# name
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

# metadata.dc.description.abstract[].value
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 efcacy 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%
confdence 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. Seri‑
ous 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 defnitively 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 signifcant and resolved spontaneously over time. As this study was not designed to com‑
pare the efcacy and safety of DPQ in the two ART groups, no formal statistical comparisons were made between the
two ART groups.
Conclusions: DPQ was highly efcacious and safe for the treatment of malaria in HIV-infected patients concurrently
taking efavirenz- or nevirapine-based ART, despite known pharmacokinetic interactions between dihydroartemisinin–
piperaquine and efavirenz- or nevirapine-based ART regimens

# metadata.dc.source[].value
Articles publicats en revistes (ISGlobal)

# metadata.dc.title[].value
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