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Helen Kelly London School of Hygiene and Tropical Medicine EUROGIN 2012 Prague July 8-11, 2012

Prospective Evaluation of Cervical Screening Methods in HIV positive women in Africa (HARP Study): Baseline Results. Helen Kelly London School of Hygiene and Tropical Medicine EUROGIN 2012 Prague July 8-11, 2012

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Helen Kelly London School of Hygiene and Tropical Medicine EUROGIN 2012 Prague July 8-11, 2012

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  1. Prospective Evaluation of Cervical Screening Methods in HIV positive women in Africa (HARP Study): Baseline Results Helen Kelly London School of Hygiene and Tropical Medicine EUROGIN 2012 Prague July 8-11, 2012 ABSTRACT AUTHORS: KELLY H, MUZAH B, SAWADOGO B, DIDELOT M, MICHELOW P, LOMPO O, DOUTRE S, GILHAM C, VON KNORRING N, ZAN S, DELANY S, OMAR T, MEDA N, DRABO J, WEISS H, LEGOOD R, NAGOT N, SEGONDY M, COSTES V, MAYAUD P http://www.harp-fp7.org/

  2. Background • Limited knowledge on cervical intraepithelial neoplasia (CIN) in Africa and no Africa-specific guidelines (particularly for HIV+) and limited implementation of cervical cancer screening and management(Firnhaber, J Int. AIDS Soc. 2012, Denny, Vaccine 2006) • HIV and cervical cancer • The relationship between HIV immunosuppression and cervical cancer incidence is mostly driven by CD4 count (Hawes, J Natl Cancer Inst. 2006, Grinsztejn, Int J Infect Dis. 2009) • The effect of antiretroviral treatment (ART) is unclear in the context of cervical cancer (Heard, AIDS 1998, Lillo, J Infect Dis. 2001) • Recent availability of CareHPV as cervical cancer screening test in low-resource settings (Qiao, Lancet Oncol. 2008)

  3. HARP (HPV in Africa Research Partnership) Aim of HARP To evaluate the diagnostic performance& cost effectiveness of cervical cancer screening methods to detect prevalent and incident CIN-2+ (at 18-months) among HIV-infected African women • HARP Study Design • South Africa & Burkina Faso • 1200 HIV+ women age >25 and <50 years • (excluding hysterectomy and pregnancy) • Participants enrolled in two strata based • on CD4 and ART use • (i) taking ART OR low CD4 count (≤350 cells/μl) • (ii) not taking ART AND high CD4 count • 6 monthly visits up to 18 months • Main endpoint => histologyCIN2+

  4. Methodology careHPV/HC2 INNO-LiPA If ANY HPV DNA+, Cytology > ASCUS or ≥ AGUS, VIA/VILI +, Colposcopy +

  5. Population characteristics at baseline

  6. Screening at baseline

  7. HR-HPV prevalence by CD4 count p-trend <0.001 81% 77% 71% 62% 58% 52% 51% HR HPV Prevalence (%) 38% n=33 n=37 n=62 n=90 n=89 n=98 n=131 n=141 CD4 count (cells/μL)

  8. Cytology by CD4 count P-trend for HSIL by CD4 count: combined sites, p< 0.003 South Africa alone < 0.006 n = 33 n = 51 Burkina Faso CD4 count South Africa

  9. HR-HPV prevalence by ART 74% 67% 493 cells/μL 52% 43% 67% 477 cells/μL 43% 459 cells/μL 382 cells/μL n = 183 n = 212 n = 42 n = 54

  10. Genotyping Results

  11. Most frequent HPV genotypes 25% 17% 13% 12% 12% 11% 11% 10% 8% 6%

  12. Summary • HIV women at high risk of cervical cancer appear not to be screened effectively, even fewer treated • Study confirms high prevalence of HR HPV types and multiple infections in this population • Similar HR genotype distribution, with HPV 52 being equally dominant in both countries • Immuno-suppression main driver of HR HPV and cytological abnormalities • Nadir CD4 count and CD4 threshold at ART initiation probably important factors for HR HPV infection and cervical disease development

  13. HARP Collaborators • London School of Hygiene & Tropical Medicine, UK • Philippe Mayaud, Helen Weiss, Rosa Legood, Clare Gilham, Helen Kelly • Wits Reproductive Health and HIV Institute, Wits University, Johannesburg, South Africa • Sinead Delany, BatanayiMuzah, Helen Rees, Nina von Knorring • National Health Laboratory Service (NHLS), Johannesburg, South Africa • David Lewis, Pam Michelow, Tanvier Omar, Adrian Puren • Centre de Recherche Internationale sur la Sante, Ouagadougou University, Ouagadougou, Burkina Faso • Joseph Drabo, Nicolas Meda, MamadouSawadogo, Bernard Sawadogo, Olga Lompo, SouleymaneZan • Centre de RechercheBiomoléculairePietroAnnigoni (CERBA), Ouagadougou, Burkina Faso • JaquesSimpore, FlorenciaDjigma • University of Montpellier 1 & INSERM U1058, France • Nicolas Nagot, Michel Segondy, Valerie Costes, Marie-Noelle Didelot-Rousseau, SylvianeDoutre, Nicolas Leventoux, Jean Ngou http://www.harp-fp7.org/

  14. Additional slides

  15. HPV testing at baseline INNO-LiPA HR HPV+ defined as + for 13 HR types as in HC2 test

  16. HR-HPV prevalence by age group

  17. Most frequent HPV genotypes

  18. Cytology at baseline 60% 32/140 (23%) CIN2+ histology 10/84 (12%) CIN2+ histology

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