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• W4386777404 abstract "Dario Cattaneo and Cristina Gervasoni recommend using a target dolutegravir trough concentration of 300 ng/mL, which they refer to as the minimum effective concentration (MEC), rather than the protein-adjusted 90% inhibitory concentration (PA-IC90) of 64 ng/mL we used.1Griesel R Zhao Y Simmons B et al.Standard-dose versus double-dose dolutegravir in HIV-associated tuberculosis in South Africa (RADIANT-TB): a phase 2, non-comparative, randomised controlled trial.Lancet HIV. 2023; 10: e433-e441Summary Full Text Full Text PDF PubMed Google Scholar MEC is defined as the minimum plasma drug concentration needed to achieve the desired effect. The geometric mean of dolutegravir trough concentrations was 300 ng/mL in 15 participants randomly assigned to the lowest dolutegravir dose of 10 mg used in the phase 2b dose-ranging study, SPRING-1.2van Lunzen J Maggiolo F Arribas JR et al.Once daily dolutegravir (S/GSK1349572) in combination therapy in antiretroviral-naive adults with HIV: planned interim 48 week results from SPRING-1, a dose-ranging, randomised, phase 2b trial.Lancet Infect Dis. 2012; 12: 111-118Summary Full Text Full Text PDF PubMed Scopus (245) Google Scholar This is not the MEC as all three dolutegravir doses tested in SPRING-1 achieved similar rates of virological suppression; therefore, the minimum concentration for an effect on viral load could not be determined. To our knowledge, the dolutegravir MEC has not been determined. The two studies they cite3Kawuma AN Wasmann RE Dooley KE Boffito M Maartens G Denti P Population pharmacokinetic model and alternative dosing regimens for dolutegravir coadministered with rifampicin.Antimicrob Agents Chemother. 2022; 66e0021522Crossref PubMed Scopus (2) Google Scholar, 4Kawuma AN Wasmann RE Dooley KE Maartens G Denti P Drug-drug interaction between rifabutin and dolutegravir: a population pharmacokinetic model.Br J Clin Pharmacol. 2023; 89: 1216-1221Crossref PubMed Scopus (2) Google Scholar in support of their statement that 300 ng/mL is the MEC were from our group. Neither study was designed to determine the dolutegravir MEC; we only reported on proportions above this target for generalisability as other authors had used it as a pharmacokinetic target. Pharmacokinetic target concentrations need to be scientifically meaningful for clinical research. The PA-IC90 is based on in-vitro virological data, whereas the target of 300 ng/mL is merely the geometric mean dolutegravir trough concentration in a small group of participants from a dose-ranging study in which all three doses had similar effects. Therefore, we feel that the PA-IC90 is the best currently available target for dolutegravir trough concentrations. RG is an employee and shareholder at ViiV Healthcare/GSK. GM declares no competing interests. Standard-dose versus double-dose dolutegravir in HIV-associated tuberculosis in South Africa (RADIANT-TB): a phase 2, non-comparative, randomised controlled trialOur findings suggest that twice-daily dolutegravir might be unnecessary in people with HIV-associated tuberculosis. Full-Text PDF Open AccessDolutegravir dosing with rifampicinRulan Griesel and colleagues1 recently showed similar rates of viral suppression in patients with HIV and tuberculosis concomitantly treated with rifampicin and dolutegravir 50 mg once versus twice daily. Full-Text PDF" @default.
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• W4386777404 date "2023-10-01" @default.
• W4386777404 modified "2023-10-06" @default.
• W4386777404 title "Dolutegravir dosing with rifampicin – Authors' reply" @default.
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• W4386777404 doi "https://doi.org/10.1016/s2352-3018(23)00230-8" @default.
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