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General introduction PASER Collaboration with SATuRN Prof Tobias Rinke de Wit

General introduction PASER Collaboration with SATuRN Prof Tobias Rinke de Wit. Thursday, November 21, 2013 Bloemfontein, South Africa. PASER & TASER networks. PASER objectives. To build capacity on the monitoring and surveillance of HIV drug resistance in Africa by:

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General introduction PASER Collaboration with SATuRN Prof Tobias Rinke de Wit

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  1. General introduction PASER Collaboration with SATuRN Prof Tobias Rinke de Wit Thursday, November 21, 2013 Bloemfontein, South Africa

  2. PASER & TASER networks

  3. PASER objectives To build capacity on the monitoring and surveillance of HIV drug resistance in Africa by: • Network development • Clinics, laboratories, research groups • Training and mentoring of medical & lab staff • Observational studies • Prospective cohort of acquired HIVDR [PASER-M] • Cross-sectional surveys of transmitted HIVDR [PASER-S] • International clinical databases + HIV sequence databases • Laboratory Quality Assurance network (TAQAS) • To disseminate information, perform advocacy and realize • policy support

  4. PASER sitesselected from >50 Situations at date of patient enrolment (2007-2009)

  5. PASER covers all important African 1st line ART regimens *+ 3TC/FTC + EFV/NVP

  6. PASER represents all major HIV-1 subtypes in Africa pol sequences, REGA and STAR algorithms (n=2436)

  7. PASER numbers 6 countries 13 clinical sites Enrolment Mar 2007 – Sept 2009 PASER S PASER M 2733 patients initiating 1st line followed up for at least 24 month • 2 cross sectional cohorts of ART-naive newly infected individuals • 81 patients in Mombasa • 77 patients in Kampala 250 patients enrolled at second line switch followed up for 24 months

  8. Baseline HIVDR in ARV-naive individuals by region and drug class Risk of primary HIVDR rose by 38% for each additional year since local ART roll-out Hamers et al. Lancet Inf Dis 2011

  9. Confirmed by WHO data • 26,102 patients from Africa, Asia, LatinAmerica • 32.9% annualincrease of HIVDR in East Africa Gupta RK et al., Lancet 380, 1250-8, 2012

  10. Baseline HIVDR doubles 1st year risk of VF and acquired HIVDR P<0.0001 P=0.001 Odds ratio Multivariate analysis adjusted for sex, age, calendar year, WHO clinical stage, BMI, pretherapy HIVRNA and CD4, prior ARV use, type of NRTI and NNRTI. Hamers et al. Lancet Inf Dis 2012

  11. Slower recovery of CD4 in patients with baseline (pre-treatment) HIVDR

  12. PASER-S studies indicate moderate TDR in Kampala and Mombasa • WHO-recommended proxy criteria for recent infection: • Newly HIV-1 diagnosed and aged ≥18 and <25 years, or lab evidence of recent HIV-1 infection Ndembi et al. AIDS, 2011 Sigaloff et al. Aids Res Hum Retro 2011

  13. Adding to WHO data 72 surveys 20 moderate level (5-15%) WHO HIV Drug Resistance Report, S Bertagnolio, IAS Conference July 26, 2012

  14. The importance of VL testing: 4x less unnecessary switches Clinical + CD4 count + targeted VL (n=186) Clinical+ CD4 count(n=64) Sigaloff et al. JAIDS 2011

  15. Lack of VL monitoring more HIVDR Cohort 1 (n=100) Virological failure by routine pVL test, 12 mo ART Cohort 2 (n=161) Clinico-immunological failure, 26 mo ART Stanford hivdbalgorithm Hamers CID12; Sigaloff JID12

  16. MARCH-Uganda study • Prospective cohort study of 360 children in Uganda on ART • Initiated in January 2010 • Funded by EDCTP, NACCAP

