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ART-A Development of an A ffordable R esistance T est for A frica

ART-A Development of an A ffordable R esistance T est for A frica. Tobias Rinke de Wit. t.rinkedewit@pharmaccess.org. Rapid Worldwide Access to ART. Towards Universal Access – Scaling up priority HIV/AIDS interventions in the health sector. WHO/UNAIDS/UNICEF, June 2008.

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ART-A Development of an A ffordable R esistance T est for A frica

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  1. ART-ADevelopment of an Affordable Resistance Test for Africa Tobias Rinke de Wit t.rinkedewit@pharmaccess.org

  2. Rapid Worldwide Access to ART Towards Universal Access – Scaling up priority HIV/AIDS interventions in the health sector. WHO/UNAIDS/UNICEF, June 2008

  3. However: Resistance is Looming Health systems Africa • Stock outages • Shortage of staff • Insufficient patient adherence support • Sub-optimal drug prescribing patterns • Limited access to virological monitoring

  4. Consequences of limited access to VL monitoring week 48 genotyping data on 8,376 patients, 10 studies, mostly Western world Gupta RK, Hill A, et al., Lancet Infect. Dis. 2009; 9: 409-17

  5. Resistance Tests: What are the Barriers? • Technically complex • Technology and kit-dependent • Sophisticated equipment required • Requires skilled staff • Requires special lab infrastructure (contamination) • Not all HIVDR mutations known • Mainly subtype B adapted (Europe, US, Australia) • Expensive 5

  6. VL + HIVDR Costs Cost for VL and HIVDR testing PASER-M program Assumptions • VL = $30 / test • HIVDR = $300 / test • 10% on 2nd line per Y • 3,000 patients target • baseline, Y1, Y2 visits • 1st line: 10% fail + 10% death/LFU • 2nd line: 10% fail + 25% death/LFU $ 1,952,139 ~ extra $250 per patient per year

  7. Goal of ART-A Consortium The ART-A Research consortium is a public private initiative that aims to develop a new and more affordable set of protocols for HIV resistance testing in resource-poor settings 7

  8. Considerations for ARTA Protocolhighlights • Should provide affordable and practical solutions for HIVDR determination in Africa • Should be HIV subtype independent • Should be web-based and freely available to interested clinics in Africa • Should ideally cover a (semi-)quantitative HIV viral load test • Should be compatible with African field conditions (DBS-based) • Should concentrate on RT inhibitors, but not exclude protease inhibitors • Should be adapted to different levels of clinics • Should produce close to real-time data • Should have a “financial mirror image” calculating costs both at clinic and country level

  9. Location of Activities 9

  10. ART-A consortium 10

  11. Public/Private (50%/50%) Public: Netherlands Organization for Research/Science for Global Development (NWO/WOTRO) under the Netherlands Africa partnership for Capacity development and Clinical Interventions Against Poverty related diseases (NACCAP) Private: VIRCO, CLS AMC - Center for Poverty related Communicable Diseases (AMC-CPCD) New algorithm for Affordable Resistance Testing, accessible via web, validated by HIVDR phenotyping Information dissemination using different tools and for different groups (Health care professionals, Health policy makers, etc.) Training & technical assistance 2 PhD programs Financial models IP protection Financing Delivery Financing and Delivery 11

  12. www.arta-africa.org

  13. Program Highlights

  14. Potential Customers Individual patients/doctors: semi-quantitative viral load, HIVDR Population level: mostly HIVDR monitoring & surveillance

  15. Individual PatientsClinic Applications Examples

  16. A B C D E Definition Clinic Levels Tertiary (teaching) hospital providing all specialized medical procedures, such as oncology, all surgeries and ICU. Availability of a full range of medical and Para-medical specialists 24/7. HIMS is used for data capturing and analysis. Laboratory, radiology and pharmacy services available. Secondary (district) hospital providing a broad spectrum of medical procedures except specialized treatment such as listed in A. Primary health center consisting of at least one MD plus registered nurse and lab technician offering minor surgery and chronic disease management. Basic health center staffed by clinical officer offering general health and maternal health care Health shop/nurse driven clinic giving advice on basic health care issues

  17. A B C D E Customized Protocols for Different Levels A: real time VL, genotying, (phenotyping), epidemiology B: (semi-quantitative) VL, genotype interpretation C: semi-quantitative VL D: DBS, VL interpretation E: DBS, VL interpretation

  18. Overview ART-A Program Activities CPCD PharmAccess P1 Wits P2 UMCU/CRP P3 VIRCO P4 CLS P5 PAF Optimizing sample collection device (DFS) and extraction protocol Optimizing HIV-1 subtype independent primers, amplification and detection protocol Developing genotyping protocol, supported by phenotyping quality control (QC) and interpretation Technology transfer to Africa Dissemination of information to various audiences Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 Step 7 Knowledge

  19. Affordable Resistance Testing for Africa:Proposed protocols • Information dissemination • Training • Capacity building • Financial mirror image 19

  20. Population LevelEpidemiological Applications Examples PASER/LAASER

  21. LAASER program Uganda UGANDA VIRUS RESEARCH INSTITUTE www.laaserhivaids.org

  22. PASER network Research centers Clinical sites Nigeria • LUTH (Lagos) The Netherlands • UMCU (Utrecht) • AMC-CPCD (Amsterdam) Uganda • JCRC-TREAT sites (Mbale, Kampala, Fort Portal) Kenya • ICRH (Mombasa) Kenya • CPGH (Mombasa) • Mater (Nairobi) Uganda • JCRC (Kampala) • UVRI/MRC (Entebbe) South Africa • Wits-MMH (Joburg) • Wits-CHRU (Joburg) Zambia • Lusaka Trust (Lusaka) • KARA Clinic (Lusaka) • Coptic Hospital (Lusaka) Reference laboratories Uganda • JCRC (Kampala) • UVRI (Entebbe) Zimbabwe • Newlands Clinic (Harare) South Africa • Muelmed Hospital (Pretoria) • RTC Themba Lethu (Joburg) • RTC Acts Clinic (White River) South Africa • Wits-MMH (Joburg)

  23. PASER-M HIV treatment centers Prospective cohort study Patients on HAART (n=240) Acquired HIVDR PASER: two study protocols Monitoring Surveillance • PASER-S • VCT/ANC/STD sites • Repetitive cross-sectional surveys • Newly infected/ARV naïve (n=85) • Transmitted HIVDR Harmonized with WHO HIVResNet protocols

  24. Baseline HIVDR mutations at 8 sitesARV naïve

  25. Progress made thus far • DBS based protocols developed that are suitable for resistance testing • Narrow down HIVDR testing strategy by excluding • PMA tests • Nested PCR • Focus on single round PCR strategies • New software developed for automatic sequence analysis • Phenotying for validating genotypes: high correlation clade B and clade C phenotyping • Transfer of technology for resistance • Financial mirror image on the ARTA algorithm in progress

  26. Affordable Resistance Testing for Africa:Proposed protocols C. Wallis L. Stuyver 26

  27. This work is supported by a grant of the Netherlands Organisation for Scientific Research / Science for Global Development (NWO/WOTRO), under the Netherlands African Partnership for Capacity Development and clinical Interventions against Poverty related Diseases (NACCAP)

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