Switching to dual therapy after 24 weeks of the triple therapy of HIV infection: efficacy and safety

• Elena I. Veselova
• Grigory A. Kaminskiy
• Eduard V. Karamov
• Dmitry A. Kudlay
• Elena A. Orlova-Morozova
• Olga V. Lovacheva
• Anastasia G. Samoilova

Abstract

The use of antiretroviral therapy (ART) can lead to the development of cumulative adverse events on the part of various organs and systems. The potential drawbacks of the three-drug ART regimen (triple therapy) served as an incentive for the study of new two-drug ART regimens (dual therapy).

The aim of the study was to determine the efficacy and safety of HIV infection treatment during switching from triple to dual therapy.

Material and methods. Naive HIV patients had no clinical manifestations of the disease (n=141) were divided into two groups. Group 1 (n=73) received triple therapy (dolutegravir, emtricitabine, tenofovir) during the first 24 weeks, then patients with an undetectable viral load and CD4-T-lymphocyte count of more than 350 cells/ml were switched to dual therapy (dolutegravir, emtricitabine). Group 2 (n=68) received triple therapy (rilpivirine/emtricitabine/tenofovir). Viral load and subpopulations of T-lymphocytes assessed in patients every 24 weeks. In addition, the size of the HIV reservoir and TREC count, biochemical parameters evaluated.

Results. After 48 weeks of ART (24 weeks of dual therapy in group 1), the proportion of patients with undetectable viral load was 87.2% in-group 1, 93.8% in group 2 (p=0.464), after 72 weeks of ART (48 weeks of dual therapy in-group 1) - 94.1 and 94.4%, respectively (p=0.833). After 48 weeks of ART, 68 (93.2%) patients of group 1 and 63 (92.6%) patients of group 2 (p=0.833) had CD4-T-lymphocyte count of more than 500 cl/mcl, and after 72 weeks of ART - 71 (97.3%) and 66 (97.1%), respectively (p=0.664). There was no significant difference in the average size of the HIV reservoir and average TREC count in patients who switched to dual therapy compared to patients who received triple therapy. Creatinine, ALT and AST levels did not significantly change during therapy in both groups.

Conclusion. The switching from triple therapy to dual therapy in naive HIV patients who have no clinical manifestations and who have achieved an undetectable viral load during triple therapy is effective and safe.

Keywords:HIV infection, dual therapy, switching, efficacy, safety

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