The efficiency and safety of ART after switching patients to the combined Russian NRTI phosphaladine in combination with elsulfavirine


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Abstract

Objective. To evaluate the efficiency and safety of the ART regimen including the combined Russian drug phosphazide/ lamivudine (PhAZT/3TC) in HIV patients switched from the ARTregimen containing mono-drugs PhAZT + 3ТС. 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) (20mg daily) for 24- 60 weeks; for ART regimen simplification, the patients were switched to the combined drug (PhAZT/3TC) at a dose of400/150 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/pl (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 authors

Alexey V. Kravchenko

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

Email: alexey-kravtchenko@yandex.ru
МD, Leader Researcher

Anastasia V. Pokrovskaya

Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being; Peoples' Friendship University of Russia

Email: pokrovskaya_av@mail.ru
Cand. Med. Sci., Senior Researcher

Ulyana A. Kuimova

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

Email: ulyanakuimova@gmail.com
Cand. Med. Sci., Researcher, Central Research Institute of Epidemiology

Marina D. Goliusova

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

Email: mad2501@yandex.ru
Infectiologist, Central Research Institute of Epidemiology

Ekaterina I. Kulabukhova

Central Research Institute of Epidemiology, Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being; Peoples' Friendship University of Russia

Email: ekulabukhova@mail.ru
Cand. Med. Sci., Infectiologist

Veronika G. Kanestri

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

Email: kanestri@yandex.ru
MD, Senior Researcher

Nadezhda V. Kozyrina

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

Email: nad-kozyrina@yandex.ru
Cand. Med. Sci., Senior Researcher

Elena V. Mityurina

Academician V.I. Kulakov National Medical Research Center of Obstetrics, Gynecology, and Perinatology, Ministry of Health of Russia

Cand. Med. Sci., Senior Researcher, Gynecology Department One

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