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System and method for detecting therapeutic agents to monitor adherence to treatment regimen

A treatment plan and kit technology, applied in antiviral agents, measuring devices, biological tests, etc., can solve problems such as lack of good correlation

Inactive Publication Date: 2022-02-01
奥瑞舒科技公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Self-reported adherence and pharmacy refill data alone did not correlate well with actual adherence in the PREP trial (Amico, K.R. 2014)

Method used

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  • System and method for detecting therapeutic agents to monitor adherence to treatment regimen
  • System and method for detecting therapeutic agents to monitor adherence to treatment regimen

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0229] Example 1: System for detecting NRTIs in urine samples

[0230] TDF / FTC (Truvada TM ) is approved for pre-exposure prophylaxis (PrEP) for HIV infection. Adherence is important for the success of PrEP, but current measures of adherence (self-report) and plasma tenofovir (TFV) levels are insufficient for real-time adherence monitoring. To develop and validate whole blood or plasma assays for measuring TDF levels to objectively monitor adherence to PrEP, three cohort studies were conducted to evaluate the use in the detection of the prodrug NRTI tenofovir disoproxil fumarate (TDF) The active metabolite TFV system. Cohort 1 was a cross-sectional study of 10 HIV-positive subjects with undetectable HIV viral load on a TDF-based regimen; Cohort 2 was a single-dose study of Truvada in 10 healthy subjects , to assess clearance of TFV in plasma and urine over 7 days; Cohort 3 was a 16-week study in which 10 HIV-negative subjects received daily PrEP to assess agreement betwee...

Embodiment 2

[0231] Example 2 Development of Whole Blood or Plasma Assays

[0232] Antiretroviral concentrations in whole blood or plasma may be useful in monitoring adherence to PrEP. Tenofovir is an attractive drug for monitoring compliance because it has a plasma half-life of 17 hours and an intracellular half-life of 150 hours (Hawkins 2005) and can be detected in whole blood or plasma for several days. Preliminary data suggest that TFV levels in whole blood or plasma can be reliably measured and that detection of TFV in whole blood or plasma reflects drug use over a window of 1 to at least 7 days after oral administration of TDF or TAF.

[0233]There is no standard measure of adherence to assess in real time the adherence of patients receiving TDF or TAF for the prevention or treatment of HIV infection. As mentioned above, whole blood or plasma assays for TDM have been shown to have clear benefits in improving compliance in several different areas, with few disadvantages when used ...

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Abstract

The disclosure provides methods, kits and systems for detecting a metabolite that is metabolized from a nucleotide reverse transcriptase inhibitor in a biological sample obtained from a subject, and uses thereof in monitoring adherence to pre-exposure prophylaxis and counseling subjects who are engaged in or prescribed pre-exposure prophylaxis. The present disclosure also provides methods of preventing HIV infection in patients at risk of contracting infection by monitoring adherence to a regimen and adjusting or modifying the dosing schedule of the regimen accordingly. The metabolite may be detected using proteomic methods, including but not limited to antibody based methods, such as a lateral flow immunoassay or lab based assays such as semi-quantitative LC-MS / MS.

Description

[0001] related application [0002] This application claims the benefit of U.S. Provisional Application No. 62 / 827,342, filed April 1, 2019, and U.S. Provisional Application No. 62 / 925,543, filed October 24, 2019, which are incorporated by reference in their entirety In this article. Background technique [0003] Human immunodeficiency virus (HIV) infects millions of people each year, causing very high morbidity and mortality as well as high healthcare costs. Although this is a deadly infectious disease, pharmaceutical interventions have been developed to control the virus in infected patients. The two most widely used drugs for this purpose are the nucleoside reverse transcriptase inhibitors (NRTIs) Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine (FTC) , which are usually combined in Truvada TM in the tablet. Another agent, Tenofovir Alafenamide (TAF), is also widely used as an NRTI. Tablet Descovy in combination with TAF and FTC TM Received FDA approval in 2019. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/50A61K31/712A61K31/7068A61P31/18C07K14/16G01N30/02G01N30/72
CPCA61P31/18G01N30/72A61K31/683A61K31/675G01N27/447G01N2030/8813G01N33/94G01N33/56988G01N33/6848G01N2570/00A61K31/685G01N30/7233G01N2030/8822
Inventor K·卡多斯G·多特里奇
Owner 奥瑞舒科技公司
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