Abstract
BackgroundIn 2009, the Papua New Guinea (PNG) Department of Health adopted artemether–lumefantrine (AL) and dihydroartemisinin–piperaquine (DHA-PPQ) as the first- and second-line treatments for uncomplicated malaria, respectively. This study was conducted to assess the efficacy of both drugs following adoption of the new policy.MethodsBetween June 2012 and September 2014, a therapeutic efficacy study was conducted in East Sepik and Milne Bay Provinces of PNG in accordance with the standard World Health Organization (WHO) protocol for surveillance of anti-malarial drug efficacy. Patients ≥ 6 months of age with microscopy confirmed Plasmodium falciparum or Plasmodium vivax mono-infections were enrolled, treated with AL or DHA-PPQ, and followed up for 42 days. Study endpoints were adequate clinical and parasitological response (ACPR) on days 28 and 42. The in vitro efficacy of anti-malarials and the prevalence of selected molecular markers of resistance were also determined.ResultsA total of 274 P. falciparum and 70 P. vivax cases were enrolled. The day-42 PCR-corrected ACPR for P. falciparum was 98.1% (104/106) for AL and 100% (135/135) for DHA-PPQ. The day-42 PCR-corrected ACPR for P. vivax was 79.0% (15/19) for AL and 92.3% (36/39) for DHA-PPQ. Day 3 parasite clearance of P. falciparum was 99.2% with AL and 100% with DHA-PPQ. In vitro testing of 96 samples revealed low susceptibility to chloroquine (34% of samples above IC50 threshold) but not to lumefantrine (0%). Molecular markers assessed in a sub-set of the study population indicated high rates of chloroquine resistance in P. falciparum (pfcrt SVMNT: 94.2%, n = 104) and in P. vivax (pvmdr1 Y976F: 64.8%, n = 54).ConclusionsAL and DHA-PPQ were efficacious as first- and second-line treatments for uncomplicated malaria in PNG. Continued in vivo efficacy monitoring is warranted considering the threat of resistance to artemisinin and partner drugs in the region and scale-up of artemisinin-based combination therapy in PNG.
Highlights
In 2009, the Papua New Guinea (PNG) Department of Health adopted artemether–lumefantrine (AL) and dihydroartemisinin–piperaquine (DHA-PPQ) as the first- and second-line treatments for uncomplicated malaria, respectively
Study sites This study was conducted in 2 sites in PNG (Maprik, East Sepik Province, and Alotau, Milne Bay Province) from 2012 to 2014 following the standard World Health Organization (WHO) protocol for surveillance of anti-malarial drug efficacy [13]
Patient enrolment and follow‐up Patients aged ≥ 6 months presenting with fever (≥ 37.5 °C) or a history of fever in the previous 72 h at one of the study health facilities were initially screened and enrolled provided they had: (i) weight ≥ 5.0 kg; (ii) Hb ≥ 5.0 g/dL; (iii) easy access to the study facility to enable follow-up; (iv) positive malaria rapid diagnostic test (RDT; CareStart Malaria Combo, Access Bio, USA); and, (v) microscopy-confirmed P. falciparum (≥ 1000 parasites/μL) or P. vivax (≥ 250 parasites/μL) mono-infection
Summary
In 2009, the Papua New Guinea (PNG) Department of Health adopted artemether–lumefantrine (AL) and dihydroartemisinin–piperaquine (DHA-PPQ) as the first- and second-line treatments for uncomplicated malaria, respectively. This study was conducted to assess the efficacy of both drugs following adoption of the new policy. Due to the emergence of resistant Plasmodium falciparum and Plasmodium vivax parasite strains [1], the World Health Organization (WHO) recommends a 3-day course of artemisinin-based combination therapy (ACT), which has a proven high efficacy [2]. In line with WHO recommendations, Papua New Guinea (PNG) introduced a new anti-malarial treatment guideline in 2009 with artemether–lumefantrine (AL) and dihydroartemisinin– piperaquine (DHA-PPQ) as the first-and second-line treatments, respectively [4, 5]. The country-wide roll-out of AL to public health facilities started 2 years after policy adoption, in late 2011 [7]
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