41598
document
Long-term ( 96-week ) follow-up of antiretroviral-naïve HIV-infected patients treated with first-line lopinavir/ritonavir monotherapy in the MONARK trial . BACKGROUND The toxicities , cost and complexity of triple combinations warrant the search for other treatment options , such as boosted protease inhibitor ( PI ) monotherapy . MONotherapy AntiRetroviral Kaletra ( MONARK ) is the first randomized trial comparing lopinavir/ritonavir monotherapy to triple combination therapy with zidovudine/lamivudine and lopinavir/ritonavir in antiretroviral-naïve patients . METHODS A total of 136 antiretroviral-naïve patients , with a CD4 cell count above 100 cells/microL and a plasma HIV RNA below 100,000 HIV-1 RNA copies/mL , were randomized and dosed with either lopinavir/ritonavir monotherapy ( n = 83 ) or lopinavir/ritonavir + zidovudine/lamivudine ( n = 53 ) . We focus here on patients in the lopinavir/ritonavir monotherapy arm followed to week 96 . The intent-to-treat ( ITT ) analysis initially involved all patients randomized to lopinavir/ritonavir monotherapy ( n = 83 ) , and then focused on patients who had an HIV RNA < 50 copies/mL at week 48 ( n = 56 ) . RESULTS At week 96 , 39 of 83 patients ( 47 % ) had HIV RNA < 50 copies/mL , five of 83 had HIV RNA between 50 and 400 copies/mL , and three of 83 had HIV RNA > 400 copies/mL . Focusing on the 56 patients with an HIV RNA < 50 copies/mL at week 48 , 38 of 56 patients ( 68 % ) had a sustained HIV RNA < 50 copies/mL to week 96 . To week 96 , a total of 28 patients ( 34 % ) had discontinued the study treatment . In addition , the allocated treatment was changed for seven patients . PI-associated resistance mutations were evident in five of 83 patients in the monotherapy arm from baseline to week 96 . CONCLUSION By ITT analysis , 39 of the 83 patients initially randomized to lopinavir/ritonavir monotherapy had HIV RNA < 50 copies/mL at week 96 . The occurrence in some patients of low-level viraemia ( 50-500 copies/mL ) may increase the risk of drug resistance . First-line lopinavir/ritonavir monotherapy can not be systematically recommended .
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Intervention_Pharmacological
monotherapy
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Intervention_Pharmacological
either lopinavir/ritonavir monotherapy
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Intervention_Pharmacological
or lopinavir/ritonavir + zidovudine/lamivudine
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Outcome_Physical
HIV RNA
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Outcome_Physical
HIV RNA
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Outcome_Other
patients
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Participant_Condition
HIV-infected