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The MONET trial: week 144 analysis of the efficacy of darunavir/ritonavir ( DRV/r ) monotherapy versus DRV/r plus two nucleoside reverse transcriptase inhibitors, for patients with viral load < 50 HIV ‐1 RNA copies/ mL at baseline
Author(s) -
Arribas JR,
Clumeck N,
Nelson M,
Hill A,
Delft Y,
Moecklinghoff C
Publication year - 2012
Publication title -
hiv medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.53
H-Index - 79
eISSN - 1468-1293
pISSN - 1464-2662
DOI - 10.1111/j.1468-1293.2012.00989.x
Subject(s) - darunavir , medicine , discontinuation , ritonavir , viral load , confidence interval , gastroenterology , nucleoside reverse transcriptase inhibitor , randomized controlled trial , human immunodeficiency virus (hiv) , antiretroviral therapy , virology
Background In the MONotherapy in Europe with Tmc114 (MONET) trial, darunavir/ritonavir ( DRV/r ) monotherapy showed noninferior efficacy vs. two nucleoside reverse transcriptase inhibitors ( NRTI s) plus DRV/r at the primary 48‐week analysis. The trial was continued to week 144 to assess the durability of the results. Methods A total of 256 patients with viral load < 50 HIV ‐1 RNA copies/ mL on current highly active antiretroviral therapy ( HAART ) for at least 6 months switched to DRV/r 800/100 mg once daily, either as monotherapy ( n = 127) or with two NRTI s ( n = 129). Treatment failure was defined as two consecutive HIV RNA levels above 50 copies/ mL [time to loss of virological response ( TLOVR )] by week 144, or discontinuation of study drugs. Results Eighty‐one per cent of patients were male and 91% were Caucasian, and they had a median baseline CD4 count of 575 cells/ uL . More patients in the DRV/r monotherapy arm had hepatitis C virus coinfection at baseline than in the control arm (18% vs. 12%, respectively). By week 144, the percentage of patients with HIV RNA < 50 copies/ mL [intent to treat ( ITT ), TLOVR , switch = failure method] was 69% vs. 75% in the DRV/r monotherapy and triple therapy arms [difference = −5.9%; 95% confidence interval ( CI ) −16.9%, +5.1%]; by a strict ITT analysis (switches not considered failures), the percentage of patients with HIV RNA < 50 copies/ mL was 84% vs. 83.5%, respectively (difference = +0.5%; 95% CI −8.7%, +9.7%). Twenty‐one and 13 patients had two consecutive HIV RNA results above 50 copies/ mL in the DRV/r monotherapy arm and triple therapy arm, respectively, of whom 18 of 21 (86%) and 10 of 13 (77%) had HIV RNA < 50 copies/ mL at week 144. Conclusions In this study, for patients with HIV RNA < 50 copies/ mL at baseline, switching to DRV/r monotherapy showed noninferior efficacy to DRV/r plus two NRTIs in a strict ITT (switches not considered failures) analysis, but not in a TLOVR switch equals failure analysis.