Efficacy and Safety of Dihydroartemisinin/Piperaquine (Artekin®) for the Treatment of Uncomplicated Malaria in Peru
Status:
Completed
Trial end date:
2005-07-01
Target enrollment:
Participant gender:
Summary
In Peru, Mefloquine plus Artesunate (MAS3), is the current first line treatment for P.
falciparum malaria in the Amazonian Region, and has proved its efficacy against
multi-resistant P. falciparum parasites, but several side effects have been reported.
Dihydroartemisinin-piperaquine (DHA-PPQ) is a new co-formulated and well tolerated ACT,
increasingly used in Southeast Asia where it has proved to be highly effective against
Plasmodium falciparum malaria. We tested the efficacy, safety and tolerability of DHA-PPQ in
patients with uncomplicated P. falciparum malaria. A RCT to evaluate DHA-PPQ was carried out,
between 2003 and 2005. Patients with uncomplicated P. falciparum malaria were randomly
allocated to receive either DHA-PPQ or MAS3 with a 63-day follow-up period. Five hundred
twenty two patients were included in the analysis, 262 were allocated to receive DHA-PPQ, and
260 to receive MAS3. The two groups were comparable at baseline in demographic and clinical
characteristics. The mean time for parasite clearance into the DHA-PPQ group was 32.0 hours
and 35.5 hours in the MAS3 group. Twenty-four hours after the first dose, the proportions of
patients whose cleared parasitaemia were 67.2% in the DHA-PPQ group, and 58.1% in the MAS3
group (RR 1.25, [95% CI 1.03-1.52], p = 0.017). All patients were able to clear parasites
within 72 hours after the first dose. The mean time for fever clearance was 28.0 and 29.5
hours in DHA-PPQ and MAS3 group respectively. (P= 0.69). Twenty-four hours after the first
dose, 85.5% and 83.1% of patients cleared fever in the DHA-PPQ and MAS3 group respectively
(p>0.05). The Adequate Clinical and Parasitological Response (ACPR), PCR adjusted, were 97.7%
and 99,2% for the DHA-PPQ and MAS3 group respectively, (RR 0.99, 95% CI [0.86-1.13], P =
0.88). No Early Treatments Failures were reported in any group. In the DHA-PPQ group,
according to the PCR adjusted results, 6 subjects had Late treatment Failures. In the MAS3
group, two Late Treatment Failures was reported. The frequency of adverse events was
significantly lower in patients treated with DHA-PPQ than in those treated with MAS3.
DHA-PPQ proved to be a highly effective antimalarial drug for the treatment of P. falciparum
malaria and suitable for use in the Peruvian Amazon region. It also has the advantage of
being better tolerated. In terms of cost, DHA-PPQ is cheaper and more affordable than MAS3
and should be considered for the National Antimalarial Drug Policy in Perú.