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Optimizing and simplifying the toolkit (drugs, dosing, and diagnostics) and delivery of ART

Optimizing and simplifying the toolkit (drugs, dosing, and diagnostics) and delivery of ART. Dr Eric Goemaere Regional TB/HIV Advisor MSF South Africa. Bending the curves. Reducing clinical workload Bending the epidemic curve Distributing tasks

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Optimizing and simplifying the toolkit (drugs, dosing, and diagnostics) and delivery of ART

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  1. Optimizing and simplifying the toolkit (drugs, dosing, and diagnostics) and delivery of ART Dr Eric Goemaere Regional TB/HIV Advisor MSF South Africa

  2. Bending the curves • Reducing clinical workload • Bending the epidemic curve • Distributing tasks • Increasing patient autonomy & adherence • Long term community based chronic care • Reducing pill burden and toxicities • ARV dosage optimization • New formulations • New ARVs

  3. Patient-centered efficiency Increased coverage Lower Cd4 threshold Reduced clinical time /patient Patient friendly regimen: easy to use low toxicity, forgiving Doctors Patient self management PHC decentralised care, nurse based CHW supported

  4. Bending the epidemic curve Moving from emergency to a chronic phase Transition needs to happen as soon as possible -> early aggressive approach ( emergency phase) Khayelitsha2001-2007

  5. Distributing tasks Clinical screening Clinical screening Consultation Psycho social support Psycho social support Drug re-fill Drug re-fill

  6. Pop. 500,000 (250,000 adults) ANC prevalence 30% =est. 60 -70,000 HIV+ Incidence =est. 4000 new infections/year What will Khayelitsha look like in 10 years ? 2009 2019

  7. KhayelitshaFacility-linked, PLWHA-led'Adherence Clubs'

  8. Thyolo, MalawiDecentralization to health posts Outreach from existing health centers if > 10 km Minimum package of HIV services ARV refills dispensed by lay health workers (HSAs) for stable patients on HAART Staffing: one community nurse and 2-3 HSAs

  9. Tete, MozambiqueCommunity-HAART Groups • PLWHA driven • Support group w/ ART provision • Rep. Elecetd to collect ARV's • Maximum 6 patients • Between June 08 and Dec 09 • 199 CHG formed 1253 patients • 95.4 % RIC • 1.7 % died • 0.2 % LTFU • 1.9 % TFO • 0.8 % returned to HC

  10. Dose optimization • Objectives: • Reduce patient toxicity • Reduce pill burden • Reduce costs • d4T: from 40 mg to 30 mg BID dose for all patients • AZT was initially marketed as 250mg bid in Europe until late 1990s. Dose still available for sale in Europe • For several HIV drugs, Phase 2 data showed no difference in efficacy between doses, but higher doses were selected for Phase 3 and registration (EFV, LPV/r, RAL, 3TC) • In drug development, dosage selection is made early and not reassessed later

  11. Reducing D4T dosage Impact on regimen safety Source: Charlotte Schultz , GFJooste ID referral unit, cape Town

  12. Potential Dose Optimization Investigations _________________________________________________________ Drug Current dose Target Optimised dose _________________________________________________________ ZDV 300mg BID 200 mg BID 3TC 300 mg OD 150 mg OD ** EFV 600 mg OD 400 mg OD ** LPV/r 400/100 mg BID 200/100 or 200/150 BID ** ATV/r 300/100 mg OD 300/50 or 200/50 mg OD DRV/r 600/100 BID 400/50 mg OD (PI naives) RTV 100mg (booster) 50mg (booster) RAL 400mg BID 100-200 mg BID _________________________________________________________ ** Encore trials : funded and support from Bill and Melinda Gates Foundation, University of New South Wales and Clinton Health Action Initiative Source: Andrew Hill

  13. Long term therapeutic strategy • Specific treatment paradigm for high prevalence LRC contexts ? • Future perspectives • Moving away from a sequential paradigm to Induction/maintenance paradigm ? • Drug required profile • Potent regimen for induction ( Raltegravir/Darunavir/r) • Systematic switch to maintenance with no monitoring • Long half life, forgiving regimen( PI based ) for maintenance • Safe, minimal side effects , • NRTI sparing

  14. New drugs,new formulations? • Promising drugs • Rilpivirine (Tibotec) – NNRTI, (Phase III) • low dose 25mg, long half life 38 hours, • Elvucitabine (Achillion) – NRTI, (Phase II) • low dose 10mg, long half life 49hrs, safety efficacy data? • CMX 157 (Chimerix) – (Phase I), • prodrug of TDF,more potent than TDF++, low dose, safety efficacy data? • S/GSK 1349572 (ViiV) (Phase IIb) • – Integrase Inhibitor, low dose 50mg, no booster required, long half life 30 hours, safety efficacy data?

  15. HIV POC tests

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