Since WHO prequalification in 2010, 168 million vials of injectable artesunate (Inj AS) have been delivered to malaria-endemic countries.
Overcoming barriers to the use of injectable artesunate
In 2011, WHO started recommending Inj AS as the preferred medicine for treating severe malaria.
Following these guidelines, MMV, WHO Global Malaria Programme and MSF convened a multi-stakeholder consultation to review and address barriers to acceptance of Inj AS. The guidance from this workshop was disseminated in the Stakeholders’ Meeting Report.
One of our priorities was to provide healthcare workers with correct dosing information in easy-to-understand materials.
MMV worked closely with partners and a public health consultant to develop clear product dosing information for use in training materials for healthcare workers. This material has now been included into nearly two dozen countries’ national training programmes.
Introducing injectable artesunate in Democratic Republic of Congo and in Nigeria
From 2012 to 2013, MMV undertook a programme aimed at improving access to Inj AS in the two countries with the most cases of severe malaria.
In Democratic Republic of Congo (DRC), Swiss TPH and MMV carried out the MATIAS study to support policy change and implement Inj AS as the preferred treatment for severe malaria.
The study demonstrated around 50% reduction in case fatality rates (3.8% for those treated with intravenous quinine vs 1.7% for those treated with Inj AS).1 This resulted in the Ministry of Health officially selecting Inj AS as the preferred treatment for most severe malaria cases, apart from those occurring in pregnant women.
In Nigeria, MMV and the Clinton Health Access Initiative (CHAI), accelerated the adoption and uptake of Inj AS via pilot projects in six states and in Abuja, the Federal Capital Territory.
Distributing six million vials of treatment to disease endemic countries
The success of both the DRC and Nigeria pilots gave rise to the Improving Severe Malaria Outcomes (ISMO) project, funded by UNITAID and led by MMV.
Almost six million vials of treatment were introduced across this multi-country project, enough to treat between one to one and a half million of children. In addition, more than 18,000 healthcare workers were trained regarding the correct preparation and administration of Inj AS, in over 2,082 healthcare facilities.
This 3-year project ended in September 2016. It was built around a consortium of implementing and procurement partners, with the participation of CHAI and Malaria Consortium.
The beneficiary countries included: Cameroon, Ethiopia (SNNPR and OROMIA), Kenya, Malawi, Nigeria (13 states) and Uganda.
Monitoring results in real-world settings
MMV worked with the African Collaborating Centre for Pharmacovigilance in Ghana to help generate more information on Inj AS in real world settings and to create a useful pharmacovigilance blueprint for countries to use.
Outcomes of a modified cohort event monitoring study (CEMISA) were gathered from over 1,000 patients in public health facilities in Ghana and Uganda over the course of 2016. The study found that Injectable AS is the most prescribed medicine in the management of severe malaria in Ghana and Uganda. However, adherence to the WHO recommendation of at least 3 doses of injectable anti-malarial in 24 h followed by a full course of ACT is low, at less than 30%.
Ongoing product innovation to simplify the preparation of Inj AS
Pursuing further innovation, and with the aim to make the preparation of Inj AS even more convenient for health workers, pharmaceutical partners are currently developing a novel formulation of Inj AS, in partnership with MMV. The new product under development will allow for reconstitution of artesunate powder in a single step, in contrast to the currently used product formulation which requires a two-step reconstitution (solvent and diluent).
MMV will support the correct use of these novel Inj AS products once they obtain WHO prequalification. To this end, MMV is developing training materials and will conduct field testing to ensure that these training materials meet the needs of the health workers and communities that will use them.