An Open-Label, Randomised Study of Dihydroartemisinin-Piperaquine Versus Artesunate-Mefloquine for Falciparum Malaria in Asia

Valecha, Neena; Phyo, Aung Pyae; Mayxay, Mayfong; Newton, Paul N.; Krudsood, Srivicha; Keomany, Sommay; Khanthavong, Maniphone; Pongvongsa, Tiengkham; Ruangveerayuth, Ronnatrai; Uthaisil, Chirapong; Ubben, David; Duparc, Stephan; Bacchieri, Antonella; Corsi, Marco; Rao, Bappanad H. K.; Bhattacharya, Prabash C.; Dubhashi, Nagesh; Ghosh, Susanta Kumar; Dev, Vas; Kumar, Ashwani; Pukittayakamee, Sasithon

doi:10.1371/journal.pone.0011880

Cited by 73 publications

(95 citation statements)

References 37 publications

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“…For the ITT population, PCR-corrected cure rates were 87.9% for DHA-PQP and 86.6% for AS-MQ. As expected, better absolute but comparatively similar results were obtained for the per protocol population with PCR-corrected cure rates of 98.7% for DHA-PQP and 97.0% for AS-MQ (Valecha et al, 2010). Comparison of the data of this study to data from other country found no differences between the primary outcome measures, further confirming that DHA-PQP was similarly active against the P. falciparum found in India, Laos and Thailand, relative to AS-MQ.…”

Section: -Day In Vivo Protocol To Test Acts Efficacysupporting

confidence: 82%

“…The 28-day follow-up protocol (Chanda et al, 2006;Denis et al, 2002;Marquino et al, 2003) or 42-day follow-up protocol (Leang et al, 2015;Mårtensson et al, 2005;Mayxay et al, 2004;Valecha et al, 2010;Yeka et al, 2008) were usually used. Few studies used 63-day follow-up protocols for efficacy monitoring of ACTs containing a long half-life partner drug (Sodiomon et al, 2016;Valecha et al, 2010). Patient follow-ups were scheduled for days 1, 2, 3, 7, 14, 21 and 28 plus any other day that the child was taken to the clinic on an unscheduled day.…”

Section: In Vivo Act Efficacy Evaluationmentioning

confidence: 99%

“…We included articles about artemether-lumefantrine (AL) alone (Chanda et al, 2006), on AL vs. artesunate-amodiaquine (AS-AQ) alone (Brasseur et al, 2009), AL vs. Artesunate-sulfamethoxypyrazine (AS-SMP) (Sagara et al, 2006), AL vs. dihydroartemisinin-piperaquine (DHA-PQP) (Kamya et al, 2007), AL vs. Artesunate-Mefloquine (AS-MQ) , AL vs Chlorproguanil-Dapsone (CPD) (Kaye et al, 2008), AQ vs Argemone mexicana (AM) (Graz et al, 2010), DHA-PQP vs AS-MQ (Valecha et al, 2010), AQ-SP vs AS-SP (Yeka et al, 2005).…”

Section: In Vivo Act Efficacy Evaluationmentioning

confidence: 99%

“…The usual PCR techniques used for this purpose are insufficiently sensitive to pick up minority populations of parasites present at Day 0. It is therefore possible that "new" parasites identified during follow-up actually represent recrudescence of parasites from a resistant minority population that was present from the start rather than true reinfections WHO day 63 protocol Sodiomon et al (2016), Valecha et al (2010) and Ashley et al (2004) Some authors have used only polymorphism markers such as MSP1 and MSP2 to distinguish recrudescence to new infection, while other authors used microsatellite. This poses a problem of standarization.…”

Section: Reference Studies Strength and Weakness Of In Vitro/ex-vivo mentioning

confidence: 99%

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Methods for monitoring artemisinin-based combination therapies efficacy

Dama¹,

Djimdé²,

Doumbo³

2017

Clin. Rev. Opinions

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Plasmodium falciparum resistance to artemisinin and its derivatives is spreading in South-East Asia, and there is growing concern that this may reach other endemic countries. Methods used to assess P. falciparum resistance to artemisinin-based combination therapies (ACTs) are multiple and often divergent. This paper is a review of online accessible research publications from the past 20 years on ACTs, ranging from in vivo, in vitro/ex-vivo, molecular markers and pharmacokinetics studies. We highlight the procedures of the four main methods used for ACTs e f f i c a c y testing and provide a summary of published data. This review indicates that the most used method for ACT efficacy testing is the in vivo 28 days follow-up with molecular correction; the most widely used and reliable in vitro and ex-vivo method for artemisinin phenotyping is the ring stage survival assay from 0 to 3 h ring (RSA 0-3h ), and the main molecular marker of P. falciparum resistance to artemisinins are mutations on P. falciparum Kelch 13 propeller domain. Day 7 pharmacokinetics could help to predict resistance to artemether-lumefantrine and dihydroartemisinin-piperaquine. Findings from this review support that the combination of in vivo, in vitro/ex-vivo, molecular markers of drug resistance and day 7 PK levels of the partner drugs may be required for the optimal surveillance of artemisinin-based combination therapy efficacy in the field.

