Adefovir dipivoxil

Drugs

Volumn 58, Issue 3, 1999, Pages 479-487

  Noble, Stuart ^a   Goa, Karen L ^a  

^a ADIS INTERNATIONAL LIMITED   (New Zealand)

Author keywords

[No Author keywords available]

Indexed keywords

ADEFOVIR; ADEFOVIR DIPIVOXIL; ANTI HUMAN IMMUNODEFICIENCY VIRUS AGENT; LAMIVUDINE; PRODRUG; RNA DIRECTED DNA POLYMERASE INHIBITOR;

ANTIVIRAL ACTIVITY; CLINICAL TRIAL; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG MECHANISM; DRUG RESISTANCE; GASTROINTESTINAL SYMPTOM; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; KIDNEY DISEASE; MAJOR CLINICAL STUDY; META ANALYSIS; ORAL DRUG ADMINISTRATION; RETROVIRUS; REVIEW;

ADENINE; ANTIVIRAL AGENTS; CLINICAL TRIALS; DRUG RESISTANCE, MICROBIAL; HUMANS; PHOSPHONIC ACIDS; PLACEBOS; PRODRUGS; REVERSE TRANSCRIPTASE INHIBITORS;

EID: 0032887069     PISSN: 00126667     EISSN: None     Source Type: Journal    
DOI: 10.2165/00003495-199958030-00010     Document Type: Review

References (45)

