Русский
Results of post-registration study of efficacy and safety of antiretroviral therapy schemes including elsulfavirine in previously non-treated HIV-infected patients (PASS-1)
DOI: https://dx.doi.org/10.18565/epidem.2024.14.3.89-100
Kravchenko A.V., Shimonova I.E., Ulyanova Y.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., Anoprienko 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, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia ; 2) Infectious Diseases Clinical Hospital No. 2 of the Moscow City Health Department, Moscow, Russia; 3) City Infectious Diseases Clinical Hospital No. 1, 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) St. Petersburg Center for the Prevention and Control of AIDS and Infectious Diseases, St. Petersburg, Russia; 7) Clinical Center for the AIDS Prevention and Control, Krasnodar, Russia; 8) Regional Center for the AIDS Prevention and Control, Astrakhan, Russia; 9) Altai Regional Center for the Prevention and Control of AIDS and Infectious Diseases, Barnaul, Russia; 10) Center for the AIDS Prevention and Control, Gorno-Altaysk, Russia; 11) AIDS Prevention and Control Center, 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) AIDS Prevention and Control Center, Surgut, Khanty-Mansiysk Autonomous District, Russia; 15) AIDS Prevention and Control Center, Nizhnevartovsk, Khanty-Mansiysk Autonomous District, Russia; 16) Magadan Regional Center for AIDS Prevention and Control, Magadan, Russia; 17) AIDS Prevention and Control Center, Khanty-Mansiysk, Khanty-Mansiysk Autonomous District, Russia; 18) Yamalo-Nenets Regional AIDS Prevention and Control Center, Noyabrsk, Russia; 19) AIDS Prevention and Control Center, Pyt-Yakh, Khanty-Mansiysk Autonomous District, 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 AIDS Prevention and Control, Yakutsk, Russia
Materials and methods. The PASS-1 study was conducted at 22 research centers in the Russian Federation and included 518 patients. All participants were prescribed ESV and 2 HIV nucleoside reverse transcriptase inhibitors (NRTIs). Follow-up period lasted lasted for 96 weeks. Efficacy was assessed in patients receiving first-line ART regimens (n = 241): ESV + TDF + 3TC (or FTC) and ESV + ABC + 3TC (or FTC), and safety – in all study participants.
Results. The virological and immunological efficacy of these first-line ART regimens were demonstrated. After 48 weeks of therapy, undetectable HIV RNA levels were achieved in 93.9–100% of patients, and after 96 weeks, in 85.0–97.0%. The median increase in CD4+ lymphocyte level after 48 weeks was 173.0– 222.0 cells/μl, after 96 weeks – 236.0–247.5 cells/μl. A favorable safety profile of ESV-based ART regimens has been demonstrated. ESV-associated adverse reactions (ARs) were reported in 21.6% of cases, 99.0% of which were mild or moderate. All reported ADRs were classified as uncommon or rare in frequency. ADRs of special interest accounted for only 26.1% of the total ADRs. No life-threatening or fatal adverse reactions were reported.
Conclusion. An ART regimen including ESV and 2 NRTIs can be recommended for most HIV-infected patients with starting treatment for the first time and, depending on the nucleoside backbone (TDF or ABC), is quite reasonably considered a preferred and alternative first-line ART regimen.
Literature
1. 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 лечения. Инфекционные болезни 2017; 15(3): 5–13. DOI: 10.20953/1729-9225-2017-3-5-13 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.). DOI: 10.20953/1729-9225-2017-3-5-13 2. 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. 3. Кравченко А.В., Покровская А.В., Куимова У.А., Канестри В.Г., Деулина М.О., Голиусова М.Д. и др. Результаты лечения больных ВИЧ-инфекцией отечественной схемой АРТ в течение 60 недель. Эпидемиол. инфекц болезни. Актуал. вопр. 2021; 11(3): 90–5. DOI: 10.18565/epidem. 2021.11.3.90-5 Kravchenko A.V., Pokrovskaya A.V., Kuimova U.A., Kanestri V.G., Deulina M.O., Goliusova M.D. et al. [Results of treatment of patients with HIV infection with the domestic ART scheme for 60 weeks]. Epidemiology and infectious diseases. Current items 2021; 11(3): 90–5. (In Russ.). DOI: 10.18565/epidem . 2021.11.3.90-5 4. Кравченко А.В., Беляева В.В., Ефремова О.С., Покровская А.В., Куимова У.А., Голиусова М.