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A prospective, randomized, open label trial of efavirenz versus lopinavir/ritonavir based HAART among antiretroviral therapy naïve, HIV-infected individuals presenting for care with CD4 cell counts <200/mm3 in Mexico
Presented by Juan Sierra Madero, Mexico.
J. Sierra Madero1, A. Villasis1, P. Mendez2, J.L. Mosqueda3, I. Torres4, F. Gutierrez5, I. Juarez6, M. Magaña7, C. Ramos8, L. Perez Saleme9, L.E. Soto Ramirez1, V. Dias Lima10, F. Belaunzaran1, J. Montaner10
1INCMNSZ, Infectious Diseases, Mexico, Mexico, 2HGZ #53, IMSS, Mexico, Mexico, 3Hospital General de Leon, Mexico, Mexico, 4Hospital General de Puebla, Puebla, Mexico, 5HGZ #72, IMSS, Mexico, Mexico, 6HGZ#25, IMSS, Mexico, Mexico, 7HGZ #1 IMSS, SLP, Mexico, Mexico, 8HGZ #29, IMSS,, Mexico, Mexico, 9Centro Médico Nacional Siglo XXI, IMSS, Mexico, Mexico, 10The BC-Centre for Excelence in HIV/AIDS, Division of AIDS, Vancouver, Canada
Background: Late presentation to care of HIV+ individuals is frequent, particularly in resource-limited settings. The relative efficacy of preferred PI or NNRTI first line HAART regimens has not been evaluated in this setting.
Objective: To compare the efficacy of efavirenz (EFV) vs lopinavir/ ritonavir (LPV/r) based HAART among ART naïve, HIV+ individuals presenting for care with CD4 cell counts <200/mm3 in Mexico.
Methods: This is a prospective, randomized, open label, multi-center trial comparing EFV vs LPV/r plus AZT and 3TC (FDC) in HIV+ ART naïve individuals with CD4<200/mm3. The primary endpoint was the percentage of patients with plasma HIV-1-RNA (pVL) <50 copies/mL at 48 weeks (ITT analysis). Secondary endpoints included: the percentage of patients with <400 copies/mL at 48 weeks (ITT), and CD4 count change by treatment group. We also evaluated the percentage of patients with pVL <50 and <400 copies/mL using OT analyses.
Results: 189 patients (85% male) were randomized: 95 to EFV and 94 to LPV/r. Median baseline CD4 was 64 and 52 cells/mm3 respectively (p=NS). By ITT analysis, the proportion of patients with pVL <50 copies/mL at week 48 was 70% with EFV and 54% with LPV/r (p=0.0141). The ITT proportion of patients with pVL <400 copies/ml at week 48 was 73% with EFV and 65% with LPV/r (p=0.25). Mean CD4 cell count increase at 48 weeks was 156.9 in EFV and 166.9 in LPV/r.Premature discontinuation occurred in 27% and 34% in EFV and LPV/r (virological failure: 7 and 16, lost to follow-up:14 and 6, AE and death: 5 and 10). OT and ITT results were consistent overall. Mean change in Cholesterol and triglyceride levels were 53 and 84 mg/dl in EFV and 62.5 and 168.5 mg/dl in LPV/r (p=0.24 and p=0.0036).
Conclusions: In these very advanced HIV infected ARV naïve subjects EFV had superior virological efficacy than LPV/r.
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