High cure rates and tolerability of artesunate–amodiaquine and dihydroartemisinin–piperaquine for the treatment of uncomplicated falciparum malaria in Kibaha and Kigoma, Tanzania

• Published in: Malaria Journal
• Main Authors: Celine I. Mandara, Filbert Francis, Mercy G. Chiduo, Billy Ngasala, Renata Mandike, Sigsbert Mkude, Frank Chacky, Fabrizio Molteni, Ritha Njau, Ally Mohamed, Marian Warsame, Deus S. Ishengoma
• Format: Article in Journal/Newspaper
• Language: English
• Published: BMC 2019
• Subjects: Efficacy; Safety; Artesunate–amodiaquine; Dihydroartemisinin–piperaquine; Plasmodium falciparum; Tanzania; Arctic medicine. Tropical medicine; RC955-962; Infectious and parasitic diseases; RC109-216; Arctic
• Online Access: https://doi.org/10.1186/s12936-019-2740-z; https://doaj.org/article/67c4f5884e6d41d9badb49778eb7c00c

Abstract Background The Tanzanian National Malaria Control Programme (NMCP) and its partners have been implementing regular therapeutic efficacy studies (TES) to monitor the performance of different drugs used or with potential use in Tanzania. However, most of the recent TES focused on artemether–lumefantrine, which is the first-line anti-malarial for the treatment of uncomplicated falciparum malaria. Data on the performance of other artemisinin-based combinations is urgently needed to support timely review and changes of treatment guidelines in case of drug resistance to the current regimen. This study was conducted at two NMCP sentinel sites (Kibaha, Pwani and Ujiji, Kigoma) to assess the efficacy and safety of artesunate–amodiaquine (ASAQ) and dihydroartemisinin–piperaquine (DP), which are the current alternative artemisinin-based combinations in Tanzania. Methods This was a single-arm prospective evaluation of the clinical and parasitological responses of ASAQ and DP for directly observed treatment of uncomplicated falciparum malaria. Children aged 6 months to 10 years and meeting the inclusion criteria were enrolled and treated with either ASAQ or DP. In each site, patients were enrolled sequentially; thus, enrolment of patients for the assessment of one artemisinin-based combination was completed before patients were recruited for assessment of the second drugs. Follow-up was done for 28 or 42 days for ASAQ and DP, respectively. The primary outcome was PCR corrected cure rates while the secondary outcome was occurrence of adverse events (AEs) or serious adverse events (SAEs). Results Of the 724 patients screened at both sites, 333 (46.0%) were enrolled and 326 (97.9%) either completed the 28/42 days of follow-up, or attained any of the treatment outcomes. PCR uncorrected adequate clinical and parasitological response (ACPR) for DP on day 42 was 98.8% and 75.9% at Kibaha and Ujiji, respectively. After PCR correction, DP’s ACPR was 100% at both sites. For ASAQ, no parasite recurrence occurred giving 100% ...