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The MONET trial: darunavir/ritonavir monotherapy shows non-inferior efficacy to standard HAART, for patients with HIV RNA < 50 copies/mL at baseline
Presented by Jose Arribas (Spain).
J. Arribas1, A. Horban2, J. Gerstoft3, G. Fatkenheuer4, M. Nelson5, N. Clumeck6, F. Pulido7, A. Hill8, Y. Van Delft9, C. Moecklinghoff10, T. Stark10
1Hospital La Paz, Medicina Interna, Madrid, Spain, 2Centrum Diagnostyki i Terapii AIDS, SPZOZ Wojewodski Szpital, Warsaw, Poland, 3Rigshospitalet, Epidemiklinikken, Copenhagen, Denmark, 4Universitat Koln, Internal Medicine, Koln, Germany, 5St Stephens Research Centre, Chelsea and Westminster Hospital, London, United Kingdom, 6CHU Saint Pierre, Maladies Infectieuses, Brussels, Belgium, 7Hosp 12 de Octubre, Unidad VIH, Madrid, Spain, 8Liverpool University, Pharmacology Research Laboratories, Liverpool, United Kingdom, 9Janssen-Cilag, Clinical, Tilburg, Netherlands, 10Janssen-Cilag, Clinical EMEA, Neuss, Germany
Background: In virologically suppressed patients, switching to DRV/r monotherapy could prevent NRTI resistance and adverse events.
Methods: 256 patients with HIV RNA < 50 on current HAART for over 24 weeks (NNRTI based (43%), or PI based (57%)), switched to DRV/r 800/100 mg once daily, either as monotherapy (n=127) or with 2NRTI (n=129). Treatment failure was 2 consecutive HIV RNA levels above 50 copies/mL (TLOVR) by Week 48, or switches off study treatment. The trial had 80% power to show non-inferiority for the DRV/r arm (delta= -12%)
Results: Patients were 81% male and 91% Caucasian, with median age 43 years, and CD4 count of 575 cells/uL. Patients in the DRV/r arm had more ARV pre-treatment, and more Hepatitis C co-infection than in the control arm. In the primary efficacy analysis, HIV RNA < 50 copies/mL by Week 48 (Per Protocol) was 86.2% versus 87.8% in the DRV/r and control arms; by Intent to Treat switch equals failure, efficacy was 84.3% versus 85.3%; by a switch included analysis, efficacy was 93.5% versus 95.1%: all three comparisons showed non-inferior efficacy for DRV/r monotherapy. 11 patients had two HIV RNA results above 50 copies/mL in the DRV/r monotherapy arm, versus 7 in the control arm. Most virological endpoints were temporary elevations in HIV RNA to 50-400 copies/mL, linked with poor adherence or intercurrent infections. Two patients per arm had sustained elevations of HIV RNA above 400 copies/mL. CD4 counts remained stable during the trial in both arms. One patient per arm showed at least one PI mutation. Nine patients per arm discontinued randomised treatment for either adverse events or other reasons. No new or unexpected safety signals were detected.
Conclusions: In this study for patients with HIV RNA< 50 copies/mL on HAART at baseline, DRV/r monotherapy showed non-inferior efficacy versus 2NRTI + DRV/r.
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