The efficacy and safety of a new Russian HIV non-nucleoside reverse transcriptase inhibitor (VM-1500, Elpivirine) as a component in an antiretroviral therapy regimen

Objective. To evaluate the impact of different dosage regimens of VM-1500 in combination with drugs used for standard antiretroviral therapy (ART) versus a combination containing efavirenz (EFV) and standard ART (2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/HtRTs)) on the efficiency of treatment in view of a reduction in viral load to an undetectable level (< 50 copies/ml) at 24 weeks in previously untreated HIV-1-infectedpatients. Subjects and methods. Study Stage 1 included 90 HIV-1-infected patients who had not previously received ART and were randomized into 3 groups at a 1:1:1 ratio: 1) VM-150 20 mg daily; 2) VM-150 40 mg daily; 3) EFV 600 mg daily (a comparison group). All the patients also took TDF/FTC. At this study stage, an interim analysis of the efficiency and safety of therapy was performed after 12-week therapy. Results. The 12-week ART regimen including VM-1500 at doses of 20 and 40 mg in combination with TDF/FTC was as effective as the EFV + TDF/FTC regimen regardless of the baseline level of HIV RNA. The proportion of patients with a HIV RNA level of < 400 copies/ml was highest in Group 1 and amounted to 93.3%, which was 11.8% below that in Group 3 (MIIT analysis). In Group 1, the incidence of all moderate (26.7%) and severe (6.7%) adverse events (AEs) was lowest as compared to that in Group 3 (60.7 and 14.3%, respectively). AEs of special interest (impairments of the central nervous system and mental activity) were substantially rarer in Groups 1 and 2 than in Group 3 (57.1%). Conclusion. There is evidence for the comparable (equivalent) efficiency of both VM-1500 doses and EFV as a component of ART. The safety of 12-week ART regimens incorporating VM-1500 was higher than that of the regimen containing EFV. VM-1500 20 mg daily was chosen to be further investigated.

VM-1500, HIV infection, antiretroviral therapy, non-nucleoside reverse transcriptase inhibitor, VM-1500