Background and importance Since 2011, the French drug agency has sponsored an expanded access programme to make Malacef (artesunate) available for the treatment of severe malaria. This drug has not yet been approved by European and US pharmaceutical agencies, while it is available in China and several African countries.
Aim and objectives The aim of this study was to assess the efficiency and real life safety of intravenous artesunate (IA) for the treatment of severe malaria.
Material and methods We performed a retrospective, monocentric, observational study. All patients who received IA from January 2016 to September 2019 were included. Data were collected from the pharmacy service computerised system, patient records and nominative expanded access authorisation forms. The primary endpoint was efficiency, assessed by the microscopic negativation of the parasitaemia. The secondary endpoint was safety, assessed by monitoring haemoglobin, transaminases, blood platelets, kaliaemia and creatinaemia.
Results Sixty-nine patients were treated with IA in our hospital. Among all patients, 59 patients (86%) had not received chemoprophylaxis. The average time between leaving the infected zone and hospital admission was 11±7 days. Patients received 3.1±0.7 doses of IA. Sixty-five patients presented at least one criterion requiring the use of IA (the most common was >4% hyperparasitaemia in 39 patients). Forty-six (67%) patients had a microscopic negativation of their parasitaemia after 3 days of treatment and 100% at day 7. Regarding tolerance, only 52% had a decrease in their haemoglobin level of >2 g/L during the whole hospitalisation. Platelets and transaminase values were normal (184–440 G/L and <35 UI/L, respectively) after 7 days of treatment in 51 patients. Nine patients displayed an abnormal kaliaemia (more than or less than 3.4–4.5 mmol/L) for more than 1 day. Finally, only 4 patients exceeded the basal level for creatinaemia (45–84 µmol/l) for more than 1 day. Three adverse events (anaemia) were reported to the pharmacovigilance centre, among which none was severe.
Conclusion and relevance The IA treatment was effective and well tolerated in all patients. These results seem to be in favour of a broader and ease of use of IA.
References and/or acknowledgements No conflict of interest.
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