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Kamini Mendis Global Malaria Programme 80 Countries Are Using Acts As First-Line Malaria Treatment

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Kamini Mendis Global Malaria Programme 80 Countries Are Using Acts As First-Line Malaria Treatment Parasite Resistance to Artemisinins WHO/MMV ARTEMISININ CONFERENCE 2009 "Ensuring Sustainable API Supply to Meet Global ACT Demand" 28th – 30th September 2009 in Mumbai, India Dr Kamini Mendis Global Malaria Programme 80 countries are using ACTs as first-line malaria treatment Countries with P.falciparum and no ACT Countries which adopted ACT as 1st-line treatment GLOBAL 2 | MALARIA PROGRAMME Parasite Resistance to Artemisinins Could reverse the malaria control achievements of the past decade……. But not inevitable, if the correct course of action is taken GLOBAL 3 | MALARIA PROGRAMME What is antimalarial drug resistance? Ability of a parasite strain to survive and/or multiply despite the administration and absorption of a drug given in doses equal to or higher than those usually recommended but within tolerance of the subject” (WHO, 1973). Therapeutic efficacy is used to detect resistance Treatment failure ≠ drug resistance (host and/or parasite factors) GLOBAL 4 | MALARIA PROGRAMME Experience in Thailand with successive drug regimens Mefloqu ine Quinin e Sulphadoxine- pyrimethamine Chloroqui ne GLOBAL 5 | MALARIA PROGRAMME Rapid development of resistance to monotherapies Year of 1st case Antimalarial introducti of drug on resistance Quinine 1632 1910 Chloroquine 1945 1957 12 years Proguanil 1948 1949 1 year Sulfadoxine-pyrimethamine 1967 1967 <1 year Mefloquine 1977 1982 5 Artemisinin derivatives 1990 - 2000 2009 years 9-20 years? GLOBAL 6Atovaquone | 1996 MALARIA 1996 <1 year PROGRAMME Paper on resistance Artemisinin resistance GLOBAL 8 | MALARIA PROGRAMME Events leading up to the confirmation of artemisinin resistance Since 2001 - Routine surveillance system in Cambodia & Thailand - coordinated by WHO ± 2003 and 2005 High failure rate and increase parasite clearance time with ACTs detected Lao PDR Thailand Paili n Tra t Vietnam Proportion with treatment failure (2001-2007) in Cambodia Proportion of positive cases on day 3 (2001-2007) ¹ETFª with AS/MEF Treatment failures with 7 days artesunate monotherapies Noedl. et al. New England Journal of Medicine, 2009, 361: 540-1. Paili n Tra t GLOBAL 14 MALARIA | PROGRAMME Parasite clearance time with AS+MQ in Trat province No of P. falciparum positives cases PCT Province Year N D2 D3 D7 (days) Trat 2003 44 14 (31%) 7 (15.9%) 2 (4.5%) 2.0 Trat 2004 15 2 (13.3%) 2 (13.3%) 0 2.1 Trat 2005 22 7 (31.8%) 2 (9%) 1(4.5%) 2.3 Trat 2006 32 10 (31.2%) 7(21.8%) 0 3.3 Trat 2007 31 14(45.1%) 5 (16.1%) 0 3.7 GLOBAL 15 MALARIA | PROGRAMME Mae Sot Trat PCR-adjusted parasitological efficacy of MAS3 at Day 42 100 n=170 n=280 95 n=482 n=276 n=406 n=252 n=212 n=176 90 n=338 n=29 n=400 85 parasitological efficacy (in %) (in efficacy parasitological n=98 3 MAS 80 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Years GLOBAL 17 MALARIA | PROGRAMME Higher drug concentrations needed to inhibit parasite growth Noedl. et al. New England Journal of Medicine, 2009, 361: 540-1. Pfmdr1 (≥ 2) copy number trend 70% 60% 50% 40% 30% Increased in copy number (2+)cn number copy in Increased 20% 10% Increased copy Increased in number % 0% 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 Years Mae Sot Trat GLOBAL 20 MALARIA | PROGRAMME Events leading up to the confirmation of artemisinin resistance Since 2001 - Routine surveillance system in Cambodia & Thailand - coordinated by WHO ± 2003 and 2005 High failure rate and increase parasite clearance 2005time - WHO with raisedACTs detected concern over artesunate resistance in "Drug Resistance Global Report" 2005 -Publication by CNM Cambodia and WHO of 2 articles on ACT failure 2006 - AFRIMS detected 2 suspected cases of artesunate resistance in Tasanh (published in 2008) Events leading up to the confirmation of artemisinin resistance Since 2001 - Routine surveillance system in Cambodia & Thailand - coordinated by WHO ± 2003 and 2005 High failure rate and increase parasite clearance 2005time - WHO with raisedACTs detected concern over artesunate resistance in "Drug Resistance Global Report" 2005 -Publication by CNM Cambodia and WHO of 2 articles on ACT failure 2006 - AFRIMS detected 2 suspected cases of artesunate resistance2007 January in Tasanh - WHO (published informal consultationin 2008) on containment of malaria multidrug resistance on Cambodia-Thailand border, Phnom Penh 2007 November - ARC3 project funded by BMGF (3.2 M) Objectives of the ARC3 project Confirm clinically relevant artemisinin resistance ± Characterize clinically relevant artemisinin resistance in-vivo by conducting clinical and pharmacokinetic-pharmacodynamic assessments of artesunate, at sites where artemisinin resistance has been