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Prospective comparison of nevirapine and atazanavir/ritonavir both combined with tenofovir DF/emtricitabine in treatment-naïve HIV-1 infected patients: ARTEN study week 48 results
V. Soriano1, S. Köppe2, H. Mingrone3, T. Lutz4, M. Opravil5, J. Andrade-Villanueva6, F. Antunes7, G. Di Perri8, D. Podzamczer9, S. Taylor10, A. Horban11, D. Duiculescu12, L. de Rossi13
1Hospital Carlos III, Dept of Infectious Diseases, Madrid, Spain, 2EPIMED GmbH, Berlin, Germany, 3Ciudad de Buenos Aires, Infectología de Asistencia Ambulatoria, Buenos Aires, Argentina, 4Infektiologicum Frankfurt, Frankfurt, Germany, 5University Hospital Zürich, Division of Infectious Diseases, Zürich, Switzerland, 6Antiguo Hospital Civil de Guadalajara, Guadalajara, Mexico, 7Hospital de Santa Maria, Serviço de Doenças Infecciosas, Lisbon, Portugal, 8University of Turin, Department of Infectious Disease, Turin, Italy, 9Hospital Universitario de Bellvitge, Infectious Disease Service, Barcelona, Spain, 10Birmingham Heartlands Hospital, Department of Sexual Medicine, Birmingham, United Kingdom, 11Hospital for Infectious Diseases, AIDS Diagnosis and Therapy Centre, Warsaw, Poland, 12Hospital for Tropical and Infectious Diseases, Bucharest, Romania, 13Boehringer Ingelheim Pharma GmbH & Co KG, Clinical Research Department Virology, Biberach, Germany
Background: Nevirapine (NVP) and atazanavir/ritonavir (ATZ/r) are effective antiretrovirals (ARVs) with favourable lipid profiles. The ARTEN study compares efficacy and safety of both ARVs combined with tenofovir DF and emtricitabine (TDF/FTC).
Methods: ARTEN is an international, non-inferiority (12% margin), randomised study comparing ATZ/r 300mg/100mg QD vs. NVP 200mg BID or 400mg QD, each combined with fixed-dose TDF 300mg/FTC 200mg QD. Treatment-naïve men and women with CD4 counts < 400 and < 250 cells/mm3, respectively, were eligible. Primary end-point was treatment response (TR), defined as plasma HIV-RNA < 50 copies/mL at two consecutive visits (i.e. weeks 24 and 36) and without subsequent rebound or change of ARVs prior to wk-48.
Results: 569 patients were randomised and treated. Baseline demographics and HIV-related characteristics were similar between groups. Mean HIV-RNA was 5.1 log10 copies/mL (64% >100,000 copies/mL); mean CD4 count was 183 cells/mL.
| Parameter | NVP (N=376) (188 BID + 188 QD) | ATZ/r
(N=193) | Comparison
NVP-ATZ/r
(95% CI) | | % TR (Primary end-point) | 66.8 | 64.8 | 2.5 (-5.4 to 10.4) | | % TR (TLOVR algorithm)* | 70.2 | 73.6 | -2.9 (-10.4 to 4.5) | | TC/HDL-ratio mean change from baseline | -0.23 | +0.13 | p=0.0001 | | HDL mean change from baseline (mg/dL) | 9.6 | 4.0 | p<0.0001 | | TG mean change from baseline (mg/dL) | +1.4 | +26.5 | p=0.0001 | | % Overall AEs (DAIDS grades 3 and 4) | 85.6 (12.0 and 5.1) | 86.5 (16.1 and 3.1) | n/a | | % Rash, all Grades (discontinued) | 16.0 (5.6) | 12.4 (0) | n/a | | % Discontinuations due to AEs | 12.5 | 3.6 | n/a |
* HIV-RNA < 50 copies/mL at wks-36 and 48 without subsequent rebound or change of ARVs
Conclusions: NVP shows non-inferior efficacy at wk-48 versus ATZ/r (both combined with fixed-dose TDF/FTC). Despite similar rates of AEs, discontinuations were more frequent in NVP than in ATZ/r patients. NVP demonstrated a more favourable lipid profile than ATZ/r.
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