Efavirenz and rifampicin in the South African context: Is there a need to dose-increase efavirenz with concurrent rifampicin therapy?

Antiviral Therapy

Volumn 16, Issue 4, 2011, Pages 527-534

  Orrell, Catherine ^a   Cohen, Karen ^a   Conradie, Francesca ^b   Zeinecker, Jennifer ^a   Ive, Prudence ^b   Sanne, Ian ^b   Wood, Robin ^a  

^a UNIVERSITY OF CAPE TOWN   (South Africa)

^b UNIVERSITY OF THE WITWATERSRAND   (South Africa)

Author keywords

[No Author keywords available]

Indexed keywords

CYTOCHROME P450 ISOENZYME; EFAVIRENZ; ETHAMBUTOL; ISONIAZID; PYRAZINAMIDE; RIFAMPICIN; STAVUDINE;

ARTICLE; BODY WEIGHT; CD4 LYMPHOCYTE COUNT; CLINICAL TRIAL (TOPIC); COHORT ANALYSIS; CONTROLLED STUDY; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG DOSE REGIMEN; DRUG MECHANISM; ENZYME INDUCTION; EVENING DOSAGE; FEMALE; HUMAN; LUNG TUBERCULOSIS; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; PATIENT COMPLIANCE; PRIORITY JOURNAL; SIDE EFFECT; SOUTH AFRICA; TREATMENT DURATION; VIRUS LOAD; WILCOXON SIGNED RANKS TEST;

AIDS-RELATED OPPORTUNISTIC INFECTIONS; ANTI-HIV AGENTS; ANTITUBERCULAR AGENTS; BENZOXAZINES; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; HIV INFECTIONS; HUMANS; MALE; REVERSE TRANSCRIPTASE INHIBITORS; RIFAMPIN; SOUTH AFRICA; TREATMENT OUTCOME; TUBERCULOSIS;

EID: 79959461052     PISSN: 13596535     EISSN: None     Source Type: Journal    
DOI: 10.3851/IMP1780     Document Type: Article

References (28)

