An assessment of the supply, programmatic use, and regulatory issues of single low-dose primaquine as a Plasmodium falciparum gametocytocide for sub-Saharan Africa

Malaria Journal

Research

Renee Shah¹  Deepika Kandula¹  Justin M. Cohen¹  Luke Rooney¹  Mark Newman¹  Ingrid Chen²  Eugenie Poirot²  Roly Gosling²  Jimee Hwang³ 

[1] Clinton Health Access Initiative, Boston, MA, USA;Global Health Sciences, University of California, San Francisco, 550 16th Street, 3rd Floor, 94158, San Francisco, CA, USA;Global Health Sciences, University of California, San Francisco, 550 16th Street, 3rd Floor, 94158, San Francisco, CA, USA;Malaria Branch, Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta, GA, USA;

关键词: Primaquine;    8-aminoquinoline;    Plasmodium falciparum;    Africa;    Glucose-6-phosphate dehydrogenase deficiency;    G6PD;    Drug dosing;    Drug production;    Drug manufacturing;    Drug regulation;    Malaria transmission;   

DOI  :  10.1186/s12936-015-0714-3

 received in 2015-02-04, accepted in 2015-04-23,  发布年份 2015

来源: Springer

【 摘 要 】

BackgroundGlobal ambitions to eliminate malaria are intensifying, underscoring a critical need for transmission blocking tools. In 2012, the WHO recommended the use of 0.25 mg/kg of single low-dose (SLD) primaquine to stop Plasmodium falciparum transmission. To ensure the availability of SLD primaquine to countries in need of this tool, more information on the supply, programmatic, and regulatory barriers to the rollout of SLD primaquine is required.MethodsChallenges to the rollout of SLD primaquine in sub-Saharan Africa were established through semi-structured qualitative interviews with three primaquine manufacturers, 43 key informants from Ethiopia, Senegal, Swaziland, Zambia, and Tanzania, and 16 malaria research experts.ResultsSanofi and Remedica are the only two sources of SRA-approved primaquine suitable for procurement by international donors. Neither manufacturer produces primaquine tablet strengths suitable for the transmission blocking indication.In-country key informants revealed that the WHO weight-based recommendation to use SLD primaquine is challenging to implement in actual field settings. Malaria programmes expressed safety concerns of SLD primaquine use in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, as well as potential interactions between primaquine and co-morbidities, and drug-drug interactions with HIV and/or tuberculosis treatments. Regulatory processes are a major barrier to the rollout of SLD primaquine, requiring multiple steps at both the country and global level. Despite these barriers, demand for SLD primaquine is growing, and malaria researchers are interested in primaquine deployment through mass screen and treat and/or mass drug administration campaigns.ConclusionDemand for primaquine as a transmission blocking agent is growing rapidly yet multiple barriers to SLD primaquine use exist. Research is needed to define the therapeutic dose range, which will guide dosing regimens in the field, inform the development of new, lower strength primaquine tablets and/or formulation(s), and allay programmatic safety concerns in individuals with G6PD deficiency. Potential interactions between primaquine and co-morbidities and treatments should be explored. To minimize regulatory delays, countries need to prepare for product registration at an early stage, WHO prequalification for suitable primaquine tablet strengths and/or new formulations should be sought, and in the meanwhile only Stringent Regulatory Authority (SRA)-approved primaquine should be used.

【 授权许可】

CC BY   
© Chen et al.; licensee BioMed Central. 2015