The Merits of Monotherapy For HIV - Key Study Results in PI Monotherapy, Dr Jose R Arribas

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The Merits of Monotherapy For HIV - Key Study Results in PI Monotherapy, Dr Jose R Arribas, Research Director HIV unit of La Paz Hospital Madrid, Spain

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  • 1. Key Study Results in PI Monotherapy Dr. Jose R Arribas HIV UNIT

2. clinicaloptions.com/hiv Disclosures ! Advisory fees, speaker fees and grant support: Tibotec, Janssen, Abbott, BMS, Gilead, MSD, ViiV 3. clinicaloptions.com/hiv 4. OK04 trial design Arribas JR. et al., JAIDS 2009 OK04 5. * Patients in the monotherapy arm who reached and maintained < 50 c/mL after resuming baseline nucleosides are considered as failures (n = 10) P=0.865; Log rank Time to HIV-1 RNA > 50 copies/mL (ITT M = F, Reinduction = F)* % 77% 77.6% Arribas JR. et al., JAIDS 2009 OK04 0 10 20 30 40 50 60 70 80 90 100 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 Weeks after randomization OK (n = 100) Triple (n = 98) 6. Proportion without therapeutic failure at Week 96* * Patients in the monotherapy arm who reached and maintained < 50 c/mL after resuming baseline nucleosides are not considered as failures (n = 10) - 9%; upper-limit 95%CI: 1.2%. Arribas JR. et al., JAIDS 2009 OK04 87 78 0 10 20 30 40 50 60 70 80 90 100 96 weeks Percentwithoutfailure OK Triple 7. *All patients with HIV-1 RNA > 500 copies/mL analyzed (blips > 500 copies/mL included) Genotypic testing through Week 96 8. Taking 2 NRTI + either NNRTI or boosted PI at screening (stratified) No prior use of darunavir (DRV) HIV RNA 50 copies/mL (Roche Amplicor HIV-1 Monitor assay 1.5) Stopping DRV/r Starting NRTIs in the monotherapy arm Stopping NRTIs in the triple therapy arm (switches in NRTIs were permitted at any time). Follow-up phase 96 weeks 256 subjects DRV/r 800/100 mg OD + 2 NRTI (re-optimised at baseline) n = 129 DRV/r 800/100 mg OD n = 127 Follow-up phase 96 weeks No run-in period SC J. Arribas et al, IAS Conference, Cape Town, SA, 21 July 2009, TUAB106-LB 30 days BL 9. MONET: Baseline Characteristics (ITT) 579 12% 6.4 (4.0) 57% 43% 48% 28% 0 15 (12%) 12 (9%) 571 14% 7.4 (4.2) 56% 44% 35% 23% 0 24 (19%) 20 (16%) Disease characteristics CD4 count (median (range), cells/uL) CD4 50 copies/mL at two visits, this is a failure, even if the HIV RNA is then suppressed