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

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

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) pa...

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Main Authors: A. V. Kravchenko, E. A. Orlova-Morozova, T. E. Shimonova, O. A. Kozyrev, F. I. Nagimova, N. G. Zaharova, E. S. Ivanova, U. A. Kuimova, A. A. Popova, O. E. Chernova, O. S. Tonkih, D. A. Gusev, A. A. Yakovlev, V. V. Pokrovsky, V. V. Bychko, N. V. Vostokova
Format: Article
Language:Russian
Published: Journal Infectology 2018-07-01
Series:Журнал инфектологии
Subjects:
hiv-infection
art
nnrti
elsulfavirine
Online Access:https://journal.niidi.ru/jofin/article/view/731
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Summary: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50 copies/ml in 48 weeks achieved 81,6%, in 96  weeks – 83,9% (MITT-analysis) and 91% (if patients withdrawn from the study due to other reasons not related to treatment were excluded).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.
ISSN:2072-6732

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