Valganciclovir for the treatment of cytomegalovirus retinitis in patients with AIDS

Expert Review of Ophthalmology

Volumn 2, Issue 3, 2007, Pages 351-361

  Eid, Albert J ^a   Razonable, raymund R ^a  

^a Mayo Clinic   (United States)

Author keywords

AIDS; cytomegalovirus; ganciclovir; HIV; prevention; therapy; valganciclovir

Indexed keywords

EID: 36248953571     PISSN: 17469899     EISSN: 17469902     Source Type: Journal    
DOI: 10.1586/17469899.2.3.351     Document Type: Article

References (64)

1. Neuwirth J, Gutman I, Hofeldt AJ et al. Cytomegalovirus retinitis in a young homosexual male with acquired immunodeficiency. Ophthalmology 89 (7), 805–808 (1982).
2. Goldberg DE, Smithen LM, Angelilli A, Freeman WR. HIV-associated retinopathy in the HAART era. Retina 25 (5), 633–649 (2005).
3. Hoover DR, Peng Y, Saah A et al. Occurrence of cytomegalovirus retinitis after human immunodeficiency virus immunosuppression. Arch. Ophthalmol. 114 (7), 821–827 (1996).
4. Gallant JE, Moore RD, Richman DD, Keruly J, Chaisson RE. Incidence and natural history of cytomegalovirus disease in patients with advanced human immunodeficiency virus disease treated with zidovudine. The Zidovudine Epidemiology Study Group. J. Infect. Dis. 166 (6), 1223–1227 (1992).
5. Khare MD, Sharland M. Cytomegalovirus treatment options in immunocompromised patients. Expert Opin. Pharmacother. 2 (8), 1247–1257 (2001).
6. Martin DF, Sierra-Madero J, Walmsley S et al. A controlled trial of valganciclovir as induction therapy for cytomegalovirus retinitis. N. Engl. J. Med. 346 (15), 1119–1126 (2002).
7. Paya CV, Razonable RR. Cytomegalovirus infection following solid organ transplantation. In: Transplant Infections. Bowden R, Ljungman P, Paya CV (Eds.). Lippincott Williams and Wilkins, 289–328 (2003).
8. Baker R. FDA approves oral ganciclovir as first drug to prevent CMV disease. Food and Drug Administration. Beta 8 (1995).
9. Spector SA, McKinley GF, Lalezari JP et al. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group. N. Engl. J. Med. 334 (23), 1491–1497 (1996).
10. Brosgart CL, Louis TA, Hillman DW et al. A randomized, placebo-controlled trial of the safety and efficacy of oral ganciclovir for prophylaxis of cytomegalovirus disease in HIV-infected individuals. Terry Beirn Community Programs for Clinical Research on AIDS. AIDS 12 (3), 269–277 (1998).
11. Salzberger B, Hartmann P, Hanses F et al. Incidence and prognosis of CMV disease in HIV-infected patients before and after introduction of combination antiretroviral therapy. Infection 33 (5–6), 345–349 (2005).
12. Spector SA, Weingeist T, Pollard RB et al. A randomized, controlled study of intravenous ganciclovir therapy for cytomegalovirus peripheral retinitis in patients with AIDS. AIDS Clinical Trials Group and Cytomegalovirus Cooperative Study Group. J. Infect. Dis. 168 (3), 557–563 (1993).
13. Jabs DA, Enger C, Bartlett JG. Cytomegalovirus retinitis and acquired immunodeficiency syndrome. Arch. Ophthalmol. 107 (1), 75–80 (1989).
14. Drew WL, Ives D, Lalezari JP et al. Oral ganciclovir as maintenance treatment for cytomegalovirus retinitis in patients with AIDS. Syntex Cooperative Oral Ganciclovir Study Group. N. Engl. J. Med. 333 (10), 615–620 (1995).
15. Jung D, Dorr A. Single-dose pharmacokinetics of valganciclovir in HIV- and CMV-seropositive subjects. J. Clin. Pharmacol. 39 (8), 800–804 (1999).
