Update from the Global Malaria Programme Interagency Pharmaceutical Coordination Group Meeting 18-19 June 2015 UNICEF SD, Copenhagen, Denmark Silvia Schwarte Diagnosis, Treatment and Vaccines Global Malaria Programme e-mail: [email protected] 1 Global Malaria Programme Outline Global Technical Strategy WHO Guidelines for the Treatment of Malaria: 3rd Edition Primaquine - Transmission blocking: Single low-dose primaquine in P. falciparum malaria - Relapse prevention: Primaquine in P. vivax / P. ovale malaria (G6PD status!) - Evidence Review Group meeting on G6PD point of care tests Antimalarial medicines - Sourcing of quality-assured products - SMC SPAQ supply shortage
Vaccine RTS,S/AS01 Since 2000, substantial progress achieved 2000 2013 Incidence rate Malaria case incidence has been reduced by 30% globally ~13 000 per 100 000 persons at risk ~9 000 per 100 000 person at risk Mortality rate 2000 2005
2010 ~50 2015 0% 20% Africa Americas 40% Eastern Mediterranean Europe 60% South-East Asia Western Pacific 80% 100%
~25 for 100 000 person at risk Re duction in m alaria m ort ality rat e s Re duction in m alaria incide nce rate s Malaria mortality rates have decreased by 47% worldwide for 100 000 person at risk 2000 2005 2010 2015 0%
20% Africa Americas 40% Eastern Mediterranean Europe 60% South-East Asia Western Pacific 80% 100% Global Technical Strategy Calls for an acceleration of efforts and a shift on strategic priorities Ambitious goals calling for an acceleration of efforts 2020 2025
2030 Reduce malaria mortality rates vs. 2015 40% 75% 90% Reduce malaria case incidence vs. 2015 40% 75% 90% Eliminate malaria from countries Prevent reestablishment in
all malaria-free countries Strategic framework increasing focus on elimination and surveillance 3 key pillars 1. Ensure universal access to malaria prevention, diagnosis and treatment 2. Accelerate efforts towards elimination and attainment of malaria-free status 3. Transform malaria surveillance into a core intervention 10 20 35 countries countries countries Prevented Prevented
Prevented 2 supportin g elements 1. Harnessing innovation and expanding research 2. Strengthening the enabling environment http://www.who.int/malaria/areas/global_technical_strategy/draft_strategy/en/ 4 WHO Guidelines for the Treatment of Malaria 3rd Edition released on World Malaria Day 2015 5 http://www.who.int/malaria/publications/atoz/9789241549127/en/ WHO Guidelines for the Treatment of Malaria What's new? (1) Prevention
IPTp-SP: Intermittent preventive treatment in pregnancy with at least three doses of sulfadoxine-pyrimethamine (SP) IPTi: Intermittent preventive treatment in infants with SP together with DPT vaccination SMC: Seasonal malaria chemoprevention with SP + AQ in areas with highly seasonal transmission Primaquine (PQ) P. falciparum (Pf): Single low dose of PQ to reduce the trans-missibility of Pf infections P.vivax (Pv) / P. ovale (Po): Recommendations for treating G6PD deficient patients with weekly PQ dose to prevent 6 relapse in Pv or Po malaria under medical supervision WHO Guidelines for the Treatment of Malaria What's new? (2) Uncomplicated Pf malaria
Revised dose recommendation for dihydroartemisinin + piperaquine in young children (< 25kg body weight) Close monitoring of people with Pf hyperparasitemia presenting with uncomplicated malaria Severe malaria Revised dose recommendation for parenteral artesunate (AS) body weight) in young children (< 20kg Recommendation for pre-referral rectal AS limited to children <6 years of age Medicines' formulation 7 Single-dose primaquine as gametocytocide in P.
