Development, validation and clinical implementation of a UPLC-MS/MS bioanalytical method for simultaneous quantification of cabotegravir and rilpivirine E-isomer in human plasma

Bevers, L.A.H.; van Ewijk – Beneken Kolmer, E.W.J.; Te Brake, L.H.M.; Burger, D.M.

doi:10.1016/j.jpba.2023.115832

Journal of Pharmaceutical and Biomedical Analysis

2024

DOI: 10.1016/j.jpba.2023.115832

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Development, validation and clinical implementation of a UPLC-MS/MS bioanalytical method for simultaneous quantification of cabotegravir and rilpivirine E-isomer in human plasma

L.A.H. Bevers,

E.W.J. van Ewijk – Beneken Kolmer,

L.H.M. Te Brake

et al.

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2024

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Cited by 5 publications

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“…Resistance testing on the latter sample identified mutations for CAB (N155S) and RPV (E138K); the HIV-1 was subtyped as A6. Plasma trough concentrations of CAB and RPV, determined by LC-MS/MS [ 3 ], were notably low: 0.91 mg/l (median population value: 1.6 mg/l; Q1 target: 1.1 mg/l [ 4 ]) and 0.026 mg/l (median population value: 0.066 mg/l; Q1 target: 0.032 mg/l [ 4 ]), respectively.…”

mentioning

confidence: 99%

Concomitant use of anabolic androgen steroids and cabotegravir/rilpivirine leading to virological failure and development of two-class resistance

Burger,

Wttewaal,

Oosterhof

et al. 2024

Aids

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mentioning

confidence: 99%

Concomitant use of anabolic androgen steroids and cabotegravir/rilpivirine leading to virological failure and development of two-class resistance

Burger,

Wttewaal,

Oosterhof

et al. 2024

Aids

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Development of a Cr2AlC MAX phase/g-C3N4 composite-based electrochemical sensor for accurate cabotegravir determination in pharmaceutical and biological samples

Bouali,

Genc,

Erk

et al. 2024

Microchim Acta

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Virological Failure After Switch to Long-Acting Cabotegravir and Rilpivirine Injectable Therapy: An In-depth Analysis

van Welzen,

Van Lelyveld,

Ter Beest

et al. 2024

Clinical Infectious Diseases

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Background Long-acting (LA) injectable therapy with cabotegravir (CAB) and rilpivirine (RPV) is currently used as maintenance treatment for HIV-1, and has a low risk for virological failure (VF). Although the risk is low, the circumstances and impact of VF in the real-world setting merits further evaluation. Methods We performed an in-depth clinical, virological and pharmacokinetic analysis on the reasons behind, and the impact of VF during LA CAB/RPV therapy in five cases from the Netherlands. Genotypic resistance testing was performed after the occurrence of VF and drug plasma (trough) concentrations were measured after VF was established and on any other samples to assess on-treatment drug levels. CAB and RPV drug levels that were below the first quartile of the population cut-off (<Q1) were considered to be low. Results Five cases who were eligible for LA CAB/RPV experienced VF despite a low predicted risk at baseline. Genotypic resistance testing revealed extensive selection of non-nucleoside reverse transcriptase inhibitor associated mutations in all, and integrase strand transfer inhibitor mutations in four cases. All cases displayed low drug levels of either CAB, RPV or both during the treatment course, likely contributing to the occurrence of VF. In three cases, we were able to identify the potential mechanisms behind these low drug levels. Conclusions This is the first in-depth multiple case analysis of VF on LA CAB/RPV therapy in a real-world setting. Our observations stress the need to be aware for (evolving) risk factors and the yield of a comprehensive clinical, virological and pharmacokinetic approach in case of failure.

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Development, validation and clinical implementation of a UPLC-MS/MS bioanalytical method for simultaneous quantification of cabotegravir and rilpivirine E-isomer in human plasma

Cited by 5 publications

References 8 publications

Concomitant use of anabolic androgen steroids and cabotegravir/rilpivirine leading to virological failure and development of two-class resistance

Concomitant use of anabolic androgen steroids and cabotegravir/rilpivirine leading to virological failure and development of two-class resistance

Development of a Cr2AlC MAX phase/g-C3N4 composite-based electrochemical sensor for accurate cabotegravir determination in pharmaceutical and biological samples

Virological Failure After Switch to Long-Acting Cabotegravir and Rilpivirine Injectable Therapy: An In-depth Analysis

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