20th International AIDS Conference - Melbourne, Australia

Abstract

LBPE18 - Poster Exhibition


Switching to dual therapy (atazanavir/ritonavir+lamivudine) vs. standard triple therapy (atazanavir/ritonavir+2 nucleos[t]ides) is safe and effective in virologically suppressed patients: 48-week results of a randomized clinical trial (SALT study)

J.A. Perez-Molina1, R. Rubio2, A. Rivero3, J. Pasquau4, I. Suárez5, M. Riera6, M. Estébanez7, J. Santos8, J. Sanz9, J. Troya10, A. Mariño11, A. Antela12, J. Navarro13, H. Esteban14, GESIDA 7011 Study Group

1Hospital Ramón y Cajal, Infectious Diseases Department, Madrid, Spain, 2Hospital Doce de Octubre, Madrid, Spain, 3Hospital Reina Sofia, Córdoba, Spain, 4Hospital Virgen de las Nieves, Granada, Spain, 5Hospital Infanta Elena, Huelva, Spain, 6Hospital Son Espases, Mallorca, Spain, 7Hospital La Paz, Madrid, Spain, 8Hospital Virgen de la Victoria, Málaga, Spain, 9Hospital Príncipe de Asturias, Alcalá de Henares, Spain, 10Hospital Infanta Leonor, Madrid, Spain, 11Hospital Arquitecto Marcide, Ferrol, Spain, 12Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain, 13Hospital de Vall d'Hebrón, Barcelona, Spain, 14Fundación SEIMC-GESIDA, Madrid, Spain

Background: Triple therapy is effective for controlling HIV infection, although it is expensive and can induce toxicity. We performed a multicentre, open-label, non-inferiority trial to determine whether 3TC+ATV/r is non-inferior to 2NRTI+ATV/r in HIV+ patients on a 3-drug regimen who switch therapy because of toxicity, intolerance, or simplification.
Methods: Inclusion criteria: no previous treatment failure or resistance mutations to the study medications, HIV-RNA < 50cop/mL for ≥6 months, and HBsAg-negative status. The investigator selected the control arm nucleosides. The primary endpoint was virological response (HIV-RNA < 50cop/mL, TLOVR). ATV/r+3TC was considered non-inferior to ATV/r+2NRTIs if the lower limit of the 95%CI for the difference between groups was ≥-12% (per-protocol population). Change in neurocognitive function (5 domains) was compared (by change in GDS).
Results: The sample comprised 286 patients (273 per-protocol). The control arm nucleos(t)ides were TDF+FTC (75.6%), ABC+3TC (23.7%), and ZDV+3TC (0.7%).

 ATV/r+3TC (n=143)ATV/r+2NUC(t)s (n=143)
Median (IQR) age, years/female45.5 (38-52)/31%45 (36-48)/22.4%
Reason for switching: intolerance/toxicity/simplification/other2.8%/22.7%/73.8%/0.7%4.3%/14.2%/80.1%/1.4%
Median (IQR) nadir/baseline CD4 cell/µL204 (90-309)/579 (397-770)222 (139-323)/617 (441-801)
Median (IQR) months of viral load <50 copies/mL27.0 (16-49)28.5 (15-58.5)
Switched treatment including NNRTI/PIr/TDF31.5%/61.5%/81.1%30.1%/64.3%/78.3%
[Baseline characteristics]

At week 48, 83.6% had HIV-RNA < 50cop/mL in the ATV/r+3TC arm vs. 78.4% in the ATV/r+2NRTIs arm (difference, 5.2%; 95%CI, -4.8% to 15.2%). The number of patients was similar in both groups for virologic failure (confirmed HIV-RNA >50cop/mL: 5 vs. 4), death (1 vs. 0), discontinuation because of ART-related toxicity (2 vs. 7), study withdrawal (7 vs. 9), and loss to follow-up (4 vs. 4). Only 1 patient (ATV/r+2NRTIs) developed resistance mutations (M184V). Values were also similar in both groups for number of blips (19 vs. 23), mean change in CD4/µL (9.9 vs. -9.2), grade III-IV adverse events (54.3% vs. 55.3%), change in GDS (-0.259 [95CI: -0.4 to -0.07] vs. -0.082 [-0.2 to 0.07]), renal function, bone density, and fat gain/distribution. Changes in lipid values were related to previous TDF and/or PI use.
Conclusions: Switching to ATV/r+3TC is effective, safe, and non-inferior to ATV+2NRTIs in virologically suppressed HIV+ patients.

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