A safety study of oral valganciclovir maintenance treatment of cytomegalovirus retinitis.

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/microL) 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/microL) (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.

• Authors: Jacob Lalezari, Janette Lindley, Sharon Walmsley, Baruch Kuppermann, Martin Fisher, Dorothy Friedberg, Richard Lalonde, Sophie Matheron, Leopoldo Nieto, Francesca J Torriani, Rod Van Syoc, Mary Ann Sutton, William Buhles, Mary Jean Stempien, Roche Valganciclovir Study Group
• Journal: Journal of acquired immune deficiency syndromes (1999) (J Acquir Immune Defic Syndr) Vol. 30 Issue 4 Pg. 392-400 (Aug 01 2002) ISSN: 1525-4135 [Print] United States
• PMID: 12138345 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antiviral Agents
• Prodrugs
• Valganciclovir
• Ganciclovir

Topics

• AIDS-Related Opportunistic Infections (drug therapy)
• Administration, Oral
• Adult
• Antiretroviral Therapy, Highly Active
• Antiviral Agents (administration & dosage, adverse effects)
• CD4 Lymphocyte Count
• Candidiasis, Oral (etiology)
• Cytomegalovirus Retinitis (complications, drug therapy)
• Drug Tolerance
• Female
• Ganciclovir (administration & dosage, adverse effects, analogs & derivatives)
• HIV Infections (complications, drug therapy, immunology)
• Humans
• Male
• Middle Aged
• Prodrugs (administration & dosage, adverse effects)
• Safety
• Valganciclovir