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A randomized comparison of dihydroartemisinin-piperaquine and artesunate-amodiaquine combined with primaquine for radical treatment of vivax malaria in Sumatera, Indonesia.

AbstractBACKGROUND:
A high prevalence of chloroquine-resistant Plasmodium vivax in Indonesia has shifted first-line treatment to artemisinin-based combination therapies, combined with primaquine (PQ) for radical cure. Which combination is most effective and safe remains to be established.
METHODS:
We conducted a prospective open-label randomized comparison of 14 days of PQ (0.25 mg base/kg) plus either artesunate-amodiaquine (AAQ + PQ) or dihydroartemisinin-piperaquine (DHP + PQ) for the treatment of uncomplicated monoinfection P. vivax malaria in North Sumatera, Indonesia. Patients were randomized and treatments were given without prior testing for G6PD status. The primary outcome was parasitological failure at day 42. Patients were followed up to 1 year.
RESULTS:
Between December 2010 and April 2012, 331 patients were included. After treatment with AAQ + PQ, recurrent infection occurred in 0 of 167 patients within 42 days and in 15 of 130 (11.5%; 95% confidence interval [CI], 6.6%-18.3%) within a year. With DHP + PQ, this was 1 of 164 (0.6%; 95% CI, 0.01%-3.4%) and 13 of 143 (9.1%; 95% CI, 4.9%-15.0%), respectively (P > .2). Intravascular hemolysis occurred in 5 patients, of which 3 males were hemizygous for the G6PD-Mahidol mutation. Minor adverse events were more frequent with AAQ + PQ.
CONCLUSIONS:
In North Sumatera, Indonesia, AAQ and DHP, both combined with PQ, were effective for blood-stage parasite clearance of uncomplicated P. vivax malaria. Both treatments were safe, but DHP + PQ was better tolerated.
CLINICAL TRIALS REGISTRATION:
NCT01288820.
AuthorsAyodhia Pitaloka Pasaribu, Watcharee Chokejindachai, Chukiat Sirivichayakul, Naowarat Tanomsing, Irwin Chavez, Emiliana Tjitra, Syahril Pasaribu, Mallika Imwong, Nicholas J White, Arjen M Dondorp
JournalThe Journal of infectious diseases (J Infect Dis) Vol. 208 Issue 11 Pg. 1906-13 (Dec 01 2013) ISSN: 1537-6613 [Electronic] United States
PMID23926329 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antimalarials
  • Artemisinins
  • Drug Combinations
  • Quinolines
  • amodiaquine, artesunate drug combination
  • Amodiaquine
  • artenimol
  • piperaquine
  • Primaquine
Topics
  • Adolescent
  • Adult
  • Aged
  • Amodiaquine (adverse effects, therapeutic use)
  • Antimalarials (adverse effects, therapeutic use)
  • Artemisinins (adverse effects, therapeutic use)
  • Child
  • Child, Preschool
  • Drug Combinations
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Genotype
  • Humans
  • Indonesia
  • Kaplan-Meier Estimate
  • Malaria, Vivax (drug therapy, parasitology)
  • Male
  • Middle Aged
  • Plasmodium vivax (drug effects)
  • Primaquine (adverse effects, therapeutic use)
  • Prospective Studies
  • Quinolines (adverse effects, therapeutic use)
  • Treatment Outcome
  • Young Adult

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