Д. и др. 96 недель терапии первой отечественной комбинацией антиретровирусных препаратов (Ф-АЗТ/3ТС + ESV). VIII Санкт-Петербургский форум по ВИЧ-инфекции с международным участием. Журнал инфектологии 2023; 15(3, приложение 2): 22–8. Kravchenko A.V., Belyaeva V.V., Efremova O.S., Pokrovskaya A.V., Kuimova U.A., Goliusova M.D. et al. [96 weeks of therapy with the first domestic combination of antiretroviral drugs (PH-AZT/3TS + ESV)]. VIII St. Petersburg Forum on HIV Infection with international participation. Journal Infectology 2023, 15(3, аppendix 2): 22–8. (In Russ.). 5. 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. 2023; 13(4, приложение). 112 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]. Epidemiology and infectious diseases. Current items 2023, 13(4, аppendix), 112 p. (In Russ.). 6. ВИЧ-инфекция у взрослых. Клинические рекомендации. Минздрава России. М.. 2024. 143 с. https://cr.minzdrav.gov.ru/recomend/79_2 [HIV infection in adults, Clinical recommendations of Ministry of Health of Russian Federation]. Moscow, 2024. 143 p. (In Russ.). https://cr.minzdrav.gov.ru/recomend/79_2 13. 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. Канестри В.Г., Кравченко А.В., Ганкина Н.Ю. Гепатотоксичность антиретровирусной терапии больных ВИЧ-инфекцией. Эпидемиол. инфекц. болезни. Актуал. вопр. 2015; (1): 31–6. Kanestri V.G., Kravchenko A.V., Gankina N.Y. [Hepatotoxicity of antiretroviral therapy in patients with HIV infection]. Epidemiology and infectious diseases. Current items 2015: (1): 31–6. (In Russ.). 8. Walmsley S., Baumgarten A., Berenguer J., Felizarta F., Florence E., Khuong-Josses M.-A. et al. Brief Report: Dolutegravir plus Abacavir/Lamivudine for the Treatment of HIV-1 Infection in Antiretroviral Therapy – Naive Patients: Week 96 and Week 144. Results from the SINGLE Randomized Clinical Trial. J. Acquir. Immune Defic. Syndr. 2015; ; 70(5): 515-9. DOI: 10.1097/QAI.0000000000000790 9. Ульянова Я.С., Капустин Д.В., Краснова Е.И., Проворова В.В, Хохлова Н.И. Оценка эффективности лечения больных острой ВИЧ-инфекции с использованием в схеме антиретровирусной терапии элсульфавирина Лечащий врач 2021; (6): 52–5. DOI: 10.51793/OS.2021.24.6.011 Ulyanova Ya.S., Kapustin D.V., Krasnova E.I., Provorova V.V., Hohlova N.I. [Evaluation of the effectiveness of treatment of patients with acute HIV infection using elsulfavirin in the antiretroviral therapy regimen]. Lechaschiy vrach 2021; (6): 52–5. (In Russ.). DOI: 10.51793/OS.2021.24.6.011
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 Clinical Hospital №. 2, Moscow Healthcare Department, Moscow, Russia; tshimonova@yandex.ru
Yana S. Ulianova, Cand. Med. Sci., Deputy Chief Physician for Medical Affairs, City Clinical Hospital №. 1, 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, St. Petersburg State 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, 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, Altai Regional Center for the Prevention and Control of AIDS and Infectious Diseases, Barnaul, Russia; infecgepatit@yandex.ru
Marina A. Ulchiekova, Infectious Disease Doctor, 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, Chief Physician, 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, Infectious Disease Specialist, Head, Medical Department, Center for the AIDS Prevention and Control, Surgut, Khanty-Mansiysk Autonomous District, Surgut, Khanty-Mansi Autonomous Okrug, Russia; anoprienko@spid86.ru
Natalya E. Malyugina, Infectious Disease Doctor, Center for the Prevention and Control of AIDS, 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, Infectious Disease Doctor, Head of the Department, Magadan Regional Center for Prevention and Control of AIDS, Magadan, Russia; aidscentrmgdn@yandex.ru
Olga V. Elistratova, Infectious Disease Doctor, Head, Medical Advisory Care, Center for Prevention and Control of AIDS, Khanty-Mansiysk, Khanty-Mansi Autonomous Okrug, Russia; elistratova@spid86.ru
Ludmila U. Volova, MD, Infectious Disease Doctor, Chief Physician, Yamal-Nenets District Center for the Prevention and Control of AIDS, Noyabrsk, Yamalo-Nenets Autonomous Okrug, Russia; info@aids.yamalmed.ru
Aksana A. Ushakova, Infectious Disease Doctor, Head of the Department, Center for Prevention and Control of AIDS, Pyt-Yakh, Khanty-Mansi Autonomous Okrug, Russia; ushakova@spid86.ru
Elena A. Lomakina, Chief Physician, Sakhalin Regional Center for Prevention and Control of AIDS, Yuzhno-Sakhalinsk, Russia; сenter@hiv65.ru
Maria G. Laseeva, Chief Physician, Mordovia Republican Center for the Prevention and Control of AIDS, Saransk, Russia; laseevamaria@yandex.ru
Margarita V. Terekhova, Infectious Disease Doctor, Yakut Republican Center for the Prevention and Control of AIDS, Yakutsk, Russia; aidsYakutsk@gov14.ru
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