1. National Department of Health, South Africa. National antiretroviral treatment guidelines. (Updated April 2004. Accessed 27 June 2010.) Available from http://hst.org.za/uploads/files/sa-ART-Guidelines1.pdf
2. National Department of Health, South Africa. Clinical guidelines for the management of HIV & AIDS in adults and adolescents. (Updated April 2010. Accessed 6 June 2010.) Available from http://www.doh.gov.za/docs/
3. Ståhle l, Moberg l, Svensson JO, Sönnerborg A. Efavirenz plasma concentrations in HIV-infected patients: inter- and intraindividual variability and clinical effects. Ther Drug Monit 2004; 26:267-270.
4. Marzolini C, Telenti A, Decosterd LA, Greub G, Biollaz J, Buclin T. Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1-infected patients. AIDS 2001; 15:71-75. (Pubitemid 32055781)
5. Gutiérrez F, Navarro A, Padilla S, et al. Prediction of neuro-psychiatric adverse events associated with long term efavirenz therapy, using plasma level monitoring. Clin Infect Dis 2005; 41:1648-1653. (Pubitemid 41691605)
6. Kappelhoff BS, van Leth F, Robinson PA, et al. Are adverse events of nevirapine and efavirenz related to plasma levels? Antivir Ther 2005; 10:489-498. (Pubitemid 41059195)
7. Núñez M, González de Requena D, Gallego l, Jiménez- Nácher I, González-Lahoz J, Soriano V. Higher efavirenz plasma levels correlate with development of insomnia. J Acquir Immune Defic Syndr 2001; 28:399-400.
8. Badri M, Wilson D, Wood R. Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study. Lancet 2002; 359:2059-2064. (Pubitemid 34680968)
9. National Department of Health, South Africa. South African tuberculosis control programme practical guidelines. (Updated 11 July 2000. Accessed 27 June 2010.) Available from http://www.capegateway.gov.za/Text/2003/tb-guidelines2000. pdf
10. Lawn SD, Wilkinson RJ, Lipman MC, Wood R. Immune reconstitution and 'unmasking' of tuberculosis during antiretroviral therapy. Am J Respir Crit Care Med 2008; 177:680-685. (Pubitemid 351490554)
11. Benedek I, Joshi A, Fiske WO, et al. Pharmacokinetic interaction between rifampicin and efavirenz in healthy volunteers. 12th World AIDS Conference. 28 June-3 July 1998, Geneva, Switzerland. Abstract 42280.
12. López-Cortés LF, Ruiz-Valderas R, Viciana P, et al. Pharmacokinetic interactions between efavirenz and rifampicin in HIV-infected patients with tuberculosis. Clin Pharmacokinet 2002; 41:681-690.
13. Sustiva (efavirenz) Package insert 2008. Prescribing Information. Bristol-Meyers Squibb Pharma Company, Princeton, NJ, USA. (Updated November 2010. Accessed 27 June 2010.) Available from http://packageinserts.bms.com/pi/ pi-sustiva.pdf
14. Lewthwaite P, Gibbons S, Vilar F, Khoo S. Efavirenz, rifampicin and rifabutin - a case for therapeutic drug monitoring. 2nd IAS Conference on HIV Pathogenesis and Treatment. 13-16 July 2003, Paris, France. Abstract 851.
15. Brennan-Benson P, Lyus R, Harrison T, Pakianathan M, Macallan D. Pharmacokinetic interactions between efavirenz and rifampicin in the treatment of HIV and tuberculosis: one size does not fit all. AIDS 2005; 19:1541-1543. (Pubitemid 41400701)
16. Ramachandran G, Hemanth Kumar AK, Rajasekaran S, et al. CYP2B6 G516T polymorphism but not rifampin coadministration influences steady-state pharmacokinetics of efavirenz in human immunodeficiency virus-infected patients in South India. Antimicrob Agents Chemother 2009; 53:863-868.
17. Boulle A, Van Cutsem G, Cohen K, et al. Outcomes of nevirapine- and efavirenz-based antiretroviral therapy when coadministered with rifampicin-based antitubercular therapy. JAMA 2008; 300:530-539.
18. Pedral-Sampaio DB, Alves CR, Netto EM, Brites C, Oliveira AS, Badaro R. Efficacy and safety of efavirenz in HIV patients on rifampin for tuberculosis. Braz J Infect Dis 2004; 8:211-216.
19. Cohen K, Grant A, Dandara C, et al. Effect of rifampicin-based antitubercular therapy and the cytochrome P450 2B6 516G>T polymorphism on efavirenz concentrations in adults in South Africa. Antivir Ther 2009; 14:687-695.
20. Manosuthi W, Kiertiburanakul S, Sungkanuparph S, et al. Efavirenz 600 mg/day versus efavirenz 800 mg/day in HIV-infected patients with tuberculosis receiving rifampicin: 48 weeks results. AIDS 2006; 20:131-132. (Pubitemid 41818129)
21. Sanne I, Orrell C, Fox MP, et al. Nurse versus doctor management of HIV-infected patients receiving antiretroviral therapy (CIPRA-SA): a randomised non-inferiority trial. Lancet 2010; 376:33-40.
22. Division of AIDS table for grading the severity of adult and pediatric adverse events. Version 1.0, December 2004. (Updated August 2009. Accessed 07 April 2011.) Available from http://rcc.tech-res.com/safetyandpharmacovigilance/
23. Ren Y, Nuttall JJ, Egbers C, et al. High prevalence of subtherapeutic plasma concentrations of efavirenz in children. J Acquir Immune Defic Syndr 2007; 45:133-136. (Pubitemid 46869804)
24. Chi J, Jayewardene AL, Stone JA, Motoya T, Aweeka FT. Simultaneous determination of five HIV protease inhibitors nelfinavir, indinavir, ritonavir, saquinavir and amprenavir in human plasma by LC/MS/MS. J Pharm Biomed Anal 2002; 30:675-684. (Pubitemid 35279694)
25. Centers for Disease Control and Prevention. Managing drug interactions in the treatment of HIV-related tuberculosis. (Updated 18 May 2008. Accessed 4 January 2010.) Available from http://www.cdc.gov/tb/publications/guidelines/HIV- AIDS.htm
26. Robertson SM, Oenzak SR, Pau A. Drug interactions in the management of HIV infection: an update. Expert Opin Pharmacother 2007; 8:2947-2963. (Pubitemid 350300966)
27. Uttayamakul S, Likanonsakul S, Manosuthi W, et al. Effects of CYP2B6 G516T polymorphisms on plasma efavirenz and nevirapine levels when co-administered with rifampicin in HIV/TB co-infected Thai adults. AIDS Res Ther 2010; 7:8.
28. DiGiacinto JL, Chan-Tack KM, Robertson SM, Reynolds KS, Struble KA. Are literature references sufficient for dose recommendations? An FDA case study of efavirenz and rifampin. J Clin Pharmacol 2008; 48:518-523. (Pubitemid 351389117)