Document Detail


Efficacy and safety of atazanavir in patients with end-stage liver disease.
MedLine Citation:
PMID:  19471855     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: No data are available on the use of atazanavir (ATV) in patients with end-stage liver disease (ESLD), and guidelines discourage its use in this setting. The objective of our study was to evaluate the efficacy and safety of unboosted ATV in patients infected with HIV and suffering from ESLD who had been screened for orthotopic liver transplantation (OLT(x)). PATIENTS AND METHODS: This was a single-arm, 24-week pilot study. Atazanavir-naïve patients undergoing a highly active antiretroviral therapy were switched to ATV 400 mg daily plus two non-thymidine nucleoside reverse transcriptase inhibitors. RESULTS: Fifteen patients (ten males and five females, age range 36-59 years) were enrolled in the study. Of these, 11 (73%) had a baseline CD4 cell count > 200 microl(-1), and 12 had undetectable plasma HIV-RNA. 12 subjects (80%) were able to remain on ATV until week 24 (n = 10) or transplantation (n = 2). At the end of the study, the median CD4 cell count was 340 microl(-1) , and nine of the ten patients had undetectable RNA. During the study period, two patients received a transplant, two died of intracerebral hemorrhage and lactic acidosis, respectively, and one discontinued ATV. Among the ten patients completing the 24-week study, no significant changes from baseline were observed for most of the liver function markers, with the exception of unconjugated bilirubin (from 1.15 mg/dl to 1.32 mg/dl, p = 0.047). CONCLUSIONS: Unboosted ATV treatment did not worsen liver disease and was able to maintain or gain immunovirological eligibility for OLT(x) in all patients, with a limited effect on unconjugated bilirubin. These results suggest that ATV is an easy-to-use drug in patients with ESLD.
Authors:
G Guaraldi; S Cocchi; A Motta; S Ciaffi; M Codeluppi; S Bonora; F Di Benedetto; M Masetti; M Floridia; S Baroncelli; D Pinetti; A Bertolini; G E Gerunda; R Esposito
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Publication Detail:
Type:  Journal Article     Date:  2009-05-26
Journal Detail:
Title:  Infection     Volume:  37     ISSN:  1439-0973     ISO Abbreviation:  Infection     Publication Date:  2009 Jun 
Date Detail:
Created Date:  2009-06-24     Completed Date:  2009-07-14     Revised Date:  2009-07-21    
Medline Journal Info:
Nlm Unique ID:  0365307     Medline TA:  Infection     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  250-5     Citation Subset:  IM    
Affiliation:
Department of Internal Medicine and Medical Specialties, Clinic of Infectious Diseases, University of Modena and Reggio Emilia, Via del Pozzo 71, 41100, Modena, Italy. g.guaraldi@unimore.it
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MeSH Terms
Descriptor/Qualifier:
Adult
Anti-HIV Agents / adverse effects,  therapeutic use*
Antiretroviral Therapy, Highly Active
CD4 Lymphocyte Count
Female
Follow-Up Studies
HIV Infections / complications*,  drug therapy*,  immunology
Humans
Liver Failure / complications*,  mortality
Liver Function Tests
Liver Transplantation
Male
Middle Aged
Oligopeptides / adverse effects,  therapeutic use*
Pilot Projects
Pyridines / adverse effects,  therapeutic use*
Treatment Outcome
Viral Load
Chemical
Reg. No./Substance:
0/Anti-HIV Agents; 0/Oligopeptides; 0/Pyridines; 198904-31-3/atazanavir

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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