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Section: -Day In Vivo Protocol To Test Acts Efficacysupporting

confidence: 82%

Section: In Vivo Act Efficacy Evaluationmentioning

confidence: 99%

Section: In Vivo Act Efficacy Evaluationmentioning

confidence: 99%

Section: Reference Studies Strength and Weakness Of In Vitro/ex-vivo mentioning

confidence: 99%

See 2 more Smart Citations

Methods for monitoring artemisinin-based combination therapies efficacy

Dama¹,

Djimdé²,

Doumbo³

2017

Clin. Rev. Opinions

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“…A novel combination currently introduced into the ACT portfolio is dihydroartemisinin-piperaquine, which performs well compared to the ACTs in current use [12][13][14].…”

Section: New Drugs: Dihydroartemisinin-piperaquine and Fosmidomycinmentioning

confidence: 99%

Highlights of a Symposium, Malaria: Where are we Today, Where are we Going?

Wieten

Vugt

Leth

et al. 2011

TOIDJ

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Malaria continues to pose a major public health threat in endemic areas. However, times are changing, and many investments have been made in recent years into funding of malaria research, the development of more and improved control tools, and applying those to the field. Consequently, there is a renewed interest in going as far as considering the prospects of malaria elimination on a global scale. This goal cannot be reached without optimising and combining biotechnical, economical and social anthropological aspects. A symposium held on 25 January 2011 in Amsterdam, the Netherlands, organised by the Amsterdam Institute for Global Health and Development, the Center for Infection and Immunity Amsterdam and the Academic Medical Center of the University of Amsterdam, focused on malaria and the malERA eradication program, summarizing the state of the art in malaria control and beyond, and offering insight into the various possible ways forward. This manuscript summarizes the information presented and the ensuing discussions.

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Dihydroartemisinin-piperaquine for treating uncomplicated Plasmodium falciparum malaria

Zani

Gathu

Donegan

et al. 2014

Cochrane Database of Systematic Reviews

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BackgroundThe World Health Organization (WHO) recommends Artemisinin-based Combination Therapy (ACT) for treating uncomplicated Plasmodium falciparum malaria. This review aims to assist the decision-making of malaria control programmes by providing an overview of the relative effects of dihydroartemisinin-piperaquine (DHA-P) versus other recommended ACTs.ObjectivesTo evaluate the effectiveness and safety of DHA-P compared to other ACTs for treating uncomplicated P. falciparum malaria in adults and children.Search methodsWe searched the Cochrane Infectious Diseases Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL) published in The Cochrane Library; MEDLINE; EMBASE; LILACS, and the metaRegister of Controlled Trials (mRCT) up to July 2013.Selection criteriaRandomized controlled trials comparing a three-day course of DHA-P to a three-day course of an alternative WHO recommended ACT in uncomplicated P. falciparum malaria.Data collection and analysisTwo authors independently assessed trials for eligibility and risk of bias, and extracted data. We analysed primary outcomes in line with the WHO 'Protocol for assessing and monitoring antimalarial drug efficacy’ and compared drugs using risk ratios (RR) and 95% confidence intervals (CI). Secondary outcomes were effects on gametocytes, haemoglobin, and adverse events. We assessed the quality of evidence using the GRADE approach.Main resultsWe included 27 trials, enrolling 16,382 adults and children, and conducted between 2002 and 2010. Most trials excluded infants aged less than six months and pregnant women.DHA-P versus artemether-lumefantrineIn Africa, over 28 days follow-up, DHA-P is superior to artemether-lumefantrine at preventing further parasitaemia (PCR-unadjusted treatment failure: RR 0.34, 95% CI 0.30 to 0.39, nine trials, 6200 participants, high quality evidence), and although PCR-adjusted treatment failure was below 5% for both ACTs, it was consistently lower with DHA-P (PCR-adjusted treatment failure: RR 0.42, 95% CI 0.29 to 0.62, nine trials, 5417 participants, high quality evidence). DHA-P has a longer prophylactic effect on new infections which may last for up to 63 days (PCR-unadjusted treatment failure: RR 0.71, 95% CI 0.65 to 0.78, two trials, 3200 participants, high quality evidence).In Asia and Oceania, no differences have been shown at day 28 (four trials, 1143 participants, moderate quality evidence), or day 63 (one trial, 323 participants, low quality evidence).Compared to artemether-lumefantrine, no difference was seen in prolonged QTc (low quality evidence), and no cardiac arrhythmias were reported. The frequency of other adverse events is probably similar with both combinations (moderate quality evidence).DHA-P versus artesunate plus mefloquineIn Asia, over 28 days follow-up, DHA-P is as effective as artesunate plus mefloquine at preventing further parasitaemia (PCR-unadjusted treatment failure: eight trials, 3487 participants, high quality evidence). Once adjusted by PCR to exclude new infections, treatment ...

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An Open-Label, Randomised Study of Dihydroartemisinin-Piperaquine Versus Artesunate-Mefloquine for Falciparum Malaria in Asia

Cited by 73 publications

References 37 publications

Methods for monitoring artemisinin-based combination therapies efficacy

Methods for monitoring artemisinin-based combination therapies efficacy

Highlights of a Symposium, Malaria: Where are we Today, Where are we Going?

Dihydroartemisinin-piperaquine for treating uncomplicated Plasmodium falciparum malaria

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