Viriom Announces the Publication of Results from an Efficacy and Safety Study with Elsulfavirine in the Journal “National Scientific Society of Infectious Disease Specialists”
December 14, 2015 – Viriom, a member of the ChemRar High-Tech Center, announced today that the article, "The efficacy and safety of a new Russian HIV non-nucleoside reverse transcriptase inhibitor (VM-1500, Elpivirine; as a component of an antiretroviral therapy regimen" was published in the journal, "Epidemiology and Infectious Diseases. Present-day Questions" № 5, 2015. (http://www.epidemiology-journal.ru). This well-regarded medical and scientific journal is a publication of the National Scientific Society of Infectious Disease Specialists.
Authors: A. V. Kravchenko, E. A. Orlova-Morozova, T. E. Shimonova, O. A. Kozyrev, F. I. Nagimova, V. V. Bychko, N. V. Vostokova, O. V. Zozulya.
Objective. To evaluate the impact of different dosage regimens of Elsulfavirine (VM-1500, elpivirine) in combination with drugs used for standard antiretroviral therapy (ART) versus a combination containing efavirenz (EFV) and standard antiretroviral therapy (2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/NtRTs) on the efficiency of treatment in the view of a reduction in viral load to an undetectable level (< 50 copies/ml) at 24 weeks in previously untreated HIV-1 infected patients.
Subjects and methods. Study Stage 1 included 90 HIV-1 infected patients who had not previously received ART and who were randomized into 3 groups at a 1:1:1 ratio: 1) received 20 mg of VM-1500 daily; 2) 40 mg of VM-1500 daily; 3) 600 mg of EFV daily (a comparison group). All the patients also took TDF/FTC. At this study stage, after 12-weeks of therapy, an interim efficacy and safety analysis was performed.
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 an HIV RNA level of < 400 copies/ml was highest in Group 1 and amounted to 93.3%, which was 11.8% above 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 dose of 20 mg daily was chosen to be further investigated.
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Viriom Inc. is a late-stage biotech company developing, manufacturing and distributing novel and affordable therapies against life threatening infections such as HIV and HBV (Hepatitis B virus). The company has an exclusive worldwide license to its Phase 2-3 HIV oral treatment Elsulfavirine from F. Hoffmann-La Roche and is developing a proprietary treatment for chronic HBV. Viriom believes its drug candidates are capable of making a breakthrough in treating and preventing HIV and chronic HBV infections in both developing and developed countries. For more information, please visit www.viriom.com.