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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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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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


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.


Anal Cancer Prevention 1st!

Kimberly A. Workowski, MDProfessor of MedicineEmory University School of MedicineAtlanta, GA


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)


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


HPV vaccine–preventable fractions of various anal disease categories among HIV+ MSM

Sahasrabuddhe. J Infect Dis. 2013 Feb;207(3):392-401.


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.


Predictors of progression from low-grade AIN (LGAIN) to high-grade AIN (HGAIN)

Coutlée F.Sex Health. 2012 Dec;9(6):547-55.


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.


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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