Русский
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)
DOI: https://dx.doi.org/10.18565/epidem.2025.15.4.99-109
Kravchenko A.V., Shimonova T.E., Ulyanova Ya.S., Kuznetsova A.V., Isaeva G.N., Sizova N.V., Palaguta A.E., Baburina A.R., Shevchenko V.V., Ulchiekova M.A., Fisenko E.G., Radzikhovskaya M.V., Musatov V.B., Аnoprienko E.A., Malyugina N.E., Pokrovskaya A.V., Zhuravkova O.L., Elistratova O.V., Volova L.Yu., Ushakova A.A., Lomakina E.A., Laseeva M.G., Terekhova M.V.
1) Central Research Institute of Epidemiology, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; 2) Infectious Diseases Clinical Hospital № 2, Moscow Healthcare Department, Moscow, Russia; 3) Novosibirsk Regional Clinical Infectious Diseases Hospital, Novosibirsk, Russia; 4) Center for the Prevention and Control of AIDS and Infectious Diseases, Khabarovsk, Russia; 5) Leningrad Region Center for the Prevention and Control of AIDS and Infectious Diseases, St. Petersburg, Russia; 6) Center for the Prevention and Control of AIDS and Infectious Diseases, St. Petersburg, Russia; 7) Clinical Center for the AIDS Prevention and Control, Ministry of Healthcare of the Krasnodar Krai, Krasnodar, Russia; 8) Regional Center for the AIDS Prevention and Control, Astrakhan, Russia; 9) Center for the Prevention and Control of AIDS and Infectious Diseases, Barnaul, Altai Krai, Russia; 10) Center for the AIDS Prevention and Control, Gorno-Altaysk, Russia; 11) Center for the AIDS Prevention and Control, Rostov-on-Don, Russia; 12) Regional Center for the Prevention and Control of AIDS and Infectious Diseases, Chelyabinsk, Russia; 13) S.P. Botkin Clinical Infectious Diseases Hospital, St. Petersburg, Russia; 14) Center for the AIDS Prevention and Control, Surgut, Khanty-Mansi Autonomous Okrug, Russia; 15) Center for the AIDS Prevention and Control, Nizhnevartovsk, Russia; 16) Magadan Regional Center for the AIDS Prevention and Control, Magadan, Russia; 17) Center for the AIDS Prevention and Control, Khanty-Mansiysk, Russia; 18) Yamalo-Nenets Regional Center for the AIDS Prevention and Control, Noyabrsk, Russia; 19) Branch of the Khanty-Mansi Autonomous Okrug - Yugra Center for the AIDS Prevention and Control, Pyt-Yakh, Russia; 20) Sakhalin Regional Center for the AIDS Prevention and Control, Yuzhno-Sakhalinsk, Russia; 21) Mordovian Republican Center for the AIDS Prevention and Control, Saransk, Russia; 22) Yakutsk Republican Center for the Prevention and Control of AIDS and Infectious Diseases, Yakutsk, Russia
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.
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About the Autors
Professor Alexey V. Kravchenko, МD, Leader Researcher, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; alexey-kravtchenko@yandex. ru; http://orcid.org/0000-0001-7857-3763
Tatiana E Shimonova, Cand. Med. Sci., Epidemiologist, Infectious Diseases Clinical Hospital №. 2, Moscow Healthcare Department, Moscow, Russia; tshimonova@yandex.ru
Yana S. Ulianova, Cand. Med. Sci., Deputy Chief Physician for Medical Affairs, Novosibirsk Regional Clinical Infectious Diseases Hospital, Novosibirsk, Russia; yanaulyanova@mail.ru
Anna V. Kuznetsova, Cand. Med. Sci., Chief Physician, Center for the Prevention and Control of AIDS and Infectious Diseases, Khabarovsk, Russia; avkuznecova@bk.ru
Galina N. Isaeva, Head, Outpatient Department, Leningrad Region Center for the Prevention and Control of AIDS and Infectious Diseases, St.Petersburg, Russia; g.n.isaeva@yandex.ru
Natalia V. Sizova, MD, Deputy Chief Physician for Outpatient Care, Center for the Prevention and Control of AIDS and Infectious Diseases, St. Petersburg, Russia; natalia_v_sizova@mail.ru
Alexander E. Palaguta, Deputy Chief Physician, Clinical Center for the Prevention and Control of AIDS, Ministry of Healthcare of Krasnodar Krai, Krasnodar, Russia; hivkuban@mail.kuban.ru
Albina R. Baburina, Head. Department of Clinical Diagnostics and Medical and Social Rehabilitation, Regional Center for the AIDS Prevention and Control, Astrakhan, Russia: 76alb76@gmail.com
Valery V. Shevchenko, MD, Chief Physician, Center for the Prevention and Control of AIDS and Infectious Diseases, Barnaul, Russia; infecgepatit@yandex.ru
Marina A. Ulchiekova, Infectiologist, Center for the AIDS Prevention and Control, Gorno-Altaisk, Republic of Altai, Russia; aids@med04.ru
Ekaterina G. Fisenko, Head of Department, Center for the AIDS Prevention and Control, Rostov-on-Don, Russia; fisenkoeg@gmail.com
Margarita V. Radzikhovskaya, MD, Infectiologist, Regional Center for the Prevention and Control of AIDS and Infectious Diseases, Chelyabinsk, Russia; chelaids@mail.ru
Vladimir B. Musatov, Cand. Med. Sci., Deputy Chief Physician for Medical Affairs, S.P. Botkin Clinical Infectious Diseases Hospital, St. Petersburg, Russia; doctormusatov@gmail.com
Elena A. Anoprienko, Infectiologist, Head, Medical Department, Center for the AIDS Prevention and Control, Surgut, Khanty-Mansi Autonomous Okrug, Russia; anoprienko@spid86.ru
Natalya E. Malyugina, Infectiologist, Center for the AIDS Prevention and Control, Nizhnevartovsk, Khanty-Mansi Autonomous Okrug, Russia; priem_nv@spid86.ru
Anastasia V. Pokrovskaya, MD, Senior Scientist, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; pokrovskaya_av@mail.ru; http://orcid.org/0000-0002-2677-0404
Olga L. Zhuravkova, Infectiologist, Head of Department, Magadan Regional Center for the AIDS Prevention and Control, Magadan, Russia; aidscentrmgdn@yandex.ru
Olga V. Elistratova, Infectiologist, Head, Consultative and Diagnostic Department, Center for the AIDS Prevention and Control, Khanty-Mansiysk, Russia; elistratova@spid86.ru
Ludmila U. Volova, MD, Infectiologist, Head, Outpatient Department, Yamal-Nenets District Center for the AIDS Prevention and Control, Noyabrsk, Russia; info@aids.yamalmed.ru
Aksana A. Ushakova, Infectiologist, Head of the Department, Branch of the Khanty-Mansiysk Autonomous Okrug-Yugra Center for the AIDS Prevention and Control, Pyt-Yakh, Russia; ushakova@spid86.ru
Elena A. Lomakina, Chief Physician, Sakhalin Regional Center for the AIDS Prevention and Control, Yuzhno-Sakhalinsk, Russia: сenter@hiv65.ru
Maria G. Laseeva, Chief Physician and Deputy Chief Physician, Mordovian Republican Center for the AIDS Prevention and Control, Saransk, Russia; laseevamaria@yandex.ru
Margarita V. Terekhova, Infectiologist, Yakutsk Republican Center for the Prevention and Control of AIDS and Infectious Diseases, Yakutsk, Russia; aidsYakutsk@gov14.ru
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