The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Ganciclovir Cidofovir Cytomegalovirus Retinitis Trial.
OBJECTIVE
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.
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000401:mortality; D000284:Administration, Oral; D000328:Adult; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000077404:Cidofovir; D017726:Cytomegalovirus Retinitis / Q000188:drug therapy* / Q000401:mortality; D003596:Cytosine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives; D018450:Disease Progression; D004311:Double-Blind Method; D004341:Drug Evaluation; D004343:Drug Implants; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007263:Infusions, Parenteral; D007668:Kidney / Q000187:drug effects; D008297:Male; D063065:Organophosphonates; D009943:Organophosphorus Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D015996:Survival Rate; D016896:Treatment Outcome; D014605:Uveitis / Q000139:chemically induced; D014792:Visual Acuity; D014823:Vitreous Hemorrhage / Q000139:chemically induced
D000998:Antiviral Agents; D004343:Drug Implants; D063065:Organophosphonates; D009943:Organophosphorus Compounds; D003596:Cytosine; D000077404:Cidofovir; D015774:Ganciclovir