Русский
The efficiency and safety of ART after switching patients to the combined Russian NRTI phosphaladine in combination with elsulfavirine
DOI: https://dx.doi.org/10.18565/epidem.2022.12.3.84-90
Kravchenko A.V., Pokrovskaya A.V., Kuimova U.A., Goliusova M.D., Kulabukhova E.I., Kanestri V.G., Kozyrina N.V., Mityurina E.V.
1) Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; 2) Peoples’ Friendship University of Russia, Moscow, Russia; 3) Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia, Moscow, Russia
Subjects and methods. The investigation involved 100 HIV-infected patients who received an effective ART regimen of PhAZT (400 mg twice daily) + 3TC (150 mg twice daily) + Elsulfavirine (ESV) (20 mg daily) for 24–60 weeks; for ART regimen simplification, the patients were switched to the combined drug (PhAZT/3TC) at a dose of 400/150 mg twice daily + ESV.
Results. Within 48 weeks after switching to the combined drug PhAZT/3TC, an undetectable level of HIV RNA was recorded in 97.5–99% of the patients; in this case > 1000 HIV RNA copies were not detected in any patient in 2 subsequent plasma samples obtained at 12-week intervals. 99–100% of patients had high adherence to treatment (they took > 95% of the prescribed doses of the drugs). In the course of treatment, there were insignificant fluctuations in the median CD4+ lymphocyte counts of 592 to 644 cells/µl (p > 0.05). During the follow-up period, none of the patients showed symptoms of secondary diseases, which indicated no clinical progression of HIV infection. The ART regimen was well tolerated; 94–96% of patients did not have any complaints at the time of examination. No treatment-related adverse events (AEs) were reported. Due to the development of AE, the therapy regimen was not discontinued or modified in any of the patients. The indicators of peripheral blood and the parameters of biochemical blood test did not change significantly. There was no decrease in blood hemoglobin < 100 g/l.
Conclusion. The results of the investigation indicate the high efficiency and good safety of the Russian ART regimen that included the combined drug PhAZT/3TC and ESV. This ART regimen can be recommended as a first-line therapy regimen for HIV-infected patients.
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About the Autors
Рrofessor 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
Anastasia V. Pokrovskaya, MD, Senior Researcher, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being; Associate Professor, Department of Infectious Diseases with Courses in Epidemiology and Phthisiology, Medical Institute, Peoples’ Friendship University of Russia, Moscow, Russia; pokrovskaya_av@mail.ru; http://orcid.org/0000-0002-2677-0404
Ulyana A. Kuimova, Cand. Med. Sci., Researcher, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; ulyanakuimova@gmail.com; http://orcid.org/0000-0002-1101-151X
Marina D. Goliusova, Infectiologist, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; mad2501@yandex.ru; https://orcid.org/ 0000-0002-5325-6857
Ekaterina I. Kulabukhova, Cand. Med. Sci., Infectiologist, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being; Head, Laboratory, Department of Infectious Diseases with Courses in Epidemiology and Phthisiology, Medical Institute, Peoples’ Friendship University of Russia, Moscow, Russia; ulyanakuimova@gmail.com; https://orcid.org/0000-0003-3645-7275
Veronika G. Kanestri, MD, Senior Researcher, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; kanestri@yandex.ru; http://orcid.org/0000-0002-2234-7094
Nadezhda V. Kozyrina, Cand. Med. Sci., Senior Researcher, Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, Moscow, Russia; nad-kozyrina@yandex.ru; htpp://orcid.org/0000-0001-5134-0054
Elena V. Mityurina, Cand. Med. Sci., Senior Researcher, Gynecology Department One, Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia, Moscow, Russia; mity-elena@yandex.ru; htpp://orcid.org/0000-0001-8830-2158
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