Efficacy and safety of pyronaridine-artesunate (Pyramax®) for the treatment of uncomplicated Plasmodium vivax malaria in Northwest Ethiopia

Hussein Mohammed; Heven Sime; Henok Hailgiorgis; Melkie Chernet; Mihreteab Alebachew; Hiwot Solomon; Gudissa Assefa; Mebrahtom Haile; Samuel Girma; Worku Bekele; Geremew Tasew; Bokretsion Gidey; Robert J. Commons; Ashenafi Assefa

doi:10.1186/s12936-022-04422-0

Efficacy and safety of pyronaridine-artesunate (Pyramax^®) for the treatment of uncomplicated Plasmodium vivax malaria in Northwest Ethiopia

Hussein Mohammed, Heven Sime, Henok Hailgiorgis, Melkie Chernet, Mihreteab Alebachew, Hiwot Solomon, Gudissa Assefa, Mebrahtom Haile, Samuel Girma, Worku Bekele, Geremew Tasew, Bokretsion Gidey, Robert J. Commons, Ashenafi Assefa

Global and Tropical Health

Research output: Contribution to journal › Article › peer-review

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Abstract

Background: Declining efficacy of chloroquine for the treatment Plasmodium vivax malaria has been reported in different endemic settings in Ethiopia. This highlights the need to assess alternative options for P. vivax treatment with artemisinin-based combination therapy, such as pyronaridine-artesunate. This treatment regimen has shown high efficacy for uncomplicated malaria in both Africa and Asia. However, limited data are available from Ethiopia. This study was conducted to assess the efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated P. vivax malaria in Northwest Ethiopia.

Methods: A single arm prospective efficacy study was conducted in the Hamusite area, Northwest Ethiopia. Fifty-one febrile adult patients with uncomplicated P. vivax malaria were enrolled between March and July 2021. Patients were treated with pyronaridine-artesunate once daily for three days. Clinical and parasitological parameters were monitored over a 42-day follow-up period using the standard World Health Organization protocol for therapeutic efficacy studies.

Results: A total of 4372 febrile patients were screened with 51 patients enrolled and 49 completing the 42-day follow-up period. The PCR-uncorrected adequate clinical and parasitological response (ACPR) was 95.9% (47/49; 95% CI 84.9–99.0) on day 42. Two patients had recurrences [4.0% (2/49); 95% CI 0.7–12.1] on days 35 and 42. The parasite clearance rate was rapid with fast resolution of clinical symptoms; 100% of participants had cleared parasitaemia on day 1 and fever on day 2. All 16 (31.4%) patients with gametocyte carriage on day 0 had cleared by day 1. There were no serious adverse events.

Conclusion: In this small study, pyronaridine-artesunate was efficacious and well-tolerated for the treatment of uncomplicated P. vivax malaria. In adults in the study setting, it would be a suitable alternative option for case management.

Original language	English
Article number	401
Pages (from-to)	1-8
Number of pages	8
Journal	Malaria Journal
Volume	21
Issue number	1
DOIs	https://doi.org/10.1186/s12936-022-04422-0
Publication status	Published - Dec 2022

Bibliographical note

Funding Information:
This study was funded by the Global fund for AIDS, Tb and malaria through the Federal Ministry of Health (FMoH).

Funding Information:
We would like to thank the Federal Ministry of Health for collaboration in the whole research progresses and funding with the support of the Global Fund and WHO for donated study drug. Our sincere gratitude also goes to the study participants and the health center staffs. RJC is supported by an Australian NHMRC Investigator Grant.

Publisher Copyright:
© 2022, The Author(s).

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s12936-022-04422-0Final published version, 1.38 MBLicence: CC BY

Cite this

Mohammed, H., Sime, H., Hailgiorgis, H., Chernet, M., Alebachew, M., Solomon, H., Assefa, G., Haile, M., Girma, S., Bekele, W., Tasew, G., Gidey, B., Commons, R. J., & Assefa, A. (2022). Efficacy and safety of pyronaridine-artesunate (Pyramax^®) for the treatment of uncomplicated Plasmodium vivax malaria in Northwest Ethiopia. Malaria Journal, 21(1), 1-8. Article 401. https://doi.org/10.1186/s12936-022-04422-0

