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Unsupervised primaquine for the treatment of Plasmodium vivax malaria relapses in southern Papua: A hospital-based cohort study.

Abstract Primaquine is the only licensed drug for eradicating Plasmodium vivax hypnozoites and, therefore, preventing relapses of vivax malaria. It is a vital component of global malaria elimination efforts. Primaquine is efficacious when supervised in clinical trials, but its effectiveness in real-world settings is unknown. We aimed to determine whether unsupervised primaquine was effective for preventing re-presentation to hospital with vivax malaria in southern Papua, Indonesia.
PMID
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Authors

Mayor MeshTerms
Keywords
Journal Title plos medicine
Publication Year Start




PMID- 28850568
OWN - NLM
STAT- MEDLINE
DA  - 20170829
DCOM- 20170908
LR  - 20170908
IS  - 1549-1676 (Electronic)
IS  - 1549-1277 (Linking)
VI  - 14
IP  - 8
DP  - 2017 Aug
TI  - Unsupervised primaquine for the treatment of Plasmodium vivax malaria relapses in
      southern Papua: A hospital-based cohort study.
PG  - e1002379
LID - 10.1371/journal.pmed.1002379 [doi]
AB  - BACKGROUND: Primaquine is the only licensed drug for eradicating Plasmodium vivax
      hypnozoites and, therefore, preventing relapses of vivax malaria. It is a vital
      component of global malaria elimination efforts. Primaquine is efficacious when
      supervised in clinical trials, but its effectiveness in real-world settings is
      unknown. We aimed to determine whether unsupervised primaquine was effective for 
      preventing re-presentation to hospital with vivax malaria in southern Papua,
      Indonesia. METHODS AND FINDINGS: Routinely-collected hospital surveillance data
      were used to undertake a pragmatic comparison of the risk of re-presentation to
      hospital with vivax malaria in patients prescribed dihydroartemisinin-piperaquine
      (DHP) combined with primaquine versus those patients prescribed DHP alone. The
      omission of primaquine was predominantly due to 3 stock outages. Individual
      clinical, pharmacy, and laboratory data were merged using individual hospital
      identification numbers and the date of presentation to hospital. Between April
      2004 and December 2013, there were 86,797 documented episodes of vivax malaria,
      of which 62,492 (72.0%) were included in the analysis. The risk of
      re-presentation with vivax malaria within 1 year was 33.8% (95% confidence
      Interval [CI] 33.1%-34.5%) after initial monoinfection with P. vivax and 29.2%
      (95% CI 28.1%-30.4%) after mixed-species infection. The risk of re-presentation
      with P. vivax malaria was higher in children 1 to <5 years of age (49.6% [95% CI 
      48.4%-50.9%]) compared to patients 15 years of age or older (24.2% [95% CI
      23.4-24.9%]); Adjusted Hazard Ratio (AHR) = 2.23 (95% CI 2.15-2.31), p < 0.001.
      Overall, the risk of re-presentation was 37.2% (95% CI 35.6%-38.8%) in patients
      who were prescribed no primaquine compared to 31.6% (95% CI 30.9%-32.3%) in those
      prescribed either a low (>/=1.5 mg/kg and <5 mg/kg) or high (>/=5 mg/kg) dose of 
      primaquine (AHR = 0.90 [95% CI 0.86-0.95, p < 0.001]). Limiting the comparison to
      high dose versus no primaquine in the period during and 12 months before and
      after a large stock outage resulted in minimal change in the estimated clinical
      effectiveness of primaquine (AHR 0.91, 95% CI 0.85-0.97, p = 0.003). Our
      pragmatic study avoided the clinical influences associated with prospective study
      involvement but was subject to attrition bias caused by passive follow-up.
