OBJECTIVE: To evaluate patients with cytomegalovirus (CMV) retinitis treated with intravenous cidofovir for long-term outcomes. DESIGN:Patients with CMV retinitis enrolled in a randomized, controlled clinical trial of intravenous cidofovir as treatment for retinitis were followed for long-term outcomes, including 21 patients initially enrolled in the deferral group who receivedcidofovir therapy after progression of retinitis. SETTING:Thirteen tertiary care clinics specializing in AIDS care and ophthalmology. PARTICIPANTS: Fifty-eight patients with AIDS and small peripheral CMV retinitis lesions. INTERVENTIONS:Cidofovir 5 mg/kg once weekly for 2 weeks followed by low-dose maintenance cidofovir therapy (3 mg/kg) in 35 patients or high-dose maintenance (5 mg/kg) in 23 patients. MAIN OUTCOME MEASURES: Time to progression of retinitis, drug toxicities. RESULTS:Median time to progression of retinitis was 2.5 months. Median time to discontinuation of cidofovir because of intolerance was 6.6 months, and did not differ significantly between the two maintenance doses. Median time to discontinuation of cidofovir for intolerance other than probenecid reaction was 16.3 months for patients treated with low-dose maintenance and 5.0 months for patients treated with high-dose maintenance (P = 0.021). Proteinuria of 2+ or more occurred at a rate of 1.22/person-year. In patients with sufficient follow-up to determine resolution of proteinuria, 89.9% of episodes resolved, and the median time to resolution was 20 days. Rates of probenecid intolerance and of cidofovir-associated uveitis were 0.35/person-year, and 0.20/person-year, respectively. CONCLUSION: Although effective for the treatment of CMV retinitis, cidofovir has potential toxicity. Toxicity typically resolves with discontinuation of therapy, but careful attention to both concomitant therapy and monitoring for toxicity is required.
RCT Entities:
OBJECTIVE: To evaluate patients with cytomegalovirus (CMV) retinitis treated with intravenous cidofovir for long-term outcomes. DESIGN:Patients with CMV retinitis enrolled in a randomized, controlled clinical trial of intravenous cidofovir as treatment for retinitis were followed for long-term outcomes, including 21 patients initially enrolled in the deferral group who received cidofovir therapy after progression of retinitis. SETTING: Thirteen tertiary care clinics specializing in AIDS care and ophthalmology. PARTICIPANTS: Fifty-eight patients with AIDS and small peripheral CMV retinitis lesions. INTERVENTIONS:Cidofovir 5 mg/kg once weekly for 2 weeks followed by low-dose maintenance cidofovir therapy (3 mg/kg) in 35 patients or high-dose maintenance (5 mg/kg) in 23 patients. MAIN OUTCOME MEASURES: Time to progression of retinitis, drug toxicities. RESULTS: Median time to progression of retinitis was 2.5 months. Median time to discontinuation of cidofovir because of intolerance was 6.6 months, and did not differ significantly between the two maintenance doses. Median time to discontinuation of cidofovir for intolerance other than probenecid reaction was 16.3 months for patients treated with low-dose maintenance and 5.0 months for patients treated with high-dose maintenance (P = 0.021). Proteinuria of 2+ or more occurred at a rate of 1.22/person-year. In patients with sufficient follow-up to determine resolution of proteinuria, 89.9% of episodes resolved, and the median time to resolution was 20 days. Rates of probenecid intolerance and of cidofovir-associated uveitis were 0.35/person-year, and 0.20/person-year, respectively. CONCLUSION: Although effective for the treatment of CMV retinitis, cidofovir has potential toxicity. Toxicity typically resolves with discontinuation of therapy, but careful attention to both concomitant therapy and monitoring for toxicity is required.