persistence in specific anatomic sites (HIV+) • Anal dysplasia +/- treatment not well defined • Incidence and clearance rates can differ among HPV types • HPV16 lower anal clearance rate (dePokomany 2009)

  18. HPV Vaccine EfficacyRandomized Controlled Trials No evidence of efficacy against existing HPV infection or disease Paavonen J et al. Lancet 2009;374:301-14, Kjaer S et al. Cancer Prev Res 2009;2:868-78, Hildesheim A et al. JAMA 2007;298:743-53, Future I/II Study Group, BMJ 2010;341, The Furture II Study Group Lancet 2007;369:1861-8, Palefsky J et al. NEJM 2011;365:1576-85 Gardasil Package Insert, page 504 Table 12

  19. HPV vaccine–preventable fractions of various anal disease categories among HIV+ MSM Sahasrabuddhe. J Infect Dis. 2013 Feb;207(3):392-401.

  20. Time to recurrence of high-grade anal neoplasia among vaccinated and unvaccinated oncogenic human papillomavirus–infected men who have sex with men with a history of high-grade anal neoplasia New York City, April 2007– April 2011 (n = 105). Figure 2. Swedish KA, Factor SH, Goldstone SE. Prevention of recurrent high-grade anal neoplasia with quadrivalent human papillomavirus vaccination of men who have sex with men: a nonconcurrent cohort study. Clin Infect Dis. 2012 Apr; 54(7):891-8.

  21. Predictors of progression from low-grade AIN (LGAIN) to high-grade AIN (HGAIN) Coutlée F.Sex Health. 2012 Dec;9(6):547-55.

  22. Logistic Regression Analysis of Factors Associated with Prevalent Abnormal Anal Cytology among MSM in the SUN Study, 2004–2006 Conley L. J Infect Dis. 2010 Nov 15;202(10):1567-76.

  23. Screening for Anal Dysplasia and Cancer in MSM • CDC, HIVMA OI guidelines: consider anal Pap tests in MSM • Evidence is limited • Natural history • Reliability of screening methods • Safety and response to treatments • Programmatic support needed • Patients with abnormal results should be evaluated with high-resolution anoscopy (HRA) • HPV DNA screening of rectum not recommended

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