falciparum malaria Single dose of primaquine at 0.25mg base/kg: is effective in transmission blocking is unlikely to cause serious toxicity in subjects with any of the G6PD variants In low transmission areas, a single 0.25 mg base/kg primaquine dose should be given to all patients with parasitologically-confirmed P. falciparum malaria on the first day of treatment in addition to an ACT, except for pregnant women, breastfeeding women in the first six months and children less than six months of age due to insufficient data on the safety of its use in these categories. G6PD testing is8 not required. Primaquine to prevent relapse in P. vivax or P. ovale malaria The G6PD status of patients should be used to guide the administration of primaquine for relapse prevention Where status is unknown and G6PD testing is unavailable, the
decision to prescribe primaquine must be based on an assessment of the risks and benefits of treating versus not treating To prevent future relapse, treat people with P. vivax or P. ovale malaria (excluding people with G6PD deficiency, pregnant, infants aged with a 14-day course (0.25-0.5mg/kg daily) of primaquine in all transmission settings. <6months, women breast-feeding infants < 6 months of age) In people with moderate G6PD deficiency, consider relapse prevention with primaquine 0.75 mg base/kg once a week for 8 weeks under close medical supervision. In women who are pregnant or breastfeeding, consider weekly chemo-prophylaxis with chloroquine until delivery and 9 treat with 14 days of breastfeeding is com-plete, then Recommendations on G6PD testing to
promote safe use of primaquine antirelapse therapy WHO recommends that G6PD status is ascertained before administering daily primaquine therapy for 14 days to prevent relapses in patients with confirmed acute P.vivax or P. ovale infection. The introduction of point-of-care G6PD tests should proceed, with appropriate investment in quality assurance and quality control including training, supervision, behaviour change communications and close monitoring of the feasibility, acceptability and ease of use of these tests. Lessons learnt from initial small scale deployment should guide decisions to expand deployment of G6PD diagnostic services across the health care system. If G6PD status is unknown, then G6PD qualitative point-of-care tests can be deployed to identify G6PD non-deficient patients prior to primaquine administration. Such tests should be >95% sensitive compared to spectro-photometry or equivalent quantitative tests, stable at temperatures expected in tropical settings (3040C) and have a negative predictive value of >95% at G6PD enzyme activity levels <30% of normal. The specific indications and contraindications for primaquine radical cure in males and females with G6PD deficiency should follow the 10
WHO-prequalified medicines Last updated 8 June 2015 no changes since November 2014 Fixed-dose combinations - AL, 20mg/120mg: Ajanta, Cipla, Ipca, Macleods, Mylan, Novartis, Strides Eurartesim (DHA-PPQ) (Uncomplicated Pf malaria) EMA approval - AL, 20mg/120mg, dispersibles: Ajanta, Novartis - Rectal AS (Pre-referral treatment of AL, 40mg/240mg: Mylan Full list severe malaria in children < 6 years) o f WHO ASAQ: Ajanta, Cipla, Guilin, Ipca, Sanofipre
PQ q (Pf transmission blocking and ualifed m edicines Pv/Po relapse prevention) availabl ASMQ: DNDi/Cipla SP (Intermittent Preventive Treatment htt e at: p Co-Blisters (Co-B) ://apps.w ho.int/p requal/ in pregnancy and during infancy) - AS + AQ: Cipla, Guilin, Ipca, Strides SP+AQ (Seasonal Malaria Chemo- AS + SP: Guilin prevention) Injectables - AS powder for injection (30mg, 60mg, 120mg): ---------------------------------------------------------------------------------------------------------------------------------------------Guilin
11 AL: artemether/lumefantrine; AS: artesunate; AQ: amodiaquine; MQ: mefloquine; SP: PQ and SP sourcing for procurement (last updated 8 June 2015) LIST OF MALARIA PHARMACEUTICAL PRODUCTS classified according to the Global Fund Quality Assurance Policy (Version 76 reviewed, April 2015) http://www.theglobalfund.org/documents/psm/PSM_ProductsMALARIA_List_en/ 12 Seasonal Malaria Chemoprevention (SMC) Medicine shortage: sulfadoxine-pyrimethamine (SP) + amodiaquine (AQ) Single-source supplier for quality-assured co-blistered SP+AQ: WHO PQ: SP+AQ (500/ 25 mg + 150 mg), GF ERP: SP+AQ (250/12.5 mg + 75 mg) Target area: Highly seasonal malaria transmission across the Sahel sub-region Target population: A complete SP+AQ treatment course should be given to children aged 3 and 59 months, at monthly
intervals beginning at the start of the transmission season, up to a maximum of four doses during the malaria transmission season. Prioritization: WHO strongly encourages prioritization of communities that have implemented SMC in the years 2013 and 2014 for continuation in 2015. Interim measure: Procurement and distribution of separate blisters / loose tablets; training, IEC materials, etc. IEC Information, education and communication13 4th set of results on RTS,S/AS01 released Effect of booster dose and longer-term follow up to an average of four years per child from vaccination Efficacy is short-lived booster dose required. Clinical malaria: Overall efficacy with booster dose in 6-12 weeks and 5-17 months old children at 26% and 36%, respectively, over full duration of trial. Severe malaria: Without booster dose, no protection in both age groups, as cases averted in the first 18 months were shifted to older age groups as efficacy wanes. With booster: Overall efficacy in 5-17 months old children at 32%. European Medicines Agency is currently reviewing under Article
58 only in case of a "positive scientific opinion" WHO will convene the Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Committee (MPAC) to assess a potential policy recommendation. RTS,S/AS01 would be evaluated as a possible addition to not a replacement for existing prevention, diagnostic and treatment measures. 14 Thank you 15 Global Malaria Programme Backup slides 16 Global Malaria Programme ACT deliveries (2005-2013) by combination
17 ACT deliveries (2005-2013) Fixed-dose combinations versus co-blisters 18 ACT versus RDT delivery / sales trends (2005-2013) 19
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