of the author and do not reflect the official views of the US Army, the US Department of Defense, or the US Government. I have no financial conflict

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Leonard Glenn
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1 Role for Militaries i in the New Era of Malaria Elimination and Eradication APMMC 2009 Colin Ohrt, MD, MPH; COL, MC Consultant to the Surgeon General for Clinical Pharmacology Chief, Department of Clinical Pharmacology & Translational Medicine Division of Experimental Therapeutics Walter Reed Army Institute of Research 1

2 Disclaimer The opinions presented in this lecture are those of the author and do not reflect the official views of the US Army, the US Department of Defense, or the US Government. I have no financial conflict of interests to declare Off label use of FDA approved drugs will be discussed with primaquine. 2

3 Agenda Current plans for malaria elimination in Asia How militaries have assisted in the past Indentify partnerships Research studies Elimination operations Vision for the future 3

4 Malaria: Scope of Disease 270 million cases annually 1-2 million people die Significant morbidity Those at risk 2 billion worldwide Travelers Deployed troops 4

5 Bill & Melinda Gates Foundation. Bill and Melinda Gates Call for New Global Commitment to Chart a Course for Malaria Eradication. (2007). New Era Bill and Melinda Gates Call for New Global l Commitment to Chart a Course for Malaria Eradication * *Bill & Melinda Gates Foundation (2007). 5

6 Roll Back Malaria Partnership launched in 1998 (WHO, UNICEF, UNDP & World Bank) Wide range of partners (not military) Vision = 2015 the malaria-related Millennium Development Goals (MDGs) achieved. malaria is no longer a major cause of mortality no longer a barrier to social and economic development Mission work together sustained delivery and use of the most effective prevention and treatment 6

7 Asia Pacific Malaria Elimination Network Recently established Led by Sir Richard UCSF Objectives Bring together: 10 eliminating countries in the Region multilateral and academic agencies Provide: leadership, advocacy, capacity building, information sharing, building of the evidence base 7

8 Key APMEN Activities Annual meetings with additional working groups Review and document country experiences Support catalytic operational research projects Develop evidence-based recommendations Establish an information hub Capacity building APMEN fellows program Training modules Special focus on P. vivax Info: 8

9 Initial Asian Countries Planned for Elimination 9

10 Western Cambodia Elimination Goal: Artemisinin resistance containment Will be challenging Multidrug-resistance Effective Rx Access Adherence Community acceptance Mass drug administration i ti Mosquito control Accurate diagnosis Migrant management Soldier management Vendor drug control Counterfeits Ineffective regimens Slide 10

11 Malaria History: World War II Sicilian campaign 21,000 malaria admissions 17,000 battle casualties Pacific theater 40% incapacitation due to malaria Guadalcanal & PNG - 5 fold more Lost time 2-3 weeks per person

25%) were severe Requiring ICU admissions Four on ventilators Key problems: Non-compliance Inability to

12 Operational Evaluation of JTF- Liberia 80 of 220 marines contracted falciparum malaria. 46 required medical evacuation 5/80 (6.25%) were severe Requiring ICU admissions Four on ventilators Key problems: Non-compliance Inability to make the diagnosis 12 They were all given their medication (Lariam), we are investigating why do we have all these guys (Marines in Liberia) coming down with this.bbc News September 10, 2003

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Useful lifespan of a new drug is 10-15 yrs

eradication Malarone is a particular problem

15 Why Do We Need More Antimalarials? Global drug resistance. Useful lifespan of a new drug is yrs Will likely lose all current drugs before eradication Malarone is a particular problem Substantial toxicities Lariam psychosis G6PD-deficiency GI tolerability Malarone 15

16 4 Species P. Falciparum P. Vivax P. Ovale P. Malaria Transmission -blocking DEET Bed nets ITN Screening Suppressive Prophylaxis & Treatment Causal Prophylaxis Radical Cure (PV/PO) 16

17 Indications for Antimalarial Drugs Prophylaxis Causal prophylaxis Suppressive prophylaxis Intermittent presumptive treatment Treatment of Disease Uncomplicated malaria P. falciparum P. vivax/p. ovale Severe and complicated malaria Antihypnozoite (radical cure) Transmission Blocking 17

18 FDA Approved Products from the US Army for Malaria Chloroquine-Primaquine CP tabs Mefloquine Lariam Halofantrine Halfan Doxycycline Vibramycin Atovaquone/Proguanil Malarone Malaria RDT BinaxNow Malaria G6PD-deficiency RDT BinaxNow G6PD 18

