A Safety Study of Oral Valganciclovir Maintenance Treatment of CMV Retinitis

Lalezari, Jacob, Lindley, Janette, Fisher, Martin, Walmsley, Sharon, Kuppermann, Baruch, Friedberg, Dorothy, Lalonde, Richard, Matheron, Sophie, Nieto, Leopoldo, Torriani, Francesca J, Van Syoc, Rod, Sutton, Mary Ann, Buhles, William and Stempien, Mary Jean (2002) A Safety Study of Oral Valganciclovir Maintenance Treatment of CMV Retinitis. Journal of Acquired Immune Deficiency Syndromes, 30 (4). pp. 392-400. ISSN 1525-4135

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Abstract

Valganciclovir, an oral prodrug of the anti-cytomegalovirus (CMV) agent ganciclovir, was evaluated in a single-arm open-label safety study. AIDS patients (median CD4 lymphocyte count of 140 cells/μL) with treated CMV retinitis (N = 212) received 900-mg once-daily valganciclovir maintenance therapy with courses of 900-mg twice-daily valganciclovir induction therapy as needed to treat progression. After a median treatment duration of 372 days, the adverse event profile was similar to that reported for intravenous (IV) and oral ganciclovir. Adverse event rates of note were diarrhea (35%), nausea (23%), fever (18%), neutropenia (absolute neutrophil count <500 cells/μL) (10%), and anemia (hemoglobin <8.0 g/dL) (12%). Consistent with prior treatment studies of oral ganciclovir, IV catheter-related adverse events were uncommon (6%) and lower than previously reported for IV ganciclovir. The mortality rate was 0.072 deaths per patient-year. Progression of CMV retinitis occurred in 17% of patients during the study treatment period, usually in association with a low CD4 cell count. Other than a higher than expected frequency of oral candidiasis (17%), no clinical toxicities or laboratory abnormalities occurred during treatment with valganciclovir that have not been observed during treatment with ganciclovir.

Item Type: Article
Schools and Departments: Brighton and Sussex Medical School > Clinical and Experimental Medicine
Depositing User: EPrints Services
Date Deposited: 21 Feb 2012 10:03
Last Modified: 10 Jan 2020 11:05
URI: http://sro.sussex.ac.uk/id/eprint/37899
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