Efficacy and safety of dihydroartemisinin–piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial
Abstract Background HIV-infected individuals on antiretroviral therapy (ART) require treatment with artemisinin-based combination therapy (ACT) when infected with malaria. Dihydroartemisinin–piperaquine (DPQ) is recommended for treatment of Plasmodium falciparum malaria, but its efficacy and safety...
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ftdoajarticles:oai:doaj.org/article:23a8bbacffde49498ffd22892dd5e4cd 2023-05-15T15:17:42+02:00 Efficacy and safety of dihydroartemisinin–piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial Esperança Sevene Clifford G. Banda Mavuto Mukaka Sonia Maculuve Salésio Macuacua Anifa Vala Mireia Piqueras Linda Kalilani-Phiri Jane Mallewa Dianne J. Terlouw Saye H. Khoo David G. Lalloo Victor Mwapasa 2019-08-01T00:00:00Z https://doi.org/10.1186/s12936-019-2909-5 https://doaj.org/article/23a8bbacffde49498ffd22892dd5e4cd EN eng BMC http://link.springer.com/article/10.1186/s12936-019-2909-5 https://doaj.org/toc/1475-2875 doi:10.1186/s12936-019-2909-5 1475-2875 https://doaj.org/article/23a8bbacffde49498ffd22892dd5e4cd Malaria Journal, Vol 18, Iss 1, Pp 1-13 (2019) Human immunodeficiency virus Antiretroviral drugs Dihydroartemisinin–piperaquine Malaria Drug–drug interactions Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 article 2019 ftdoajarticles https://doi.org/10.1186/s12936-019-2909-5 2022-12-31T05:05:05Z Abstract Background HIV-infected individuals on antiretroviral therapy (ART) require treatment with artemisinin-based combination therapy (ACT) when infected with malaria. Dihydroartemisinin–piperaquine (DPQ) is recommended for treatment of Plasmodium falciparum malaria, but its efficacy and safety has not been evaluated in HIV-infected individuals on ART, among whom drug–drug interactions are expected. Day-42 adequate clinical and parasitological response (ACPR) and incidence of adverse events were assessed in HIV-infected individuals on non-nucleoside reverse transcriptase inhibitor-based ART (efavirenz and nevirapine) with uncomplicated P. falciparum malaria treated with dihydroartemisinin–piperaquine. Methods An open label single arm clinical trial was conducted in Malawi (Blantyre and Chikhwawa districts) and Mozambique (Manhiça district) involving patients aged 15–65 years with uncomplicated P. falciparum malaria who were on efavirenz-based or nevirapine-based ART. They received a directly-observed 3-day standard treatment of DPQ and were followed up until day 63 for malaria infection and adverse events. Day-42 PCR-corrected-ACPRs (95% confidence interval [CI]) were calculated for the intention-to-treat (ITT) population. Results The study enrolled 160 and 61 patients on efavirenz and nevirapine-based ART, with a baseline geometric mean (95% CI) parasite density of 2681 (1964–3661) and 9819 (6606–14,593) parasites/µL, respectively. The day-42 PCR-corrected ACPR (95% CI) was 99.4% (95.6–99.9%) in the efavirenz group and 100% in the nevirapine group. Serious adverse events occurred in 5.0% (8/160) and 3.3% (2/61) of the participants in the efavirenz and nevirapine group, respectively, but none were definitively attributable to DPQ. Cases of prolonged QT interval (> 60 ms from baseline) occurred in 31.2% (48/154) and 13.3% (8/60) of the patients on the efavirenz and nevirapine ART groups, respectively. These were not clinically significant and resolved spontaneously over time. As this study was not designed ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic Malaria Journal 18 1 |
institution |
Open Polar |
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Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
topic |
Human immunodeficiency virus Antiretroviral drugs Dihydroartemisinin–piperaquine Malaria Drug–drug interactions Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
spellingShingle |
Human immunodeficiency virus Antiretroviral drugs Dihydroartemisinin–piperaquine Malaria Drug–drug interactions Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 Esperança Sevene Clifford G. Banda Mavuto Mukaka Sonia Maculuve Salésio Macuacua Anifa Vala Mireia Piqueras Linda Kalilani-Phiri Jane Mallewa Dianne J. Terlouw Saye H. Khoo David G. Lalloo Victor Mwapasa Efficacy and safety of dihydroartemisinin–piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial |
topic_facet |