16. Pescovitz MD. Oral ganciclovir and pharmacokinetics of valganciclovir in liver transplant recipients. Transpl. Infect. Dis. 1 (Suppl. 1), 31–34 (1999).
17. Pescovitz MD, Rabkin J, Merion RM et al. Valganciclovir results in improved oral absorption of ganciclovir in liver transplant recipients. Antimicrob. Agents Chemother. 44 (10), 2811–2815 (2000).
18. Danner SA, Matheron S. Cytomegalovirus retinitis in AIDS patients: a comparative study of intravenous and oral ganciclovir as maintenance therapy. AIDS 10 (Suppl. 4), S7 –S11 (1996).
19. Lalezari JP, Friedberg DN, Bissett J et al. High dose oral ganciclovir treatment for cytomegalovirus retinitis. J. Clin. Virol. 24 (1–2), 67–77 (2002).
20. Chou S, Marousek G, Guentzel S et al. Evolution of mutations conferring multidrug resistance during prophylaxis and therapy for cytomegalovirus disease. J. Infect. Dis. 176 (3), 786–789 (1997).
21. Limaye AP, Corey L, Koelle DM, Davis CL, Boeckh M. Emergence of ganciclovir-resistant cytomegalovirus disease among recipients of solid-organ transplants. Lancet 356 (9230), 645–649 (2000).
22. Limaye AP, Raghu G, Koelle DM, Ferrenberg J, Huang ML, Boeckh M. High incidence of ganciclovir-resistant cytomegalovirus infection among lung transplant recipients receiving preemptive therapy. J. Infect. Dis. 185 (1), 20–27 (2002).
23. Spector SA, Busch DF, Follansbee S et al. Pharmacokinetic, safety, and antiviral profiles of oral ganciclovir in persons infected with human immunodeficiency virus: a phase I/II study. AIDS Clinical Trials Group, and Cytomegalovirus Cooperative Study Group. J. Infect. Dis. 171 (6), 1431–1437 (1995).
24. Henry K, Cantrill H, Fletcher C, Chinnock BJ, Balfour HH Jr. Use of intravitreal ganciclovir (dihydroxy propoxymethyl guanine) for cytomegalovirus retinitis in a patient with AIDS. Am. J. Ophthalmol. 103 (1), 17–23 (1987).
25. Cantrill HL, Henry K, Melroe NH, Knobloch WH, Ramsay RC, Balfour HH Jr. Treatment of cytomegalovirus retinitis with intravitreal ganciclovir. Long-term results. Ophthalmology 96 (3), 367–374 (1989).
26. Musch DC, Martin DF, Gordon JF, Davis MD, Kuppermann BD. Treatment of cytomegalovirus retinitis with a sustained-release ganciclovir implant. The Ganciclovir Implant Study Group. N. Engl. J. Med. 337 (2), 83–90 (1997).
27. 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. 112 (12), 1531–1539 (1994).
28. Martin DF, Kuppermann BD, Wolitz RA, Palestine AG, Li H, Robinson CA. Oral ganciclovir for patients with cytomegalovirus retinitis treated with a ganciclovir implant. Roche Ganciclovir Study Group. N. Engl. J. Med. 340 (14), 1063–1070 (1999).
29. Shane TS, Martin DF. Endophthalmitis after ganciclovir implant in patients with AIDS and cytomegalovirus retinitis. Am. J. Ophthalmol. 136 (4), 649–654 (2003).
30. Foscarnet–Ganciclovir Cytomegalovirus Retinitis Trial. 4. Visual outcomes. Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group. Ophthalmology 101 (7), 1250–1261 (1994).
31. Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS. The Cytomegalovirus Retreatment Trial. The Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Arch. Ophthalmol. 114 (1), 23–33 (1996).
32. Lalezari JP, Stagg RJ, Kuppermann BD et al. Intravenous cidofovir for peripheral cytomegalovirus retinitis in patients with AIDS. A randomized, controlled trial. Ann. Intern. Med. 126 (4), 257–263 (1997).
33. Lalezari JP, Holland GN, Kramer F et al. Randomized, controlled study of the safety and efficacy of intravenous cidofovir for the treatment of relapsing cytomegalovirus retinitis in patients with AIDS. J. Acquir. Immune Defic. Syndr. Hum. Retrovirol. 17 (4), 339–344 (1998).
