Mekong Malaria Elimination

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1 Mekong Malaria Elimination Hiromasa Okayasu Coordinator, MME March 2018 Global Malaria Programme

2 Malaria is caused by Parasite (Plasmodium) 2

3 Distribution of Vectors Human malaria is transmitted only by females of the genus Anopheles. Of the approximately 430 Anopheles species, only transmit malaria (i.e., are "vectors") in nature. 3 Anophelines are found worldwide except Antarctica.

4 Four Species for Human Malaria Four known speices for human malaria: Plasmodium falciparum, P. vivax P. ovale P. malariae P. falciparum, P. vivax are more common P. vivax and P. ovale can persist in the liver and cause relapse 4

5 Symptom of Malaria The classical (but rarely observed) malaria attack lasts 6-10 hours. It consists of: a cold stage (sensation of cold, shivering) a hot stage (fever, headaches, vomiting; seizures in young children) and finally a sweating stage (sweats, return to normal temperature, tiredness). Classically the attacks occur every second day with the "tertian" parasites (P. falciparum, P. vivax, and P. ovale) and every third day with the parasite (P. malariae). More commonly, the patient presents with a combination of the following symptoms: Fever Chills Sweats Headaches Nausea and vomiting Body aches General malaise 5

6 Severe Malaria Cerebral malaria, with abnormal behavior, impairment of consciousness, seizures, coma, or other neurologic abnormalities Severe anemia due to hemolysis (destruction of the red blood cells) Hemoglobinuria (hemoglobin in the urine) due to hemolysis Acute respiratory distress syndrome (ARDS) Severe malaria occurs when infections are complicated by serious organ failures 6

7 Malaria Endemic Areas 7

Global Portfolio of Antimalarial Medicines SAR121 Sanofi AN13762 UCT943 H3D Cape Town NPC1161B Mississippi MK4815 Merck Preclinical Translational Product development Access M5717 Merck KGaA MMV253

8 Global Portfolio of Antimalarial Medicines SAR121 Sanofi AN13762 UCT943 H3D Cape Town NPC1161B Mississippi MK4815 Merck Preclinical Translational Product development Access M5717 Merck KGaA MMV253 Zydus Cadila SC83288 Heidelberg University DM1157 DesignMedix Human volunteers Patient exploratory Patient Regulatory review confirmatory P218 Janssen (Biotec Thailand) SJ733 Kentucky/Eisai ACT Actelion CDRI 9778 Ipca N-tert butyl Isoquine LSTM/Liverpool/GSK Artefenomel/ Ferroquine Sanofi KAF156/ Lumefantrine Novartis Cipargamin Novartis DSM265 Takeda (UTSW) Fosmidomycin Piperaquine Jomaa Pharma/GmbH Methylene Blue/ amodiaquine Heidelberg SAR97276 Sanofi Artemisone UHKST Tafenoquine GSK/MMV GSK/US Army Dihydroartemisininpiperaquine dispersible Alfasigma/Pierre Fabre Co-trimoxazole ITM Antwerp Artemisininnaphthoquine Kunming Pharma Co Artemether sub-lingual spray MRC/Suda Sulfadoxinepyrimethamine+ Amodiaquine dispersible S Kant 3 6 Arterolanepiperaquine Sun Pharma Rectal artesunate Strides Artesunate for Injection Guilin Approved/ ERP Artemetherlumefantrine Various Manufactures Artemetherlumefantrine Dispersible Various Manufacturers Dihydroartemisininpiperaquine Various manufacturers Pyronaridine- Artesunate Shin Poong Pyronaridineartesunate granules Shin Poong Artesunateamodiaquine Various Manufacturers Artesunatemefloquine Cipla AQ13 Immtech Sevuparin Dilaforette MMV048 (UCT) Sulfadoxinepyrimethamine+ amodiaquine* Guilin Sulfadoxinepyrimethamine+ amodiaquine ** Guilin Rectal artesunate Cipla/WHO-TDR July 2017

9 The renewed response 9

10 Malaria Elimination Strategy 10

11 WHO s Global Malaria Strategy 11

12 Are we on track? 12

13 Number of malaria cases worldwide, (in Millions) Cases

14 Number of malaria deaths worldwide, Deaths 900, , , , , , , , , , , , , , , , , , , , , , , , , ,

estimated 2016 70% of deaths are in children

15 An unfinished agenda remaining burden 216 million cases estimated deaths estimated % of deaths are in children under 5 a child dies from malaria every 2 minutes - 15

16 The challenges Funding gaps financing will need to triple from current levels. Current annual spending: US$ 2.7 billion Annual spending required by 2030: US$ 8.7 billion Coverage gaps one in four children in sub-saharan Africa are still living in a household without at least one ITN or protection from IRS. 60 million malaria cases go undiagnosed and untreated 15 million pregnant women do not receive a single dose of IPTp Biological challenges HRP2 deletions Drug and Insecticide resistance New Tools Renewed and intensified commitment for R&D 16

falciparum resistance to artemisinin along the Cambodia-Thailand border To date P.

