Results of the evaluation of the efficacy and safety of an ART regimen including elsulfavirine in HIV-infected patients transferred from effective ART regimens due to unsatisfactory safety (PRIB-2 study)

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  • Authors: Kravchenko A.V.1, Shimonova T.E.2, Ulyanova Y.S.3, Kuznetsova A.V.4, Isaeva G.N.5, Sizova N.V.6, Palaguta A.E.7, Baburina A.R.8, Shevchenko V.V.9, Ulchiekova M.A.10, Fisenko E.G.11, Radzikhovskaya M.V.12, Musatov V.B.13, Anoprienko E.A.14, Malyugina N.E.15, Pokrovskaya A.V.1, Zhuravkova O.L.16, Elistratova O.V.17, Volova L.Y.18, Ushakova A.A.19, Lomakina E.A.20, Laseeva M.G.21, Terekhova M.V.22
  • Affiliations:
    1. Central Research Institute of Epidemiology, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being
    2. Infectious Diseases Clinical Hospital № 2, Moscow Healthcare Department
    3. Novosibirsk Regional Clinical Infectious Diseases Hospital
    4. Center for the Prevention and Control of AIDS and Infectious Diseases, Khabarovsk
    5. Leningrad Region Center for the Prevention and Control of AIDS and Infectious Diseases
    6. Center for the Prevention and Control of AIDS and Infectious Diseases, St. Petersburg
    7. Clinical Center for the AIDS Prevention and Control, Ministry of Healthcare of the Krasnodar Krai
    8. Regional Center for the AIDS Prevention and Control, Astrakhan
    9. Center for the Prevention and Control of AIDS and Infectious Diseases, Barnaul
    10. Center for the AIDS Prevention and Control, Gorno-Altaysk
    11. Center for the AIDS Prevention and Control, Rostov-on-Don
    12. Regional Center for the Prevention and Control of AIDS and Infectious Diseases, Chelyabinsk
    13. S.P. Botkin Clinical Infectious Diseases Hospital
    14. Center for the AIDS Prevention and Control, Surgut
    15. Center for the AIDS Prevention and Control, Nizhnevartovsk
    16. Magadan Regional Center for the AIDS Prevention and Control
    17. Center for the AIDS Prevention and Control, Khanty-Mansiysk
    18. Yamalo-Nenets Regional Center for the AIDS Prevention and Control
    19. Branch of the Khanty-Mansi Autonomous Okrug – Yugra Center for the AIDS Prevention and Control
    20. Sakhalin Regional Center for the AIDS Prevention and Control
    21. Mordovian Republican Center for the AIDS Prevention and Control
    22. Yakutsk Republican Center for the Prevention and Control of AIDS and Infectious Diseases
  • Issue: Vol 15, No 4 (2025)
  • Pages: 99-109
  • Section: Exchange of Experience
  • URL: https://journals.rcsi.science/2226-6976/article/view/375466
  • DOI: https://doi.org/10.18565/epidem.2025.15.4.99-109
  • ID: 375466

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Abstract

Objective. Evaluation of the efficacy and safety of elsulfavirine (ESV)-based antiretroviral therapy (ART) regimens in HIV-infected patients switched from effective ART regimens due to adverse events (PRIB-2).

Materials and methods. The PRIB-2 study was conducted at 22 research centers in the Russian Federation and included 724 patients receiving effective ART containing ESV or protease inhibitors. Due to intolerance to their current ART regimen, all participants were switched to an ESV-based regimen and a backbone therapy consisting of two HIV nucleoside reverse transcriptase inhibitors (NRTIs). The follow-up period was 96 weeks. Efficacy was assessed in 447 patients receiving first-line ART regimens: ESV + TDF + 3TC (or FTC) and ESV + ABC + 3TC (or FTC), while safety was assessed in all study participants.

