Simplification to Abacavir/Lamivudine + Atazanavir Maintains Viral Suppression and Improves Bone and Renal Biomarkers in ASSURE, a Randomized, Open Label, Non-Inferiority Trial: e96187

• Published in: PloS one 2014-05, Vol.9 (5)
• Main Authors: Wohl, David A, Bhatti, Laveeza, Small, Catherine B, Edelstein, Howard, Zhao, Henry H, Margolis, David A, DeJesus, Edwin, Weinberg, Winkler G, Ross, Lisa L, Shaefer, Mark S
• Format: Article
• Language: English
• Subjects: Human immunodeficiency virus 1
• ISSN: 1932-6203
• DOI: 10.1371/journal.pone.0096187

Objective Simplification of antiretroviral therapy in patients with suppressed viremia may minimize long-term adverse effects. The study's primary objective was to determine whether abacavir/lamivudine + atazanavir (ABC/3TC+ATV) was virologically non-inferior to tenofovir/emtricitabine + atazanavir/ritonavir (TDF/FTC+ATV/r) over 24 weeks in a population of virologically suppressed, HIV-1 infected patients. Design This open-label, multicenter, non-inferiority study enrolled antiretroviral experienced, HIV-infected adults currently receiving a regimen of TDF/FTC+ATV/r for greater than or equal to 6 months with no history of virologic failure and whose HIV-1 RNA had been less than or equal to 75 copies/mL on 2 consecutive measurements including screening. Patients were randomized 1:2 to continue current treatment or simplify to ABC/3TC+ATV. Methods The primary endpoint was the proportion of patients with HIV-RNA