Open AccessA Safety Study of Oral Valganciclovir Maintenance Treatment of Cytomegalovirus Retinitis
Author(s) -
Jacob Lalezari,
Janette Lindley,
Sharon Walmsley,
Baruch D. Kuppermann,
Martin Fisher,
Dorothy N. Friedberg,
Richard Lalonde,
Sophie Matheron,
Leopoldo Nieto,
Francesca J. Torriani,
Rod Van Syoc,
Mary Ann Sutton,
William Buhles,
Mary Jean Stempien
Publication year - 2002
Publication title -
journal of acquired immune deficiency syndromes
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.162
H-Index - 157
eISSN - 1944-7884
pISSN - 1525-4135
DOI - 10.1097/00042560-200208010-00004
Subject(s) - mental health , medicine , quality of life (healthcare) , depression (economics) , cytomegalovirus retinitis , viral load , psychiatry , family medicine , human immunodeficiency virus (hiv) , immunology , retinitis , human cytomegalovirus , virus , nursing , economics , macroeconomics
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.