Research

Artemisinin-naphthoquine combination (ARCO™) therapy for uncomplicated falciparum malaria in adults of Papua New Guinea: A preliminary report on safety and efficacy

Francis W Hombhanje¹ , David Linge² , Adolf Saweri² , Cynthia Kuanch³ , Robert Jones⁴ , Stephen Toraso⁵ , Jacobed Geita⁵ , Andrew Masta² , Isi Kevau² , Gilbert Hiawalyer⁶ and Mathias Sapuri²

¹  Faculty of Health Sciences, Divine Word University, Madang, Madang Province, Papua New Guinea

²  School of Medicine and Health Sciences, University of Papua New Guinea, Papua New Guinea

³  St. Mary's Private Hospital, Port Moresby, Central Province, Papua New Guinea

⁴  Port Moresby General Hospital, Port Moresby, Papua New Guinea

⁵  Madang Modilon Hospital, Madang, Madang Province, Papua New Guinea

⁶  United Nations Family and Population Agency, Port Moresby, Papua New Guinea

author email corresponding author email

Malaria Journal 2009, 8:196doi:10.1186/1475-2875-8-196

Published:	12 August 2009

Abstract

Background

The use of anti-malarial drug combinations with artemisinin or with one of its derivatives is now widely recommended to overcome drug resistance in falciparum as well as vivax malaria. The fixed oral dose artemisinin-naphthoquine combination (ANQ, ARCO™) is a newer artemisinin-based combination (ACT) therapy undergoing clinical assessment. A study was undertaken to assess the safety, efficacy and tolerability of ANQ combination in areas of multi-drug resistance to generate preliminary baseline data in adult population of Papua New Guinea.

Methods

The clinical assessment was an open-labeled, two-arm, randomized study comparing ANQ combination as a single dose regimen and three days regimen (10 mg/kg/day) of chloroquine plus single dose sulphadoxine-pyrimethamine (CQ+SP) for the treatment of uncomplicated falciparum malaria with 28 days follow-up in an adult population. The primary outcome measures for efficacy were day 1, 2, 3 7, 14 and 28-day cure rates. Secondary outcomes included parasite clearance time, fever clearance time, and gametocyte carriage. The main outcome measures for safety were incidences of post-treatment clinical and laboratory adverse events.

Results

Between June 2005 and July 2006, 130 patients with confirmed uncomplicated P. falciparum were randomly assigned to receive ANQ and CQ+SP, only 100 patients (51 in ANQ group and 49 in CQ+SP group) were evaluated for clinical and parasitological outcomes. All the patients treated with ANQ and CQ+SP showed adequate clinical and parasitological response with 28 days follow-up. The cure rate for ANQ on day 1, 2, 3, 7, 14, and 28 was 47%, 86%, 92%, 94%, 94% and 94%, respectively. Recrudescence account for 6%; all were cleared on day 21. For CQ+SP treated group the cure rates were 24%, 67%, 82%, 82%, 84% and 88%, respectively. Recrudescence accounted for 10%; all were cleared on day 28 except for one patient. Both regimens were well tolerated with no serious adverse events. The proportion of gametocyte carriers was higher in CQ+SP treated group than ANQ treatment (41% versus 12%; p < 0.05).

Conclusion

While these data are not themselves sufficient, it strongly suggests that the ANQ combination as a single dose administration is safe and effective for the treatment of uncomplicated P. falciparum malaria in the adult population of Papua New Guinea and deserves further clinical evaluation.