1. Naesens L, Snoeck R, Andrei G, et al. HPMPC (cidofovir), PMEA (adefovir) and related acyclic nucleoside phosphonate analogues: a review of their pharmacology and clinical potential in the treatment of viral infections. Antiviral Chem Chemother 1997 Jan; 8: 1-23
2. Naesens L, De Clercq E. Therapeutic potential of HPMPC (cidofovir), PMEA (adefovir) and related acyclic nucleoside phosphonate analogues as broad-spectrum antiviral agents. Nucleosides Nucleotides 1997; 16 (7-9): 983-92
3. Balzarini J. Metabolism and mechanism of antiretroviral action of purine and pyrimidine derivatives. Pharm World Sci 1993; 16 (2): 113-26
4. Holy A, Votruba I, Mena A, et al. Acyclic nucleotide analogues: synthesis, antiviral activity and inhibitory effects on some cellular and virus-encoded enzymes in vitro. Antiviral Res 1990; 13:295-312
5. Balzarini J, Hao Z, Herdewijn P, et al. Intracellular metabolism and mechanism of anti-retrovirus action of 9-(2-phosphonylmethoxyethyl)adenine, a potent anti-human immunodeficiency viras compound. Proc Natl Acad Sci U S A 1991 Feb 15; 88: 1499-503
6. Srinivas RV, Connely M, Fridland A. (S)-1-(3-hydroxy-2-phosphonylmethoxypropyl)cytosine (HPMPC) inhibits HIV-1 replication in epithelial cells, but not T-lymphocytes. Antiviral Res 1997 Jun; 35: 23-7
7. Perno CF, Yarchoan R, Balzarini J, et al. Different pattern of activity of inhibitors of the human immunodeficiency virus in lymphocytes and monocyte/macrophages. Antiviral Res 1992 Apr; 17: 289-304
8. Perno C-F, Balestra h, Aquaro S, et al. Potent inhibition of human immunodeficiency virus and herpes simplex virus type 1 by 9-(2-phosphonylmethoxyethyl)adenine in primary macrophages is determined by drug metabolism, nucleotide pools, and cytokines. Mol Pharmacol 1996 Aug; 50: 359-66
9. Mulato AS, Cherrington JM. Anti-HIV activity of adefovir (PMEA) and PMPA in combination with antiretroviral compounds: in vitro analyses. Antiviral Res 1997 Nov; 36: 91-7
10. Balzarini J, Vahlenkamp T, Egberink H, et al. Antiretroviral activities of acyclic nucleoside phosphonates [9-(2-phosphonylmethoxyethyl)adenine, 9-(2-phosphonylmethoxyethyl)-guanine, (R)-9-(2-phosphonylmethoxypropyl)adenine, and MDL 74,968] in cell cultures and murine sarcoma virus-infected newborn NMRI mice. Antimicrob Agents Chemother 1997 Mar; 41: 611-6
11. Balzarini J, Naesens L, Slachmuylders J, et al. 9-(2-Phosphonylmethoxyethyl)adenine (PMEA) effectively inhibits retrovirus replication in vitro and simian immunodeficiency virus infection in rhesus monkeys. AIDS 1991 Jan; 5: 21-8
12. Balzarini J, Aquaro K, Perno CE, et al. Activity of the (R)-en-antiomers of 9-(2-phosphonylmethoxypropyl)-adenine and 9-(2-phosphonylmethoxypropyl)-2,6-diaminopurine against human immunodeficiency virus in different human cell systems. Biochem Biophys Res Commun 1996 Feb 15; 219: 337-41
13. Srinivas RV, Robbins BL, Connelly MC, et al. Metabolism and in vitro antiretroviral activities of bis(pivaloyloxymethyl) prodrugs of acyclic nucleoside phosphonates. Antimicrob Agents Chemother 1993 Oct; 37: 2247-50
14. Shirasaka T, Chokekijchai S, Yamada A, et al. Comparative analysis of anti-human immunodeficiency virus type 1 activities of dideoxynucleoside analogs in resting and activated peripheral blood mononuclear cells. Antimicrob Agents Chemother 1995 Nov; 39: 2555-9
15. Starrett Jr JE, Tortolani DR, Hitchcock MJM, et al. Synthesis and in vitro evaluation of a phosphonate prodrug: bis(pivaloyloxymethyl) 9-(2-phosphonylmethoxyethyl)adenine. Antiviral Res 1992 Sep 1; 19: 267-73
16. Gu Z, Salomon H, Cherrington JM, et al. K65R mutation of human immunodeficiency virus type 1 reverse transcriptase encodes cross-resistance to 9-(2-phosphonylmethoxyethyl)-adenine. Antimicrob Agents Chemother 1995 Aug; 39: 1888-91
17. Foli A, Sogocio KM, Anderson B, et al. In vitro selection and molecular characterization of human immunodeficiency virus type 1 with reduced sensitivity to 9-[2-(phosphonomethoxy)ethyl]adenine (PMEA). Antiviral Res 1996 Oct; 32: 91-8
18. Cherrington JM, Mulato AS, Fuller MD, et al. Novel mutation (K70E) in human immunodeficiency virus type 1 reverse transcriptase confers decreased susceptibility to 9-[2-(phosphonomethoxy)ethyl]adenine in vitro. Antimicrob Agents Chemother 1996 Sep; 40: 2212-6
19. Gong Y-F, Marshall DR, Srinivas RV, et al. Susceptibilities of zidovudine-resistant variants of human immunodeficiency virus type 1 to inhibition by acyclic nucleoside phosphonates. Antimicrob Agents Chemother 1994 Jul; 38: 1683-7
20. Miller MD, Anton KE, Mulato AS, et al. Human immunodeficiency virus type 1 expressing the lamivudine-associated M184V mutation in reverse transcriptase shows increased susceptibility to adefovir and decreased replication capability in vitro. J Infect Dis 1999 Jan; 179: 92-100
21. Mulato AS, Lamy PD, Miller MD, et al. Genotypic and pheno typic characterization of human immunodeficiency virus type 1 variants isolated from AIDS patients after prolonged adefovir dipivoxil therapy. Antimicrob Agents Chemother 1998 Jul; 42 (7): 1620-8
22. Cherrington JM, Mulato JS, Lamy PD, et al. Adefovir dipivoxil (bis-POM PMEA) therapy significntly decreases HIV RNA in patients with high-level AZT/3TC-resistant HIV [abstract no.1-84]. 38th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1998 Sep 24-27; San Diego, 388
23. Calio R, Villani N, Balestra E, et al. Enhancement of natural killer activity and interferon induction by different acyclic nucleoside phosphonates. Antiviral Res 1994 Jan; 23: 77-89
