Relationship between weight, efavirenz exposure, and virologic suppression in HIV-infected patients on rifampin-based tuberculosis treatment in the AIDS clinical trials group A5221 STRIDE study

Clinical Infectious Diseases

Volumn 57, Issue 4, 2013, Pages 586-593

  Luetkemeyer, Anne F ^a   Rosenkranz, Susan L ^b   Lu, Darlene ^b   Marzan, Florence ^c   Ive, Prudence ^d   Hogg, Evelyn ^e   Swindells, Susan ^f   Benson, Constance A ^g   Grinsztejn, Beatriz ^h   Sanne, Ian M ^d   Havlir, Diane V ^a   Aweeka, Francesca ^c  

^a UNIVERSITY OF CALIFORNIA   (United States)

^b CENTER FOR BIOSTATISTICS IN AIDS RESEARCH   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF THE WITWATERSRAND   (South Africa)

^e SOCIAL AND SCIENTIFIC SYSTEMS INC   (United States)

^f UNIVERSITY OF NEBRASKA AT OMAHA   (United States)

^g UNIVERSITY OF CALIFORNIA   (United States)

^h Funda??o Oswaldo Cruz   (Brazil)

Author keywords

Efavirenz; HIV AIDS; Pharmacokinetics; Rifampin; Tuberculosis

Indexed keywords

EFAVIRENZ; EMTRICITABINE; RIFAMPICIN; TENOFOVIR DISOPROXIL; VIRUS RNA;

ADULT; ANTIVIRAL THERAPY; ARTICLE; BODY MASS; BODY WEIGHT; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG DOSE INCREASE; DRUG EXPOSURE; FEMALE; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; TUBERCULOSIS;

EFAVIRENZ; HIV/AIDS; PHARMACOKINETICS; RIFAMPIN; TUBERCULOSIS;

ADULT; ANTI-HIV AGENTS; ANTITUBERCULAR AGENTS; BENZOXAZINES; BODY WEIGHT; DRUG INTERACTIONS; FEMALE; HIV INFECTIONS; HUMANS; MALE; RIFAMPIN; TREATMENT OUTCOME; TUBERCULOSIS; VIRAL LOAD;

EID: 84880965736     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cit246     Document Type: Article

References (43)

