Implementation of G6PD testing and radical cure in P. vivax endemic countries: considerations

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Implementatin f G6PD testing and radical cure in P. vivax endemic cuntries: cnsideratins Malaria Plicy Advisry Cmmittee Geneva, Switzerland 16-18 September 2015 1

WHO Guidelines n Radical Cure WHO guidelines fr the treatment f malaria 2015 (3 rd ed) 2

WHO Guidelines n Radical Cure Cntrl and eliminatin f Plasmdium vivax malaria: A technical brief Launched in WHO SEARO n 29 July 2015 at a Glbal Meeting in New Delhi attended by cuntries in all WHO Regins with endemic P. vivax Discussins n translating guidelines int plicy and strategy in prgrammes 3

WHO Guidelines n Radical Cure In bth, recmmendatins are based n: the need t radically cure patients using primaquine minimizing the risk f primaquine-induced acute haemlysis in thse wh are deficient in the enzyme glucse-6-phspate dehydrgenase (G6PD) 4

WHO Guidelines 5

Difficulties in Implementatin Expressed by Cuntries The lack f a rbust, easy-t-use pint-f-care test fr G6PD makes it difficult t test at the lwer levels f the health system. Referral t higher levels is prblematic, and may result in P. vivax patients nt being treated. Sme cuntries (eg, in the Americas) are already implementing radical cure at HF level withut testing fr G6PD G6PD deficiency allele frequency is very lw (and variants are mild) r absent. - benefits exceed the risks Full cmpliance with recmmendatins culd prevent expansin and reverse implentatin 6

Cuntries Request Practical Guidance frm WHO T mve twards testing and radical cure when imprved tls are available, & until then, nt cmprmise the early treatment f P. vivax in settings where G6PD testing is currently nt feasible. Hw t perfrm risk-benefit assessment when G6PD status is unknwn n making a decisin n administering r withhlding radical cure 7

MPAC Advice t WHO Current WHO recmmendatins remain unchanged in bth dcuments. In translating these recmmendatins t actin plans in cuntries, the fllwing (r similar) guidelines be prvided by WHO in (r as an addendum t) the P. vivax technical brief. 8

MPAC Advice t WHO Where feasible, all patients with cnfirmed P. vivax and P. vale shuld be tested fr G6PD deficiency befre administratin f 14-day radical treatment with primaquine. Because current G6PD tests may nt be apprpriate fr use at the lwer levels f the health system, cuntries may use the fllwing guiding principles: 9

MPAC Advice t WHO All cuntries in the phases f malaria eliminatin and/r in preventin f re-intrductin: ensure that all P. vivax patients wh d nt knw their G6PD status are tested befre the administratin f primaquine anti-relapse therapy. Cuntries where the prevalence f G6PD deficiency is knwn t be very lw, and where G6PD testing is nt currently cnsidered mandatry: shuld cntinue, while taking all precautins t educate the patient abut the pssible risk and strengthen their pharmacvigilance systems and the respnse arm. 10

MPAC Advice t WHO Where bth the burden f P. vivax malaria and the prevalence f G6PD deficiency is cnsiderable: P. vivax patients shuld cntinue t be tested fr malaria and treated fr the bld-stage infectin at all levels f the health system, particularly at the cmmunity level. A decisin t administer primaquine anti-relapse therapy shuld be n ne r bth f the fllwing: individual patient assessment f the risk/benefits referring the patient t a higher level health facility fr G6PD testing and primaquine treatment after prviding treatment fr the bldstage infectin. 11

MPAC Advice t WHO WHO shuld prvide mre specific guidance t cuntries n: determining the ppulatin prevalence f G6PD and variants; making risk benefit assessments fr radical cure; assessing the feasibility f managing an acute haemlytic event when the G6PD status is unknwn; G6PD testing f patients, where it is feasible, and interpretatin f test results. 12

On page 31. "T achieve a radical cure (cure and preventin f relapse), a 14-day curse f primaquine is recmmended, after exclusin f G6PD deficiency. 13