A safety study of oral valganciclovir maintenance treatment of cytomegalovirus retinitis.
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.
Lalezari
Jacob
J
Quest Clinical Research, San Francisco, California 94115, USA. drjay@questclinical.com
Lindley
Janette
J
Walmsley
Sharon
S
Kuppermann
Baruch
B
Fisher
Martin
M
Friedberg
Dorothy
D
Lalonde
Richard
R
Matheron
Sophie
S
Nieto
Leopoldo
L
Torriani
Francesca J
FJ
Van Syoc
Rod
R
Sutton
Mary Ann
MA
Buhles
William
W
Stempien
Mary Jean
MJ
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000284:Administration, Oral; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D000998:Antiviral Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D018791:CD4 Lymphocyte Count; D002180:Candidiasis, Oral / Q000209:etiology; D017726:Cytomegalovirus Retinitis / Q000150:complications / Q000188:drug therapy*; D004361:Drug Tolerance; D005260:Female; D015774:Ganciclovir / Q000008:administration & dosage* / Q000009:adverse effects* / Q000031:analogs & derivatives*; D015658:HIV Infections / Q000150:complications / Q000188:drug therapy / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011355:Prodrugs / Q000008:administration & dosage / Q000009:adverse effects; D012449:Safety; D000077562:Valganciclovir
D000998:Antiviral Agents; D011355:Prodrugs; D000077562:Valganciclovir; D015774:Ganciclovir