Document Detail

A safety study of oral valganciclovir maintenance treatment of cytomegalovirus retinitis.
MedLine Citation:
PMID:  12138345     Owner:  NLM     Status:  MEDLINE    
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.
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;
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of acquired immune deficiency syndromes (1999)     Volume:  30     ISSN:  1525-4135     ISO Abbreviation:  J. Acquir. Immune Defic. Syndr.     Publication Date:  2002 Aug 
Date Detail:
Created Date:  2002-07-24     Completed Date:  2002-08-23     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  100892005     Medline TA:  J Acquir Immune Defic Syndr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  392-400     Citation Subset:  IM; X    
Quest Clinical Research, San Francisco, California 94115, USA.
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MeSH Terms
AIDS-Related Opportunistic Infections / drug therapy*
Administration, Oral
Antiretroviral Therapy, Highly Active
Antiviral Agents / administration & dosage*,  adverse effects*
CD4 Lymphocyte Count
Candidiasis, Oral / etiology
Cytomegalovirus Retinitis / complications,  drug therapy*
Drug Tolerance
Ganciclovir / administration & dosage*,  adverse effects*,  analogs & derivatives*
HIV Infections / complications,  drug therapy,  immunology
Middle Aged
Prodrugs / administration & dosage,  adverse effects
Reg. No./Substance:
0/Antiviral Agents; 0/Prodrugs; 0/valganciclovir; 82410-32-0/Ganciclovir

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