Drug Therapy: Ganciclovir

New England Journal of Medicine

Volumn 335, Issue 10, 1996, Pages 721-729

  Crumpacker, Clyde S ^a  

^a BETH ISRAEL DEACONESS MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT; CIDOFOVIR; FOSCARNET; GANCICLOVIR; PROBENECID;

ANTIVIRAL ACTIVITY; AZOOSPERMIA; CLINICAL TRIAL; CYTOMEGALOVIRUS INFECTION; DRUG MECHANISM; DRUG RESISTANCE; GASTROINTESTINAL INFECTION; GRANULOCYTOPENIA; HUMAN; HYPOCALCEMIA; INTRAVENOUS DRUG ADMINISTRATION; NEPHROTOXICITY; NEUROLOGIC DISEASE; ORAL DRUG ADMINISTRATION; PHARMACOKINETICS; PRIORITY JOURNAL; RETINITIS; REVIEW; SEIZURE; THROMBOCYTOPENIA; VIRUS PNEUMONIA; ANTIBIOTIC RESISTANCE; CYTOMEGALIC INCLUSION BODY DISEASE; GASTROINTESTINAL DISEASE; PERIPHERAL NEUROPATHY; PNEUMONIA;

ANTIVIRAL AGENTS; CYTOMEGALOVIRUS INFECTIONS; DRUG RESISTANCE, MICROBIAL; GANCICLOVIR; GASTROINTESTINAL DISEASES; HUMANS; PERIPHERAL NERVOUS SYSTEM DISEASES; PNEUMONIA;

EID: 0030570951     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199609053351007     Document Type: Review

References (86)

