Hepatic Safety and Antiretroviral Effectiveness in HIV-Infected Patients Receiving Naltrexone

Authors

  • Jeanette M. Tetrault,

    1. From the Department of Internal Medicine (JMT, JLG, LES, ACJ, DAF), Yale University School of Medicine, New Haven, Connecticut; Veterans Aging Cohort Study (JPT, KAM, JLG, ACJ, DAF), West Haven, Connecticut; VA Connecticut Healthcare System (JPT, JLG, ACJ), West Haven, Connecticut; Center for Health Equity Research and Promotion (KAM), VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; and the National Institute on Alcohol Abuse and Alcoholism (KB), Rockville, Maryland.
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  • Janet P. Tate,

    1. From the Department of Internal Medicine (JMT, JLG, LES, ACJ, DAF), Yale University School of Medicine, New Haven, Connecticut; Veterans Aging Cohort Study (JPT, KAM, JLG, ACJ, DAF), West Haven, Connecticut; VA Connecticut Healthcare System (JPT, JLG, ACJ), West Haven, Connecticut; Center for Health Equity Research and Promotion (KAM), VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; and the National Institute on Alcohol Abuse and Alcoholism (KB), Rockville, Maryland.
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  • Kathleen A. McGinnis,

    1. From the Department of Internal Medicine (JMT, JLG, LES, ACJ, DAF), Yale University School of Medicine, New Haven, Connecticut; Veterans Aging Cohort Study (JPT, KAM, JLG, ACJ, DAF), West Haven, Connecticut; VA Connecticut Healthcare System (JPT, JLG, ACJ), West Haven, Connecticut; Center for Health Equity Research and Promotion (KAM), VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; and the National Institute on Alcohol Abuse and Alcoholism (KB), Rockville, Maryland.
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  • Joseph L. Goulet,

    1. From the Department of Internal Medicine (JMT, JLG, LES, ACJ, DAF), Yale University School of Medicine, New Haven, Connecticut; Veterans Aging Cohort Study (JPT, KAM, JLG, ACJ, DAF), West Haven, Connecticut; VA Connecticut Healthcare System (JPT, JLG, ACJ), West Haven, Connecticut; Center for Health Equity Research and Promotion (KAM), VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; and the National Institute on Alcohol Abuse and Alcoholism (KB), Rockville, Maryland.
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  • Lynn E. Sullivan,

    1. From the Department of Internal Medicine (JMT, JLG, LES, ACJ, DAF), Yale University School of Medicine, New Haven, Connecticut; Veterans Aging Cohort Study (JPT, KAM, JLG, ACJ, DAF), West Haven, Connecticut; VA Connecticut Healthcare System (JPT, JLG, ACJ), West Haven, Connecticut; Center for Health Equity Research and Promotion (KAM), VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; and the National Institute on Alcohol Abuse and Alcoholism (KB), Rockville, Maryland.
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  • Kendall Bryant,

    1. From the Department of Internal Medicine (JMT, JLG, LES, ACJ, DAF), Yale University School of Medicine, New Haven, Connecticut; Veterans Aging Cohort Study (JPT, KAM, JLG, ACJ, DAF), West Haven, Connecticut; VA Connecticut Healthcare System (JPT, JLG, ACJ), West Haven, Connecticut; Center for Health Equity Research and Promotion (KAM), VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; and the National Institute on Alcohol Abuse and Alcoholism (KB), Rockville, Maryland.
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  • Amy C. Justice,

    1. From the Department of Internal Medicine (JMT, JLG, LES, ACJ, DAF), Yale University School of Medicine, New Haven, Connecticut; Veterans Aging Cohort Study (JPT, KAM, JLG, ACJ, DAF), West Haven, Connecticut; VA Connecticut Healthcare System (JPT, JLG, ACJ), West Haven, Connecticut; Center for Health Equity Research and Promotion (KAM), VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; and the National Institute on Alcohol Abuse and Alcoholism (KB), Rockville, Maryland.
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  • David A. Fiellin,

    1. From the Department of Internal Medicine (JMT, JLG, LES, ACJ, DAF), Yale University School of Medicine, New Haven, Connecticut; Veterans Aging Cohort Study (JPT, KAM, JLG, ACJ, DAF), West Haven, Connecticut; VA Connecticut Healthcare System (JPT, JLG, ACJ), West Haven, Connecticut; Center for Health Equity Research and Promotion (KAM), VA Pittsburgh Healthcare System, Pittsburgh, Pennsylvania; and the National Institute on Alcohol Abuse and Alcoholism (KB), Rockville, Maryland.
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  • For the Veterans Aging Cohort Study Team


  • The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of any of the funding agencies, including the Department of Veterans Affairs or the United States government. The funding agencies had no further role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication.

Reprint requests: Jeanette M. Tetrault, MD, 367 Cedar Street, 4th Floor, New Haven, CT 06510; Tel.: 203-785-2470; Fax 203-737-3306; E-mail: jeanette.tetrault@yale.edu

Abstract

Background:  We sought to determine the impact of naltrexone on hepatic enzymes and HIV biomarkers in HIV-infected patients.

Methods:  We used data from the Veterans Aging Cohort Study-Virtual Cohort, an electronic database of administrative, pharmacy, and laboratory data. We restricted our sample to HIV-infected patients who received an initial oral naltrexone prescription of at least 7 days duration. We examined aspartate aminotransferase (AST) and alanine aminotransferase (ALT) and HIV biomarker (CD4 and HIV RNA) values for the 365 days prior to, during, and for the 365 days post-naltrexone prescription. We also examined cases of liver enzyme elevation (LEE; defined as >5 times baseline ALT or AST or >3.5 times baseline if baseline ALT or AST was >40 IU/l).

Results:  Of 114 HIV-infected individuals, 97% were men, 45% white, 57% Hepatitis C co-infected; median age was 49 years; 89% of the sample had a history of alcohol dependence and 32% had opioid dependence. Median duration of naltrexone prescription was 49 (interquartile range 30 to 83) days, representing 9,525 person-days of naltrexone use. Mean ALT and AST levels remained below the upper limit of normal. Two cases of LEE occurred. Mean CD4 count remained stable and mean HIV RNA decreased after naltrexone prescription.

Conclusions:  In HIV-infected patients, oral naltrexone is rarely associated with clinically significant ALT or AST changes and does not have a negative impact on biologic parameters. Therefore, HIV-infected patients with alcohol or opioid dependence can be treated with naltrexone.

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