New HIV integrase inhibitor dolutegravir – based antiretroviral therapy in previously untreated patients

• Alexey V. Kravchenko
• Semen L. Maksimov

Abstract

The analysis of three, large international randomized phase III studies (SPRING-2, SINGLE, FLAMINGO) results is presented. This studies involving 2139 patients with HIV-1 infection who have not received antiretroviral treatment (ART) before. An 96–144 weeks study with comparative evaluation of the effectiveness and safety of different ART regimens was made. This regimens included: 2 Nucleotide Reverse Transcriptase Inhibitors (NRTIs) and dolutegravir (DTG); 2 NRTIs and integrase inhibitors (RAL); non-nucleoside reverse transcriptase inhibitors (EFV); PI (DRV/r). Virological efficacy of DTG (1 time per day) was comparable to the efficacy of RAL and exceed the efficiency of EFV and DRV/r.

In case of 5.9% of patients treated with DTG there was a virological treatment failure. Thereby performed analysis in no case revealed viral resistance mutations to integrase inhibitors. It argues for high genetic barrier of DTG which that is comparable with protease inhibitors. Immunologic effectiveness of ART regimens (that included DTG) was comparable with the efficiency of RAL or DRV/r including regimens and was more effective than regimen with EFV.

Safety Assessment of ART regimens showed that tolerability of DTG (1 time per day) was comparable to tolerability of RAL (2 times per day). Comparison of DTG with EFV and DRV/r revealed best tolerability profile of integrase inhibitors and smaller frequency of elimination of patients from the study due to adverse events.

Currently HIV integrase inhibitor dolutegravir in combination with 2 NRTIs is recommended as the drug of choice in preferred schemes of ART in previously untreated HIV-infected patients.

Keywords:HIV infection, antiretroviral therapy, integrase inhibitor dolutegravir

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