Comparison of malaria treatment outcome of generic and innovator’s anti-malarial drugs containing artemether–lumefantrine combination in the management of uncomplicated malaria amongst Tanzanian children

BACKGROUND: In 2006, artemether–lumefantrine (ALU), specifically Coartem(®) (Novartis Pharma AG, Basel Switzerland), was approved as the first-line drug for treatment of uncomplicated malaria in Tanzania. Due to poor availability and affordability of the innovator’s product, the government of Tanzania in 2013 prequalified the use of generic anti-malarial drugs, whereby Artefan(®) (Ajanta, Pharma Ltd, India) was the first to be approved. METHODS: This was an equivalence prospective study that aimed to determine the effectiveness of anti-malarial generic Artefan(®) in comparison with innovator’s product Coartem(®). Patients aged 6 to 59 months with uncomplicated malaria were recruited and randomized to either receive Artefan(®) or Coartem(®) as a control. Participants were required to revisit clinic five times as follow up to monitor treatment outcome as per World Health Organization recommendations. On each visit, thick and thin blood smears, dried blood spot (DBS), haemoglobin concentrations and auxiliary temperature were performed and documented. RESULTS: Out of 230 recruited participants, 200 met inclusion criteria and were randomized equally to receive Artefan(®) and Coartem(®). The overall PCR uncorrected cure rate were 80% for Artefan(®) and 75% for Coartem(®) (p = 0.44). Adequate clinical and parasitological response were 82.1% for Artefan(®) and 74.7% for Coartem(®), and there was no early treatment failure (ETF) observed in both arms of treatment. Both drugs showed excellent early parasite clearance, whereby no participants had peripheral parasitaemia on day 3. Late clinical failures (LCF) were 3.6% for Artefan(®) and 1.3% for Coartem(®) (p = 0.31), and late parasitological failure (LPF) were 15.4% for Artefan(®) and 22.7% for Coartem(®) (p = 0.32). Mean haemoglobin (g/dl) concentrations observed on day 28 were higher compared to day 0 for both drugs, although not statistically significant. Only one (1.3%) participant on Artefan(®) had temperature ≥ 37.5 °C on day 3. CONCLUSION: The findings of this study indicate that both Artefan(®) and Coartem(®) are equivalent and effective in the management of uncomplicated malaria amongst children in the Coast part of Tanzania.