34. Grillone LR, Lanz R. Fomivirsen. Drugs Today (Barc.) 37 (4), 245–255 (2001).
35. The Vitravene Study Group. A randomized controlled clinical trial of intravitreous fomivirsen for treatment of newly diagnosed peripheral cytomegalovirus retinitis in patients with AIDS. Am. J. Ophthalmol. 133 (4), 467–474 (2002).
36. The Vitravene Study Group. Randomized dose-comparison studies of intravitreous fomivirsen for treatment of cytomegalovirus retinitis that has reactivated or is persistently active despite other therapies in patients with AIDS. Am. J. Ophthalmol. 133 (4), 475–483 (2002).
37. The Vitravene Study Group. Safety of intravitreous fomivirsen for treatment of cytomegalovirus retinitis in patients with AIDS. Am. J. Ophthalmol. 133 (4), 484–498 (2002).
38. Sugawara M, Huang W, Fei YJ, Leibach FH, Ganapathy V, Ganapathy ME. Transport of valganciclovir, a ganciclovir prodrug, via peptide transporters PEPT1 and PEPT2. J. Pharm. Sci. 89 (6), 781–789 (2000).
39. Czock D, Scholle C, Rasche FM, Schaarschmidt D, Keller F. Pharmacokinetics of valganciclovir and ganciclovir in renal impairment. Clin. Pharmacol. Ther. 72 (2), 142–150 (2002).
40. Brown F, Banken L, Saywell K, Arum I. Pharmacokinetics of valganciclovir and ganciclovir following multiple oral dosages of valganciclovir in HIV- and CMV-seropositive volunteers. Clin. Pharmacokinet. 37 (2), 167–176 (1999).
41. Paya CV. A randomized, double-blind, double-dummy, active comparator-controlled, multicenter study of the efficacy and safety of valganciclovir vs. oral ganciclovir for the prevention of CMV disease in 372 high-risk (CMV D+/R-) heart, liver, and kidney transplant recipients. 42nd Interscience Conference on Antimicrobial Agents and Chemotherapy. American Society for Microbiology Press, CA, USA, LB-4 (2002).
42. Wohl D, Kendall M, Andersen J et al. Randomized, placebo controlled trial of valganciclovir to prevent CMV end-organ disease among HIV-infected subjects with detectable plasma CMV DNA PCR: ACTG 5030. 13th Conference on Retroviruses and Opportunistic Infections. CO, USA, February 6–9 (2006).
43. Lalezari J, Lindley J, Walmsley S et al. A safety study of oral valganciclovir maintenance treatment of cytomegalovirus retinitis. J. Acquir. Immune Defic. Syndr. 30 (4), 392–400 (2002).
44. Wiltshire H, Hirankarn S, Farrell C, Zuideveld K, Group ftVSOTS. Cytomegalovirus suppression in relation to levels of ganciclovir exposure following valganciclovir prophylaxis in solid organ transplant recipients. 43rd Interscience Conference on Antimicrobial Agents and Chemotherapy. American Society for Microbiology Press, IL, USA, A-1794 (2003).
45. Drew WL, Paya CV, Emery V. Cytomegalovirus (CMV) resistance to antivirals. Am. J. Transplant. 1 (4), 307–312 (2001).
46. Boivin G, Gilbert C, Gaudreau A, Greenfield I, Sudlow R, Roberts NA. Rate of emergence of cytomegalovirus (CMV) mutations in leukocytes of patients with acquired immunodeficiency syndrome who are receiving valganciclovir as induction and maintenance therapy for CMV retinitis. J. Infect. Dis. 184 (12), 1598–1602 (2001).
47. Jabs DA, Enger C, Dunn JP, Forman M. Cytomegalovirus retinitis and viral resistance: ganciclovir resistance. CMV Retinitis and Viral Resistance Study Group. J. Infect. Dis. 177 (3), 770–773 (1998).
