Lack of an effect of human immunodeficiency virus coinfection on the pharmacokinetics of entecavir in hepatitis B virus-infected patients

Antimicrobial Agents and Chemotherapy

Volumn 52, Issue 8, 2008, Pages 2836-2841

  Zhu, Min ^a   Bifano, Marc ^a   Xu, Xu ^a   Wang, Yonghua ^a   Lacreta, Frank ^a   Grasela, Dennis ^a   Pfister, Marc ^a,b  

^a BRISTOL MYERS SQUIBB RESEARCH AND DEVELOPMENT   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENTECAVIR; LAMIVUDINE; PLACEBO;

ADOLESCENT; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BAYES THEOREM; BIOEQUIVALENCE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CREATININE CLEARANCE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE ESCALATION; FEMALE; HEPATITIS B; HEPATITIS B VIRUS; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MAJOR CLINICAL STUDY; MALE; MIXED INFECTION; MONOTHERAPY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STEADY STATE;

ALGORITHMS; ANTIVIRAL AGENTS; AREA UNDER CURVE; GUANINE; HEPATITIS B; HIV INFECTIONS; HUMANS; METABOLIC CLEARANCE RATE; MODELS, BIOLOGICAL; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 48749095257     PISSN: 00664804     EISSN: None     Source Type: Journal    
DOI: 10.1128/AAC.01366-07     Document Type: Article

References (35)