19 Antimalarial Products in Development from the US DoD D Vaccines RTSS vaccine Whole sporozoite vaccine Diagnostics 4 efforts to get more sensitive methods Validated samples Drugs IV Artesunate Weekly atovaquone-proguanil (Malarone ) Azithromycin combinations Tafenoquine 19

20 Prophylaxis Drugs in Malaria a a Elimination Needed properties Used successfully on Aneityum island Residual foci (transmission reservoir) Epidemic control Bring down high level transmission Endorsed by malera (Gates research planning group) Pharmaceutical company leadership 20

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22 Military Contribution Not spread malaria Malaria diagnostics Clinical trials for product approval Support of elimination operations 22

23 Not Spread Malaria - Examples % Gametocyte Carriage in Thai troops during elimination in Eastern Thailand 70% CH n=150 60% TQH 50% n=274 40% QD n=85 On Admission At Any Time 30% 20% 10% HE n=59 SA n=40 0% Years, Study Code, and Number of Participants 23

24 Not Spread Malaria - Examples South Korean troops P. vivax Eliminated in 1970 s Returned to demilitarized zone in 1993 Peaked in 2000 with 4100 cases Troops thought to be spreading to civilian populations Methods Targeted prophylaxis Radical cure before discharge 24

25 Not Spread Malaria - Examples Indonesian troops Overall in 2005 in Indonesia 10M cases 20K deaths Java and Bali 70% of 300M populations Nearly eliminated in 1964 Since resurged Elimination planned again Large numbers of troops 6 month rotations in highly malarious outer islands Will continuously reintroduce the diseases Solutions urgently needed 25

26 Not Spread Malaria - Solutions Effective diagnosis and treatment Consider ITN, IRS, Permethrin-treated treated uniforms Long-term prophylaxis Post-exposure radical cure Need Directly observed therapy Better diagnostic tools for carriers Pf and Pv antibody monitoring should be helpful New methods under development 26

27 Clinical Trials Malaria prophylaxis trials challenging Long-term prophylaxis Post-exposure/deployment p radical cure Asian militaries have been outstanding study populations Thai Indonesian Seek partners Sufficient malaria exposure Access for Directly Observed Therapy (DOT) 27

28 Example Clinical Trials 28

29 Example Clinical Trial Walsh et al. Efficacy of monthly tafenoquine for prophylaxis of Plasmodium vivax and multidrug-resistant P. falciparum malaria. JID 2004 Taylor et al. Malaria prophylaxis using azithromycin a double-blind, placebo-controlled trial in Irian Jaya, Indonesia. CID 1999 Ohrt et al. Mefloquine compared with doxycycline for the prophylaxis p of malaria in Indonesian soldiers. A randomized, double-blind, placebo-controlled trial. Annals of Internal Medicine

30 Products Needing Evaluation Drugs for weekly prophylaxis Tafenoquine Malarone Chloroquine-azithromycin Other methods to prevent disease Impregnated uniforms Other mosquito prevention methods 30

31 Support of Elimination Operations Military strengths Planning Training Logistics Organization Human resource Technical expertise 31

32 Possible Application of Military Strengths Training Access to drugs, ITN, IRS/security Independent monitoring/security Above interventions Village health workers Drug quality (counterfeits, inappropriate regiments) Mass drug administration Border/migrant monitoring Resistance monitoring Ensure they are not transmitting the disease 32

33 Malaria Diagnostics Center of Excellence Train & certify microscopists Training materials External QA Assess new diagnostics 33

34 Possible Additional Benefits Multi-task training Mil-mil collaborative effort training Capacity building Mil-civilian rapport building Potential broader application Influenza Dengue Disaster response 34

35 DoD Global Malaria Research Program & Partners WRAIR & NMRC Washington, DC NAMRU-3 Cairo, Egypt Ghana AFRIMS Bangkok, Thailand, Cambodia, & Nepal AMI Brisbane, Australia USAMRU-Kenya NMRCD Lima, Peru NAMRU-2 Jakarta, Indonesia, Solomon Islands 35

36 ?? Questions Comments?? We seek Partnerships!! 36

Progress on the Containment of Artemisinin Tolerant Malaria Parasites in South-East Asia (ARCE) Initiative

Progress on the Containment of Artemisinin Tolerant Malaria Parasites in South-East Asia (ARCE) Initiative I. Background For many years, the border area between Cambodia and Thailand has been the source