Human immunodeficiency virus Antiretroviral drugs Dihydroartemisinin–piperaquine Malaria Drug–drug interactions Arctic medicine. Tropical medicine RC955-962 Infectious and parasitic diseases RC109-216 |
description |
Abstract Background HIV-infected individuals on antiretroviral therapy (ART) require treatment with artemisinin-based combination therapy (ACT) when infected with malaria. Dihydroartemisinin–piperaquine (DPQ) is recommended for treatment of Plasmodium falciparum malaria, but its efficacy and safety has not been evaluated in HIV-infected individuals on ART, among whom drug–drug interactions are expected. Day-42 adequate clinical and parasitological response (ACPR) and incidence of adverse events were assessed in HIV-infected individuals on non-nucleoside reverse transcriptase inhibitor-based ART (efavirenz and nevirapine) with uncomplicated P. falciparum malaria treated with dihydroartemisinin–piperaquine. Methods An open label single arm clinical trial was conducted in Malawi (Blantyre and Chikhwawa districts) and Mozambique (Manhiça district) involving patients aged 15–65 years with uncomplicated P. falciparum malaria who were on efavirenz-based or nevirapine-based ART. They received a directly-observed 3-day standard treatment of DPQ and were followed up until day 63 for malaria infection and adverse events. Day-42 PCR-corrected-ACPRs (95% confidence interval [CI]) were calculated for the intention-to-treat (ITT) population. Results The study enrolled 160 and 61 patients on efavirenz and nevirapine-based ART, with a baseline geometric mean (95% CI) parasite density of 2681 (1964–3661) and 9819 (6606–14,593) parasites/µL, respectively. The day-42 PCR-corrected ACPR (95% CI) was 99.4% (95.6–99.9%) in the efavirenz group and 100% in the nevirapine group. Serious adverse events occurred in 5.0% (8/160) and 3.3% (2/61) of the participants in the efavirenz and nevirapine group, respectively, but none were definitively attributable to DPQ. Cases of prolonged QT interval (> 60 ms from baseline) occurred in 31.2% (48/154) and 13.3% (8/60) of the patients on the efavirenz and nevirapine ART groups, respectively. These were not clinically significant and resolved spontaneously over time. As this study was not designed ... |
format |
Article in Journal/Newspaper |
author |
Esperança Sevene Clifford G. Banda Mavuto Mukaka Sonia Maculuve Salésio Macuacua Anifa Vala Mireia Piqueras Linda Kalilani-Phiri Jane Mallewa Dianne J. Terlouw Saye H. Khoo David G. Lalloo Victor Mwapasa |
author_facet |
Esperança Sevene Clifford G. Banda Mavuto Mukaka Sonia Maculuve Salésio Macuacua Anifa Vala Mireia Piqueras Linda Kalilani-Phiri Jane Mallewa Dianne J. Terlouw Saye H. Khoo David G. Lalloo Victor Mwapasa |
author_sort |
Esperança Sevene |
title |
Efficacy and safety of dihydroartemisinin–piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial |
title_short |
Efficacy and safety of dihydroartemisinin–piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial |
title_full |
Efficacy and safety of dihydroartemisinin–piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial |
title_fullStr |
Efficacy and safety of dihydroartemisinin–piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial |
title_full_unstemmed |
Efficacy and safety of dihydroartemisinin–piperaquine for treatment of Plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in Malawi and Mozambique: an open label non-randomized interventional trial |
title_sort |
efficacy and safety of dihydroartemisinin–piperaquine for treatment of plasmodium falciparum uncomplicated malaria in adult patients on antiretroviral therapy in malawi and mozambique: an open label non-randomized interventional trial |
publisher |
BMC |
publishDate |
2019 |
url |
https://doi.org/10.1186/s12936-019-2909-5 https://doaj.org/article/23a8bbacffde49498ffd22892dd5e4cd |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
Malaria Journal, Vol 18, Iss 1, Pp 1-13 (2019) |
op_relation |
http://link.springer.com/article/10.1186/s12936-019-2909-5 https://doaj.org/toc/1475-2875 doi:10.1186/s12936-019-2909-5 1475-2875 https://doaj.org/article/23a8bbacffde49498ffd22892dd5e4cd |
op_doi |
https://doi.org/10.1186/s12936-019-2909-5 |
container_title |
Malaria Journal |
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18 |
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1 |
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1766347947679678464 |