Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis

dc.creatorBoulanger, Catherine
dc.creatorRolla, Valeria
dc.creatorAl-Shaer, Mohammad H.
dc.creatorPeloquin, Charles
dc.date2020-03-24T14:12:02Z
dc.date2020-03-24T14:12:02Z
dc.date2020
dc.date.accessioned2023-09-26T21:04:07Z
dc.date.available2023-09-26T21:04:07Z
dc.identifierBOULANGER, Catherine et al. Evaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis. International Journal of Antimicrobial Agents, v. 55, n. 2, p. 1-19, 2020.
dc.identifier0924-8579
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/40473
dc.identifier10.1016/j.ijantimicag.2019.10.021
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8868625
dc.descriptionRifampicin induces the metabolism of many drugs. To overcome the reduction in serum concentrations of lopinavir/ritonavir (LPV/r) when used in combination with rifampicin, 800/200 mg or 400/400 mg doses are used. This study evaluated super-boosted LPV/r (400/400 mg) in HIV/TB co-infected patients for adequate concentrations as well as short-term safety, tolerability and clinical response to therapy. This was an open-label, non-randomised pharmacokinetic (PK) study in HIV/TB patients. The primary objective was to determine the PK profile of super-boosted LPV/r when given with a rifampicin-based TB regimen. Secondary objectives were short-term safety, tolerability and clinical response. Primary endpoints were a lopinavir trough concentration (Cmin) >1.0 µg/mL and a rifampicin maximum concentration (Cmax) of 8-24 µg/mL. Secondary PK endpoints were a rifampicin area under the concentration-time curve from 0-24 h (AUC0-24) of 44-70 µg·h/mL, a lopinavir Cmax of 6-14 µg/mL and a lopinavir AUC0-12 of 56-130 µg·h/mL. Eleven patients (10 male, age 25-43 years) were enrolled. Two patients were discontinued due to non-compliance. A lopinavir Cmin of >1.0 µg/mL was achieved in a least one of the PK samplings in all nine subjects who completed treatment. All patients met lopinavir Cmax and AUC0-12 targets. Five patients achieved the primary endpoint of rifampicin Cmax (≥8 µg/mL) in at least one of the PK samplings, and five achieved the minimum rifampicin AUC0-24 (≥44 µg·h/mL). One grade 3 adverse event was reported. Super-boosted LPV/r was safe and effective in HIV/TB patients. [ClinicalTrials.gov ID NCT01700790.].
dc.formatapplication/pdf
dc.languageeng
dc.publisherElsevier
dc.rightsopen access
dc.subjectHIV
dc.subjectLopinavir
dc.subjectPharmacokinetics
dc.subjectRifampicin
dc.subjectRitonavir
dc.subjectTuberculosis
dc.titleEvaluation of super-boosted lopinavir/ritonavir in combination with rifampicin in HIV-1-infected patients with tuberculosis
dc.typePreprint


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