reported, where parasite clearance is prolonged but treatment failure not yet manifest, and where artesunate efficacy is preserved; ± Establish a reference repository of parasite isolates from clinically validated cases of resistance. If clinical resistance is confirmed, further characterize this resistance to define resistant in vitro phenotypes and genotypes for use in global surveillance for artemisinin resistance To establish the prevalence on substandard and fake drugs on the Thai-Cambodia border Develop strategies to combat the spread of artemisinin resistant malaria within SoutheastGLOBAL Asia and 23 internationally MALARIA | PROGRAMME ARC3 project Funded by BMGF (3.2 M) Coordinated by GMP/HQ Major partners: ± Wellcome Trust-Mahidol University, Oxford Tropical Medicine Research Programme, Bangkok, THAILAND ± US Armed Forces Research Institute of Medical Sciences (AFRIMS), Bangkok, THAILAND ± Réseau des Instituts Pasteur, Cambodge, Phnom Penh, CAMBODIA ± University of Vienna, Vienna, AUSTRIA ± University of Maryland School of Medicine, Baltimore, Maryland, USA ± University of South Florida, Tampa, Florida, USA ± USP, Rockville, Madison, USA ± National Malaria Control Programme, Phnom Penh, CAMBODIA ± National Malaria Control Programme, Bangkok, THAILAND ± WHO Mekong project, Bangkok, THAILAND ± Western Pacific Regional Office, Manila, PHILIPPINES GLOBAL 24 MALARIA | PROGRAMME (Bandarban )University of Vienna Artesunate 2 mg/kg vs 4 mg/kg vs quinine+tetracycline over 7 days (Mae Sot )SMUR (completed) Same design as Pailin (Tasahn )AFRIMS Artesunate 2 mg/kg vs 4 mg/kg vs 6 mg/kg over 7 days (Pailin )MORU( )Completed Artesunate 2 mg/kg over 7 days vs artesunate 4 mg/kg over 3 days + sequential mefloquine 25 mg/kg over 2 days If< 6 patients with PCT < 96 h Artesunate 6 mg/kg/over 7 days → vs artesunate 8 mg/kg over 3 days + sequential mefloquine 25 mg/kg (over 2 days )split PCT in Pailin study 2007 AS 2 mg/kg FULLY SENSITIVE AS 4 mg/kg & MQ PARASITES 100 1000 10 100 1 10 1 0.1 0.1 0.01 (individual data) 0.01 (geometric mean) 0.001 0.001 0.0001 0 parasitaemia as % from admission 0 96 24 60 72 84 12 36 48 parasitaemia as % from admission 84 96 72 12 24 36 48 60 108 120 108 120 time (hours) time (hours) GLOBAL 26 MALARIA | PROGRAMME Parasite Clearance (p=0.0001 for ∆ slopes between sites) Thai- Cambodia border Thai- Myanmar border PCT in Pailin with artesunate 6 and 8 mg/kg/d N=4 0 Mechanism of artemisinin resistance? 48 hours Artemisinin Quinine Inexorable, contiguous spread of chloroquine resistance from limited foci following rare, complex genetic event Spread of chloroquine resistant P.falciparum GLOBAL 31 MALARIA | PROGRAMME Preliminary conclusions • The proportion of patients who are parasitaemic on day 3 is the best measure of slow parasite clearance from available clinical trial data. • The in vivo phenotype does not correlate to standard in vitro assays: • There is no correlation between artesunate IC50s and PRR at 24 h and 48 h, proportions of patient still parasitemic on day 1, day 2 or day 3 or PCT; • The lack of in vitro correlation may be because we are using the wrong tool, therefore there is a need to develop novel in vitro studies. • There was no correlation between a number of different mutations (pfSERCA or mtDNA mutations - coxIII gene) or pfmdr1 copy number and clinical GLOBAL 32 MALARIA outcomes. | PROGRAMME Artemisinin resistance: research priorities · What is it? · What is it caused by? · How can it be readily detected? · How far has it spread? · How should artemisinin resistance infections be treated? · How can it be eliminated? GLOBAL 33 MALARIA | PROGRAMME Artemisinin resistance GLOBAL 34 MALARIA | PROGRAMME Events leading up to the confirmation of artemisinin resistance Since 2001 - Routine surveillance system in Cambodia & Thailand - coordinated by WHO ± 2003 and 2005 High failure rate and increase parasite clearance 2005time - WHO with raisedACTs detected concern over artesunate resistance in "Drug Resistance Global Report" 2005 -Publication by CNM Cambodia and WHO of 2 articles on ACT failure 2006 - AFRIMS detected 2 suspected cases of artesunate resistance2007 January in Tasanh - WHO (published informal consultationin 2008) on containment of malaria multidrug resistance on Cambodia-Thailand border, Phnom Penh 2007 November - ARC3 project funded by BMGF (3.2 M) 2008 January - WHO meeting on containment of artemisinin tolerance, Geneva 2008 February - ARC3 Clinical trial meeting, Bangkok ± Informal consultation to define strategy to contain/eliminate P. falciparum parasites with altered response to artemisinin, Bangkok Thailand 2008 June - Informal consultation on resource mobilisation for the containment of artemisinin tolerant malaria on the Cambodia-Thailand border 2008 November - Containment project funded by BMGF (22.5 M) Structure of the containment project Objectives of containment
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