1. Martin JC, Dvorak CA, Smee DF, Matthews TR, Verheyden JPH. 9-[(1,3-Dihydroxy-2-propoxy)methyl]guanine: a new potent and selective antiherpes agent. J Med Chem 1983;26:759-61.
2. Ashton WT, Karkas JD, Field AK, Tolman RL. Activation by thymidine kinase and potent antiherpetic activity of 2′-nor-2′-deoxyguanosine (2′NDG). Biochcm Biophys Res Commun 1982;108:1716-21.
3. Ogilvie UK, Cheriyan UD, Radatus OX, Smith KO, Callaway KS, Kennell WL. Biologically active acyclonucleoside analogues. II. The synthesis of 9-(2-hydroxy-1-[hydroxymethyl, ethoxymethyl]guanine) BIOLF-62. Can J Chem 1982;60:3005-10.
4. Schaeffer HJ. Nucleosides, nuclcotides and their biological applications. In: Rideout JL, Henri GW, Beacham LM III, eds. Nucieosides with antiviral activity. New York: Academic Press, 1982:1-17.
5. Smith KO, Galloway KS, Kennell WL, Ogilvie KK, Radatus BK. A new nucleoside analog, 9-([2-hydroxy-1-(hydroxymethyl)ethoxy]methyi) guanine, highly active in vitro against herpes simplex virus types 1 and 2. Antimicrob Agents Chemother 1982;22:55-61.
6. Cheng YC, Huang ES, Lin JC, et al. Unique spectrum of activity of 9-[(1,3-dihydroxy-2-propoxy)methyl]-guanine against herpesviruses in vitro and its mode of action against herpes simplex virus type 1. Proc Natl Acad Sci USA 1983;80:2767-70.
7. Field AK, Davies ME, DeWitt C, et al. 9([2-Hydroxy-1-(hydroxymethyl)ethoxy]methyljguanine: a selective inhibitor of herpes group virus replication. Proc Natl Acad Sci U S A 1983;80:4139-43.
8. Oliver S, Bubley G, Crumpacker CS. Inhibition of HSV-transformed murine cells by nucleoside analogs, 2′-NDG and 2′-nor-cGMP: mechanisms of inhibition and reversal by exogenous nucleosides. Virology 1985; 145:84-93.
9. Cheng YC, Grill SP, Dutschman GE, Nakayama K, Bastow KF. Metabolism of 9-(1,3-dihydroxy-2-propoxymethyl)guanine, a new anti-herpes virus compound, in herpes simplex virus-infected cells. J Biol Chem 1983; 258:12460-4.
10. Hamzeh FM, Lietman PS. Intranuclear accumulation of subgenomic noninfectious human cytomegalovirus DNA in infected cells in the presence of ganciclovir. Antimicrob Agents Chemother 1991;35:1818-23.
11. Hamzeh FM, Lietman PS, Gibson W, Hayward GS. Identification of the lytic origin of DNA replication in human cyromegaiovirus by a novel approach utilizing ganciclovir-induced chain termination. J Virol 1990;64: 6184-95.
12. Sullivan V, Talarico CL, Stanat SC, Davis M, Coen DM, Biron KK. A protein kinase homologue controls phosphorylation of ganciclovir in human cytomegalovirus-infected cells. Nature 1992;358:162-4. [Errata, Nature 1992;359:85, 1993;366:756.]
13. Littler E, Stuart AD, Chee MS. Human cytomegalovirus UL97 open reading frame encodes a protein that phosphorylates the antiviral nucleoside analogue ganciclovir. Nature 1992;358:160-2.
14. Chee MS, Lawrence GL, Barrell BG. Alpha-, beta- and gammaherpesviruses encode a putative phosphotransferase. J Gen Virol 1989;70:1151-60.
15. Brenner S. Phosphotransferase sequence homology. Nature 1987;329: 21-5.
16. Metzger C, Michel D, Schneider K, Luske A, Schlicht HJ, Mertens T. Human cytomegalovirus UL97 kinase confers gandciovir susceptibility to recombinant vaccinia virus. J Virol 1994;68:8423-7.
17. Biron KK, Stanat SC, Sorrell IB, et al. Metabolic activation of the nucleoside analog 9-([2-hydroxy-1-(hydroxymethyl)ethoxy]methyl)guanine in human diploid fibroblasts infected with human cytomegalovirus. Proc Natl Acad Sci U S A 1985;82:2473-7.
18. Vile RG, Hart IR. Use of tissue-specific expression of the herpes simplex virus thymidine kinase gene to inhibit growth of established murine melanomas following direct intratumoral injection of DNA. Cancer Res 1993;53:3860-4.
19. Erlich KS, Mills J, Chatis P, et al. Acyclovir-resistant herpes simplex virus infection in patients with the acquired immunodeficiency syndrome. N Engl J Med 1989;320:293-6.
20. Tatarowicz WA, Lurain NS, Thompson KD. A ganciclovir-resistant clinical isolate of human cytomegalovirus exhibiting cross-resistance to other DNA polymerase inhibitors. J Infect Dis 1992;166:904-7.
21. Stanat SC, Reardon JE, Erice A, Jordan MC, Drew WL, Biron KK. Ganciclovir-resisiant cytomegalovirus clinical isolates: mode of resistance to ganciclovir. Antimicrob Agents Chemother 1991;35:2191-7.
