Pharmacokinetics of low-dose protease inhibitors and efavirenz in low-and middle-income countries

Current Opinion in HIV and AIDS

Volumn 5, Issue 1, 2010, Pages 90-96

  Gorowara, Meena ^a,b   Burger, David ^c   Hill, Andrew ^d   Ruxrungtham, Kiat ^a,b  

^a THAI RED CROSS AIDS RESEARCH CENTRE   (Thailand)

^b CHULALONGKORN UNIVERSITY   (Thailand)

^c RADBOUD UNIVERSITY NIJMEGEN   (Netherlands)

^d UNIVERSITY OF LIVERPOOL   (United Kingdom)

Author keywords

Low dose antiretroviral therapy; Pharmacokinetics; Resource limited; Thailand

Indexed keywords

ATAZANAVIR; ATAZANAVIR PLUS RITONAVIR; EFAVIRENZ; INDINAVIR; INDINAVIR PLUS RITONAVIR; LAMIVUDINE; LOPINAVIR PLUS RITONAVIR; PROTEINASE INHIBITOR; RITONAVIR; RITONAVIR PLUS SAQUINAVIR; SAQUINAVIR; STAVUDINE;

ANALYTICAL PARAMETERS; CLINICAL TRIAL; DEVELOPING COUNTRY; DIZZINESS; DRUG COST; DRUG DOSE COMPARISON; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; DRUG WITHDRAWAL; HEALTH ECONOMICS; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IMMUNE RESPONSE; LOW DRUG DOSE; LOWEST INCOME GROUP; NEPHROTOXICITY; PRIORITY JOURNAL; REVIEW; SIDE EFFECT; SOCIAL STATUS; THAILAND; WEIGHT REDUCTION;

ANTI-HIV AGENTS; BENZOXAZINES; DEVELOPING COUNTRIES; HIV INFECTIONS; HIV PROTEASE INHIBITORS; HIV-1; HUMANS; POVERTY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REVERSE TRANSCRIPTASE INHIBITORS; THAILAND;

EID: 74349123323     PISSN: 1746630X     EISSN: 17466318     Source Type: Journal    
DOI: 10.1097/COH.0b013e3283339caf     Document Type: Review

References (35)

