Abstract PE7/1
 
Safety and Efficacy of Switching to Dual Therapy (Atazanavir/Ritonavir+Lamivudine) vs. Triple Therapy (Atazanavir/Ritonavir+Two Nucleos(t)ides) in Patients on Virologically Stable Antiretroviral Therapy: 24-week Interim Analysis from a Randomized Clinical Trial (SALT Study) Print
 
J.A. Perez-Molina1, A. Rivero2, J. Pasquau3, R. Rubio4, M. Estébanez5, J. Sanz6, J. Santos7, J. Pedreira8, A. Mariño9, J. Navarro10, A. Antela11, J.A. Iribarren12, M. Ramírez13, and GESIDA 7011 Study Group
1Hospital Universitario Ramon y Cajal-IRYCIS, Infectious Diseases, Madrid, Spain, 2Hospital Universitario Reina Sofía, Córdoba, Spain, 3Hospital Universitario Virgen de las Nieves, Granada, Spain, 4Hospital Universitario 12 de Octubre, Madrid, Spain, 5Hospital Universitario La Paz, Madrid, Spain, 6Hospital Universitario Príncipe de Asturias, Alcalá de Henares, Spain, 7Hospital Universitario Virgen de la Victoria, Málaga, Spain, 8Complejo Hospitalario Universitario A Coruña, A Coruña, Spain, 9Hospital Arquitecto Marcide, Ferrol, Spain, 10Hospital Universitario Vall D’Hebrón, Barcelona, Spain, 11Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain, 12Hospital de Donostia, San Sebastián, Spain, 13Fundación SEIMC-GESIDA, Madrid, Spain
 
Objective: SALT is a 96-week, multicentre, open-label clinical trial that compares ATV/r+3TC with ATV/r+2NUC(t)s in HIV-positive patients on a stable 3-drug regimen who switch therapy because of toxicity, intolerance, or simplification.
Methods: The inclusion criteria were no previous treatment failure or resistance mutations to the study medications, HIV-RNA < 50 copies/mL for ≥6 months, and HBsAg-negative status. Treatment was assigned according to HCV status and “third drug” (PI/r, NNRTI, CCR5 antagonist, or integrase inhibitor). Patients were randomly switched to ATV/r+3TC or ATV/r plus 2NUC(t)s selected at the discretion of the investigator. A pre-planned interim analysis was performed for safety purposes when a third of the patients reached 24 weeks of follow-up. If the 99.95% confidence interval of the difference in efficacy between study arms in the per-protocol population (randomized patients with no major protocol violations) indicated inferiority of the ATV/r+3TC arm, the trial was to be interrupted.
Results: The study population comprised 131 patients. At week 24 there were no virological failures (confirmed as HIV RNA >50 copies/mL).
 ATV/r+3TC (n=64)ATV/r+2NUC(t)s (n=67)
Median age (IQR)/ Female / HCV-RNA+44 (37-50); 26.6%; 17.2%42 (33-47); 22.4%; 17.9%
Reason for switching: Intolerance/Toxicity/Simplification1.6%; 20.3%; 78.1%1.5%; 13.4%; 85.1%
Median years of HIV infection (IQR)4.6 (2.9-8.3)4.1 (2.4-7.9)
Median nadir/baseline CD4 cell/µL (IQR)218 (69-310)/579 (404-702)227 (145-334)/578 (425-796)
Median months of viral load <50 copies/mL (IQR)24.5 (16.3-39.4)27.0 (15-46)
Switched treatment including NNRTI/PIr/TDF32.8%; 62.5%; 85.9%32.8%; 65.7%; 82.1%
Discontinued therapy at 24 weeks (n)85
Informed consent withdrawn62
Toxicity/virological failure/other1/0/13/0/0
[Baseline characteristics]

Toxicity leading to interruption of treatment was secondary to grade 3-4 hyperbilirubinemia with/without jaundice. The 3 severe adverse events recorded—acute pyelonephritis and traumatic bone fracture (ATV/r+3TC) and toxicity due to drugs of abuse (ATV/r+2NUC(t)s)—were not related to the study medications. Treatment efficacy (missing/discontinuation/treatment change=failure) was as follows: ATV/r+3TC 87.5% (56/64) vs. ATV/r+2NUC(t)s 92.5% (62/67) (difference -5%; 99.95% CI, -26.3% to 15.5%). Average change in CD4 cells/µL from baseline was +57 and -27 cells/µL for ATV/r+3TC and ATV/r+2NUC(t)s, respectively (difference, 84 cells/µL; 95%CI, 19-149).
Conclusions: Dual therapy with ATV/r+3TC seems to be as safe and effective in the short term as switching therapy in virologically controlled patients requiring a change in treatment as a result of simplification, intolerance, or toxicity.


Assigned speakers:
Jose A Perez-Molina , Hospital Universitario Ramon y Cajal-IRYCIS , Madrid , Spain

Assigned in sessions:
17.10.2013, 12:00-14:00, Poster Session, Poster Session 1, Exhibition
18.10.2013, 12:00-14:00, Poster Session, Poster Session 2, Exhibition