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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50 copies/ml in 48 weeks achieved 81,6%, in 96  weeks – 83,9% (MITT-analysis) and 91% (if patients withdrawn from the study due to other reasons not related to treatment were excluded).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. Kravchenko
Central Research Institute of Epidemiology
Russian Federation
Moscow, Russia


E. A. Orlova-Morozova
Moscow Regional AIDS Center
Russian Federation
Moscow, Russia


T. E. Shimonova
Clinical Infectious Diseases Hospital № 2
Russian Federation
Moscow, Russia


O. A. Kozyrev
Volgograd Regional AIDS Center
Russian Federation
Volgograd, Russia


F. I. Nagimova
AIDS Center of the Republic of Tatarstan
Russian Federation
Kazan, Russia


N. G. Zaharova
Saint-Petersburg City AIDS Center
Russian Federation
Saint-Petersburg, Russia


E. S. Ivanova
Perm Region AIDS Center
Russian Federation
Perm, Russia


U. A. Kuimova
Central Research Institute of Epidemiology
Russian Federation
Moscow, Russia


A. A. Popova
Central Research Institute of Epidemiology
Russian Federation
Moscow, Russia


O. E. Chernova
Togliatti Town Clinical Hospital № 5
Russian Federation
Togliatti, Russia


O. S. Tonkih
Lipetsk Regional AIDS Center
Russian Federation
Lipetsk, Russia


D. A. Gusev
Saint-Petersburg City AIDS Center
Russian Federation
Saint-Petersburg, Russia


A. A. Yakovlev
Clinical Infectious Diseases Hospital named after S.P. Botkin
Russian Federation
Saint-Petersburg, Russia


V. V. Pokrovsky
Central Research Institute of Epidemiology
Russian Federation
Moscow, Russia


V. V. Bychko
LLC «Viriom»
Russian Federation
Khimki, Russia


N. V. Vostokova
LLC «IPHARMA»
Russian Federation
Khimki, Russia


References

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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

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ISSN 2072-6732 (Print)