1. UNAIDS. 2008 Report on the global AIDS epidemic. Executive summary. UNAIDS; 2008.
2. Youle M. Overview of boosted protease inhibitors in treatment-experienced HIV-infected patients. J Antimicrob Chemother 2007; 60:1195-1205.
3. Cheer SM, Goa KL. Stavudine once daily. Drugs 2002; 62:2667-2674.
4. King J, Aberg JA. Clinical impact of patient population differences and genomic variation in efavirenz therapy. AIDS 2008; 22:1709-1717.
5. Huang SM, Temple R. Is this the drug or dose for you? Impact and consideration of ethnic factors in global drug development, regulatory review, and clinical practice. Clin Pharmacol Ther 2008; 84:287-294.
6. Burger D, Van Der Heiden I, La Porte C, et al. Interpatient variability in the pharmacokinetics of the HIV nonnucleoside reverse transcriptase inhibitor of efavirenz: the effect of gender, race, and CYP2B6 polymorphism. Br J Clin Pharmacol 2006; 61:148-154.
7. Ananworanich J, Moor Z, Siangphoe U, et al. Incidence and risk factors for rash in Thai patients randomized to regimens with nevirapine, efavirenz or both drugs. AIDS 2005; 19:185-192.
8. Van Leth F, Phanuphak P, Ruxrungtham K, et al. Comparison of first-line antiretroviral therapy with regimens including nevirapine, efavirenz, or both drugs, plus stavudine and lamivudine: a randomised open-label trial, the 2NN study. Lancet 2004; 363:1253-1263.
9. Boyd M, Mootsikapun P, Burger D, et al. Pharmacokinetics of reduced-dose indinavir/ritonavir 400/100 mg twice daily in HIV-1-infected Thai patients. Antivir Ther 2005; 10:301-307.
10. Burger D, Boyd M, Duncombe C, et al. Pharmacokinetics and pharmacodynamics of indinavir with or without low dose ritonavir in HIV-infected Thai patients. J Antimicrob Chemother 2003; 51:1231-1238.
11. Wasmuth JC, la Porte CJ, Schneider K, et al. Comparison of two reduceddose regimens of indinavir (600mg vs 400mg twice daily) and ritonavir (100 mg twice daily) in healthy volunteers (COREDIR). Antivir Ther 2004; 9:213-220.
12. Ghosn J, Lamotte C, Ait-Mohand H, et al. Efficacy of a twice-daily antiretroviral regimen containing 100mg ritonavir/400mg indinavir in HIV-infected patients. AIDS 2003; 17:209-214.
13. Avihingsanon A, Van Der Lugt J, Kerr SJ, et al. A low dose of ritonavir-boosted atazanavir provides adequate pharmacokinetic parameters in HIV-1-infected Thai adults. Clin Pharmacol Ther 2008; 85:402-408.
14. Reyataz (atazanavir sulfate) capsule [prescribing information (online)]. New York, New York: Bristol-Myers Squibb Company; 2008. http://www.bms.com. [Accessed 12 May 2009]
15. Von Hentig N, Dauer B, Haberl A, et al. Tenofovir comedication does not impair the steady-state pharmacokinetics of ritonavir-boosted atazanavir in HIV-1- infected adults. Eur J Clin Pharmacol 2007; 63:935-940.
16. Van Der Lugt J, Autar RS, Ubolyam S, et al. Pharmacokinetics and short-term efficacy of a double-boosted protease inhibitor regimen in treatment-naive HIV-1-infected adults. J Antimicrob Chemother 2008; 61:1145-1153.
17. Cameron DW, Becker S, King MS, et al. Exploratory study comparing the metabolic toxicities of a lopinavir/ritonavir plus saquinavir dual protease inhibitor regimen versus a lopinavir/ritonavir plus zidovudine/ lamivudine nucleoside regimen. J Antimicrob Chemother 2007; 59:957-963.
18. Van Der Lugt J, Gorowara M, Avihingsanon A, et al. Reducing the boosting dose of ritonavir does not affect saquinavir plasma concentrations in HIV-1- infected individuals. AIDS 2009; 23:1176-1179.
19. Van Der Lugt J, Puthanakit T, Gorowara M, et al. Low-dose lopinavir/ritonavir provides adequate plasma concentrations in Thai HIV-infected children [poster #16]. In: 9th International Workshop on Clinical Pharmacology of HIV Therapy; 7-9 April 2008; New Orleans, Louisiana.
20. Ananworanich J, Kosalaraksa P, Hill A, et al. Pharmacokinetics and 24-week efficacy/safety of dual boosted saquinavir/lopinavir/ritonavir in nucleosidepretreated children. Pediatr Infect Dis J 2005; 24:874-879.
21. Saez-Llorens X, Vioari A, Deetz C, et al. Forty-eight week evaluation of lopinavir/ritonavir a new protease inhibitor, in human immunodeficiency virus-infected children. Pediatr Infect Dis J 2003; 22:216-223.
22. Mootsikapun P, Chetchotisakd P, Anunnatsiri S, et al. Efficacy and safety of indinavir/ritonavir 400/100mg twice daily plus two nucleoside analogues in treatment-naive HIV-1-infected patients with CD4+ T-cell counts
23. Kanopnicki D, De Wit S, Poll B, et al. Indinavir/ritonavir-based therapy in HIV- 1-infected antiretroviral therapy-naive patients: comparison of 800/100mg and 400/100 mg twice daily. HIV Med 2005; 6:1-6.
24. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services; 2008. pp. 1-139. http:// www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. [Accessed 28 April 2008]
25. Harrison TS, Scott LJ. Atazanavir: a review of its use in the management of HIV infection. Drugs 2005; 65:2309-2336.
26. Bristol-Myers Squibb Company. Reyataz (atazanavir sulfate) capsules: prescribing information [online]. http://www.bms.com. [Accessed 28 April 2008]
27. Chetchotisakd P, Anunnatsiri S. Low-dose, once-daily atazanavir/ritonavir (200/100): an effective treatment for HIV-infected patients in Thailand. J Acquir Immune Defic Syndr 2008; 49:230-231.
28. Chetchotisakd P, Anunnatsiri S, Mootsikapun P, et al. Efficacy and tolerability of a double boosted protease inhibitor (lopinavir + saquinavir/ritonavir) regimen in HIV-infected patients who failed treatment with nonnucleoside reverse transcriptase inhibitors. HIV Med 2007; 8:529-535.
29. Manosuthi W, Sungkanuparph S, Ruxrungtham K, et al. Plasma levels, safety, and 60-week efficacy of a once-daily double-boosted protease inhibitor regimen of atazanavir, saquinavir, and ritonavir. J Acquir Immune Defic Syndr 2008; 47:127-129.
30. Molto J, Santos JR, Valle M, et al. Monitoring atazanavir concentrations with boosted or unboosted regimens in HIV-infected patients in routine clinical practice. Ther Drug Monit 2007; 29:648-651.
31. MalanDR,KrantzE,DavidN,et al. Efficacyandsafetyofatazanavir,withorwithout ritonavir, as part of once-daily highly active antiretroviral therapy regimens in antiretroviral-naive patients. J Acquir Immune Defic Syndr 2008; 47:161-167.
32. Kilby JM, Hill A, Buss N. The effect of ritonavir on saquinavir plasma concentration is independent of ritonavir dosage: combined analysis of pharmacokinetic data from 97 subjects. HIV Med 2002; 3:97-104.
33. Haas D, Ribaudo H, Kim R, et al. Pharmacogenetics of efavirenz and central nervous system side effects: an adult AIDS clinical trials group study. AIDS 2004; 18:2391-2399.
34. Stöhr W, Back D, Dunn D, et al. Factors influencing efavirenz and nevirapine plasma concentration: effect of ethnicity, weight and co-medication. Antivir Ther 2008; 13:675-685.
35. Avihingsanon A, Van Der Lugt J, Gorowara M, et al. A low dose of efavirenz provides adequate efavirenz plasma concentrations in Thai HIV-1 infected adults [TUPE0079]. In: XVII International AIDS Conference; 3-8 August 2008; Mexico City, Mexico.