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A Safety Study of Oral Valganciclovir Maintenance Treatment of CMV Retinitis
journal contribution
posted on 2023-06-08, 10:51 authored by Jacob Lalezari, Janette Lindley, Martin Fisher, Sharon Walmsley, Baruch Kuppermann, Dorothy Friedberg, Richard Lalonde, Sophie Matheron, Leopoldo Nieto, Francesca J Torriani, Rod Van Syoc, Mary Ann Sutton, William Buhles, Mary Jean StempienValganciclovir, 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.
History
Publication status
- Published
Journal
Journal of Acquired Immune Deficiency SyndromesISSN
1525-4135Publisher
Lippincott, Williams & WilkinsPublisher URL
Issue
4Volume
30Page range
392-400Department affiliated with
- Clinical and Experimental Medicine Publications
Full text available
- No
Peer reviewed?
- Yes
Legacy Posted Date
2012-02-21Usage metrics
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