Hepatic Safety and Lack of Antiretroviral Interactions With Buprenorphine/Naloxone in HIV-Infected Opioid-Dependent Patients

Vergara-Rodriguez, Pamela; Tozzi, Mary Jo; Botsko, Michael; Nandi, Vijay; Altice, Frederick L.; Egan, James E.; O’Connor, Patrick G.; Sullivan, Lynn E.; Fiellin, David A.

doi:10.1097/qai.0b013e31820a820f

Cited by 22 publications

(17 citation statements)

References 21 publications

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“…Buprenorphine can be used with atazanavir, however slower upward titration of dosing is advised with monitoring. In a recent study, however, a lack of oversedation was seen in a prospective cohort of HIV-infected opioid dependent patients on buprenorphine [178]. This study, however, occurred after the previous publications cautioning providers on the rate of build-up and it is unclear if the lack of oversedation was the result of a slower upward titration or a lack of effect [179].…”

Section: Interactions Between Buprenorphine and Specific Antiretrovirmentioning

confidence: 99%

A review of pharmacological interactions between HIV or hepatitis C virus medications and opioid agonist therapy: implications and management for clinical practice

Bruce

Moody

Altice

et al. 2013

Expert Review of Clinical Pharmacology

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Global access to opioid agonist therapy and HIV/HCV treatment is expanding but when used concurrently, problematic pharmacokinetic and pharmacodynamic interactions may occur. Review of articles from 1966 into 2012 in Medline using the following keywords: HIV, AIDS, HIV therapy, HCV, HCV therapy, antiretroviral therapy, HAART, drug interactions, methadone, and buprenorphine. Additionally, abstracts from national and international meetings and a review of conference proceedings were conducted; selected reports were reviewed as well. The metabolism of both opioid and antiretroviral therapies, description of their known interactions, and clinical implications and management of these interactions are reviewed. Important pharmacokinetic and pharmacodynamic drug interactions affecting either methadone or HIV medications have been demonstrated within each class of antiretroviral agents. Drug interactions between methadone, buprenorphine and HIV medications are known and may have important clinical consequences. Clinicians must be alert to these interactions and have a basic knowledge regarding their management.

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Section: Interactions Between Buprenorphine and Specific Antiretrovirmentioning

confidence: 99%

A review of pharmacological interactions between HIV or hepatitis C virus medications and opioid agonist therapy: implications and management for clinical practice

Bruce

Moody

Altice

et al. 2013

Expert Review of Clinical Pharmacology

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“…Buprenorphine is associated with enhanced HIV treatment outcomes, including increased HAART initiation rates, adherence, and CD4 + cell counts among HIV-infected opioid-dependent individuals (Moatti et al, 2000; Altice et al, 2011). Fewer interactions exist between buprenorphine and HAART than between methadone and HAART (Sullivan and Fiellin, 2005; Gruber et al, 2012; Vergara-Rodriguez et al, 2011). Buprenorphine is safe and effective in combination with pegylated interferon plus ribavirin (Conway et al, 2004; Chossegros et al, 2008).…”

mentioning

confidence: 99%

Buprenorphine for Human Immunodeficiency Virus/Hepatitis C Virus–coinfected Patients

Taylor

Maynard

Friedmann

et al. 2012

Journal of Addiction Medicine

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Objectives Buprenorphine is associated with enhanced human immunodeficiency virus (HIV) treatment outcomes including increased antiretroviral therapy initiation rates, adherence, and CD4+ cell counts among HIV-infected opioid-dependent individuals. Buprenorphine facilitates hepatitis C virus (HCV) treatment in opioid-dependent patients with HCV monoinfection. Less is known about buprenorphine’s role in HIV/HCV coinfection. Methods We conducted a retrospective chart review to evaluate HCV care for HIV-infected buprenorphine patients in the first 4 years of buprenorphine’s integration into a Rhode Island HIV clinic. Results Sixty-one patients initiated buprenorphine. All had HCV antibody testing; 57 (93%) were antibody-positive. All antibody-positive patients underwent HCV RNA testing; 48 (84%) were RNA-positive. Of these, 15 (31%) were not referred to HCV care. Among chronically infected patients, 3 received HCV treatment after buprenorphine; all had cirrhosis and none achieved viral eradication. At buprenorphine induction, most patients had inadequately controlled HIV infection, with detectable HIV RNA (59%) or CD4+ cell count less than or equal to 350/µL (38%). Conclusions Buprenorphine has shown limited success to date as a bridge to HCV treatment within an HIV clinic. Buprenorphine’s stabilization of opioid dependence and HIV disease may permit the use of HCV therapy over time.

