Pharmacokinetic study of two different rifabutin doses co-administered with lopinavir/ritonavir in African HIV and tuberculosis co-infected adult patients.
AIDS-Related Opportunistic Infections
/ drug therapy
Adult
Antibiotics, Antitubercular
/ administration & dosage
Burkina Faso
Chromatography, High Pressure Liquid
Coinfection
/ drug therapy
Drug Therapy, Combination
Female
Follow-Up Studies
HIV Protease Inhibitors
/ therapeutic use
Humans
Lopinavir
/ therapeutic use
Male
Microbial Sensitivity Tests
Pilot Projects
Random Allocation
Rifabutin
/ administration & dosage
Ritonavir
/ therapeutic use
Tandem Mass Spectrometry
Tuberculosis
/ drug therapy
Burkina Faso
HIV/tuberculosis co-infection
Lopinavir
Pharmacokinetic
Rifabutin
Journal
BMC infectious diseases
ISSN: 1471-2334
Titre abrégé: BMC Infect Dis
Pays: England
ID NLM: 100968551
Informations de publication
Date de publication:
26 Jun 2020
26 Jun 2020
Historique:
received:
18
06
2019
accepted:
17
06
2020
entrez:
28
6
2020
pubmed:
28
6
2020
medline:
8
7
2020
Statut:
epublish
Résumé
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. 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. The Cmax and AUC 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. PACTR201310000629390, 28th October 2013.
Sections du résumé
BACKGROUND
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
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
RESULTS
The Cmax and AUC
CONCLUSION
CONCLUSIONS
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
BACKGROUND
PACTR201310000629390, 28th October 2013.
Identifiants
pubmed: 32590942
doi: 10.1186/s12879-020-05169-2
pii: 10.1186/s12879-020-05169-2
pmc: PMC7318514
doi:
Substances chimiques
Antibiotics, Antitubercular
0
HIV Protease Inhibitors
0
Rifabutin
1W306TDA6S
Lopinavir
2494G1JF75
Ritonavir
O3J8G9O825
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
449Subventions
Organisme : EDCTP
ID : TA.2011.40200.026
Organisme : European and Developing Countries Clinical Trials Partnership
ID : TA.2011.40200.026
Références
Clin Chest Med. 2009 Dec;30(4):685-99, viii
pubmed: 19925961
Antivir Ther. 2005;10(4):469-77
pubmed: 16038472
PLoS One. 2014 Jan 22;9(1):e84866
pubmed: 24465443
Antimicrob Agents Chemother. 2011 Jul;55(7):3195-200
pubmed: 21537021
Clin Chem. 1999 Sep;45(9):1465-76
pubmed: 10471649
Antimicrob Agents Chemother. 2012 Aug;56(8):4303-9
pubmed: 22644026
J Antimicrob Chemother. 2009 Oct;64(4):871-3
pubmed: 19628472
Bull World Health Organ. 2012 Sep 1;90(9):693-8
pubmed: 22984314
Neth J Med. 1996 Jun;48(6):211-5
pubmed: 8710040
PLoS One. 2012;7(6):e38598
pubmed: 22761688
Can Respir J. 2011 Jul-Aug;18(4):225-9
pubmed: 22059181
Pharmacotherapy. 2009 May;29(5):503-10
pubmed: 19397460
Clin Pharmacol Ther. 2003 Dec;74(6):591-2; discussion 592-3
pubmed: 14663461
PLoS One. 2016 Aug 18;11(8):e0160481
pubmed: 27536864
BMC Pharmacol Toxicol. 2014 Nov 19;15:61
pubmed: 25406657
Eur J Clin Pharmacol. 1996;49(4):251-4
pubmed: 8857068
Drugs. 2014 Jun;74(8):839-54
pubmed: 24846578
Clin Infect Dis. 1996 Apr;22 Suppl 1:S15-21; discussion S21-2
pubmed: 8785251
Clin Infect Dis. 1995 Sep;21(3):594-8
pubmed: 8527549
Eye (Lond). 2007 Dec;21(12):1540-1
pubmed: 17962822
Antimicrob Agents Chemother. 1997 May;41(5):924-6
pubmed: 9145845
BMC Med. 2013 Dec 02;11:253
pubmed: 24295487
PLoS One. 2014 Nov 12;9(11):e112017
pubmed: 25391135
Clin Infect Dis. 2009 Nov 1;49(9):1305-11
pubmed: 19807276
Clin Infect Dis. 1996 Apr;22 Suppl 1:S3-13; discussion S13-4
pubmed: 8785253
Antimicrob Agents Chemother. 1998 Mar;42(3):631-9
pubmed: 9517944
Clin Pharmacokinet. 1984 Nov-Dec;9(6):511-44
pubmed: 6391781
Br J Clin Pharmacol. 2012 Jan;73(1):27-36
pubmed: 21831196
Drugs. 1994 Jun;47(6):983-1009
pubmed: 7521834
Clin Pharmacokinet. 2014 Jun;53(6):489-507
pubmed: 24777631
JAMA. 1996 Oct 16;276(15):1229-35
pubmed: 8849750
J Antimicrob Chemother. 2012 Oct;67(10):2470-3
pubmed: 22678727
Int Health. 2011 Jun;3(2):101-7
pubmed: 24038182
Drug Metabol Drug Interact. 2009;24(2-4):259-74
pubmed: 20408503
PLoS One. 2013 Aug 05;8(8):e70611
pubmed: 23940604