17 Mekong Malaria Elimination (MME) :Background 2000 Cambodia introduces ACTs on a national scale 2006 Early warning signs of P. falciparum resistance to artemisinin detected in Cambodia 2008 Confirmed reports of P. falciparum resistance to artemisinin along the Cambodia-Thailand border To date P. falciparum resistance to artemisinin has been detected in 5 countries of the GMS: Cambodia, Lao PDR, Myanmar, Thailand and Viet Nam Photo V. Sokhin/WHO Mekong Malaria Elimination 17

18 MME Strategy Targets By 2020 or earlier Transmission of P. falciparum malaria interrupted in all areas of multidrug resistance, including ACT resistance By 2020 P. falciparum malaria eliminated in Cambodia All species of human malaria eliminated in Yunnan Province, China By 2025 P. falciparum malaria eliminated in all countries of the GMS All species of human malaria eliminated in Cambodia and Thailand By 2030 All species of human malaria eliminated in all countries of the GMS Mekong Malaria Elimination 18

19 Significant Progress from 2012 to % 41% drop in number of malaria cases from 2012 to 2016 of malaria cases from 2015 to 2016 drop in number Mekong Malaria Elimination 19

20 Significant Challenges in 2017 Changes in number of malaria cases in GMS countries Number of cases is higher in 2017, compared to 2016, in Cambodia and Viet Nam China Cambodia Lao PDR (Yunnan) Thailand Viet Nam Myanmar Number of cases is higher in second half of 2017, compared to 2H 2016, in Lao PDR Mekong Malaria Elimination 20

21 Monthly Case Count in GMS Countries (2017) Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Sep-17 Oct-17 Nov-17 Dec-17 Cambodia China Lao PDR Myanmar Thailand Viet Nam RDSP enables to track changes in the case monthly across countries Regional Data Sharing Platform RDSP) now enables The case has increased changes in Cambodia in monthly in the case second count half of to 2017 be tracked across GMS Cases increased in Cambodia in the second half of 2017 Source: WHO subregional database Mekong Malaria Elimination 21

subregional database * Province-level in

22 Epidemiology of Malaria in GMS in 2017 Regional Map of Confirmed Cases by Province Annual Parasite Incidence (API) by District* API/1000 Source: WHO subregional database * Province-level in Viet Nam and Thailand Mekong Malaria Elimination 22

23 Epidemiology of Malaria in GMS (Continued) Annual Blood Examination Rate (ABER) in 2017 % of P. falciparum cases in 2017 ABER/1000 % P. falciparum Source: WHO subregional database Mekong Malaria Elimination 23

24 Case Distribution in Lao PDR (2017) Source: WHO subregional database Mekong Malaria Elimination 24

25 Case Distribution in Cambodia (2017) Villages Cases by HFs Mekong Malaria Elimination 25

26 Case Distribution in Viet Nam (2017) Mekong Malaria Elimination 26

Areas with Multidrug Resistance Areas with documented multidrug resistance when the GMS elimination strategy was launched (May 2015) Additional

27 Areas with Multidrug Resistance Areas with documented multidrug resistance when the GMS elimination strategy was launched (May 2015) Additional areas that could be considered for inclusion as priority These areas with MDR should eliminate P. falciparum by 2020 Mekong Malaria Elimination 27

28 Major Issues in MME a. Political commitment and sustainable funding b. Implementation of the project c. Drug quality assurance and management d. Improving surveillance Mekong Malaria Elimination 28

29 a. Secure Commitment by Countries Funding contributions to malaria programme (Million USD, 5 GMS countries, excluding China) Other donors Global Fund Government Significant investment is made in GMS countries but primarily with external sources (esp. GF) Domestic funding is less than 20% of total funding and declining in Cambodia, Lao PDR and Viet Nam Data Source: World Malaria Report (2016). Note that 2016 figures are preliminary and have yet to be finalized. Government spending includes both national malaria control programmes (NMCPs) and passive case detection (PCD). Mekong Malaria Elimination 29

30 a. Complex Partner Landscape Requiring significant Government efforts Example from Myanmar Source: Malaria supply chain in the GMS, WHO (2017) Mekong Malaria Elimination 30

31 Distribution of Partners (Myanmar Example) Malaria Cases by Province in 2017 (Jan-Dec) Distribution of Implementing Partners (2016) Mekong Malaria Elimination 31

