Efficacy and safety of novel russian non-nucleoside reverse transcriptase inhibitor elsulfavirine in combination with 2 nucleoside/nucleotide reverse transcriptase inhibitors in first-line HIV treatment – 96-week study
https://doi.org/10.22625/2072-6732-2018-10-2-76-82
Abstract
A randomized multicenter 96-week study of an elsulfavirine (ESV), non-nucleoside reverse transcriptase inhibitor (NNRTI) of novel generation, in combination with 2 nucleoside/ nucleotide reverse transcriptase inhibitors (NRTIs) was conducted in naive HIV adult patients, divided by 2 parts: 1) partially blind comparative to efavirenz (EFV) 48-week study, 2) open-label observational study during additional 48 weeks. High virological and immunological effectiveness maintained during the study: proportion of patients with HIV RNA <50 copies/ml in 48 weeks achieved 81,6%, in 96 weeks – 83,9% (MITT-analysis) and 91% (if patients withdrawn from the study due to other reasons not related to treatment were excluded). No resistance mutations were found in patients with viral replication blips (HIV RNA 50-1300 copies/ml). CD4+-lymphocytes count was increased by 187,5 at week 48 and 251,0 cells/mcl at week 96. Good tolerability and safety were confirmed during second year of treatment: no additional safety data which could influence benefit/risk ratio were recorded as well as withdrawal from the treatment due to adverse events. Serious adverse events, connected with treatment, allergic reactions were not registered during the whole 96-week study.
Conclusion. Results of the 96-week study confirm earlier data from 48-week study on high efficacy and safety of ESV. Based on these data ESV was included into “National recommendations on dispensary follow-up and treatment of patients with HIV-infection” as the first-line ART regime in combination with 2 NRTIs.
About the Authors
A. V. KravchenkoRussian Federation
Moscow, Russia
E. A. Orlova-Morozova
Russian Federation
Moscow, Russia
T. E. Shimonova
Russian Federation
Moscow, Russia
O. A. Kozyrev
Russian Federation
Volgograd, Russia
F. I. Nagimova
Russian Federation
Kazan, Russia
N. G. Zaharova
Russian Federation
Saint-Petersburg, Russia
E. S. Ivanova
Russian Federation
Perm, Russia
U. A. Kuimova
Russian Federation
Moscow, Russia
A. A. Popova
Russian Federation
Moscow, Russia
O. E. Chernova
Russian Federation
Togliatti, Russia
O. S. Tonkih
Russian Federation
Lipetsk, Russia
D. A. Gusev
Russian Federation
Saint-Petersburg, Russia
A. A. Yakovlev
Russian Federation
Saint-Petersburg, Russia
V. V. Pokrovsky
Russian Federation
Moscow, Russia
V. V. Bychko
Russian Federation
Khimki, Russia
N. V. Vostokova
Russian Federation
Khimki, Russia
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Review
For citations:
Kravchenko A.V., Orlova-Morozova E.A., Shimonova T.E., Kozyrev O.A., Nagimova F.I., Zaharova N.G., Ivanova E.S., Kuimova U.A., Popova A.A., Chernova O.E., Tonkih O.S., Gusev D.A., Yakovlev A.A., Pokrovsky V.V., Bychko V.V., Vostokova N.V. Efficacy and safety of novel russian non-nucleoside reverse transcriptase inhibitor elsulfavirine in combination with 2 nucleoside/nucleotide reverse transcriptase inhibitors in first-line HIV treatment – 96-week study. Journal Infectology. 2018;10(2):76-82. (In Russ.) https://doi.org/10.22625/2072-6732-2018-10-2-76-82