High adherence to malaria treatment: promising results of an adherence study in South Kivu, Democratic Republic of the Congo.

BACKGROUND: In resource-poor settings, treatment adherence is a major determinant of response to anti-malarial drugs as most are taken at home without medical supervision. Evidence on adherence to artemisinin-based combination therapy (ACT) is limited. The study aimed to measure adherence and identify reasons for non-adherence to a 3-day, fixed-dose combination (FDC) of artesunate-amodiaquine (ASAQ), the first-line treatment for uncomplicated malaria in the Médecins Sans Frontières project in the Shabunda Health Zone, South Kivu, Democratic Republic of Congo, a highly malarious and conflict-affected area. METHODS: The study took place in the health centres/outpatient departments of the Shabunda general hospital, the quarter Mbangayo, and participant households. Patients prescribed FDC ASAQ were visited at home on the day after their regimen finished and asked to complete an adherence questionnaire. Patients/caretakers were also interviewed when exiting the outpatient department to understand their attitude towards FDC ASAQ and assess the quality of the prescribing process. RESULTS: 148 patients/caretakers completed the adherence questionnaire: 11.5 % (17/148, 95 % CI 7-17) had ≥1 tablet left at the time of the home visit and were defined as certainly non-adherent; 13.5 % (20/148, 95 % CI 8-19) were probably non-adherent; thus total non-adherence was 25.0 % (37/148, 95 % CI 18-32). 75 % (111/148, 95 % CI 68-82) were defined as probably adherent. In exit interviews, 87.5 % (105/120) knew they had malaria or could name the correct signs/symptoms. 89 % (107/120) could identify FDC ASAQ as anti-malarials among all tablets given and correctly repeat the intake instructions given at the outpatient department. CONCLUSIONS: This is the first study to assess adherence to an FDC of ACT under real treatment conditions in a context of high instability. High quality prescribing of anti-malarials at health centre level and patient adherence to the correct intake of ACT were possible in this setting. Adherence to treatment regimen requires careful and constant monitoring which might be better guaranteed at health centre rather than community level. It could, nevertheless, be a precondition to the successful introduction of home- or community based management of malaria.

Efficacy of fixed-dose combination artesunate-amodiaquine versus artemether-lumefantrine for uncomplicated childhood Plasmodium falciparum malaria in Democratic Republic of Congo: a randomized non-inferiority trial.

BACKGROUND: In 2005, the Democratic Republic of Congo (DRC) adopted artesunate and amodiaquine (ASAQ) as first-line anti-malarial treatment. In order to compare the efficacy of the fixed-dose formulation ASAQ versus artemether-lumefantrine (AL), a randomized, non-inferiority open-label trial was conducted in Katanga. METHODS: Children aged six and 59 months with uncomplicated Plasmodium falciparum malaria were enrolled and randomly allocated into one of the two regimens. The risk of recurrent parasitaemia by day 42, both unadjusted and adjusted by PCR genotyping to distinguish recrudescence from new infection, was analysed. RESULTS: Between April 2008 and March 2009, 301 children were included: 156 with ASAQ and 145 with AL. No early treatment failures were reported. Among the 256 patients followed-up at day 42, 32 patients developed late clinical or parasitological failure (9.9% (13/131) in the ASAQ group and 15.2% (19/125) in the AL group). After PCR correction, cure rates were 98.3% (95%CI, 94.1-99.8) in the ASAQ group and 99.1% (95%CI, 94.9-99.9) in the AL group (difference -0.7%, one sided 95% CI -3.1). Kaplan-Meier PCR-adjusted cure rates were similar. Both treatment regimens were generally well tolerated. CONCLUSION: Both ASAQ and AL are highly effective and currently adequate as the first-line treatment of uncomplicated falciparum malaria in this area of Katanga, DRC. However, in a very large country, such as DRC, and because of possible emergence of resistance from other endemic regions, surveillance of efficacy of artemisinin-based combination treatments, including other evaluations of the resistance of ASAQ, need to be done in other provinces. TRIAL REGISTRATION: The protocol was registered with the clinicaltrials.gov, open clinical trial registry under the identifier number NCT01567423.