The efficacy and safety of Elpivirine as part of a 24-48-week antiretroviral therapy regimen versus an Efavirenz-containing regimen

  • Authors: Kravchenko A.V1, Orlova-Morozova E.A2, Shimonova T.E3, Kozyrev O.A4, Nagimova F.I5, Zakharova N.G6, Ivanova E.S7, Sonin D.B8, Chernova O.E9, Tonkikh O.S10, Yakovlev A.A11, Kurina N.V12, Pokrovsky V.V1, Bychko V.V13, Vostokova N.V14, Zozulya O.V14
  • Affiliations:
    1. Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare
    2. Moscow Regional Center for Prevention and Control of AIDS and Infectious Diseases
    3. Clinical Infectious Diseases Hospital Two, Moscow Healthcare Department
    4. Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases
    5. Republican Center for Prevention and Control of AIDS and Infectious Diseases, Ministry of Health of the Republic of Tatarstan
    6. Center for Prevention and Control of AIDS and Infectious Diseases
    7. Perm Territorial Center for Prevention and Control of AIDS and Infectious Diseases
    8. Regional Clinical Dermatovenereology Dispensary, Ryazan
    9. Tolyatti Town Clinical Hospital Five
    10. Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases
    11. S.P. Botkin Clinical Infectious Diseases Hospital
    12. Republican Clinical Infectious Diseases, Ministry of Health of the Udmurt Republic
    13. OOO «Viriom»
    14. OOO «IFARMA»
  • Issue: No 5 (2016)
  • Pages: 73-80
  • Section: Articles
  • URL: https://journals.eco-vector.com/2226-6976/article/view/278519
  • ID: 278519

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Abstract

The article presents the results of a HIV-VM1500-04 study after 24-48 weeks of treatment. Subjects and methods. The study included 120 adult HIV-infected patients randomized into 2 groups equally: 1) TDF/FTC +Elpivirine (VM-1500, Elpida®) (a study group), and 2) TDF/FTC + EFV(a control group). Treatment has been completed or is being continued by 91.7 and 80% in Groups 1 and 2, respectively. Results. Following 24-48 weeks of treatment, the antiretroviral therapy (ART) regimen including Elpivirint 20 mg/ day in combination with TDF/FTC was no less effective than the EFV + TDF/FTC regimen, regardless of the baseline viral load level. After 24 weeks of ART, in the study group the proportion of patients with HIV-RNA <50 copies/ml was substantially higher than that in the control group: 84.5 and 66.7% (MITT analysis; p = 0.031). At 24-48 weeks of treatment, the safety of the ART regimen including Epivirtm was higher than that containing EFV. The development of adverse events of special interest (impairments in the central nervous system and mental activity) was significantly less frequently detected in the study group (30%) than in the control one (62.1; p < 0.001). The study is expected to be completed in November 2016.

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About the authors

A. V Kravchenko

Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare

Email: kravtchenko@hivrussia.net

E. A Orlova-Morozova

Moscow Regional Center for Prevention and Control of AIDS and Infectious Diseases

Email: orlovamorozova@gmail.com

T. E Shimonova

Clinical Infectious Diseases Hospital Two, Moscow Healthcare Department

Email: tshimonova@mail.ru

O. A Kozyrev

Volgograd Regional Center for Prevention and Control of AIDS and Infectious Diseases

Email: volghiv@mail.ru

F. I Nagimova

Republican Center for Prevention and Control of AIDS and Infectious Diseases, Ministry of Health of the Republic of Tatarstan

Email: nagimova@list.ru

N. G Zakharova

Center for Prevention and Control of AIDS and Infectious Diseases

Email: aidscentr@zdrav.spb.ru

E. S Ivanova

Perm Territorial Center for Prevention and Control of AIDS and Infectious Diseases

Email: aids_ivanova@mail.ru

D. B Sonin

Regional Clinical Dermatovenereology Dispensary, Ryazan

Email: rokkvd@mail.ru

O. E Chernova

Tolyatti Town Clinical Hospital Five

Email: oks2309@gmail.com

O. S Tonkikh

Lipetsk Regional Center for Prevention and Control of AIDS and Infectious Diseases

Email: aids-centre@mail.ru

A. A Yakovlev

S.P. Botkin Clinical Infectious Diseases Hospital

Email: kibbotkin@mail.ru

N. V Kurina

Republican Clinical Infectious Diseases, Ministry of Health of the Udmurt Republic

Email: nachmed@spid18.ru

V. V Pokrovsky

Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Welfare

Email: pokrovsky@hivrussia.net

V. V Bychko

OOO «Viriom»

Email: vbichko@viriom.com

N. V Vostokova

OOO «IFARMA»

Email: nv@ipharma.ru

O. V Zozulya

OOO «IFARMA»

Email: ovz@ipharma.ru

References

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