Pharmacokinetic study of two different rifabutin doses co-administered with lopinavir/ritonavir in African HIV and tuberculosis co-infected adult patients.

Szczegóły
Abstrakt

Tytuł:: Pharmacokinetic study of two different rifabutin doses co-administered with lopinavir/ritonavir in African HIV and tuberculosis co-infected adult patients.
Autorzy:: Kouanda S; Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso. .
Ouedraogo HG; Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.
Cisse K; Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.
Compaoré TR; Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.
Sulis G; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.; McGill International TB Centre, McGill University, Montreal, QC, Canada.
Diagbouga S; Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.
Roggi A; Institute of Infectious and Tropical Diseases, Brescia University Hospital, Brescia, Italy.
Tarnagda G; Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.
Villani P; Institute of Pharmacology, IRCCS, San Matteo University Hospital, Pavia, Italy.
Sangare L; Yalgado Ouedraogo University Teaching Hospital, Ouagadougou, Burkina Faso.
Simporé J; Centre de Recherche Biomoléculaire Pietro Annigoni (CERBA), Ouagadougou, Burkina Faso.
Regazzi M; Institute of Pharmacology, IRCCS, San Matteo University Hospital, Pavia, Italy.
Matteelli A; Institute of Infectious and Tropical Diseases, Brescia University Hospital, Brescia, Italy.
Źródło:: BMC infectious diseases [BMC Infect Dis] 2020 Jun 26; Vol. 20 (1), pp. 449. Date of Electronic Publication: 2020 Jun 26.
Typ publikacji:: Journal Article
Język:: English
Imprint Name(s):: Original Publication: London : BioMed Central, [2001-
MeSH Terms:: AIDS-Related Opportunistic Infections/*drug therapy
Antibiotics, Antitubercular/*administration & dosage
Antibiotics, Antitubercular/*therapeutic use
Coinfection/*drug therapy
HIV Protease Inhibitors/*therapeutic use
Lopinavir/*therapeutic use
Rifabutin/*administration & dosage
Rifabutin/*therapeutic use
Ritonavir/*therapeutic use
Tuberculosis/*drug therapy
Adult ; Antibiotics, Antitubercular/adverse effects ; Antibiotics, Antitubercular/blood ; Burkina Faso ; Chromatography, High Pressure Liquid ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Humans ; Male ; Microbial Sensitivity Tests ; Pilot Projects ; Random Allocation ; Rifabutin/adverse effects ; Rifabutin/blood ; Tandem Mass Spectrometry
References:: Clin Chest Med. 2009 Dec;30(4):685-99, viii. (PMID: 19925961)
Antivir Ther. 2005;10(4):469-77. (PMID: 16038472)
PLoS One. 2014 Jan 22;9(1):e84866. (PMID: 24465443)
Antimicrob Agents Chemother. 2011 Jul;55(7):3195-200. (PMID: 21537021)
Clin Chem. 1999 Sep;45(9):1465-76. (PMID: 10471649)
Antimicrob Agents Chemother. 2012 Aug;56(8):4303-9. (PMID: 22644026)
J Antimicrob Chemother. 2009 Oct;64(4):871-3. (PMID: 19628472)
Bull World Health Organ. 2012 Sep 1;90(9):693-8. (PMID: 22984314)
Neth J Med. 1996 Jun;48(6):211-5. (PMID: 8710040)
PLoS One. 2012;7(6):e38598. (PMID: 22761688)
Can Respir J. 2011 Jul-Aug;18(4):225-9. (PMID: 22059181)
Pharmacotherapy. 2009 May;29(5):503-10. (PMID: 19397460)
Clin Pharmacol Ther. 2003 Dec;74(6):591-2; discussion 592-3. (PMID: 14663461)
PLoS One. 2016 Aug 18;11(8):e0160481. (PMID: 27536864)
BMC Pharmacol Toxicol. 2014 Nov 19;15:61. (PMID: 25406657)
Eur J Clin Pharmacol. 1996;49(4):251-4. (PMID: 8857068)
Drugs. 2014 Jun;74(8):839-54. (PMID: 24846578)
Clin Infect Dis. 1996 Apr;22 Suppl 1:S15-21; discussion S21-2. (PMID: 8785251)
Clin Infect Dis. 1995 Sep;21(3):594-8. (PMID: 8527549)
Eye (Lond). 2007 Dec;21(12):1540-1. (PMID: 17962822)
Antimicrob Agents Chemother. 1997 May;41(5):924-6. (PMID: 9145845)
BMC Med. 2013 Dec 02;11:253. (PMID: 24295487)
PLoS One. 2014 Nov 12;9(11):e112017. (PMID: 25391135)
Clin Infect Dis. 2009 Nov 1;49(9):1305-11. (PMID: 19807276)
Clin Infect Dis. 1996 Apr;22 Suppl 1:S3-13; discussion S13-4. (PMID: 8785253)
Antimicrob Agents Chemother. 1998 Mar;42(3):631-9. (PMID: 9517944)
Clin Pharmacokinet. 1984 Nov-Dec;9(6):511-44. (PMID: 6391781)
Br J Clin Pharmacol. 2012 Jan;73(1):27-36. (PMID: 21831196)
Drugs. 1994 Jun;47(6):983-1009. (PMID: 7521834)
Clin Pharmacokinet. 2014 Jun;53(6):489-507. (PMID: 24777631)
JAMA. 1996 Oct 16;276(15):1229-35. (PMID: 8849750)
J Antimicrob Chemother. 2012 Oct;67(10):2470-3. (PMID: 22678727)
Int Health. 2011 Jun;3(2):101-7. (PMID: 24038182)
Drug Metabol Drug Interact. 2009;24(2-4):259-74. (PMID: 20408503)
PLoS One. 2013 Aug 05;8(8):e70611. (PMID: 23940604)
Grant Information:: TA.2011.40200.026 EDCTP; TA.2011.40200.026 European and Developing Countries Clinical Trials Partnership
Contributed Indexing:: Keywords: Burkina Faso; HIV/tuberculosis co-infection; Lopinavir; Pharmacokinetic; Rifabutin
Substance Nomenclature:: 0 (Antibiotics, Antitubercular)
0 (HIV Protease Inhibitors)
1W306TDA6S (Rifabutin)
2494G1JF75 (Lopinavir)
O3J8G9O825 (Ritonavir)
Entry Date(s):: Date Created: 20200628 Date Completed: 20200707 Latest Revision: 20200707
Update Code:: 20240105
PubMed Central ID:: PMC7318514
DOI:: 10.1186/s12879-020-05169-2
PMID:: 32590942
: Czasopismo naukowe