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title = "Efficacy and safety of pyronaridine-artesunate (Pyramax{\textregistered}) for the treatment of uncomplicated Plasmodium vivax malaria in Northwest Ethiopia",

abstract = "Background: Declining efficacy of chloroquine for the treatment Plasmodium vivax malaria has been reported in different endemic settings in Ethiopia. This highlights the need to assess alternative options for P. vivax treatment with artemisinin-based combination therapy, such as pyronaridine-artesunate. This treatment regimen has shown high efficacy for uncomplicated malaria in both Africa and Asia. However, limited data are available from Ethiopia. This study was conducted to assess the efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated P. vivax malaria in Northwest Ethiopia. Methods: A single arm prospective efficacy study was conducted in the Hamusite area, Northwest Ethiopia. Fifty-one febrile adult patients with uncomplicated P. vivax malaria were enrolled between March and July 2021. Patients were treated with pyronaridine-artesunate once daily for three days. Clinical and parasitological parameters were monitored over a 42-day follow-up period using the standard World Health Organization protocol for therapeutic efficacy studies. Results: A total of 4372 febrile patients were screened with 51 patients enrolled and 49 completing the 42-day follow-up period. The PCR-uncorrected adequate clinical and parasitological response (ACPR) was 95.9\% (47/49; 95\% CI 84.9–99.0) on day 42. Two patients had recurrences [4.0\% (2/49); 95\% CI 0.7–12.1] on days 35 and 42. The parasite clearance rate was rapid with fast resolution of clinical symptoms; 100\% of participants had cleared parasitaemia on day 1 and fever on day 2. All 16 (31.4\%) patients with gametocyte carriage on day 0 had cleared by day 1. There were no serious adverse events. Conclusion: In this small study, pyronaridine-artesunate was efficacious and well-tolerated for the treatment of uncomplicated P. vivax malaria. In adults in the study setting, it would be a suitable alternative option for case management.",

keywords = "Efficacy, Ethiopia, Plasmodium vivax, Pyronaridine-artesunate",

author = "Hussein Mohammed and Heven Sime and Henok Hailgiorgis and Melkie Chernet and Mihreteab Alebachew and Hiwot Solomon and Gudissa Assefa and Mebrahtom Haile and Samuel Girma and Worku Bekele and Geremew Tasew and Bokretsion Gidey and Commons, \{Robert J.\} and Ashenafi Assefa",

note = "Funding Information: This study was funded by the Global fund for AIDS, Tb and malaria through the Federal Ministry of Health (FMoH). Funding Information: We would like to thank the Federal Ministry of Health for collaboration in the whole research progresses and funding with the support of the Global Fund and WHO for donated study drug. Our sincere gratitude also goes to the study participants and the health center staffs. RJC is supported by an Australian NHMRC Investigator Grant. Publisher Copyright: {\textcopyright} 2022, The Author(s).",

year = "2022",

month = dec,

doi = "10.1186/s12936-022-04422-0",

language = "English",

volume = "21",

pages = "1--8",

journal = "Malaria Journal",

issn = "1475-2875",

publisher = "BioMed Central",

number = "1",

}

Mohammed, H, Sime, H, Hailgiorgis, H, Chernet, M, Alebachew, M, Solomon, H, Assefa, G, Haile, M, Girma, S, Bekele, W, Tasew, G, Gidey, B, Commons, RJ & Assefa, A 2022, 'Efficacy and safety of pyronaridine-artesunate (Pyramax^®) for the treatment of uncomplicated Plasmodium vivax malaria in Northwest Ethiopia', Malaria Journal, vol. 21, no. 1, 401, pp. 1-8. https://doi.org/10.1186/s12936-022-04422-0

TY - JOUR

T1 - Efficacy and safety of pyronaridine-artesunate (Pyramax®) for the treatment of uncomplicated Plasmodium vivax malaria in Northwest Ethiopia

AU - Mohammed, Hussein

AU - Sime, Heven

AU - Hailgiorgis, Henok

AU - Chernet, Melkie

AU - Alebachew, Mihreteab

AU - Solomon, Hiwot

AU - Assefa, Gudissa

AU - Haile, Mebrahtom

AU - Girma, Samuel

AU - Bekele, Worku

AU - Tasew, Geremew

AU - Gidey, Bokretsion

AU - Commons, Robert J.

