Viriom, Inc. Announces the Publication of Results from an Efficacy and Safety Study with Elsulfavirine in the Journal “National Scientific Society of Infectious Disease Specialists”

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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About Viriom

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.