Efficacy and safety of switching to raltegravir plus atazanavir dual therapy in pretreated HIV-1-infected patients over 144 weeks: a cohort study. (December 2014)

• Record Type: Journal Article
• Authors: Gantner, Pierre; Koeppel, Christine; Partisani, Marialuisa; Batard, Marie-Laure; Bernard-Henry, Claudine; Cheneau, Christine; De Mautort, Erik; Priester, Michele; Muret, Patrice; Sueur, Charlotte; Fafi-Kremer, Samira; Rey, David
• Is Part Of: Scandinavian journal of infectious diseases. Volume 46:Number 12(2014:Dec.)
• Page Start: 838
• Page End: 845
• Publication Date: 2014-12
• Subjects: Communicable diseases -- Periodicals; Infection -- Periodicals; 616.9
• DOI: 10.3109/00365548.2014.947318
• Languages: English
• ISSNs: 0036-5548

Abstract

<abstract> <title>Abstract</title> <p> <italic>Background:</italic> To decrease drug burden among HIV-1-positive adults, we need a new gold standard for antiretroviral therapy maintenance strategies. <italic>Methods:</italic> This retrospective study aimed to assess efficacy in maintenance strategy of atazanavir (ATV) and raltegravir (RAL) dual therapy. The proportion of patients with HIV-1 RNA < 40 copies/ml at specific time points was recorded. Immunological response, safety, and pharmacokinetics were assessed. <italic>Results:</italic> Overall, 39 patients were switched to a RAL/ATV (<italic>n</italic> = 32) or RAL/ATV plus ritonavir (<italic>n</italic> = 7) regimen. Almost all patients (95%) received RAL twice daily. Most patients (70%) received a 400 mg ATV dosing per day, once (26%) or twice daily (44%). The percentages of virological success at weeks 24, 48, 96, and 144 were 92% (95% confidence interval (CI), 83–10), 86% (95% CI, 74–98), 70% (95% CI, 52–88), and 63% (95% CI, 42–84), respectively. Overall, 12 (31%) patients stopped dual therapy: 7 patients because of adverse events, mostly clinical myositis (<italic>n</italic> = 3). Confirmed virological failure occurred in three patients; two of them developed RAL resistance patterns. A significant increase in the CD4+/CD8 + T-cell ratio was observed at week 48 (<italic>p</italic> < 0.005). Only grade 1–2 adverse events were observed. Trough plasma levels presented a wide variability. Suggested trough concentrations were achieved in 79% and 94% of patients for ATV and RAL, respectively. An unboosted 400 mg per day ATV dosing seemed to be appropriate, regarding the targeted levels achieved and the lack of grade 3 or 4 hyperbilirubinemia. <italic>Conclusions:</italic> We demonstrated, on a 3-year follow-up, the efficacy and safety of RAL plus ATV maintenance dual therapy.</p> </abstract>