Results. The virological and immunological efficacy of the studied first-line ART regimens was demonstrated. It was found that after 48 weeks of treatment, undetectable HIV RNA levels were recorded in 93.8–94.0% of patients, and in 96.3–100.0% of patients, respectively. The median increase in CD4+ lymphocyte count after 48 weeks was 41.0 cells/μL, and after 96 weeks, 87.0 cells/μL. A favorable safety profile was demonstrated for ESV-based ART regimens. Adverse reactions (ARs) associated with ESV were reported in 21.6% of cases, 99.0% of which were mild or moderate. ARs of particular interest accounted for 26.1% of all ARs. No life-threatening or fatal ARs were reported. Switching from effective ART regimens to ART regimens containing ESV resulted in no negative changes in virological and immunological responses, with a more favorable safety profile.

Conclusion. An ART regimen containing ESV and two NRTIs can be recommended for patients with HIV infection receiving effective ART regimens with safety and/or tolerability concerns.

About the authors

Alexey V. Kravchenko

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

Author for correspondence.
Email: alexey-kravtchenko@yandex.ru
ORCID iD: 0000-0001-7857-3763

МD, Professor, Leader Researcher

Russian Federation, Moscow

Tatiana E. Shimonova

Infectious Diseases Clinical Hospital № 2, Moscow Healthcare Department

Email: tshimonova@yandex.ru

Cand. Med. Sci., Epidemiologist

Russian Federation, Moscow

Yana S. Ulyanova

Novosibirsk Regional Clinical Infectious Diseases Hospital

Email: yanaulyanova@mail.ru

Cand. Med. Sci., Deputy Chief Physician for Medical Affairs

Russian Federation, Novosibirsk

Anna V. Kuznetsova

Center for the Prevention and Control of AIDS and Infectious Diseases, Khabarovsk

Email: avkuznecova@bk.ru

Cand. Med. Sci., Chief Physician

Russian Federation, Khabarovsk

Galina N. Isaeva

Leningrad Region Center for the Prevention and Control of AIDS and Infectious Diseases

Email: g.n.isaeva@yandex.ru

Head, Outpatient Department

Russian Federation, St. Petersburg

Natalia V. Sizova

Center for the Prevention and Control of AIDS and Infectious Diseases, St. Petersburg

Email: natalia_v_sizova@mail.ru

MD, Deputy Chief Physician for Outpatient Care

Russian Federation, St. Petersburg

Alexander E. Palaguta

Clinical Center for the AIDS Prevention and Control, Ministry of Healthcare of the Krasnodar Krai

Email: hivkuban@mail.kuban.ru

Deputy Chief Physician

Russian Federation, Krasnodar

Albina R. Baburina

Regional Center for the AIDS Prevention and Control, Astrakhan

Email: 76alb76@gmail.com

Head, Department of Clinical Diagnostics and Medical and Social Rehabilitation

Russian Federation, Astrakhan

Valery V. Shevchenko

Center for the Prevention and Control of AIDS and Infectious Diseases, Barnaul

Email: infecgepatit@yandex.ru

MD, Chief Physician

Russian Federation, Barnaul

Marina A. Ulchiekova

Center for the AIDS Prevention and Control, Gorno-Altaysk

Email: aids@med04.ru

Infectiologist

Russian Federation, Gorno-Altaysk

Ekaterina G. Fisenko

Center for the AIDS Prevention and Control, Rostov-on-Don

Email: fisenkoeg@gmail.com

Head of Department

Russian Federation, Rostov-on-Don

Margarita V. Radzikhovskaya

Regional Center for the Prevention and Control of AIDS and Infectious Diseases, Chelyabinsk

