Drug-drug and drug-food interactions between tenofovir disoproxil fumarate and didanosine

Journal of Clinical Pharmacology

Volumn 45, Issue 12, 2005, Pages 1360-1367

  Kearney, Brian P ^a   Sayre, John R ^a   Flaherty, John F ^a   Chen, Shan Shan ^a   Kaul, Sanjeev ^b   Cheng, Andrew K ^a  

^a GILEAD SCIENCES   (United States)

^b BRISTOL MYERS SQUIBB   (United States)

Author keywords

Didanosine EC; Drug interaction; HIV; Pharmacokinetics; Tenofovir DF

Indexed keywords

DIDANOSINE; TENOFOVIR DISOPROXIL;

ABDOMINAL PAIN; ADULT; AREA UNDER THE CURVE; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIET RESTRICTION; DIZZINESS; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; FEMALE; FLATULENCE; FOOD DRUG INTERACTION; HEADACHE; HUMAN; MALE; NAUSEA; NORMAL HUMAN;

ADENINE; ADULT; ANTI-HIV AGENTS; DIDANOSINE; DRUG INTERACTIONS; DRUG THERAPY, COMBINATION; FEMALE; FOOD-DRUG INTERACTIONS; HUMANS; MALE; PHOSPHONIC ACIDS; PRODRUGS; REVERSE TRANSCRIPTASE INHIBITORS;

EID: 27844456830     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270005281351     Document Type: Article

References (27)

