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The MONET trial: Week 144 analysis of efficacy of darunavir/ritonavir monotherapy versus DRV/r + 2NRTIs, for patients with HIV RNA <50 copies/mL at baseline
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Reported by Jules Levin
6th IAS Conference on HIV Pathogenesis, Treatment and Prevention, Rome, Italy, July 2011
1. Jose R Arribas, Hospital la Paz, Madrid, Spain 2. Nathan Clumeck, CHU Saint-Pierre / Maladies Infectieuses, Brussels, Belgium 3. Mark Nelson, Chelsea and Westminster Hospital, London, UK 5. Andrew Hill, Pharmacology Research Laboratories, University of Liverpool, UK 6. Yvon van Delft, Janssen EMEA, Tilburg, Netherlands 7. Christiane Moecklinghoff, Janssen EMEA, Neuss, Germany
Conclusions
In this study for patients with HIV RNA <50 copies/mL at baseline, switching to DRV/r monotherapy showed non-inferior efficacy to DRV/r + 2NRTI in the switch included analysis, but not in the TLOVR switch equals failure analysis.
Background
In the MONET trial, DRV/r monotherapy showed non-inferior efficacy versus 2NRTI + DRV/r at the primary 48 week analysis. The trial was continued to Week 144 to assess durability of the results.
Methods
256 patients with HIV RNA <50 copies/mL on current HAART for at least 6 months switched to DRV/r 800/100 mg once daily, either as monotherapy (n=127) or with 2NRTIs (n=129).
Treatment failure was defined as two consecutive HIV RNA levels above 50 copies/mL (TLOVR.s ) by Week 144, or discontinuation of study drug
Results
Patients were 81% male, 91% Caucasian, and had median baseline CD4 count of 575 cells/uL. More patients in the DRV/r monotherapy arm had Hepatitis C co-infection at baseline than in the control arm (19% vs 12%).
By Week 144, HIV RNA <50 copies/mL (ITT, TLOVR, Switch=Failure) was 69% versus 75% in the DRV/r monotherapy and triple therapy arms (difference=-5.9%, 95% C.I.-16.9%, +5.1%).
By a switch included analysis, HIV RNA <50 copies/mL was 84% versus 83.5% (difference = +0.5%, 95% C.I.: -8.7%, +9.7%).
21 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 18/21 (86%) and 10/13 (77%) had HIV RNA <50 copies/mL at Week 144.
HIV RNA at baseline and Hepatitis C co-infection were significantly associated with transient viraemia during the trial (p<0.05 for each comparison).
Treatment arm was not associated with virological failure in any analysis.
Of 54 patients genotyped during the trial, one per arm showed a major IAS-USA PI mutation before Week 24.
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