22. Biron KK, Fyfe JA, Stanat SC, et al. A human cytomegalovirus mutant resistant to the nucleoside analog 9-([2-hydroxy-1-(hydroxymethyl)ethoxy]methyl)guanine (BW B759U) induces reduced levels of BW B759U triphosphate. Proc Natl Acad Sci U S A 1986;83:8769-73.
23. Lurain NS, Spafford LE, Thompson KD. Mutation in the UL97 open reading frame of human cytomegalovirus strains resistant to ganciclovir. J Virol 1994;68:4427-31.
24. Baldanti F, Silini E, Sarasini A, et al. A three-nucleotide. deletion in the UL97 open reading frame is responsible for the ganciclovir resistance of a human cytomegalovirus clinical isolate. J Virol 1995;69:796-800.
25. Chou S, Erice A, Jordan MC, et al. Analysis of the UL97 phosphotransferase coding sequence in clinical cytomegalovirus isolates and identification of mutations conferring ganciclovir resistance. J Infect Dis 1995; 171:576-83.
26. Chou S, Guentzel S, Michels KR, Miner RC, Drew WL. Frequency of UL97 phosphotransferase mutations related to ganciclovir resistance in clinical cytomegalovirus isolates. J Infect Dis 1995;172:239-42.
27. Lurain NS, Thompson KD, Holmes EW, Read GS. Point mutations in the DNA polymerase gene of human cytomegalovirus that result in resistance to antiviral agents. J Virol 1992;66:7146-52.
28. Sullivan V, Biron KK, Talarico C, et al. A point mutation in the human cytomegalovirus DNA polymerase gene confers resistance to ganciclovir and phosphonylmethoxyailkyl derivatives. Antimicrob Agents Chemother 1993;37:19-25.
29. Crumpacker CS, Kowalsky PN, Oliver SA, Schnipper LE, Field AK. Resistance of herpes simplex virus to 9-([2-hydroxy-1-(hydroxymethyl)ethoxy]methyl)guanine: physical mapping of drug synergism within the viral DNA polymerase locus. Proc Natl Acad Sci U S A 1984;81:1556-60.
30. Erice A, Chou S, Biron KK, Stanat SC, Balfour HH Jr, Jordan MC. Progressive disease due to ganciclovir-resistant cytomegaiovirus in immunocompromised patients. N Engl J Med 1989;320:289-93.
31. Drew WL, Miner RC, Busch DF, et al. Prevalence of resistance in patients receiving ganciclovir for serious cytomegalovirus infection. J Infect Dis 1991;163:716-9.
32. Jacobson MA, Drew WL, Feinberg J, et al. Foscarnet therapy for ganciclovir-resistant cytomegalovirus retinitis in patients with AIDS. J Infect Dis 1991,163:1348-50.
33. Jacobson MA, Wulfsohn M, Feinberg JE, et at. Phase II dose-ranging trial of foscarnet salvage therapy for cytomegalovirus retinitis in AIDS patients intolerant of or resistant to ganciclovir (ACTG protocol 093). AIDS 1994;8:451-9.
34. Sullivan V, Coen OM. Isolation of foscarnet-resistant human cytomegalovirus patterns of resistance and sensitivity to other antiviral drugs. J Infect Dis 1991;164:781-4.
35. Tocci MJ, Liveili TJ, Perry HC, Crumpacker CS, Field AK. Effects of the nucleoside analog 2′-nor-2′-deoxyguanosine (M human cytomegalovirus replication. Antimicrob Agents Chemother 1984;25:247-52.
36. Plotkin SA, Drew WL, Felsenstein D, Hirsch MS. Sensitivity of clinical isolates of human cytomegalovirus to 9-(1,3-dihydroxy-2-propoxymethyl)guanine. J Infect Dis 1985;152:833-4.
37. Mar EC, Cheng YC, Huang ES. Effect of 9-(1,3-dihydroxy-2-propoxymethyl)guanine on human cytomegalovirus replication in vitro. Antimicrob Agents Chemother 1983;24:518-21.
38. Lin JC, Smith MC, Pagano JS. Prolonged inhibitory effect of 9-(1,3-dihydroxy-2-propoxymethyi)guanine against replication of Epstein-Barr virus. J Virol 1984;50:50-5.
39. Agut H, Huraux JM, Collandre H, Montagnier L. Susceptibility of human herpesvirus 6 to acyclovir and ganciclovir. Lancet 1989;2:626.
40. Anderson RD, Griffy KG, Jung D, Dorr A, Hulse JD, Smith RB. Ganciclovir absolute bioavailability and steady-state pharmacokinetics after oral administration of two 3000-mg/d dosing regimens in human immunodeficiency virus- and cytomegalovirus-seropositive patients. Clin Ther 1995; 17:425-32.
41. DeArmond B. Future directions in the management of cytomegalovirus infections. J Acquir Immune Defic Syndr 1991;4:Suppl 1:S53-S56.
42. Fletcher C, Sawchuk R, Chinnock B, de Miranda P, Balfour HH Jr. Human pharmacokinetics of the antiviral drug DHPG. Clin Pharmacol Ther 1986;40:281-6.
43. Drew WL, Miner R, Saleh E. Antiviral susceptibility testing of cytomegalovirus: criteria for detecting resistance to antivirals. Clin Diagn Virol 1993;1:179-85.