1. Abdool Karim SS, Naidoo K, Grobler A, et al. Timing of initiation of antiretroviral drugs during tuberculosis therapy. N Engl J Med 2010; 362:697-706.
2. Havlir DV, Kendall MA, Ive P, et al. Timing of antiretroviral therapy for HIV-1 infection and tuberculosis. New Engl J Med 2011; 365:1482-91.
3. Blanc FX, Sok T, Laureillard D, et al. Earlier versus later start of antiretroviral therapy in HIV-infected adults with tuberculosis. N Engl J Med 2011; 365:1471-81.
4. World Health Organization. WHO policy on collaborative TB/HIV activities: guidelines for national programmes and other stakeholders. Geneva, Switzerland: WHO, 2012.
5. Rotger M, Tegude H, Colombo S, et al. Predictive value of known and novel alleles of CYP2B6 for efavirenz plasma concentrations in HIV-infected individuals. Clin Pharmacol Ther 2007; 81:557-66.
6. 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; 18:2391-400.
7. 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; 14:687-95.
8. Wang J, Sonnerborg 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; 16:191-8.
9. Grady BJ, Ritchie MD, Acosta EP, et al. Genome wide association study (GWAS) of plasma efavirenz pharmacokinetics in AIDS Clinical Trials Group (ACTG) protocols. In: 19th Conference on Retroviruses and Opportunistic Infections, Seattle, WA,2012. Abstract 593.
10. King J, Aberg JA. Clinical impact of patient population differences and genomic variation in efavirenz therapy. AIDS 2008; 22:1709-17.
11. Kwara A, Lartey M, Sagoe KW, Rzek NL, Court MH. CYP2B6 (c.516G->T) and CYP2A6 (9B and/or 17) polymorphisms are independent predictors of efavirenz plasma concentrations in HIV-infected patients. Br J Clin Pharmacol 2009; 67:427-36.
12. 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; 53:863-8.
13. Nishimura Y, Kurata N, Sakurai E, Yasuhara H. Inhibitory effect of antituberculosis drugs on human cytochrome P450-mediated activities. J Pharmacol Sci 2004; 96:293-300.
14. Court MH, Almutain F, Greenblatt D, et al. Identification of isoniazid as a potent inhibitor of CYP2A6-mediated efavirenz 7-hydroxylation in CYP2B66 GENOTYPED HUMAN LIVER MICROSOMES. In: 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, GA, 2013. Abstract 517.
15. Lee L, Soon GH, Chew N, Else N, Amara A, Khoo S. Differential induction of efavirenz metabolism by rifampin without and with isoniazid in healthy volunteers with CYP2B6 516GG and TT genotypes. In: 20th Conference on Retroviruses and Opportunistic Infections Atlanta, GA, 2013. Abstract 516.
16. Efavirenz package insert. Available at: http://packageinserts.bms.com/pi/ pi-sustiva.pdf. Accessed 15 April 2013.
17. 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; 41:681-90.
18. Yenny N, Djoerban Z, Setiabudy R. Pharmacokinetic interaction between efavirenz and rifampicin in healthy volunteers. Int J Clin Pharmacol Ther 2011; 49:162-8.
19. Ren Y, Nuttall JJ, Eley BS, et al. Effect of rifampicin on efavirenz pharmacokinetics in HIV-infected children with tuberculosis. J Acquir Immune Defic Syndr 2009; 50:439-43.
20. Kwara A, Lartey M, Sagoe KW, Court MH. Paradoxically elevated efavirenz concentrations in HIV/tuberculosis-coinfected patients with CYP2B6 516TT genotype on rifampin-containing antituberculous therapy. AIDS 2010; 25:388-90.
21. Gengiah TN, Holford NH, Botha JH, Gray AL, Naidoo K, Abdool Karim SS. The influence of tuberculosis treatment on efavirenz clearance in patients co-infected with HIV and tuberculosis. Eur J Clin Pharmacol 2011; 68:689-95.
22. Food and Drug Administration. Sustiva labeling update/dosing adjustment with rifampin. Available at: http://www.fda.gov/ForConsumers/ByAudience/ ForPatientAdvocates/HIVandAIDSActivities/ucm294476. htm. Accessed 12 August 2012.
23. Pozniak AL, Coyne KM, Miller RF, et al. British HIVAssociation guidelines for the treatment of TB/HIV coinfection 2011. HIV Med 2011; 12:517-24.
24. World Health Organization. Antiretroviral therapy for HIV infection in adults and adolescents. Recommendations for a public health approach: 2010 revision. Geneva, Switzerland: WHO, 2010.
25. 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; 15:71-5.
26. Stahle L, Moberg L, Svensson JO, Sonnerborg A. Efavirenz plasma concentrations in HIV-infected patients: inter-and intraindividual variability and clinical effects. Ther Drug Monit 2004; 26:267-70.
27. Centers for Disease Control and Prevention. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents. Morbidity and Mortality Weekly Report 2009; 58(RR-4): 1-216.
28. Huang L, Parikh S, Rosenthal PJ, et al. Concomitant efavirenz reduces pharmacokinetic exposure to the antimalarial drug artemether-lumefantrine in healthy volunteers. J Acquir Immune Defic Syndr 2012; 61:310-6.
29. Liu E, Spiegelman D, Semu H, et al. Nutritional status and mortality among HIV-infected patients receiving antiretroviral therapy in Tanzania. J Infect Dis 2011; 204:282-90.
30. Thiebaut R, Malvy D, Marimoutou C, Davis F. Anthropometric indices as predictors of survival in AIDS adults. Aquitaine Cohort, France, 1985-1997. Groupe d'Epidemiologie Clinique du Sida en Aquitaine (GECSA). Eur J Epidemiol 2000; 16:633-9.
31. Van Lettow M, Kumwenda JJ, Harries AD, et al. Malnutrition and the severity of lung disease in adults with pulmonary tuberculosis in Malawi. Int J Tuberc Lung Dis 2004; 8:211-7.
32. 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; 8:211-6.
33. 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; 58:1299-302.
34. Swaminathan S, Padmapriyadarsini C, Venkatesan P, et al. Efficacy and safety of once-daily nevirapine-or efavirenz-based antiretroviral therapy in HIV-associated tuberculosis: a randomized clinical trial. Clin Infect Dis 2011; 53:716-24.
35. Bonnet M, Bhatt N, Baudin E, et al. Nevirapine versus efavirenz for patients co-infected with HIV and tuberculosis: a randomised non-inferiority trial. Lancet Infect Dis 2013; 13:303-12.
36. 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; 300:530-9.
37. 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; 20:131-2.
38. Orrell C, Cohen K, Conradie F, et al. Efavirenz and rifampicin in the South African context: is there a need to dose-increase efavirenz with concurrent rifampicin therapy? Antivir Ther 2011; 16:527-34.
39. 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; 41:1648-53.
40. 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; 19:1541-3.
41. Trends in tuberculosis-United States, 2010. MMWR Morb Mortal Wkly Rep 2011; 60:333-7.
42. World Health Organization. WHO report 2011, global tuberculosis control. Available at: http://www.who.int/tb/publications/global-report/en/index.html. Accessed 15 April 2013.
43. Chan-Tack K, Liu J, Jadhav P, et al. Interaction-Why did the FDA approve EFV 800 mg When Co-adminstered with Rifampin? San Diego, CA: American College of Clinical Pharmacology Annual Meeting 2012. Abstract 1385545.