The Results of the Efficacy and Safety of the New Russian Drug 6нр in the Antiretroviral Therapy Regimens of Hiv-Infected Patients

Abstract

The aim of the study was to assess the efficacy and safety of ART regimens that included different doses of the drug 6НР with the reception of QD, in comparison with the scheme of ART, containing, PhAZT, to select the daily dose 6НР in conducting phase III clinical trials.Patients and methods. 125 patients were randomized to 25 people in 4 groups, depending on the daily dose of the drug 6НР (600, 800, 1000, 1200 mg), and in the comparison group (phosphazide). For a daily dose of the drug 6НР the study was blind. All patients, in addition to the studied drugs were receiving 3TC and EFV. The effectiveness of ART regimens was assessed by the proportion of patients with HIV RNA <50 copies/ml and CD4+lymphocyte increase after 24 weeks of therapy.Results. The use of ART scheme, which included 6НР + 3TС + EFV, was highly effective regardless of the daily dose of the drug 6НР, and is comparable to the effectiveness of the comparison mode (PhAZT+3TC+EFV). More than 95.5% of patients receiving 600 mg and 800 mg of the drug 6НР QD, after 24 weeks of therapy, the level of HIV RNA was < 50 copies/ml (in the comparison group – 87.5%). In patients of all groups there was a significant increase in the median CD4+lymphocytes. The maximum result of increasing the median CD4 + lymphocyte count (164 cells/µl) was observed in patients receiving the drug 6НР – 600 mg/day. All the studied modes was safe because of the 24-week study made up 94% of the patients receiving 6НР, and 96% of receiving PhAZT. Only 1 patient (1%) receiving the maximum daily dose 6НР (1200 mg), marked AES possibly related to study medication, and which led to the cancellation of the treatment.Conclusions. The effectiveness and safety of all modes of ART did not depend on the daily dose of the drug 6НР and was comparable to the comparison scheme, which included PhAZT. The maximum virological and immunological response after 24 weeks of therapy was achieved in patients receiving the drug 6НР at a dose of 600 mg QD in the ART scheme. The drug 6HP is recommended for phase III study in a daily dose of 600 mg in the ART.

25 years of the use of domestic original antiretroviral drugs in first-line ART regimens of HIV-infection

“…В 2016-2018 гг. было проведено многоцентровое рандомизированое частично слепое клиническое исследование эффективности и безопасности препарата 6НР в сравнении с препаратом ФАЗТ на фоне стандартной терапии, состоящей из 3TC и EFV, у ранее не получавших АРТ ВИЧ-инфицированных больных [24]. Оценивали эффективность и безопасность схем АРТ, включавших различные суточные дозировки препарата 6НР (от 600 до 1200 мг) для выбора суточной дозы 6НР по сравнению со схемой АРТ, содержавшей ФАЗТ (III фаза клинических исследований).…”

“…Максимальный вирусологический и иммунологический ответ через 24 нед терапии был достигнут у пациентов, получавших препарат 6НР в дозе 600 мг/сут в составе схемы АРТ. Препарат 6НР был рекомендован для проведения исследования III фазы в суточной дозе 600 мг в составе схемы АРТ [24]. В настоящее время проводится клиническое исследование III фазы по эффективности и безопасности препарата 6НР (600 мг/сут) в комбинации с 3ТС и долутегравиром (DTG) в сравнении со схемой TDF + 3TC + DTG.…”