44. Jabs DA, Enger C, Bartlett JG. Cytomegalovirus retinitis and acquired immunodeficiency syndrome. Arch Ophthalmol 1989;107:75-80.
45. Buhles WC Jr, Mastre BJ, Tinker AJ, Strand V, Koretz SH, Syntex Collaborative Ganciclovir Treatment Study Group. Ganciclovir treatment of life- or sight-threatening cytomegalovirus infection: experience in 314 immunocompromised patients. Rev Infecc Dis 1988;10:Suppl 3:S495-S506.
46. Freeman WR, Henderly DE, Wan WL, et al. Prevalence, pathophysiology, and treatment of rhegmatogenous retinal detachment in treated cytomegalovirus retinitis. Am J Ophthalmol 1987;103:537-36.
47. Crumpacker CS, Marlowe S, Zhang JL, Abrams S, Watkins P, Ganciclovir Bone Marrow Transplant Treatment Group. Treatment of cytomegalovirus pneumonia. Rev Infect Dis 1988;10:Suppl 3:S538-S546.
48. Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Mortality in patients with .the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. N Engl J Med 1992;326:213-20. [Erratum, N Engl J Med 1992;326:1172.]
49. The Studies of Ocular Complications of AIDS Research Group, AIDS Clinical Trials Group. Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS: the Cytomegalovirus Retreatment Trial. Arch Ophthalmol 1996;114:23-33.
50. Drew WL, Ives D, Lalezari JP, et al. Oral ganciclovir as maintenance treatment for cytomegalovirus retinitis in patients with AIDS. N Engl J Med 1995;333:615-20.
51. The Oral Ganciclovir European and Australian Cooperative Study Group. Intravenous versus oral ganciclovir: European/Australian comparative study of efficacy and safety in the prevention of cytomegalovirus retinitis recurrence in patients with AIDS. AIDS 1995;9:471-7.
52. Spector SA, McKinley GF, Lalezari JP, et al. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. N Engl J Med 1996;334:1491-7.
53. Martin DF, Parks DJ, Mellow SD, et al. Treatment of cytomegalovirus retinitis with an intraocular sustained-release ganciclovir implant: a randomized controlled clinical trial. Arch Ophthalmol 1994;112:1531-9.
54. Heinemann MH. Long-term intravitreal ganciclovir therapy for cytomegalovirus retinopathy. Arch Ophthalmol 1989;107:1767-72
55. Pape JVV. Treatment of gastrointestinal infections. AIDS 1988;2:Suppl LS161-S167.
56. Collaborative DHPG Treatment Study Group. Treatment of serious cytomegalovirus infections with 9-(1,3-dihydroxy-2-propoxymetnyl)guanine in patients with AIDS and other immunodeficiencies. N Engl J Med 1986;314:801-5.
57. Dieterich DT, Kotler DP, Busch DF, et al. Ganciclovir treatment of cytomegalovirus colitis in AIDS: a randomized, double-blind, placebo-controlled multicenter study. J Infect Dis 1992;167:278-82.
58. Reed EC, Wolford JL, Kopecky KJ, et al. Ganciclovir for the treatment of cytomegalovirus gastroenteritis in bone marrow transplant patients: a randomized, placebo-controlled trial. Ann Intern Med 1990;112:505-10.
59. Kotler DP, Tierney AR, Altilio D, Wang J, Pierson RN. Body mass repletion during ganciclovir treatment of cytomegalovirus infections in patients with acquired immunodeficiency syndrome. Arch Intern Med 1989; 149:901-5.
60. Hecht DW, Snydman DR, Crumpacker CS, Werner BG, Heinzc-Lacey B, Boston Renal Transplant CMV Study Group. Ganciclovir for treatment of renal transplant-associated primary cytomegalovirus pneumonia. J Infect Dis 1988;157:18790.
61. Shepp DH, Dandliker PS, de Miranda P, et al. Activity of 9 [2-hydroxy-1-(hydroxymethyl)ethoxymethyl]guanine in the treatment of cytomegalovirus pneumonia. Ann Intern Med 1985;103:368-73.
62. Emanuel D, Cunningham I, Jules-Elysee K, et al. Cytomegalovirus pneumonia after bone marrow transplantation successfully treated with the combination of ganciclovir and high-dose intravenous immune globulin. Ann Intern Med 1988;109:777-82.
63. Reed EC, Bowden RA, Dandliker PS, Lilleby KE, Meyers JD. Treatment of cytomegalovirus pneumonia with ganciclovir and intravenous cytomegalovirus immunoglobulin in patients with bone marrow transplants. Ann Intern Med 1988;109:783-8.
64. Schmidt GM, Kovacs A, Zaia IA, et al. Ganciclovir/immunoglobulin combination therapy for the treatment of human cytomegalovirus associated interstitial pneumonia in bone marrow allograft recipients. Transplantation 1988;46:905-7.
65. Eidelberg D, Sotrel A, Vogel H, Walker P, Kleefield J, Crumpackcr CS III. Progressive polyradiculopathy in acquired immune deficiency syndrome. Neurology 1986;36:912-6.
