
The malaria community was abuzz this week with news of the approval of a drug to treat babies 2-5 kg for malaria. Swissmedic approved Riamet Baby (also known as Coartem baby), the first drug designed specifically to treat malaria in very young children. It is available as a dispersible, cherry-flavoured formulation to help improve administration. A friend alerted me to a BBC news article on July 8 that erroneously referred to it as a vaccine (since corrected). MalariaWorld has link to Novartis Press Release also.
It is a new reformulation of the well-established ACT (artemisinin combination therapy) artemether-lumefantrine. The current paediatric version (pictured) for children ≥5kg on the market, Coartem dispersible, has 20 mg of artemether and 120 mg of lumefantrine. Novartis is the only major producer of artemether-lumefantrine and will benefit for many years from intellectual property protection of this new formulation. I only found one generic version of this ACT, the Indian produced Falcynate LF 80/480mg tablets only suitable for people >35 kg.
Novartis have produced a very readable patient summary of the trial to approve the new formulation and a more detailed summary. The trial included just 28 babies (10 boys, 18 girls) in Burkina Faso (7) and DRC (21), 22 older than 1 month and 6 younger than 1 month who tested positive to malaria parasites whether symptomatic or not. The reason for the reformulation was that in a trial of young babies with 20/120 formulation artemether reached higher levels than expected while lumefantrine stayed at expected levels. Dosing was twice a day for three days by syringe of dispersed tablet in mouth after feeding. Blood was tested at intervals for artemether and lumefantrine. They were also retested for malaria parasites that cleared in 35 hours. Malaria recurred (or was reinfected) in 8/22 of the older babies. The formulation met its design goal and both actives were within expected limits during the trial.
75% (21/28) had adverse events (10 fever, 9 recurring malaria, 7 anaemia, 6 vomiting, 2 bacterial rhinitis). The researchers stated none died and there were no ‘serious adverse events’. However, there was no control. Only five of the babies had fever at the start of the trial and no other symptoms are mentioned. This suggests that the vast majority (82%, 23/28) were asymptomatic. But 75% became sick in some manner in the trial.
The study concludes that the safety profile was consistent with the safety profile of artemether and lumefantrine. Serious side effects include worsening malaria symptoms; severe vomiting, loss of appetite, or being unable to eat; fast or pounding heartbeats; a light-headed feeling, like you might pass out.
Hardly a game changer. Without a control the trial is nearly worthless.