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“…Some non-comparative longitudinal studies, including a report from the safety phase of this trial, have reported statistically significant increases in transaminase levels in individuals initiating treatment with BUP/NX (Lucas et al, 2011; Petry et al, 2000), although another study of HIV-infected individuals starting BUP/NX found no significant increase in transaminase levels (Vergara-Rodriguez et al, 2011). In the current study, we observed that ALT concentrations increased by an average of approximately 20 U/L at follow-up visits compared with baseline, with no significant difference between arms.…”

Section: Discussionmentioning

confidence: 91%

Hepatotoxicity in a 52-week randomized trial of short-term versus long-term treatment with buprenorphine/naloxone in HIV-negative injection opioid users in China and Thailand

Lucas

Young

Donnell

et al. 2014

Drug and Alcohol Dependence

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Background Buprenorphine/naloxone (BUP/NX), an effective treatment for opioid dependence, has been implicated in hepatic toxicity. However, as persons taking BUP/NX have multiple hepatic risk factors, comparative data are needed to quantify the risk of hepatoxicity with BUP/NX. Methods We compared rates of alanine aminotransferase (ALT) elevation ≥ grade 3 (ALT ≥ 5.1 times the upper limit of normal) and graded bilirubin elevations in HIV-negative opioid injectors randomized to long-term (52 weeks) or short-term (18 days) medication assisted treatment (LT-MAT and ST-MAT, respectively) with BUP/NX in a multisite trial conducted in China and Thailand. ALT and bilirubin were measured at baseline, 12, 26, 40 and 52 weeks, times temporally remote from BUP/NX exposure in the ST-MAT participants. Results Among1036 subjects with at least one laboratory follow-up measurement, 76 (7%) participants experienced ALT elevation ≥ grade 3. In an intent-to-treat analysis, the risk of ALT events was similar in participants randomized to LT-MAT compared with ST-MAT (adjusted hazard ratio 1.25, 95% confidence interval 0.79 to 1.98). This finding was supported by an as-treated analysis, in which actual exposure to BUP/NX was considered. Hepatitis C seroconversion during follow-up was strongly associated with ALT events. Bilirubin elevations ≥ grade 2 occurred in 2% of subjects, with no significant difference between arms. Conclusions Over 52-week follow-up, the risk of hepatotoxicity was similar in opioid injectors receiving brief and prolonged treatment with BUP/NX. These data suggest that most hepatotoxic events observed during treatment with BUP/NX are due to other factors.

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Hepatic Safety and Lack of Antiretroviral Interactions With Buprenorphine/Naloxone in HIV-Infected Opioid-Dependent Patients

Abstract: Buprenorphine/naloxone did not produce measurable hepatic toxicity or pharmacodynamic interaction with atazanavir in HIV-infected opioid-dependent patients.

Cited by 22 publications

References 21 publications

A review of pharmacological interactions between HIV or hepatitis C virus medications and opioid agonist therapy: implications and management for clinical practice

A review of pharmacological interactions between HIV or hepatitis C virus medications and opioid agonist therapy: implications and management for clinical practice

Buprenorphine for Human Immunodeficiency Virus/Hepatitis C Virus–coinfected Patients

Hepatotoxicity in a 52-week randomized trial of short-term versus long-term treatment with buprenorphine/naloxone in HIV-negative injection opioid users in China and Thailand

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