AU - Assefa, Ashenafi

N1 - Funding Information: This study was funded by the Global fund for AIDS, Tb and malaria through the Federal Ministry of Health (FMoH). Funding Information: We would like to thank the Federal Ministry of Health for collaboration in the whole research progresses and funding with the support of the Global Fund and WHO for donated study drug. Our sincere gratitude also goes to the study participants and the health center staffs. RJC is supported by an Australian NHMRC Investigator Grant. Publisher Copyright: © 2022, The Author(s).

PY - 2022/12

Y1 - 2022/12

N2 - Background: Declining efficacy of chloroquine for the treatment Plasmodium vivax malaria has been reported in different endemic settings in Ethiopia. This highlights the need to assess alternative options for P. vivax treatment with artemisinin-based combination therapy, such as pyronaridine-artesunate. This treatment regimen has shown high efficacy for uncomplicated malaria in both Africa and Asia. However, limited data are available from Ethiopia. This study was conducted to assess the efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated P. vivax malaria in Northwest Ethiopia. Methods: A single arm prospective efficacy study was conducted in the Hamusite area, Northwest Ethiopia. Fifty-one febrile adult patients with uncomplicated P. vivax malaria were enrolled between March and July 2021. Patients were treated with pyronaridine-artesunate once daily for three days. Clinical and parasitological parameters were monitored over a 42-day follow-up period using the standard World Health Organization protocol for therapeutic efficacy studies. Results: A total of 4372 febrile patients were screened with 51 patients enrolled and 49 completing the 42-day follow-up period. The PCR-uncorrected adequate clinical and parasitological response (ACPR) was 95.9% (47/49; 95% CI 84.9–99.0) on day 42. Two patients had recurrences [4.0% (2/49); 95% CI 0.7–12.1] on days 35 and 42. The parasite clearance rate was rapid with fast resolution of clinical symptoms; 100% of participants had cleared parasitaemia on day 1 and fever on day 2. All 16 (31.4%) patients with gametocyte carriage on day 0 had cleared by day 1. There were no serious adverse events. Conclusion: In this small study, pyronaridine-artesunate was efficacious and well-tolerated for the treatment of uncomplicated P. vivax malaria. In adults in the study setting, it would be a suitable alternative option for case management.

AB - Background: Declining efficacy of chloroquine for the treatment Plasmodium vivax malaria has been reported in different endemic settings in Ethiopia. This highlights the need to assess alternative options for P. vivax treatment with artemisinin-based combination therapy, such as pyronaridine-artesunate. This treatment regimen has shown high efficacy for uncomplicated malaria in both Africa and Asia. However, limited data are available from Ethiopia. This study was conducted to assess the efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated P. vivax malaria in Northwest Ethiopia. Methods: A single arm prospective efficacy study was conducted in the Hamusite area, Northwest Ethiopia. Fifty-one febrile adult patients with uncomplicated P. vivax malaria were enrolled between March and July 2021. Patients were treated with pyronaridine-artesunate once daily for three days. Clinical and parasitological parameters were monitored over a 42-day follow-up period using the standard World Health Organization protocol for therapeutic efficacy studies. Results: A total of 4372 febrile patients were screened with 51 patients enrolled and 49 completing the 42-day follow-up period. The PCR-uncorrected adequate clinical and parasitological response (ACPR) was 95.9% (47/49; 95% CI 84.9–99.0) on day 42. Two patients had recurrences [4.0% (2/49); 95% CI 0.7–12.1] on days 35 and 42. The parasite clearance rate was rapid with fast resolution of clinical symptoms; 100% of participants had cleared parasitaemia on day 1 and fever on day 2. All 16 (31.4%) patients with gametocyte carriage on day 0 had cleared by day 1. There were no serious adverse events. Conclusion: In this small study, pyronaridine-artesunate was efficacious and well-tolerated for the treatment of uncomplicated P. vivax malaria. In adults in the study setting, it would be a suitable alternative option for case management.

KW - Efficacy

KW - Ethiopia

KW - Plasmodium vivax

KW - Pyronaridine-artesunate

UR - https://www.scopus.com/pages/publications/85145420632

U2 - 10.1186/s12936-022-04422-0

DO - 10.1186/s12936-022-04422-0

M3 - Article

C2 - 36587210

AN - SCOPUS:85145420632

SN - 1475-2875

VL - 21

SP - 1

EP - 8

JO - Malaria Journal

JF - Malaria Journal

IS - 1

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ER -