1. Alberti, A., N. Clumeck, S. Collins, W. Gerlich, J. Lundgren, G. Palu, P. Reiss, R. Thiebaut, O. Weiland, Y. Yazdanpanah, and S. Zeuzem. 2005. Short Statement of the first European consensus conference on the treatment of chronic hepatitis B and C in HIV co-infected patients. J. Hepatol. 42:615-624.
2. Barrett, J. S., L. Labbe, and M. Pfister. 2005. Application and impact of population pharmacokinetics in the assessment of antiretroviral pharmacotherapy. Clin. Pharmacokinet. 44:591-625.
3. Beal, S. L., L. B. Sheiner, and A. J. Boeckmann (ed.). 1989-2006. NONMEM users guides. Icon Development Solutions, Ellicott City, MD.
4. Benhamou, Y., M. Bochet, V. Di Martine, F. Charlotte, F. Azria, A. Coutellier, M. Vidaud, F. Bricaire, P. Opolon, C. Katlama, and T. Poynard. 1999. Liver fibrosis progression in HIV and HCV infected patients. Hepatology 30:1054-1058.
5. Bifano, M., J. H. Yan, J. Xie, S. Rahim, E. Elefant, D. Zhang, D. Grasela, and F. LaCreta. 2005. Lack of pharmacokinetic interaction when entecavir is co-administered with lamivudine, adefovir, or tenofovir. J. Hepatol. 42:171.
6. Buster, E. H., and H. L. Janssen. 2006. Antiviral treatment for chronic hepatitis B virus infection-immune modulation or viral suppression. Neth. J. Med. 64:175-185.
7. Chang, T. T., R. G. Gish, S. J. Hadziyannis, J. Cianciara, M. Rizzetto, E. R. Schiff, G. Pastore, B. R. Bacon, T. Poynard, S. Joshi, K. S. Klesczewski, A. Thiry, R. E. Rose, R. J. Colonno, and R. G. Hindes. 2005. A dose-ranging study of the efficacy and tolerability of entecavir in lamivudine-refractory chronic hepatitis B patients. Gastroenterology 129:1198-1209.
8. Cockroft, D. W., and M. H. Gault. 1976. Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41.
9. Colonno, R., L. Discotto, Y. F. Gong, B. Kimmel, and S. P. Weinheimer. 2004. Combination studies involving entecavir and HIV nucleoside reverse transcriptase inhibitors showed no antagonistic effects on HBV or HIV activity in vitro. 2004, abstr. 366. Abstr. 39th Eur. Assoc. Study Liver Meeting.
10. De Man, R. A., L. M. M. Wolters, F. Nevens, D. Chua, M. Sherman, C. L. Lai, A. Gadano, Y. Lee, F. Mazzotta, N. Thomas, and D. DeHertogh. 2001. Safety and efficacy of oral entecavir given for 28 days in patients with chronic hepatitis B virus infection. Hepatology 34:578-582.
11. Gurumurthy, P., G. Ramachandran, A. K. H. Kumar, S. Rajasekaran, C. Padmapriyadarsini, S. Swaminathan, S. Bhagavathy, P. Venkatesan, L. Sekar, N. Mahilmaran, and P. Paramesh. 2004. Decreased bioavailability of rifampin and other antituberculosis drugs in patients with advanced human immunodeficiency virus disease. Antimicrob. Agents Chemother. 48:4473-4475.
12. Hoff, J., F. Bani-Sadr, M. Gassin, and F. Raffi. 2001. Evaluation of chronic hepatitis B virus (HBV) infection in coinfected patients receiving lamivudine as a component of anti-human immunodeficiency virus regimens. Clin. Infect. Dis. 32:963-969.
13. Hsu, Y. S., R. N. Chien, C. T. Yeh, L. S. Sheen, H. Y. Chiou, C. M. Chu, and Y. F. Law. 2002. Long term outcome after spontaneous HBeAg seroconversion in patients with HBV. Hepatology 35:1522-1527.
14. Jain, M. K., C. K. Opio, C. C. Osuagwu, R. Phllai, P. Keiser, and W. M. Lee. 2007. Do HIV care providers appropriately manage hepatitis B in coinfected patients treated with antiretroviral therapy. Clin. Infect. Dis. 44:996-1000.
15. Kane, M. A. 1993. Progress of the control of hepatitis B infection through immunization. Gut 34:S10-S12.
16. Kirkpatirk, C. M., S. B. Duffull, and E. J. Begg. 1999. Pharmacokinetics of gentamicin in 957 subjects with varying renal function dosed once daily. Br. J. Clin. Pharmacol. 47:637-643.
17. LaCreta, F., D. Mould, M. Bifano, D. M. Grasela, and M. Pfister. 2005. Simulation based support of dose recommendation of entecavir for renally impaired subjects. Clin. Pharm. Ther. 72:20.
18. Lai, C. L., M. Rosmawati, J. Lao, H. van Vlierberghe, F. H. Anderson, N. Thomas, and D. Dehertogh. 2002. Entecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B infection. Gastroenterology 123:1831-1838.
19. McMahon, M. A., B. L. Jilek, T. P. Brennan, L. Shen, Y. Zhou, M. Wind-Rotolo, S. Xing, S. Bhat, B. Hale, R. Hegarty, C. R. Chong, J. O. Liu, R. F. Siliciano, and C. L. Thio. 2007. The HBV drug entecavir - effects on HIV replication and resistance. N. Engl. J. Med. 356:2614-2621.
20. Mommeja-Marin, H., E. Mondou, M. R. Blum, and F. Rousseau. 2003. Serum HBV DNA as a marker of efficacy during therapy for chronic HBV infection: analysis and review of the literature. Hepatology 37:1309-1319.
21. Owens, S. R., and J. K. Greenson. 2007. The pathology of malabsorption: current concepts. Histopathology 50:64-82.
22. Paramesh, P., G. Ramachandran, A. K. H. Kumar, S. Rajasekaran, C. Padmapriyadarsini, S. Swaminathan, P. Venkatesan, L. S. Kumar, O. R. Krishnarajasekhar, and P. Paramesh. 2004. Malabsorption of rifampin and isoniazid in HIV-infected patients with and without tuberculosis Clin. Infect. Dis. 38:280-283.
23. Paratheodoridis, G. V., E. Dimou, K. Dimakopoulos, S. Manolakopoulos, I. Rapti, G. Kitis, D. Tzourmakliotis, E. Manesis, and S. J. Hadziyannis. 2005. Outcome of hepatitis B e antigen negative chronic hepatitis B on long term nucleos(t)ide analog therapy starting with lamivudine. Hepatology 42:121-129.
24. Peloquin, C. A., A. A. MacPhee, and S. E. Berning. 1993. Malabsorption of antimycobacterial medications. N. Engl. J. Med. 332:336-337.
25. Pessoa, M. G., B. Gazzard, A. Huang, C. E. Brandao-Mello, L. Cassetti, M. C. Correa, V. Soriano, P. Phiri, A. Hall, E. Ledesma, and R. Willber. 2005. Entecavir in HIV/HBV co-infected patients: safety and efficacy in a phase II study (ETV-038), abstr. 123. Abstr. 12th Conf. Retrovir. Opportunistic Infect.
26. Pessoa, M. G., A. Huang, C. M. Nelson, L. Cassetti, M. C. Correa, J. M. Miro, J. Rockstroh, A. Hall, P. Phiri, J. Yang, R. Willber, and E. Ledesma. 2005. Entecavir in HIV/HBV co-infected patients: week 48 results (ETV-038), abstr. H-415. Abstr. 45th Intersci. Conf. Antimicrob. Agents Chemother. American Society for Microbiology, Washington, DC.
27. Pinheiro, J. C., and D. M. Bates. 2000. Statistics and computing mix-effects models in S and S-Plus. Springer, New York, NY.
28. Robinson, D. M., L. J. Scott, and G. L. Plosker. 2006. Entecavir: a review of its use in chronic hepatitis B. Drugs 66:1605-1622.
29. Rustgi, K., J. H. Hoofnagle, and J. L. Gerin. 1984. Hepatitis B infection in the acquired immunodeficiency syndrome. Ann. Intern. Med. 101:795-797.
30. Sheiner, L. B., B. Rosenberg, and V. V. Marathe. 1977. Estimation of population characteristics of pharmacokinetics parameters from routine clinical data. J. Pharmacokinet. Biopharm. 5:445-479.
31. Sherman, M. 2006. Optimizing management strategies in special patient populations. Am. J. Gastroenterol. 101:S26-S31.
32. Soriano, V., P. Barreiro, and M. Nunez. 2006. Management of chronic hepatitis B and C in HIV coinfected patients. J. Antimicrob. Chemother. 57:815-818.
33. Thio, C. L., E. C. Seaberg, R. Jr. Skolasky, J. Phair, B. Visscher, A. Munoz, and D. L. Thomas. 2002. Multicenter AIDS Cohort Study. HIV-1, hepatitis B virus, and risk of liver-related mortality in the multicenter cohort study (MACS). Lancet 360:1921-1926.
34. World Health Organization. 2001. AIDS epidemic update. December. http://www.unaids.org. World Health Organization, Geneva, Switzerland.
35. Yan, J. H., B. Bifano, S. Olsen, R. A. Smith, D. Zhang, D. M. Grasela, and F. LaCreta. 2006. Entecavir pharmacokinetics, safety and tolerability after multiple ascending doses in healthy subjects. j. Clin. Pharmacol. 46:1250-1258.