24. DeI-Gobbo V, Foli A, Balzarini J, et al. Immunomodulalory activity of 9-(2-phospbonyl methoxyethy])adenine (PMEA), a potent anti-HIV nucleotide analogue, on in vivo murine models. Antiviral Res 1991 Jul; 16: 65-75
25. Cundy KC. Clinical pharmacokinetics of the antiviral nucleotide analogues cidofovir and adefovir. Clin Pharmacokinet 1999 Feb; 36 (2): 127-43
26. Cundy KC, Barditch-Crovo P, Walker RE, et al. Clinical pharmacokinetics of adefovir in human immunodeficiency virus type I-infected patients. Antimicrob Agents Chemother 1995 Nov; 39: 2401-5
27. Cundy KC, Sue I-L, Visor GC, et al. Oral formulations of ad efovir dipivoxil: in vitro dissolution and in vivo bioavailability in dogs. J Pharm Sci 1997 Dec; 86 (12); 1334-8
28. Cundy KC, Shaw J-P, Lee WA. Oral, subcutaneous, and intramuscular bioavailabilities of the antiviral nucleotide analog 9-(2-phosphonylmethoxyethyl) adenine in cynomolgus monkeys. Antimicrob Agents Chemother 1994 Feb; 38: 365-8
29. Palu G, Stefanelli S, Rassu M, et al. Cellular uptake of phosphonylmethoxyalkylpurine derivatives. Antiviral Res 1991 Jul; 16: 115-9
30. Cihlar T, Rosenberg I, Votruba I, et al. Transport of 9-(2-phosphonomethoxyethyl)adenine across plasma membrane of HeLa S3 cells is protein mediated. Antimicrob Agents Chemother 1995 Jan; 39: 117-24
31. Shaw JP, Cundy KC. Biological screens of PMEA prodrugs. Poster presentation, 8th Annual Meeting of the American Association of Pharmaceutical Scientists; 1993 Nov 14-18; Lake Buena Vista (FL)
32. Annaert P, Kingel R, Naesens L, et al. Transport, uptake, and metabolism of the bis(pivaloyloxymethyl)-ester prodrug of 9-(2-phosphonylmethoxyethyl)adenine in an in vitro cell culture system of the intestinal mucosa (Caco-2). Pharm Res 1997 Apr; 14:492-6
33. Naesens L, Balzarini J, Bischofberger N, et al. Antiretroviral activity and pharmacokinetics in mice of oral bis(pivaloyloxymethyl)-9-(2-phospnonylmetnoxyethyl)adenine, the bis(pivaloyloxymethyl) ester prodrug of 9-(2-phosphonylmethoxyethyl)adenine. Antimicrob Agents Chemother 1996 Jan; 40: 22-8
34. Cundy KC, Fishback JA, Shaw J-P, et al. Oral bioavailability of the antiretroviral agent 9-(2-phosphonylmethoxyethyl) adenine (PMEA) from three formulations of the prodrug bis-(pivaloyloxymethyl)-PMEA in fasted male cynomolgus monkeys. Pharm Res 1994 Jun; 11: 839-43
35. Barditch-Crovo P, Toole J, Hendrix CW, et al. Anti-human immunodeficiency virus (HIV) activity, safety, and phamnacokinetics of adefovir dipivoxil (9-[2-(bis-pivaloyloxymethyl)-phosphonylmethoxyethyl]adenine) in HIV-infccted patients. J Infect Dis 1997 Aug; 176: 406-13
36. Barditch-Crovo PA, Cundy KC, Wachsman M, et al. Pharmacokinetic profile of 9-[2-(bispivaloyloxy-methyl) phosphonylmethoxy]adenine (bis-POM PMEA), an orally bioavailable prodrug of the antiviral nucleotide, PMEA [abstract no. 488]. 2nd National Conference on Human Retroviruses and Related Infections; 1995 Jan 29-Feb 2; Washington DC, 145
37. Deeks SG, Collier A, Lalezari J, et al. The safety and efficacy of adefovir dipivoxil, a novel anti-human immunodeficiency virus (HIV) therapy, in HIV-infectcd adults: a randomized, double-blind, placebo-controlled trial. J Infect Dis 1997 Dec; 176: 1517-23
38. Hardy WD. Adefovir dipivoxil study 408: a multicenter, randomized, double-blind placebo-controlled study of the efficacy and safety of adefovir dipivoxil (ADV) when added to standard antiretroviral therapy for the treatment of HIV-infected patients. Oral presentation, 4th International Congress on Drug Therapy in HIV Infection; 1998 Nov 8-12; Glasgow
39. Kahn J, Lagakos S, Weng D, et al. A multicenter, randomized, double-blind placebo controlled study of the efficacy and safety of adefovir dipivoxil (Adv) when added to standard antiretroviral therapy (Art) [abstract no. 1-108]. 38th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1998 Sep 24-27; San Diego, 396
40. Brosgart C. GS-417: a randomized, double-Mind study of adefovir dipivoxil (ADV) at two dose levels (120 mg 60 mg) as part of combination therapy in NRTI-expericnced patients with no prior PI therapy. Oral presentation, 12th International Conference on Antiviral Research; 1999 Mar 21-26; Jerusalem
41. Gallant J. Study GS-96-411; a randomized, open-label study of adefovir dipivoxil (ADV) and indinavir (IDV) in combination with AZT, 3TC or d4T for the treatment of therapy-naive HIV-infected patients. Oral presentation, 38th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1998 Sep 24-27; San Diego
42. Wiznia A, Nelson R, Van Dyke R, et al. Phase I/II study of combination adefovir dipivoxil (ADV) and nelfinavir (NLF) in children with HIV infection and previous antiretroviral experience [abstract no. 1-9]. 38th Interscience Conference on Antimicrobial Agents and Chemotherapy; 1998 Sep 24-27; San Diego, 365
43. Barriere S, Winslow D, Coakley D, et al. Safety of adefovir dipivoxil in the treatment of HIV infection [abstract no. 12386]. 12th World AIDS Conference; 1998 Jun 28-Jul 3; Geneva: 90-1
44. Gilead Sciences. Preveon (adefovir dipivoxil): information for caregivers [online]. Available from: http://www.gilead.com [Accessed 1998 Nov 2]
45. Nuessle SJ, Barriere SL, Rooney JF, et al. The Preveon® Expanded Access Program: safety of adefovir dipivoxil (ADV) in antiretroviral treatment experienced patients with advanced HIV disease (poster no. 379). Poster presentation, 6th Conference on Retroviruses and Opportunistic Infections; 1999 Jan 31-Feb 4; Chicago