Results of treatment with a 60-week Russian ART regimen in patients with HIV infection

Objective. To evaluate the effectiveness and safety of a 96-week Russian ART regimen, including phosphaside (P-AZT), lamivudine (3TS), and elsulfavirine (ESV), used in HIV-infected patients who have not previously received therapy. Subjects and methods. The investigation enrolled 98 HIV-infected patients who had not previously received ART. As of April 1, 2021, 90, 80, and 72patients completed 24-, 48- and 60- week treatment, respectively. The investigation is being continued. 73.5% of the patients were men. The patients’ age ranged from 22 to 70 years (the median age was 35years). Before starting therapy, the median CD4+ lymphocyte count was 449 cells/pl; the immunoregulatory index (CD4/CD8 lymphocyte ratio) was equal to 0.458. The median HIVRNA was 15,286 copies/ml. Results. At 4 and 12 weeks after starting ART, the patients with a HIV RNA level of < 50 copies/ml were 45.9% and 80%, respectively. At 24, 48, and 60 weeks, the patients achieved undetectable HIV RNA levels in 95.4%, 100%, and 95.3%, respectively. After 24, 48, and 60 weeks of the investigation, the increase in the median CD4+ lymphocyte count was 62, 173, and 190 cells/pl, respectively. The median immunoregulatory index was recorded to increase up to 0.828 at 60 weeks of ART. The tolerability of the ART regimen was good: 92.5-95% of the patients noticed no therapy-related adverse events (AEs). At the beginning of therapy, most of the AEs were generally found to be mild and to require no correction of the treatment regimen or the use of additional therapy. Conclusion. The Russian combination of drugs, including P-AZT + 3TS + ESV, was highly effective and safe during 60-weeks treatment in HIV-infected of patients who had not previously received ART. The use of ESV in combination not only with TDF and FTC, but also with P-AZT and 3TS can be recommended in the first-line ART regimens.

HIV infection, ART, elsulfavirine