Email: chelaids@mail.ru

MD, Infectiologist

Russian Federation, Chelyabinsk

Vladimir B. Musatov

S.P. Botkin Clinical Infectious Diseases Hospital

Email: doctormusatov@gmail.com

Cand. Med. Sci., Deputy Chief Physician for Medical Affairs

Russian Federation, St. Petersburg

Elena A. Anoprienko

Center for the AIDS Prevention and Control, Surgut

Email: anoprienko@spid86.ru

Infectiologist, Head, Medical Department

Russian Federation, Surgut

Natalya E. Malyugina

Center for the AIDS Prevention and Control, Nizhnevartovsk

Email: priem_nv@spid86.ru

Infectiologist

Russian Federation, Nizhnevartovsk

Anastasia V. Pokrovskaya

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

Email: pokrovskaya_av@mail.ru
ORCID iD: 0000-0002-2677-0404

MD, Senior Scientist

Russian Federation, Moscow

Olga L. Zhuravkova

Magadan Regional Center for the AIDS Prevention and Control

Email: aidscentrmgdn@yandex.ru

Infectiologist, Head of Department

Russian Federation, Magadan

Olga V. Elistratova

Center for the AIDS Prevention and Control, Khanty-Mansiysk

Email: elistratova@spid86.ru

Infectiologist, Head, Consultative and Diagnostic Department

Russian Federation, Khanty-Mansiysk

Ludmila Yu. Volova

Yamalo-Nenets Regional Center for the AIDS Prevention and Control

Email: info@aids.yamalmed.ru

MD, Infectiologist, Head, Outpatient Department

Russian Federation, Noyabrsk

Aksana A. Ushakova

Branch of the Khanty-Mansi Autonomous Okrug – Yugra Center for the AIDS Prevention and Control

Email: ushakova@spid86.ru

Infectiologist, Head of the Department

Russian Federation, Pyt-Yakh

Elena A. Lomakina

Sakhalin Regional Center for the AIDS Prevention and Control

Email: center@hiv65.ru

Chief Physician

Russian Federation, Yuzhno-Sakhalinsk

Maria G. Laseeva

Mordovian Republican Center for the AIDS Prevention and Control

Email: laseevamaria@yandex.ru

Chief Physician, Deputy Chief Physician

Russian Federation, Saransk

Margarita V. Terekhova

Yakutsk Republican Center for the Prevention and Control of AIDS and Infectious Diseases

