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The design of this study was an open label study in HIV-infected adult patients who received the co-formulated antimalarial artemether/lumefantrine (80/480mg) twice daily for three days while on steady state nevirapine ART for 3.5 years. This pharmacokinetic (PK) study was done to assess whether there was pertinent drug-drug interactions between the therapeutic regimens. PK sampling was performed at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 and 96 hours following the last dose of artemether/lumefantrine. (n=11) HIV infected subjects aged (31-59) years underwent pharmacokinetic sampling, results were compared to (n=16) HIV-uninfected controls not on ART. Geometric least squares ratios and 90% confidence intervals were estimated.
Based on GMRs and 90% confidence intervals, exposure to artemether as estimated by AUC decreased by 65% in patients that concomitantly received nevirapine-based ART when compared to controls. Exposure to lumefantrine was 60% lower in those on nevirapine ART as compared to controls.
Per the authors, exposure to both artemether and lumefantrine are significantly reduced in HIV infected, malaria-uninfected adults receiving nevirapine based ART. The potential for suboptimal antimalarial response due to inadequate artemether/lumefantrine exposure warrants evaluation when these agents are used concomitantly.
Parikh S, Fehintola F, Huang L. Artemether-lumefantrine exposure in hiv-infected nigerian subjects on nevirapine-containing antiretroviral therapy. Antimicrobial Agents And Chemotherapy . 2015; 12: 7852-7856.