48. Yust I, Fox Z, Burke M et al. Retinal and extraocular cytomegalovirus end-organ disease in HIV-infected patients in Europe: a EuroSIDA study, 1994–2001. Eur. J. Clin. Microbiol. Infect. Dis. 23 (7), 550–559 (2004).
49. Lin DY, Warren JF, Lazzeroni LC, Wolitz RA, Mansour SE. Cytomegalovirus retinitis after initiation of highly active antiretroviral therapy in HIV infected patients: natural history and clinical predictors. Retina 22 (3), 268–277 (2002).
50. Jabs DA, Van Natta ML, Thorne JE et al. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: 1. Retinitis progression. Ophthalmology 111 (12), 2224–2231 (2004).
51. Jabs DA, Van Natta ML, Thorne JE et al. Course of cytomegalovirus retinitis in the era of highly active antiretroviral therapy: 2. Second eye involvement and retinal detachment. Ophthalmology 111 (12), 2232–2239 (2004).
52. Michelet C, Arvieux C, Francois C et al. Opportunistic infections occurring during highly active antiretroviral treatment. AIDS 12 (14), 1815–1822 (1998).
53. Jabs DA, Van Natta ML, Kempen JH et al. Characteristics of patients with cytomegalovirus retinitis in the era of highly active antiretroviral therapy. Am. J. Ophthalmol. 133 (1), 48–61 (2002).
54. + counts. Ophthalmology 105 (7), 1259–1264 (1998).
55. Whitcup SM, Fortin E, Lindblad AS et al. Discontinuation of anticytomegalovirus therapy in patients with HIV infection and cytomegalovirus retinitis. JAMA 282 (17), 1633–1637 (1999).
56. Reed JB, Schwab IR, Gordon J, Morse LS. Regression of cytomegalovirus retinitis associated with protease-inhibitor treatment in patients with AIDS. Am. J. Ophthalmol. 124 (2), 199–205 (1997).
57. Macdonald JC, Torriani FJ, Morse LS, Karavellas MP, Reed JB, Freeman WR. Lack of reactivation of cytomegalovirus (CMV) retinitis after stopping CMV maintenance therapy in AIDS patients with sustained elevations in CD4 T cells in response to highly active antiretroviral therapy. J. Infect. Dis. 177 (5), 1182–1187 (1998).
58. Kaplan JE, Masur H, Holmes KK. Guidelines for preventing opportunistic infections among HIV-infected persons – 2002. Recommendations of the U.S. Public Health Service and the Infectious Diseases Society of America. MMWR Recomm. Rep. 51 (RR-8), 1–52 (2002).
59. Recommendations from the Centers for Disease Control and Prevention tNIoH, and the HIV Medicine Association/Infectious Diseases Society of America. Treating opportunistic infections among HIV-infected adults and adolescents. Clin. Infect. Dis. 40 (Suppl. 3) (2005).
60. Stone SF, Price P, Tay-Kearney ML, French MA. Cytomegalovirus (CMV) retinitis immune restoration disease occurs during highly active antiretroviral therapy-induced restoration of CMV-specific immune responses within a predominant Th2 cytokine environment. J. Infect. Dis. 185 (12), 1813–1817 (2002).
61. Deayton JR, Wilson P, Sabin CA et al. Changes in the natural history of cytomegalovirus retinitis following the introduction of highly active antiretroviral therapy. AIDS 14 (9), 1163–1170 (2000).
62. Mutimer HP, Akatsuka Y, Manley T et al. Association between immune recovery uveitis and a diverse intraocular cytomegalovirus-specific cytotoxic T cell response. J. Infect. Dis. 186 (5), 701–705 (2002).
63. Henderson HW, Mitchell SM. Treatment of immune recovery vitritis with local steroids. Br. J. Ophthalmol. 83 (5), 540–545 (1999).
64. Kosobucki BR, Goldberg DE, Bessho K et al. Valganciclovir therapy for immune recovery uveitis complicated by macular edema. Am. J. Ophthalmol. 137 (4), 636–638 (2004).