1. Naesens L, Balzarini J, Bischofberger N, De Clercq E. Antiretroviral activity and pharmacokinetics in mice of oral bis(pivaloyloxymethyl) -9-(2-phosphonylmethoxyethyl)adenine, the bis(pivaloyloxymethyl) ester prodrug of 9-(2-phosphonylmethoxyethyl)adenine. Antimicrob Agents Chemother. 1996;40:22-28.
2. Srinivas RV, Robbins BL, Connelly MC, Gong YF, Bischofberger N, Fridland A. Metabolism and in vitro antiretroviral activities of bis(pivaloyloxymethyl) prodrugs of acyclic nucleoside phosphonates. Antimicrob Agents Chemother. 1993;37:2247-2250.
3. Robbins BL, Srinivas RV, Kim C, Bischofberger N, Fridland A. Anti-human immunodeficiency virus activity and cellular metabolism of a potential prodrug of the acyclic nucleoside phosphonate 9-R-(2-phosphonomethoxypropyl)adenine (PMPA), Bis(isopropyloxymethylcarbonyl)PMPA. Antimicrob Agents Chemother. 1998;42:612-617.
4. Barditch-Crovo P, Deeks SG, Collier A, et al. Phase I/II trial of the pharmacokinetics, safety, and antiretroviral activity of tenofovir disoproxil fumarate in human immunodeficiency virus-infected adults. Antimicrob Agents Chemother. 2001;45:2733-2739.
5. Deeks SG, Barditch-Crovo P, Lietman PS, et al. Safety, pharmacokinetics, and antiretroviral activity of intravenous 9-{2-(R)-(Phosphonomethoxy)propyl} adenine, a novel anti-human immunodeficiency virus (HIV) therapy, in HIV-infected adults. Antimicrob Agents Chemother. 1998;42:2380-2384.
6. Kearney BP, Gill SC, Flaherty JF, et al. Effect of demographic variables on the pharmacokinetics of tenofovir DF in HIV-infected patients and healthy subjects. Paper presented at: 41st Interscience Conference on Antimicrobial Agents and Chemotherapy, December 2001; Chicago, Ill. Abstract 504.
7. Viread [prescribing information]. Foster City, Calif: Gilead; June 2004.
8. Kearney BP, Flaherty JF, Shah J. Tenofovir disoproxil fumarate: clinical pharmacology and pharmacokinetics. Clin Pharmacokinet. 2004;43:595-612.
9. Knupp CA, Shyu WC, Dolin R, et al. Pharmacokinetics of didanosine in patients with acquired immunodeficiency syndrome-related complex. Clin Pharmacol Ther. 1991;49:523-535.
10. Perry CM, Balfour JA. Didanosine: an update on its antiviral activity, pharmacokinetic properties and therapeutic efficacy in the management of HIV disease. Drugs. 1996;52:928-962.
11. Videx [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Co; December 2000.
12. Videx EC [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Co; January 2004.
13. Shyu WC, Knupp CA, Pittman KA, Dunkle L, Barbhaiya RH. Food-induced reduction in bioavailability of didanosine. Clin Pharmacol Ther. 1991;50:503-507.
14. Damle BD, Yan JH, Behr D, et al. Effect of food on the oral bioavailability of didanosine from encapsulated enteric-coated beads. J Clin Pharmacol. 2002;42:419-427.
15. Damle BD, Mummaneni V, Kaul S, Knupp C. Lack of effect of simultaneously administered didanosine encapsulated bead formulation (Videx EC) on oral absorption of indinavir, ketoconazole, or ciprofloxicin. Antimicrob Agents Chemother. 2002;46:385-391.
16. Kearney BP, Flaherty JF, Sayre JR, Wolf JJ, Coakley DF. A multiple-dose, randomized, crossover drug interaction study between tenofovir DF and lamivudine or didanosine. Paper presented at: First International AIDS Society Conference on HIV Pathogenesis and Treatment; July 2001; Buenos Aires, Argentina. Abstract 337.
17. Flaherty J, Kearney B, Wolf J, et al. Co-administration of tenofovir DF and didanosine: a pharmacokinetic and safety evaluation. Paper presented at: 41st Interscience Conference on Antimicrobial Agents and Chemotherapy; December 2001; Chicago, Ill. Abstract 1729.
18. Jung D, Griffy K, Dorr A. Effect of high-dose oral ganciclovir on didanosine disposition in human immunodeficiency virus (HFV)-positive patients. J Clin Pharmacol. 1998;38:1057-1062.
19. Cimoch PJ, Lavelle J, Pollard R, et al. Pharmacokinetics of oral ganciclovir alone and in combination with zidovudine, didanosine, and probenecid in HIV-infected subjects. J Acquir Immune Defic Syndr Hum Retrovirol. 1998;17:227-234.
20. Boelaert JR, Dom GM, Huitema AD, Beijnen JH, Lange JM. The boosting of didanosine by allopurinol permits a halving of the didanosine dosage. AIDS. 2002;16:2221-2223.
21. Kaul S, Shyu WC, Shukla UA, Dandekar KA, Barbhaiya RH. Absorption, disposition, and metabolism of {14C}didanosine in the beagle dog. Drug Metab Dispos. 1993;21:447-453.
22. Ray AS, Olson L, Fridland A. Role of purine nucleoside phosphorylase in interactions between 2′,3′-dideoxyinosine and allopurinol, ganciclovir, or tenofovir. Antimicrob Agents Chemother. 2004;48:1089-1095.
23. Grasela TH, Walawander CA, Beltangady M, et al. Analysis of potential risk factors associated with the development of pancreatitis in Phase I patients with AIDS or AIDS-related complex receiving didanosine. J Infect Dis. 1994;168:1250-1255.
24. Kearney BP, Ramanathan S, Cheng AC, Ebrahimi R, Shah J. Systemic and renal pharmacokinetics of adefovir and tenofovir upon coadministration. J Clin Pharmacol. 2005;45:935-940.
25. Chow S-C, Liu J-P. Design and Analysis of Bioavailability and Bioequivalence Studies. New York: Marcel Dekker; 1992.
26. US Department of Health and Human Services. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Updated October 28, 2004. Washington, DC: US Department of Health and Human Services.
27. Kaul S, Damle B, Bassi K, et al. Pharmacokinetic evaluation of reduced doses of didanosine enteric coated capsules (ddI-EC) in combination with tenofovir disoproxil fumarate (TDF) and food for a once-daily antiretroviral regimen. Paper presented at: The Fourth International Workshop on Clinical Pharmacology of HIV Infection; 2003; Cannes, France. Abstract 8.1.