Pharmacokinetics of lamivudine & stavudine in generic fixed-dose combinations in HIV-1 infected adults in India

Indian Journal of Medical Research

Volumn 130, Issue 4, 2009, Pages 451-457

  Hemanth Kumar, A K ^a   Ramachandran, Geetha ^a   Rajasekaran, S ^b   Padmapriyadarsini, C ^a   Narendran, G ^a   Subramanyam, S Anitha Sudha ^a   Kumaraswami, V ^a   Swaminathan, Soumya ^a  

^a NATIONAL INSTITUTE FOR RESEARCH IN TUBERCULOSIS   (India)

^b Government Hospital of Thoracic Medicine   (India)

Author keywords

Generic FDCs; India; Lamivudine; Pharmacokinetics; Stavudine

Indexed keywords

ANTIVIRUS AGENT; COTRIMOXAZOLE; LAMIVUDINE; LAMIVUDINE PLUS STAVUDINE; STAVUDINE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; BODY MASS; CD4 LYMPHOCYTE COUNT; CLINICAL ARTICLE; DRUG BLOOD LEVEL; DRUG HALF LIFE; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS 1 INFECTION; IMMUNE SYSTEM; INDIA; MALE; MAXIMUM PLASMA CONCENTRATION; SEX DIFFERENCE; TIME TO MAXIMUM PLASMA CONCENTRATION;

ADULT; ANTI-HIV AGENTS; DRUG COMBINATIONS; FEMALE; HIV INFECTIONS; HIV-1; HUMANS; INDIA; LAMIVUDINE; MALE; MIDDLE AGED; PREGNANCY; STAVUDINE;