Email: aidsYakutsk@gov14.ru

Infectiologist

Russian Federation, Yakutsk

References

  1. ВИЧ-инфекция у взрослых. Клинические рекомендации. Минздрав России. М. 2024. 143 с. https://cr.minzdrav.gov.ru/preview-cr/79_2 / [HIV infection in adults. Clinical recommendations]. Ministry of Health of Russia. Moscow. 2024. 143 p. (In Russ.). https://cr.minzdrav.gov.ru/preview-cr/79_2
  2. Покровский В.В., Юрин О.Г., Кравченко А.В., Беляева В.В., Ермак Т.Н., Шахгильдян В.И. и др. Рекомендации по лечению ВИЧ-инфекции и связанных с ней заболеваний, химиопрофилактике заражения ВИЧ. Эпидемиол. инфекц. болезни. Актуал. вопр. 2024; 14(4, приложение). 107 с. / Pokrovsky V.V., Yurin O.G., Kravchenko A.V., Belyaeva V.V., Ermak T.N., Shakhgildyan V.I. et al. [Recommendations for the treatment of HIV infection and related diseases, chemoprophylaxis of HIV infection]. Epidemiоlоgy and infectious diseases. Сurrent items 2024; 14(4, appendix). 107 p. (In Russ.).
  3. Кравченко А.В., Орлова-Морозова Е.А., Шимонова Т.Е., Козырев О.А., Нагимова Ф.И. Захарова Н.Г. и др. Эффективность и безопасность нового российского ненуклеозидного ингибитора обратной транскриптазы элсульфавирина в сочетании с тенофовиром/эмтрицитабином – многоцентровое сравнительное исследование с эфавирензом у пациентов с ВИЧ-инфекцией, ранее не получавших лечение. Инфекционные болезни 2017; 15(3): 5–13. / Kravchenko A.V., Orlova-Morozova E.A., Shimonova T.E., Kozyrev O.A., Nagimova F.I., Zakharova N.G. et al. [The efficacy and safety of the new Russian non–nucleoside reverse transcriptase inhibitor elsulfavirin in combination with tenofovir/emtricitabine is a multicenter comparative study with efavirenz in patients with HIV infection who had not previously received treatment]. Infectious diseases 2017; 15(3): 5–13. (In Russ.).
  4. Кравченко А.В., Орлова-Морозова Е.А., Шимонова Т.Е., Козырев О.А., Нагимова Ф.И., Захарова Н.Г. и др. Эффективность и безопасность нового российского ненуклеозидного ингибитора обратной транскриптазы элсульфавирина в первой линии лечения ВИЧ-инфекции в комбинации с двумя нуклеозидными/ нуклеотидными ингибиторами обратной транскриптазы – исследование 96 недель. Журнал Инфектологии 2018; 10(2): 76–82. doi: 10.22625/2072-6732-2018-10-2-76-82 / Kravchenko A.V., Orlova-Morozova E.A., Shimonova T.E., Kozyrev O.A., Nagimova F.I., Zakharova N.G. et al. [Efficacy and safety of the new Russian non-nucleoside reverse transcriptase inhibitor elsulfavirin in the first–line treatment of HIV infection in combination with two nucleoside/nucleotide reverse transcriptase inhibitors – a 96-week study]. Journal Infectology 2018; 10(2): 76–82. (In Russ.). doi: 10.22625/2072-6732-2018-10-2-76-82
  5. Кравченко А.В., Шимонова Т.Е., Ульянова Я.С., Кузнецова А.В., Исаева Г.Н., Сизова Н.В. и др. Результаты пострегистрационного исследования эффективности и безопасности схем антиретровирусной терапии, включающей элсульфавирин, у пациентов с ВИЧ-инфекцией, ранее не получавших лечения (ПРИБ-1). Эпидемиол. инфекц, болезни. Актуал. Вопр. 2024; 14(3): 89–100. doi: 10.18565/epidem. 2024.14.3.89-100 / Kravchenko A.V., Shimonova T.E., Ulyanova Ya.S., Kuznetsova A.V., Isaeva G.N., Sizova N.V. et al. [Results of a post-marketing study of the efficacy and safety of antiretroviral therapy regimens, including elsulfavirin, in patients with HIV infection who had not previously received treatment (PASS-1)]. Epidemiology and infectious diseases. Current issues 2024; 14(3): 89–100. (In Russ.). doi: 10.18565/epidem. 2024.14.3.89-100
  6. Division of AIDS (DAIDS). Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1, July 2017, 32 p. https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf.
  7. Munoz-Moreno J., Fumaz C., Ferrer M., Gonzalez-Garcia M., Molto J., Negredo E. et al. Neuropsychiatric symptoms associated with efavirenz: prevalence, correlates and management. A neurobehavioral review. AIDS Rev. 2009; 11: 103–109.
  8. Lv Z., Chu Y., Wang Y. HIV protease inhibitors: a review of molecular selectivity and toxicity. HIV AIDS (Auckl) 2015; 7: 95–104.
  9. Gazzard B., Balkin A., Hill A. Analysis of neuropsychiatric adverse events during clinical trials of efavirenz in antiretroviral-naive patients: a systematic review. AIDS Rev. 2010; 12(2): 67–75.
  10. Sempere A., Alonso R., Berrocal L., Calvo J., Foncillas A., Chivite I. et al. The Role of Protease Inhibitors in HIV Treatment: Who Still Needs Them in 2025? Infect. Dis. Ther. 2025; 14(11): 2551–2563. doi: 10.1007/s40121-025-01229-9
  11. Brehm T., Franz M., Hüfner A., Hertling S., Schmiedel S., Degen O. et al. Safety and efficacy of elvitegravir, dolutegravir, and raltegravir in a real-world cohort of treatment-naïve and -experienced patients. Medicine (Baltimore) 2019; 98(32): e16721. doi: 10.1097/MD.0000000000016721
  12. Cahn P., Pozniak A., Mingrone H., Shuldyakov A., Brites C., Andrade-Villanueva J. et al. Dolutegravir versus raltegravir in antiretroviral-experienced, integrase-inhibitor-naive adults with HIV: week 48 results from the randomised, double-blind, non-inferiority SAILING study. Lancet 2013; 382(9893): 700–708. doi: 10.1016/S0140-6736(13)61221-0.
  13. Aboud M., Kaplan R., Lombaard J., Zhang F., Hidalgo J., Mamedova E. et al. Dolutegravir versus ritonavir-boosted lopinavir both with dual nucleoside reverse transcriptase inhibitor therapy in adults with HIV-1 infection in whom first-line therapy has failed (DAWNING): an open-label, non-inferiority, phase 3b trial. Lancet Infect. Dis. 2019; 19(3): 253–264. doi: 10.1016/S1473-3099(19)30036-2.

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