TY - JOUR
T1 - The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome
T2 - The Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial
AU - Jabs, D. A.
N1 - Funding Information:
This work was supported by cooperative agreements from the National Eye Institute to The Johns Hopkins University School of Medicine (U10 EY08052), The Johns Hopkins University School of Hygiene and Public Health (U10 EY08057), and the University of Wisconsin, Madison (U10 EY08067). Additional support was provided by the National Center for Research Resources through the General Clinical Research Center Grants 5MO1 RR00350 (Baylor College of Medicine), 5MO1 RR05096 (Louisiana State University), 5MO1 RR00865 (University of California, Los Angeles), 5MO1 RR05280 (University of Miami), 5MO1 RR00046 (University of North Carolina), 5M01 RR00043 (University of Southern California), and 5M01 RR00047 (Weill Medical College of Cornell University). Support also was provided by the National Institute of Allergy and Infectious Diseases through cooperative agreements U01 AI 27688 (The Johns Hopkins University School of Medicine), U01 AI 27674 (Louisiana State University at Tulane), U01 AI 27660 (University of California, Los Angeles), U01 AI 27670 (University of California, San Diego), U01 AI 27663 (University of California, San Francisco), U01 AI 25868 (University of North Carolina), U01 AI 25903 (Washington University at St. Louis), and U01 AI 32783 (University of Pennsylvania).
PY - 2001
Y1 - 2001
N2 - PURPOSE: To compare the regimen of the ganciclovir implant plus oral ganciclovir to one of intravenous cidofovir for the treatment of cytomegalovirus retinitis. METHODS: Sixty-one patients with acquired immunodeficiency syndrome and cytomegalovirus retinitis were randomized either to the regimen of the ganciclovir implant plus oral ganciclovir, 1 gm three times daily, or intravenous cidofovir, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week. RESULTS: Mortality was similar between the two treatment groups. Mortality rates were 0.41 per person-year in patients assigned to the ganciclovir regimen and 0.49 per person-year in patients assigned to cidofovir (P = .59). Ocular outcomes were similar between the two groups. Retinitis progression occurred at a rate of 0.67 per person-year in the ganciclovir group and 0.71 per person-year in the cidofovir group (P = .72). A loss of visual acuity of 15 letters or more occurred at a rate of 0.78 per person-year in the ganciclovir group and 0.47 per person-year in the cidofovir group (P = .28). The rate of loss of visual field was 7 degrees per month in the ganciclovir group and 2 degrees per month in the cidofovir group (P = .048). Vitreous hemorrhage was more common in the ganciclovir implant group (0.13 per person-year) than in the cidofovir group (no cases, P = .014), whereas uveitis appeared to be more common in the cidofovir group (0.35 per person-year) than in the ganciclovir group (0.09 per person-year, P = .066). Nephrotoxicity (serum creatinine 1.6 mg/dL or greater) occurred at a rate of 0.18 per person-year in the ganciclovir group and 0.48 per person-year in the cidofovir group (P = .10). CONCLUSIONS: Although the small number of patients in this study limits definitive interpretation, these data suggest that in the era of highly active antiretroviral therapy, the regimens of the ganciclovir implant plus oral ganciclovir and of intravenous cidofovir are similar for controlling cytomegalovirus retinitis and preventing visual loss but have different side effects.
AB - PURPOSE: To compare the regimen of the ganciclovir implant plus oral ganciclovir to one of intravenous cidofovir for the treatment of cytomegalovirus retinitis. METHODS: Sixty-one patients with acquired immunodeficiency syndrome and cytomegalovirus retinitis were randomized either to the regimen of the ganciclovir implant plus oral ganciclovir, 1 gm three times daily, or intravenous cidofovir, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week. RESULTS: Mortality was similar between the two treatment groups. Mortality rates were 0.41 per person-year in patients assigned to the ganciclovir regimen and 0.49 per person-year in patients assigned to cidofovir (P = .59). Ocular outcomes were similar between the two groups. Retinitis progression occurred at a rate of 0.67 per person-year in the ganciclovir group and 0.71 per person-year in the cidofovir group (P = .72). A loss of visual acuity of 15 letters or more occurred at a rate of 0.78 per person-year in the ganciclovir group and 0.47 per person-year in the cidofovir group (P = .28). The rate of loss of visual field was 7 degrees per month in the ganciclovir group and 2 degrees per month in the cidofovir group (P = .048). Vitreous hemorrhage was more common in the ganciclovir implant group (0.13 per person-year) than in the cidofovir group (no cases, P = .014), whereas uveitis appeared to be more common in the cidofovir group (0.35 per person-year) than in the ganciclovir group (0.09 per person-year, P = .066). Nephrotoxicity (serum creatinine 1.6 mg/dL or greater) occurred at a rate of 0.18 per person-year in the ganciclovir group and 0.48 per person-year in the cidofovir group (P = .10). CONCLUSIONS: Although the small number of patients in this study limits definitive interpretation, these data suggest that in the era of highly active antiretroviral therapy, the regimens of the ganciclovir implant plus oral ganciclovir and of intravenous cidofovir are similar for controlling cytomegalovirus retinitis and preventing visual loss but have different side effects.
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U2 - 10.1016/S0002-9394(01)00840-6
DO - 10.1016/S0002-9394(01)00840-6
M3 - Article
C2 - 11292409
AN - SCOPUS:0035059340
SN - 0002-9394
VL - 131
SP - 457
EP - 467
JO - American journal of ophthalmology
JF - American journal of ophthalmology
IS - 4
ER -