Delving into the Latest Updates on Ainuovirine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

艾诺韦林片

+ [2]

Target

RT

Mechanism

RT inhibitors(Reverse transcriptase inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesUrogenital Diseases

Active Indication

HIV Infections

Inactive Indication

Acquired Immunodeficiency Syndrome

Originator Organization

Jiangsu Aidea Pharmaceutical Co., Ltd.

Active Organization

Jiangsu Aidea Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (25 Jun 2021),

HIV Infections

RegulationSpecial Review Project (CN), Priority Review (CN)

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Structure

Molecular FormulaC18H19N3O3

InChIKeyAYPIJAMXGVYYRQ-UHFFFAOYSA-N

CAS Registry1097628-00-6

Background Ainuovirine, as a third-generation non-nucleoside reverse transcriptase inhibitor against HIV-1, is widely used in China. To evaluate its therapeutic efficacy and disadvantages, a comparative study based on Ainuovirine had been conducted. Method We investigated 199 people living with HIV-1 who received Ainuovirine (ANV)/lamivudine/tenofovir and 202 people living with HIV-1 who received Efavirenz (EFV)/lamivudine/tenofovir. Results After 48 weeks of therapy, ANV and EFV showed similar viral inhibitory effects. However, in the ANV group, more participants had CD4/CD8 ratios restored to the normal range, lower levels of triglycerides and low-density lipoprotein, relatively normal liver alanine aminotransferase, and fewer adverse events. Conclusion Therefore, due to its role in immune reconstitution, dyslipidemia, and safety, ANV may be a recommended option for people living with HIV-1.

20 Oct 2024·Chinese Medical Journal

Population pharmacokinetics of Ainuovirine and exposure–response analysis in human immunodeficiency virus-infected individuals

Article

Author: Qin, Hong ; Wu, Hao ; Zheng, Qingshan ; Zhang, Yihang ; Wang, Yao ; Sun, Lijun ; Sun, Jin ; Peng, Haiyan ; Xia, Wei ; Yun, Xinming ; Su, Bin ; Jiang, Taiyi ; Han, Xiaoxu ; Zhang, Tong

AbstractBackground:Ainuovirine (ANV) is a new generation of non-nucleoside reverse transcriptase inhibitor for the treatment of human immunodeficiency virus (HIV) type 1 infection. This study aimed to evaluate the population pharmacokinetic (PopPK) profile and exposure–response relationship of ANV among people living with HIV.Methods:Plasma concentration-time data from phase 1 and phase 3 clinical trials of ANV were pooled for developing the PopPK model. Exposure estimates obtained from the final model were used in exposure–response analysis for virologic responses and safety responses.Results:ANV exhibited a nonlinear pharmacokinetic profile, which was best described by a two-compartment model with first-order elimination. There were no significant covariates correlated to the pharmacokinetic parameters of ANV. The PopPK parameter estimate (relative standard error [%]) for clearance adjusted for bioavailability (CL/F) was 6.46 (15.00) L/h, and the clearance of ANV increased after multiple doses. The exposure–response model revealed no significant correlation between the virologic response (HIV-RNA <50 copies/mL) at 48 weeks and the exposure, but the incidence of adverse events increased with the increasing exposure (P value of steady-state trough concentration and area under the steady-state curve were 0.0177 and 0.0141, respectively).Conclusions:Our PopPK model supported ANV 150 mg once daily as the recommended dose for people living with HIV, requiring no dose adjustment for the studied factors. Optimization of ANV dose may be warranted in clinical practice due to an increasing trend in adverse reactions with increasing exposure.Trial registration:Chinese Clinical Trial Registry https://www.chictr.org.cn (Nos. ChiCTR1800018022 and ChiCTR1800019041).

01 Sep 2024·British Journal of Clinical Pharmacology

Effect of fluconazole on the pharmacokinetics of ainuovirine in healthy adult subjects

Article

100 Deals associated with Ainuovirine

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