학술논문
Pharmacokinetics and Safety of Ainuovirine/Lamivudine/Tenofovir Combination Tablets in Young and Elderly Patients with Human Immunodeficiency Virus-1 Infection
Document Type
article
Author
Source
Infectious Diseases and Therapy, Vol 12, Iss 10, Pp 2457-2469 (2023)
Subject
Language
English
ISSN
2193-8229
2193-6382
2193-6382
Abstract
Abstract Introduction Ainuovirine/lamivudine/tenofovir is a novel antiretroviral therapy regimen used to treat human immunodeficiency virus-1 (HIV-1) infection. This study aimed to compare the pharmacokinetics of ainuovirine/lamivudine/tenofovir in HIV-1-infected patients aged ≥ 65 (elderly patients) and ≤ 40 years (young patients). Methods This prospective, open-label, parallel controlled clinical study included 15 young and 15 elderly patients. Blood (1 mL) was collected 30 min before dosing and at 0.5, 1, 1.5, 2, 3, 4, 8, 12, 16, and 24 h after dosing, to measure the plasma concentrations of ainuovirine/lamivudine/tenofovir. Safety was assessed by monitoring the adverse events, physical examinations, and clinical laboratory tests. Results Plasma concentrations of each ainuovirine/lamivudine/tenofovir component reached peak levels 1–4 h after dosing and gradually decreased during the remaining observation period. Compared with the young group, ainuovirine had significantly higher T 1/2Ke, AUC0–24, and AUC0–inf (all P