Are literature references sufficient for dose recommendations? An FDA case study of efavirenz and rifampin

Journal of Clinical Pharmacology

Volumn 48, Issue 4, 2008, Pages 518-523

  DiGiacinto, Jennifer L ^a   Chan Tack, Kirk M ^a   Robertson, Sarah M ^a   Reynolds, Kellie S ^a   Struble, Kimberly A ^a,b  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b WO 22 ^*  (United States)

Author keywords

Drug interaction; Efavirenz; HIV; Rifampin; Tuberculosis

Indexed keywords

EFAVIRENZ; RIFAMPICIN; TUBERCULOSTATIC AGENT;

AREA UNDER THE CURVE; CENTRAL NERVOUS SYSTEM DISEASE; CLINICAL TRIAL; DRUG BLOOD LEVEL; DRUG DOSE COMPARISON; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; DRUG SAFETY; DRUG WITHDRAWAL; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEPATITIS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; LIVER FUNCTION; MEDICAL LITERATURE; RASH; RECOMMENDED DRUG DOSE; REVIEW; SIDE EFFECT; TUBERCULOSIS;

ANTI-HIV AGENTS; ANTITUBERCULAR AGENTS; BENZOXAZINES; DATABASES, BIBLIOGRAPHIC; DRUG INTERACTIONS; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REFERENCE STANDARDS; RIFAMPIN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 40749123011     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270008315308     Document Type: Review

References (22)

1. Dean GL, Edwards SG, Ives NJ, et al. Treatment of tuberculosis in HIV-infected persons in the era of highly active antiretroviral therapy. AIDS. 2002 ; 16: 75-83.
2. Badri M., Wilson D., Wood R. Effect of HAART on incidence of TB in South Africa: a cohort study. Lancet. 2002 ; 359: 2059-2064.
3. US Department of Health and Human Services (DHHS) Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents. October 10, 2006. Available at: http://www.aidsinfo.nih.gov/guidelines/. Accessed June 29, 2007.
4. Faucette SR, Zhang TC, Moore R., et al. Relative activation of human pregnane X receptor versus constitutive androstane receptor defines distinct classes of CYP2B6 and CYP3A4 inducers. J Pharmacol Exp Ther. 2007 ; 320: 72-80.
5. Ward BA, Gorski JC, Jones DR, Hall SD, Flockhart DA, Desta Z. The cytochrome P450 2B6 (CYP2B6) is the main catalyst of efavirenz primary and secondary metabolism: implication for HIV/AIDS therapy and utility of efavirenz as a substrate marker of CYP2B6 catalytic activity. J Pharmacol Exp Ther. 2003 ; 306: 287-300.
6. Sustiva [efavirenz capsules and tablets]. Princeton, NJ: Bristol-Myers Squibb Company ; 2007.
7. Gutierrez F., Navarro A., Padilla S., et al. Prediction of neuropsychiatric adverse events associated with long-term efavirenz therapy, using plasma drug level monitoring. Clin Infect Dis. 2005 ; 41: 1648-1653.
8. Marzolini C., Telenti A., Decostered LA, et al. Efavirenz plasma levels can predict treatment failure and central nervous system side effects in HIV-1 infected patients. AIDS. 2001 ; 15: 71-75.
9. Lang T., Klein K., Fischer J., et al. Extensive genetic polymorphism in the human CYP2B6 gene with impact on expression and function in human liver. Pharmacogenetics. 2001 ; 11: 399-415.
10. Haas DW, Ribaudo HJ, Kim RB, et al. Pharmacogenetics of efavirenz and central nervous system side effects: an Adult AIDS Clinical Trials Group study. AIDS. 2004 ; 18: 2391-2400.
11. Rodriguez-Novoa S., Barreiro P., Rendon A., Jimenez-Nacher I., Gonzalez-Lahoz J., Soriano V. Influence of 516G>T polymorphisms at the gene encoding the CYP450-2B6 isoenzyme on efavirenz plasma concentrations in HIV-infected subjects. Clin Infect Dis. 2005 ; 40: 1358-1361.
12. Pozniak AL, Miller RF, Lipman MCI, et al, on behalf of the BHIVA Guidelines Writing Committee. BHIVA treatment guidelines for HIV/TB infection. February 2005. Available at: http://www.bhiva.org/. Accessed June 29, 2007.
13. Lopez-Cortes 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.
14. Manosuthi W., Sungkanuparph S., Thakkinstian A., et al. Efavirenz levels and 24-week efficacy in HIV-infected patients with tuberculosis receiving highly active antiretroviral therapy and rifampicin. AIDS. 2005 ; 19: 1481 - 1486.
15. 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.
16. 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.
17. Friedland G., Khoo S., Jack C., Lalloo U. Administration of efavirenz (600 mg/day) with rifampicin results in highly variable levels but excellent clinical outcomes in patients treated for tuberculosis and HIV. J Antimicrob Chemother. 2006 ; 58: 1299-1302.
18. Gazzard B., on behalf of the BHIVA Writing Committee. British HIV Association (BHIVA) guidelines for the treatment of HIV-infected adults with antiretroviral therapy, 2006. HIV Med. 2006 ; 7: 487 - 503.
19. Gonzalez de Requena D., Gallego O., Corral A., Jimenz-Hacher J., Soriano V. Higher efavirenz concentrations determine the response to viruses carrying non-nucleoside reverse transcriptase resistance mutations. AIDS. 2004 ; 18: 2091-2094.
20. Gatanaga H., Hayashida T., Tsuchiya K. Successful efavirenz dose reduction in HIV type 1-infected individuals with cytochrome P450 2B6*6 and *26. Clin Infect Dis. 2007 ; 45: 1230-1237.
21. Wang J., Sönnerborg A., Rane A., et al. Identification of a novel specific CYP2B6 allele in Africans causing impaired metabolism of the HIV drug efavirenz. Pharmacogenet Genomics. 2006 ; 16: 191-198.
22. Burger D., van der Heiden I., la Porte C., et al. Interpatient variability in the pharmacokinetics of the HIV non-nucleoside reverse transcriptase inhibitor efavirenz: the effect of gender, race, and CYP2B6 polymorphism. Br J Clin Pharmacol. 2006 ; 61: 148-154.