66. Miller RG, Storey JR1 Greco CM. Ganciclovir in the treatment of progressive AIDS-related polyradiculopathy. Neurology 1990;40:569-74.
67. Graveleau P, Perol R, Chapman A. Regression of cauda equina syndrome in AIDS patients being treated with ganciclovir. Lancet 1989;1:511-2.
68. Fuller GN, Gill SK, Guiloff RJ, et al. Ganciclovir for lumbosacral polyradiculopathy in AIDS. Lancet 1990;335:48-9.
69. Jacobson MA, Mills J, Rush J, et al. Failure of antiviral therapy for acquired immunodeficiency syndrome-related cytomegalovirus myelitis. Arch Neurol 1988;45:1090-2.
70. Fox JD, Brink NS, Zuckerman MA, et al. Detection of herpesvirus DNA by nested polymerase chain reaction in cerebrospinal fluid of human immunodeficiency virus-infected persons with neurologic disease: a prospective evaluation. J Infect Dis 1995;172:1087-90.
71. Wolf DG, Spector SA. Diagnosis of human cytomegalovirus central nervous system disease in AIDS patients by DNA amplification from cerebrospinal fluid. J Infect Dis 1992;166:1412-5.
72. Fuller GN. Cytomegalovirus and the peripheral nervous system in AIDS. J Acquir Immune Defic Syndr 1992;5:Suppl 1:S33-S36.
73. Enting R, de Gans J, Reiss P, Jansen C, Portegies P Ganciclovir/foscarnet for cytomegalovirus meningoencephalitis in AIDS. Lancet 1992; 340:559-60.
74. Brosgart CL, Craig C, Hillman D, et al. A randomized, placebo-controlled trial of the safety and efficacy of oral gancidovir for prophylaxis of CMV retinal and gastrointestinal mucosal disease in HIV-infected individuals with severe immunosuppression. In: Program and abstracts of the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, September 17-20, 1995. Washington, D.C: American Society for Microbiology, 1995. abstract.
75. Schmidt GM, Horack DA, Niland JC, et al. A randomized, controlled trial of prophylactic ganciclovir for cytomegalovirus pulmonary infection in recipients of allogeneic bone marrow transplants. N Engl J Med 1991;324: 1005-11.
76. Goodrich JM, Mori M, Gleaves CA, et al. Early treatment with ganciclovir to prevent cytomegalovirus disease after allogeneic bone marrow transplantation. N Engl J Med 1991;325:1601-7.
77. Merigan TC, Renlund DG, Keay S, et al. A controlled trial of ganciclovir to prevent cytomegalovirus disease after heart transplantation. N Engl J Med 1992;326:1182-6.
78. Winston DJ, Wirin D, Shaked A, Busuttil RW. Randomised comparison of ganciclovir and high-dose acyclovir for long-term cytomegalovirus prophylaxis in liver-transplant recipients. Lancet 1995;346:69-74.
79. Singh N, Yu VL, Mieles L, Wagener MM, Miner RC, Gayowski T. High-dose acyclovir compared with short-course preemptive gancilovir therapy to prevent cytomegalovirus disease in liver transplant recipients: a randomized trial. Ann Intern Med 1994;120.-375-81.
80. Hibberd PL, Tolkoff-Rubin NE, Conti D, et al. Preemptive ganciclovir therapy to prevent cytomegalovirus disease in cytomegalovirus antibody-positive renal transplant recipients: a randomized controlled trial. Ann Intern Med 1995;123:18-26.
81. Hardy WD. Combined gancidovir and recombinant human granulocyte-macrophage colony-stimulating factor in the treatment of cytomegalovirus retinitis in AIDS patients. J Acquir Immune Defic Syndr 1991;4: Suppl 1:S22-S28.
82. Hochster H, Dieterich D, Bozzette S, et al. Toxicity of combined ganciclovir and zidovudine for cytomegalovirus disease associated with AIDS: an AIDS Clinical Trials Group study. Ann Intern Med 1990;113: 111-7.
83. Crumpacker CS. Mechanism of action of foscarnet against viral polymerases. Am J Med 1992;92:Suppl 2A:2A-3S-2A-7S.
84. Dieterich DT, Poles MA, Lew EA, et al. Concurrent use of ganciclovir and foscarnet to treat cytomegalovirus infection in AIDS patients. J Infect Dis 1993;167:1184-8.
85. Ho HT, Woods KL, Bronson JJ, De Boeck H, Martin JC, Hitchcock MJM. Intracellular metabolism of the antiherpes agent (S)-1-[ 3-hydroxy-2-(phosphonylmethoxy)propyl]cytosine. Mol Pharmacol 1992;41:197-202.
86. Lalezari J, Holland G, Stagg R, et al. A randomized, controlled study of cidofovir (CDV) for relapsing cytomegalovirus retinitis (CMV-R) in patients with AIDS, In: Program and abstracts of the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, September 17-20, 1995. Washington, D.C.: American Society for Microbiology, 1995. abstract.