Full Text Finder

Background: This study aimed to assess the pharmacokinetic profile of 150 mg rifabutin (RBT) taken every other day (every 48 h) versus 300 mg RBT taken every other day (E.O.D), both in combination with lopinavir/ritonavir (LPV/r), in adult patients with human immunodeficiency virus (HIV) and tuberculosis (TB) co-infection.
Methods: This is a two-arm, open-label, pharmacokinetic, randomised study conducted in Burkina Faso between May 2013 and December 2015. Enrolled patients were randomised to receive either 150 mg RBT EOD (arm A, 9 subjects) or 300 mg RBT EOD (arm B, 7 subjects), both associated with LPV/r taken twice daily. RBT plasma concentrations were evaluated after 2 weeks of combined HIV and TB treatment. Samples were collected just before drug ingestion and at 1, 2, 3, 4, 6, 8, and 12 h after drug ingestion to measure plasma drug concentration using an HPLC-MS/MS assay.
Results: The Cmax and AUC 0-12h medians in arm A (Cmax = 296 ng/mL, IQR: 205-45; AUC 0-12h = 2528 ng.h/mL, IQR: 1684-2735) were lower than those in arm B (Cmax = 600 ng/mL, IQR: 403-717; AUC 0-12h = 4042.5 ng.h/mL, IQR: 3469-5761), with a statistically significant difference in AUC 0-12h (p = 0.044) but not in Cmax (p = 0.313). No significant differences were observed in Tmax (3 h versus 4 h). Five patients had a Cmax below the plasma therapeutic limit (< 300 ng/mL) in the 150 mg RBT arm, while the Cmax was above this threshold for all patients in the 300 mg RBT arm. Additionally, at 48 h after drug ingestion, all patients had a mycobacterial minimum inhibitory concentration (MIC) above the limit (> 64 ng/mL) in the 300 mg RBT arm, while 4/9 patients had such values in the 150 mg RBT arm.
Conclusion: This study confirmed that the 150 mg dose of rifabutin ingested EOD in combination with LPV/r is inadequate and could lead to selection of rifamycin-resistant mycobacteria.
Trial Registration: PACTR201310000629390, 28th October 2013.

Informacja