Effects of fremanezumab-vfrm injection: A Synthesis of Findings from 1 Studies

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Original Abstract of the Article

Key Research Findings

Fostemsavir, a prodrug of the human immunodeficiency virus attachment inhibitor temsavir (TMR), is under development for the treatment of HIV-1 infection in adults with multidrug-resistant HIV-1 infection. 1

This study investigated the effects of fostemsavir on the QT interval at therapeutic and supratherapeutic concentrations of TMR. 1

Fostemsavir 1,200 mg twice daily did not result in a clinically meaningful change from placebo in baseline-adjusted Fridericia-corrected QTc (ddQTcF); however, at a supratherapeutic dose of 2,400 mg twice daily, the upper bound of the two-sided 90% confidence interval (CI) of ddQTcF was 13.2 msec, exceeding the clinically important 10 msec threshold. 1

A linear model of ddQTcF as a function of TMR plasma concentrations described these observations. 1

Based on simulations with this model, TMR concentrations up to 7,500 ng/mL are expected to have an upper 90% CI bound for QTcF ≤ 10 msec. 1

This concentration is 4.2-fold higher than the geometric mean TMR peak plasma concentration (Cmax) of 1,770 ng/mL in heavily treatment-experienced HIV-1 infected patients administered fostemsavir 600 mg twice daily in the phase III BRIGHTE study (NCT02362503). 1

Benefits and Risks

Benefits Summary

Fostemsavir, a prodrug of the human immunodeficiency virus attachment inhibitor temsavir (TMR), is under development for the treatment of HIV-1 infection in adults with multidrug-resistant HIV-1 infection. 1

Fostemsavir 1,200 mg twice daily did not result in a clinically meaningful change from placebo in baseline-adjusted Fridericia-corrected QTc (ddQTcF). 1

Risks Summary

Fostemsavir at a supratherapeutic dose of 2,400 mg twice daily may prolong the QT interval. 1

Comparison between Studies

Commonalities

This study investigated the effects of fostemsavir on the QT interval at therapeutic and supratherapeutic concentrations of TMR. 1

Differences

This study investigated the effects of fostemsavir on the QT interval at therapeutic and supratherapeutic concentrations of TMR. 1

Consistency and Contradictions

Fostemsavir 1,200 mg twice daily did not result in a clinically meaningful change from placebo in baseline-adjusted Fridericia-corrected QTc (ddQTcF). 1

However, at a supratherapeutic dose of 2,400 mg twice daily, the upper bound of the two-sided 90% confidence interval (CI) of ddQTcF was 13.2 msec, exceeding the clinically important 10 msec threshold. 1

Real-World Applications and Considerations

Caution is advised when prescribing fostemsavir to treatment-experienced adults with multidrug-resistant HIV-1 infection due to the potential for QT interval prolongation. 1

Limitations of Current Research

This study investigated the effects of fostemsavir on the QT interval at therapeutic and supratherapeutic concentrations of TMR. 1

This study investigated the effects of fostemsavir on the QT interval at therapeutic and supratherapeutic concentrations of TMR. 1

Future Research Directions

Further investigation of the effects of fostemsavir on the QT interval at therapeutic and supratherapeutic concentrations of TMR is warranted. 1

Additionally, studies evaluating the impact of fostemsavir on the QT interval in combination with other antiretroviral agents are needed. 1

Conclusion

Fostemsavir is a prodrug of the human immunodeficiency virus attachment inhibitor temsavir (TMR), under development for the treatment of HIV-1 infection in adults with multidrug-resistant HIV-1 infection. 1

Fostemsavir 1,200 mg twice daily did not result in a clinically meaningful change from placebo in baseline-adjusted Fridericia-corrected QTc (ddQTcF). 1

However, at a supratherapeutic dose of 2,400 mg twice daily, the upper bound of the two-sided 90% confidence interval (CI) of ddQTcF was 13.2 msec, exceeding the clinically important 10 msec threshold. 1

Caution is advised when prescribing fostemsavir to treatment-experienced adults with multidrug-resistant HIV-1 infection due to the potential for QT interval prolongation. 1

Future research should further investigate the effects of fostemsavir on the QT interval at therapeutic and supratherapeutic concentrations of TMR. 1

Keywords
Benefit Keywords
HIV-1 treatment
1
Risk Keywords
Arrhythmia
QTc prolongation
1
Literature analysis of 1 papers
Positive Content
1
Neutral Content
0
Negative Content
0
Article Type
1
0
0
0
1
1.

Effects of Temsavir, Active Moiety of Antiretroviral Agent Fostemsavir, on QT Interval: Results From a Phase I Study and an Exposure-Response Analysis.

Author: LagishettyChakradhar, MooreKaty, AckermanPeter, LlamosoCyril, MageeMindy

HIV-1 treatment
Arrhythmia
QTc prolongation

Fostemsavir, a prodrug of temsavir, was found to be safe for treating multidrug-resistant HIV infection at therapeutic doses. However, supratherapeutic doses showed a potential for QTc prolongation.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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