  17. >40 publications: international journals • Hamers, R.L., Schuurman R., van Vugt, M., Derdelinckx, I. and Rinke de Wit, T.F. De ontwikkeling van hiv-1 resistentiesurveillance in Afrika. NedTijdschrGeneeskd 151, 2666-2671, 2007. • Hamers, R., de Beer IH, Kaura, H., van Vugt, M., Caparos, L. and Rinke de Wit, T.F. Diagnostic accuracy of 2 oral fluid-based tests for HIV surveillance in Namibia. JAIDS 48, 116-118, 2008. • Hamers, R.L., Derdelinckx, I., van Vugt, M., Stevens, W., Rinke de Wit, T.F. and Schuurman, R. The status of HIV-1 resistance to antiretroviral drugs in sub-SaharanAfrica. Antivir. Ther. 13, 625-639, 2008. • Hamers, R.L., Rinke de Wit, T.F., Schellekens, O.P. and van Vugt, M. Aidsbehandeling in Afrika. NedTijdschrGeneeskd 152, 654, 2008. • Hamers, R.L., Smit, P., Stevens W., Schuurman, R. and Rinke de Wit, T.F. Dried fluid spots for HIV type-1 viral load and resistance genotyping: a systematic review. AntiviralTherapy 14, 619-629, 2009. • Wallis C., Papathanasopoulos, M., Rinke de Wit, T.F. and Stevens, W. Affordable in-house drug resistance assay with good performance in non-subtype B HIV-1. J Virol Meth 168, 505-508, 2010. • Hamers, R.L., Siwale, M., Wallis, C.L., Labib, M., van Hasselt, R., Stevens, W., Schuurman, R., van Vugt, M. And Rinke de Wit, T.F. Baseline drug-resistant HIV-1 at initiation of first-lineantiretroviraltherapy in Lusaka, Zambia. JAIDS 55, 95-101, 2010. • Hamers, R.L., Oyomopito R., Kityo, C., Phanuphak, P., Siwale, M., Sungkannuparph S., Conradie, F., Kumarasamy, N., Botes, Sirisanthana, T., M.E., Abdallah, S., Li, P.C.K., Ngorima N., Kantipong P., Osibogun, A., Lee, C.K.C., Stevens, Kamarulzaman, A., W.S., Derdelinckx, I., Arthur Chen, Y.-M., Schuurman, R., van Vugt, M. and Rinke de Wit, T.F. Cohort profile: the PharmAccess African (PASER-M) and the TREAT Asia (TASER-M) monitoring studies to evaluate resistance – HIV drug resistance in sub-Saharan Africa and the Asia-Pacific. Int J Epidemiol, Epub, Nov 2010. • Steegen, K., Bronze, M., van Craenenbroeck, E., Winters, B., van der Borght, K., Wallis, C.L., Stevens, W., Rinke de Wit, T.F. and Stuyver, L. A comparativeanalysis of HIV drug resistanceinterpretationbasedon short reversetranscriptasesequencfes versus full sequences. AIDS Res & Ther 7, 38, 2010: http://www.aidsrestherapy.com/content/7/1/38. • Ndembi, N., Hamers, R.L., Sigaloff, K.C.E., Lyagoba, F., Magambo, B., Nanteza, B., Watera, C., Kaleebu, P. and Rinke de Wit, T.F. Transmitted antiretroviral drug resistance among newly HIV-1 diagnosed young individuals in Kampala. AIDS 25, 905-910, 2011. • Sigaloff, K.C.E., Hamers, R.L., Wallis, C.L., Kityo, C., Siwale, M., Ive, P., Botes, M.E., Mandaliya, K., Wellington, M., Osibogun, A., Stevens, W.S., van Vugt, M. and Rinke de Wit, T.F. Unnecessary antiretroviral treatment switches and accumulation of HIV resistance mutations; two arguments for viral load monitoring in Africa. J.Acquir.ImmuneDefic. Syndr, 58, 23-31, 2011. • Hamers, R.L., Wallis, C.L., Kityo, C., Siwale, M.M., Mandaliya, K., Conradie, F., Botes, M.E., Wellington, M., Osibogun, A., Sigaloff, K., Nankya, I., Schuurman, R., Wit, F., Stevens, W., van Vugt, M. and Rinke de Wit, T.F. HIV-1 drug resistance among antiretroviral-naïve individuals in sub-Saharan Africa after rollout of antiretroviral therapy: multicentre observational study. Lancet Inf. Dis., DOI:10.1061/S1473-3099(11)70149-9, published on line, July 28, 2011. • Sigaloff K.C.E., Calis, J.C., Geelen, S.P., van Vugt, M. and Rinke de Wit, T.F. Resistance-associated mutations among children on antiretroviral treatment in resource-poor settings: a systematic review. Lancet Inf. Dis., DOI:10.1016/S1473-3099(11)70141-4, August 26, 2011. • Hamers, R.L., Schuurman, R., Sigaloff, K.C.E., Wallis, C.L., Kityo, C., Siwale, M., Mandaliya, K., Ive, P., Botes, M.E., Wellington, M., Osibogun, A., Wit, F.W., van Vugt, M., Stevens, W. and Rinke de Wit, T.F. Effect of pre-treatment drug-resistance on immunological, virological and drug-resistance outcomes after the first year of antiretroviral therapy for HIV-1: multicentre cohort in six African countries. Lancet InfDis, DOI:10.1016/S1473-3099(11)70255-9, published online, October 28, 2011. • Sigaloff, K.C., Mandaliya, K., Hamers, R.L., Otieno, F., Jao, I.M., Lyagoba, F., Magambo, B., Kapaata, A., Ndembi, N. and Rinke de Wit, T.F. High prevalence of transmitted antiretroviral drug resistance among newly HIV type 1 diagnosed adults in Mombasa, Kenya. AIDS Res. Hum. Retrovir., 2012 (Epubahead of print). Can be distributed on request, many on your USB sticks!

  18. Capacity building:Regional Workshops & on-site training * ARTA = Affordable Resistance Testing for Africa

  19. Advocacy: keep HIVDR on the map  STAR, South Africa March 7, 2011 The Nation, Kenya August 1, 2011   Daily Monitor, Uganda April 25,2012

  20. Collaboration PASER – SATuRN • Expansion of clinical and laboratory databases on African HIV drug resistance, incl. new HIV subtypes (non-C) and incl. retrospective data >2007 • Strengthened joint training programs for African HIV clinicians • Strengthened joint advocacy of HIVDR through presentations at conferences, papers in journals, grey literature, mass media, websites, twitter, etc. • Improved advice to African HIV cliniciansr.e. treatment of patients who are failing ART • Coordinated development, validation and marketing of more affordable HIVDR tests • Improved joint research options with increased data available; coordinated grant proposal writing (NIH, UNITAID, EDCTP)

  21. Acknowledgements Clinical sites PIs and study teams Study participants University of the Witwatersrand, South Africa Wendy Stevens Carole Wallis Kim Steegen JCRC, Uganda Cissy Kityo Peter Mugyenyi MRC/UVRI, Uganda Nicaise Ndembi Pontiano Kaleebu PharmAccess Foundation Dept of Global Health AMC-UvA Amsterdam Institute for Global Health and Development Elske Straatsma John Dekker Annedien Plantenga Nicole Spieker Raph Hamers Kim Sigaloff Desiree Lathouwers Aletta Kliphuis Peggy van Leeuwen Corry Manting Pascale Ondoa Joep Lange Michèle van Vugt Tobias Rinke de Wit UMCU Virology, The Netherlands Rob Schuurman Annemarie Wensing

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