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Abstract
Lopinavir/ritonavir as single-drug maintenance therapy in patients with HIV-1 viral suppression: Forty eight week results of a randomized, controlled, open label, clinical trial (OK04 Study)
J. Arribas1, F. Pulido2, R. Delgado3, E. Cabrero4, C. Cepeda2, J. Gonzalez-García1, M.J. Pérez-Elias5, A. Arranz6, J. Portilla7, J. Pasquau8, J.A. Iribarren9, R. Rubio2, A. Ocampo10, P. Miralles11, H. Knobel12, F. Gaya13, R. Muñoz1, M. Norton14, OK04 Study Group
1Hospital La Paz, HIV Unit, Madrid, Spain, 2Hospital Doce de Octubre, HIV Unit, Madrid, Spain, 3Hospital Doce de Octubre, Laboratory of Molecular Microbiology, Madrid, Spain, 4Abbott, Virology. Medical Dpt., Madrid, Spain, 5Hospital Ramón y Cajal, HIV Unit, Madrid, Spain, 6Hospital Príncipe de Asturias, HIV Unit, Alcalá de Henares, Spain, 7Hospital General de Alicante, HIV Unit, Alicante, Spain, 8Hospital Virgen de las Nieves, HIV Unit, Granada, Spain, 9Hospital de Donostia, HIV Unit, San Sebastián, Spain, 10Hospital Xeral Cies, HIV Unit, Vigo, Spain, 11Hospital Gregorio Marañón, HIV Unit, Madrid, Spain, 12Hospital del Mar, HIV Unit, Barcelona, Spain, 13Hospital La Paz, Investigation Unit, Madrid, Spain, 14Abbott, Antivirals. GPRD, Abbot Park. IL, United States
Background: In patients with suppressed HIV replication on lopinavir/ritonavir (LPV/r) and two nucleosides, this study compared continuation of triple therapy (T) vs. LPV/r monotherapy (MT) followed by reinduction with two nucleosides if virological rebound occurred [without major protease inhibitor (PI) mutations] .
Methods: Patients were eligible for this non-inferiority trial (upper limit of 95% CI for T-MT <12%) if they had no history of virological failure while receiving a PI and were receiving 2 nucleosides + LPV/r with serum HIV RNA <50 c/mL for >6 months. Primary endpoint was percent of patients without therapeutic failure, defined as confirmed HIV RNA >500 c/mL with exclusion of MT patients who re-suppressed to <50 c/mL after resuming baseline nucleosides, or loss to follow-up, or change of randomized therapy other than reinduction.
Results: 198 patients were randomised to the MT (n=100) or T (n=98) arms. Baseline characteristics were similar in both arms. After 48 weeks, percentage of patients without therapeutic failure: 94% (MT) vs 90% (T) (T-MT= - 4%; upper limit 95%CI: 3.4%). Percentage of patients with HIV RNA <50/500 c/mL at 48 weeks (ITT, M = F, Reinduction = F): 85/89% (MT) vs 90/90% (T) (p=0.4/0.99). Therapeutic failures: 6/100 in MT (3 lost to follow-up, 2 confirmed rebound with PI resistance, 1 treatment change) and 10/98 in T [4 lost to follow up, 3 confirmed rebound (2 without and 1 with PI resistance), 3 adverse events]. 4 patients with confirmed rebound after MT were reinduced and remain with HIV RNA <50 c/mL.
Conclusions: In this trial, 48 weeks of LPV/r MT was non-inferior to continuation of T in patients with prior stable suppression. The majority of MT patients maintained HIV RNA < 50 c/ml without reinduction.
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