EID: 71449112957     PISSN: 09715916     EISSN: 09715916     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. Kumarasamy N, Solomon S, Chaguturu SK, Cecelia AJ, Vallabhaneni S, Flanigan TP, et al. The changing natural history of HIV disease: before and after the introduction of generic antiretroviral therapy in southern India. Clin Infect Dis 2005; 41: 1525-8.
2. Cressey TR, Lallemant M. Pharmacogenetics of antiretroviral drugs for the treatment of HIV-infected patients: an update. Infect Genet Evol 2007; 7: 333-42.
3. Yeh KC, Deutsch PJ, Haddix H, Hesney M, Hoagland V, Ju WD, et al. Single-dose pharmacokinetics of indinavir and the effect of food. Antimicrob Agents Chemother 1998; 42: 332-8.
4. Fletcher CV, Jiang H, Brundage RC, Acosta EP, Haubrich R, Katzenstein D, et al. Sex-based differences in saquinavir pharmacology and virologic response in AIDS Clinical Trials Group Study 359. J Infect Dis 2004; 189: 1176-84.
5. Anderson PL, Lamba J, Aquilante CL, Schuetz E, Fletcher CV. Pharmacogenetic characterisitics of indinavir, zidovudine, and lamivudine therapy in HIV-infected adults: a pilot study. J Acquir Immune Defic Syndr 2006; 42: 441-9.
6. Gurumurthy P, Ramachandran G, Hemanth Kumar AK, Rajasekaran S, Padmapriyadarsini C, Swaminathan S, et al. Decreased bioavailability of rifampin and other anti-tuberculosis drugs in patients with advanced human immunodeficiency virus disease. Antimicrob Agents Chemother 2004; 48: 4473-5.
7. Keating J, Bjarnason I, Somasundaram S, Macpherson A, Francis N, Price AB, et al. Intestinal absorptive capacity, intestinal permeability and jejunal histology in HIV and their relation to diarrhoea. Gut 1995; 37: 623-9.
8. Lopez-Cortes LF, Ruiz-Valderas R, Viciana P, Alarcon-Gonzalez A, Gomez-Mateos J, Leon-Jimenez E, et al. Pharmacokinetic interactions between efavirenz and rifampicin in HIV-infected patients with tuberculosis. Clin Pharmacokinet 2002; 41: 681-90.
9. Matteelli A, Regazzi M, Villani P, De Iaco G, Cusato M, Carvalho AC, et al. Multiple-dose pharmacokinetics of efavirenz with and without the use of rifampicin in HIV-positive patients. Curr HIV Res 2007; 5: 349-53.
10. Ramachandran G, Hemanthkumar AK, Rajasekaran S, Padmapriyadarsini C, Narendran G, Anitha S, et al. Steady-state pharmacokinetics of nevirapine in HIV-1 infected adults in India. J Int Assoc Physicians AIDS Care (Chic 111) 2007; 6: 251-4.
11. Moyer TP, Temesgen Z, Enger R, Estes L, Charlson J, Oliver L, et al. Drug monitoring of antiretroviral therapy for HIV-1 infection: method validation and results of a pilot study. Clin Chem 1999; 45: 1465-76.
12. Dietary guidelines for Indians - a manual. National Institute of Nutrition (Indian Council of Medical Research), Hyderabad, India; 2003. p. 43-44. Available at: http://www.ninindia.org, accessed on April 15, 2008.
13. Narang VS, Lulla A, Malhotra G, Purandare S. Pharmacokinetic profiling and bioequivalence evaluation of 2 lamivudine tablet formulations after single oral administration in healthy human Indian volunteers. J Acquir Immune Defic Syndr 2005; 38: 566-9.
14. Bruno R, Regazzi MB, Ciappina V, Villani P, Sacchi P, Montagna M, et al. Comparison of the plasma pharmacokinetics of lamivudine during twice and once daily administration in patients with HIV. Clin Pharmacokinet 2001; 40: 695-700.
15. Johnson MA, Moore KH, Yuen GJ, Bye A, Pakes GE. Clinical pharmacokinetics of lamivudine. Clin Pharmacokinet 1999; 36: 41-66.
16. van Praag RM, van Weert EC, van Heeswijk RP, Zhou XJ, Sommadossi JP, Jurriaans S, et al. Stable concentrations of zidovudine, stavudine, lamivudine, abacavir and nevirapine in serum and cerebrospinal fluid during 2 years of therapy. Antimicrob Agents Chemother 2002; 46: 896-9.
17. Moore KH, Yuen GJ, Hussey EK. Analysis of potential gender differences in lamivudine disposition using population pharmacokinetics from two phase III trials in HIV-infected patients. In: Abstract book of the National Conference on Women and HIV, Los Angeles, 1997 (Abstract 1298).
18. Sabo JP, Lamson MJ, Leitz G, Yong C, MacGregor TR. AAPS PharmSci 2002; 2: Available at: http://www.aapspharmsci.org, accessed on May 22, 2008.
19. Moore KH, Yuen GJ, Raasch RH, Eron JJ, Martin D, Mydlow PK, et al. Pharmacokinetics of lamivudine administered alone and with trimethoprim-sulfamethoxazole. Clin Pharmacol Ther 1996; 59: 550-8.
20. Kaul S, Christofalo B, Raymond RH, Stewart MB, Macleod CM. Effect of food on the bioavailability of stavudine in subjects with human immunodeficiency virus infection. Antimicrob Agents Chemother 1998; 42: 2295-8.
21. Piscitelli SC, Kelly G, Walker RE, Kovacs J, Falloon J, Davey RT Jr, et al. A multiple drug interaction study of stavudine with agents for opportunistic infections in human immunodeficiency virus-infected patients. Antimicrob Agents Chemother 1999; 43: 647-50.
22. Rana KZ, Dudley MN. Clinical pharmacokinetics of stavudine. Clin Pharmacokinet 1997; 33: 276-84.
23. Back D, Gatti G, Fletcher C, Garraffo R, Haubrich R, Hoetelmans R, et al. Therapeutic drug monitoring in HIV infection: current status and future directions. AIDS 2002; 16 (Suppl 1): S5-37.
24. NACO guidelines on ART for adults and adolescents, 2007. Available from: www.nacoonline.org, accessed on April 24, 2008.
25. World Health Organization 2006: Antiretroviral therapy for HIV infection in adults and adolescents: recommendation for a public health approach. Available at http://www.who.int/hiv/pub/guidelines/artadultguidelines.pdf, accessed on April 15, 2008.