32 b. Provide Services to Mobile Population % of mobile people that used an ITN the last time they slept in transmission areas Country Cambodia NA NA 51% NA Lao PDR 16% NA NA Ongoing Myanmar 43% NA 50% NA Thailand NA NA NA 98.5% Vietnam NA 85% 89% 95.6% % of mobile population with fever in the last three months that accessed parasite-based diagnosis Country Cambodia NA NA 29% NA Lao PDR 77% NA NA Ongoing Myanmar 44% NA 39% NA Thailand NA NA NA 27% Vietnam NA 84% 87% 90.5% Mekong Malaria Elimination 32

c. Addressing multidrug resistance GMS countries continue to be the epicenter of antimalarial drug resistance Recent studies demonstrate high ACT failure rates 3 to 4 ACTs failing in Cambodia, Lao

33 c. Addressing multidrug resistance GMS countries continue to be the epicenter of antimalarial drug resistance Recent studies demonstrate high ACT failure rates 3 to 4 ACTs failing in Cambodia, Lao PDR and Thailand WHO supports expansion of therapeutic efficacy studies (TES) and integrated drug efficacy surveillance (ides) in select areas of low malaria transmission. Mekong Malaria Elimination 33

34 c. Drug Quality Assurance and Management Major Issues Supply management (e.g. procurement and distribution) National regulatory authority capacity to accelerate introduction of appropriate antimalarial drugs (e.g. new ACTs in resistant foci, second-line treatment) Timely updates and implementation of national guidelines (e.g. use of low-dose primaquine) Quality assurance throughout the lifecycle (e.g. pre-shipment testing, postmarketing surveillance) Proposed support by WHO Support NMCPs to update and operationalize national treatment guidelines based on recent TES data Support timely, need-based access to Global Fund's Rapid Supply Mechanism (RSM) Support procurement and supply chain management (based on surveillance data) Strengthen regulatory system in conjunction with other partners to ensure access to all available and new antimalarials and to expand pharmacovigilance and quality assurance Mekong Malaria Elimination 34

35 d. Challenges in Surveillance Malaria Surveillance for Elimination Key Areas of Work Data Collection and Reporting Data Use Challenges Ensure sufficient coverage in remote areas Include surveillance data from partners and private sector into the national database Timely reporting to the national database Implementation of case-based surveillance Analyse & share surveillance data Take timely programmatic actions Validation Regular validation of surveillance data Surveillance assessment Mekong Malaria Elimination 35

36 Thank you Mekong Malaria Elimination 36

37 Footnotes: Global Portfolio Target Product Profiles and Target Candidate Profiles MMV has defined Target Product Profiles and Target Candidate Profiles for medicines to support the eradication campaign. Burrows JN et al., New developments in anti-malarial target candidate and product profiles et al. Malar J (2017) 16:26 updates the previous profiles in Burrows J et al.; Malaria Journal :187 Target Product Profiles indicated by bars at the bottom of each compound box 3-day cure, artemisinin-based combination therapies Combinations aiming at a new Single exposure radical cure (TPP-1) Severe malaria treatment and pre-referral intervention Intermittent/seasonal malaria chemoprevention Products targeting prevention of relapse for P. vivax There are currently no products in the development portfolio meeting the single-exposure chemoprotection (SEC) TPP-2 Footnote for Generic names on Global Portfolio 1. First approval: Novartis (Brand name: Coartem ). Generics by Ajanta, Cipla, Ipca, Strides, Macleods, Mylan; 2. First approval: Novartis (Brand name: Coartem Dispersible). Generic by Ajanta; 3. Brand name: Artesun ; 4. Brand name: Eurartesim ; 5. Brand name: Pyramax tablets and granules; 6. First approval fixed-dose combination: Sanofi/DNDi (Brand name: ASAQ Winthrop). Generics by Ajanta, Cipla, Guilin, Ipca, Strides; 7. Brand name: SPAQ-CO TM; Target Candidate Profiles activities for each individual molecule, indicated by symbols added to each compound in the translational portfolio Burrows Burrows et al., 2013 et al., 2017 Asexual blood stages (TCP-1,2) TCP-1 Relapse prevention (TCP-3a) TCP-3 Transmission reduction (TCP-3b) TCP-5 Chemoprotection (TCP- 4) TCP-4 Additional Symbols on Global Portfolio Brought into portfolio after approval; collaborations with DNDi No progress report in the last two years Global Fund Expert Review Panel (ERP) reviewed product permitted for time-limited procurement, while regulatory/who prequalification review is ongoing. Paediatric formulation WHO Prequalified OR approved/positive opinion by regulatory bodies who are ICH members/observers. Approved in several countries but not approved by WHO pre-qualification nor regulatory bodies who are ICH members or observers * For children months; ** For infants 3 12 months. Mekong Malaria Elimination 37

Malaria eradication: marching to the beat of the global drum

1 Malaria eradication: marching to the beat of the global drum vivax malaria, was added to WHO s List of Prequalified Medicinal Products in 2016.. This will facilitate its delivery to the very young the