Efficacy and Safety of Atazanavir in Patients with End-Stage Liver Disease
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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 (OLTx).
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.
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 μl–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 μl–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).
Unboosted ATV treatment did not worsen liver disease and was able to maintain or gain immunovirological eligibility for OLTx 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.
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- 1.Darby SC, Ewart DW, Giangrande PL, Spooner RJ, Rizza CR, Dusheiko GM, Lee CA, Ludlam CA, Preston FE: Mortality from liver cancer and liver disease in haemophilic men and boys in UK given blood products contaminated with hepatitis C. UK Haemophilia Centre Directors’ Organisation. Lancet 1997; 350: 1425–1431.PubMedCrossRefGoogle Scholar
- 2.Soto B, Sanchez-Quijano A, Rodrigo L, del Olmo JA, Garcia-Bengoechea M, Hernandez-Quero J, Rey C, Abad MA, Rodriguez M, Sales Gilabert M, Gonzalez F, Miron P, Caruz A, Relimpio F, Torronteras R, Leal M, Lissen E: Human immunodeficiency virus infection modifies the natural history of chronic parenterallyacquired hepatitis C with an unusually rapid progression to cirrhosis. J Hepatol 1997; 26: 1–5.PubMedCrossRefGoogle Scholar
- 6.Cacoub P, Geffray L, Rosenthal E, Perronne C, Veyssier P, Raguin G: Mortality among human immunodeficiency virus-infected patients with cirrhosis or hepatocellular carcinoma due to hepatitis C virus in French Departments of Internal Medicine/Infectious Diseases, in 1995 and 1997. Clin Infect Dis 2001; 32: 1207–1214.PubMedCrossRefGoogle Scholar
- 10.The Panel on Clinical Practices for Treatment of HIV infection convened by the Department of Health and Human Services (DHHS) and the Henry J. Kaiser Family Foundation. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents (29 Jan 2008). Available at: http://aidsinfo.nih.gov/Guidelines. Accessed 23 Feb 2008.
- 14.Kaul S, Bassi K, Damle B, Xie J, Gale J, Kearne B, Hanna. Abstract 43rd Interscience Conf Antimicrobial Agents Chemotherapy. Abstract A-1616 2003.Google Scholar
- 15.Cahn P, Piliero P, Giordano M, Thiry A, Schnitman S. Abstract 42nd Interscience Conf Antimicrobial Agents Chemotherapy. Abstract H-1730 2002.Google Scholar
- 16.Brouwer KLR, Dukes GE, Powell JR: Influence of liver function on drug disposition. In: Evans WE, Schentag JJ, Jusko WJ (eds) Applied pharmacokinetics, principles of therapeutic drug monitoring. 3rd edition Appl Therapeutics, Vancouver 1992, pp 6.1–6.59.Google Scholar