      CONCLUSIONS: Unsupervised primaquine for vivax malaria, prescribed according to
      the current World Health Organization guidelines, was associated with a minimal
      reduction in the risk of clinical recurrence within 1 year in Papua, Indonesia.
      New strategies for the effective radical cure of vivax malaria are needed in
      resource-poor settings.
FAU - Douglas, Nicholas M
AU  - Douglas NM
AUID- ORCID: http://orcid.org/0000-0002-7214-4244
AD  - Global and Tropical Health Division, Menzies School of Health Research, Charles
      Darwin University, Darwin, Northern Territory, Australia.
AD  - Division of Infectious Diseases, Christchurch Hospital, Christchurch, New
      Zealand.
FAU - Poespoprodjo, Jeanne Rini
AU  - Poespoprodjo JR
AD  - Timika Malaria Research Program, Papuan Health and Community Development
      Foundation, Timika, Papua, Indonesia.
AD  - Department of Child Health, Faculty of Medicine, University Gadjah Mada,
      Yogyakarta, Indonesia.
FAU - Patriani, Dewi
AU  - Patriani D
AD  - Department of Child Health, Faculty of Medicine, University Gadjah Mada,
      Yogyakarta, Indonesia.
FAU - Malloy, Michael J
AU  - Malloy MJ
AD  - Centre for Epidemiology and Biostatistics, Melbourne School of Population and
      Global Health, University of Melbourne, Melbourne, Victoria, Australia.
AD  - Victorian Cytology Service Ltd., Melbourne, Victoria, Australia.
FAU - Kenangalem, Enny
AU  - Kenangalem E
AD  - Timika Malaria Research Program, Papuan Health and Community Development
      Foundation, Timika, Papua, Indonesia.
AD  - Mimika District Hospital, Timika, Papua, Indonesia.
FAU - Sugiarto, Paulus
AU  - Sugiarto P
AD  - Rumah Sakit Mitra Masyarakat, Timika, Papua, Indonesia.
FAU - Simpson, Julie A
AU  - Simpson JA
AD  - Centre for Epidemiology and Biostatistics, Melbourne School of Population and
      Global Health, University of Melbourne, Melbourne, Victoria, Australia.
FAU - Soenarto, Yati
AU  - Soenarto Y
AD  - Department of Child Health, Faculty of Medicine, University Gadjah Mada,
      Yogyakarta, Indonesia.
FAU - Anstey, Nicholas M
AU  - Anstey NM
AD  - Global and Tropical Health Division, Menzies School of Health Research, Charles
      Darwin University, Darwin, Northern Territory, Australia.
FAU - Price, Ric N
AU  - Price RN
AUID- ORCID: http://orcid.org/0000-0003-2000-2874
AD  - Global and Tropical Health Division, Menzies School of Health Research, Charles
      Darwin University, Darwin, Northern Territory, Australia.
AD  - Centre for Tropical Medicine and Global Health, Nuffield Department of Clinical
      Medicine, University of Oxford, Oxford, United Kingdom.
LA  - eng
PT  - Journal Article
DEP - 20170829
PL  - United States
TA  - PLoS Med
JT  - PLoS medicine
JID - 101231360
RN  - 0 (Antimalarials)
RN  - 0 (Artemisinins)
RN  - 0 (Quinolines)
RN  - 6A9O50735X (dihydroartemisinin)
RN  - A0HV2Q956Y (piperaquine)
RN  - MVR3634GX1 (Primaquine)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antimalarials/*therapeutic use
MH  - Artemisinins/*therapeutic use
MH  - Child
MH  - Child, Preschool
MH  - Cohort Studies
MH  - Drug Therapy, Combination
MH  - Female
MH  - Humans
MH  - Indonesia
MH  - Infant
MH  - Malaria, Vivax/*drug therapy/prevention & control
MH  - Male
MH  - Middle Aged
MH  - Primaquine/*therapeutic use
MH  - Quinolines/*therapeutic use
MH  - Recurrence
MH  - Retrospective Studies
MH  - Young Adult
EDAT- 2017/08/30 06:00
MHDA- 2017/09/09 06:00
CRDT- 2017/08/30 06:00
PHST- 2017/02/23 [received]
PHST- 2017/07/27 [accepted]
AID - 10.1371/journal.pmed.1002379 [doi]
AID - PMEDICINE-D-17-00655 [pii]
PST - epublish
SO  - PLoS Med. 2017 Aug 29;14(8):e1002379. doi: 10.1371/journal.pmed.1002379.
      eCollection 2017 Aug.