Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058

Gregory M. Lucas; Geetha Beauchamp; Apinun Aramrattana; Yiming Shao; Wei Liu; Liping Fu; J. Brooks Jackson; David D. Celentano; Paul Richardson; David Metzger

doi:10.1016/j.drugpo.2011.06.005

Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058

Gregory M. Lucas
, Geetha Beauchamp
, Apinun Aramrattana
, Yiming Shao
, Wei Liu
, Liping Fu
, J. Brooks Jackson
, David D. Celentano
, Paul Richardson
, David Metzger

Administration (TMED)

Research output: Contribution to journal › Article › peer-review

9 Scopus citations

Abstract

Background: Buprenorphine/naloxone (BUP/NX) is not licenced for use in China or Thailand and there was little clinical experience with this drug combination in these countries at the inception of HIV Prevention Trial Network (HPTN) 058, a randomized trial comparing risk reduction counselling combined with either short-term or long-term medication assisted treatment with BUP/NX to prevent HIV infection and death amongst opioid-dependent injectors. Methods: We conducted a safety phase that included the first 50 subjects enrolled at each of the three initial study sites (N= 150). Clinical and laboratory assessments were conducted at baseline and weekly for the first 4 weeks. Changes in laboratory parameters were estimated with random effects models. Results: BUP/NX was well tolerated by study subjects and opioid withdrawal scores decreased substantially during the 3-day induction. Two participants experienced grade 3 clinical adverse events, which were categorized as probably not related to the study drug. Grade 2 or 3 increases in alanine aminotransferase (ALT) occurred in 25 (17%) subjects. The magnitude of ALT increase over 4-week follow-up was strongly associated with baseline ALT elevation. Conclusions: In Chinese and Thai opioid-dependent injectors, we found BUP/NX to be effective in reducing opioid withdrawal symptoms and safe during short-term use. ALT increases were observed over 4-week-follow-up, which are consistent with reports from Western populations. Long-term safety and efficacy evaluations are indicated.

Original language	English (US)
Pages (from-to)	162-165
Number of pages	4
Journal	International Journal of Drug Policy
Volume	23
Issue number	2
DOIs	https://doi.org/10.1016/j.drugpo.2011.06.005
State	Published - Mar 2012

Bibliographical note

Funding Information:
This study was approved by Chiang Mai University Research Institute for Health Sciences, Thailand; Ministry of Public Health Ethical Review Committee for Research in Human Subjects, Nonthaburi, Thailand; Guangxi Centre for Disease Prevention and Control Institutional Review Board (IRB), China; Xinxiang Uighur Autonomous Region Bureau of Health Disease Control and Treatment IRB, China; The Chinese National Centre for AIDS/STD Control and Prevention IRB; and Johns Hopkins Medicine IRB, United States. This study was supported by the HIV Prevention Trials Network (HPTN) and sponsored by the National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and Office of AIDS Research, of the National Institutes of Health, U.S. Department of Health and Human Services under award number UM1 AI068619. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health. The buprenorphine/naloxone (Suboxone) used in the safety phase of this trial was donated by Reckitt Benckiser Pharmaceuticals, Inc. We want to acknowledge Marek Chawarski, David Burns, Deborah Donnell, and Scott Rose for their valuable input on the manuscript.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being
SDG 5 Gender Equality

Keywords

Buprenorphine/naloxone
HIV prevention
Hepatic toxicity
Injection drug use
Opioid dependence
Risk reduction counselling
Safety

Publisher link

10.1016/j.drugpo.2011.06.005

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Lucas, G. M., Beauchamp, G., Aramrattana, A., Shao, Y., Liu, W., Fu, L., Jackson, J. B., Celentano, D. D., Richardson, P., & Metzger, D. (2012). Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058. International Journal of Drug Policy, 23(2), 162-165. https://doi.org/10.1016/j.drugpo.2011.06.005

Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058. / Lucas, Gregory M.; Beauchamp, Geetha; Aramrattana, Apinun et al.
In: International Journal of Drug Policy, Vol. 23, No. 2, 03.2012, p. 162-165.

Research output: Contribution to journal › Article › peer-review

Lucas, GM, Beauchamp, G, Aramrattana, A, Shao, Y, Liu, W, Fu, L, Jackson, JB, Celentano, DD, Richardson, P & Metzger, D 2012, 'Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058', International Journal of Drug Policy, vol. 23, no. 2, pp. 162-165. https://doi.org/10.1016/j.drugpo.2011.06.005

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title = "Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058",

abstract = "Background: Buprenorphine/naloxone (BUP/NX) is not licenced for use in China or Thailand and there was little clinical experience with this drug combination in these countries at the inception of HIV Prevention Trial Network (HPTN) 058, a randomized trial comparing risk reduction counselling combined with either short-term or long-term medication assisted treatment with BUP/NX to prevent HIV infection and death amongst opioid-dependent injectors. Methods: We conducted a safety phase that included the first 50 subjects enrolled at each of the three initial study sites (N= 150). Clinical and laboratory assessments were conducted at baseline and weekly for the first 4 weeks. Changes in laboratory parameters were estimated with random effects models. Results: BUP/NX was well tolerated by study subjects and opioid withdrawal scores decreased substantially during the 3-day induction. Two participants experienced grade 3 clinical adverse events, which were categorized as probably not related to the study drug. Grade 2 or 3 increases in alanine aminotransferase (ALT) occurred in 25 (17\%) subjects. The magnitude of ALT increase over 4-week follow-up was strongly associated with baseline ALT elevation. Conclusions: In Chinese and Thai opioid-dependent injectors, we found BUP/NX to be effective in reducing opioid withdrawal symptoms and safe during short-term use. ALT increases were observed over 4-week-follow-up, which are consistent with reports from Western populations. Long-term safety and efficacy evaluations are indicated.",

keywords = "Buprenorphine/naloxone, HIV prevention, Hepatic toxicity, Injection drug use, Opioid dependence, Risk reduction counselling, Safety",

author = "Lucas, \{Gregory M.\} and Geetha Beauchamp and Apinun Aramrattana and Yiming Shao and Wei Liu and Liping Fu and Jackson, \{J. Brooks\} and Celentano, \{David D.\} and Paul Richardson and David Metzger",

note = "Funding Information: This study was approved by Chiang Mai University Research Institute for Health Sciences, Thailand; Ministry of Public Health Ethical Review Committee for Research in Human Subjects, Nonthaburi, Thailand; Guangxi Centre for Disease Prevention and Control Institutional Review Board (IRB), China; Xinxiang Uighur Autonomous Region Bureau of Health Disease Control and Treatment IRB, China; The Chinese National Centre for AIDS/STD Control and Prevention IRB; and Johns Hopkins Medicine IRB, United States. This study was supported by the HIV Prevention Trials Network (HPTN) and sponsored by the National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and Office of AIDS Research, of the National Institutes of Health, U.S. Department of Health and Human Services under award number UM1 AI068619. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health. The buprenorphine/naloxone (Suboxone) used in the safety phase of this trial was donated by Reckitt Benckiser Pharmaceuticals, Inc. We want to acknowledge Marek Chawarski, David Burns, Deborah Donnell, and Scott Rose for their valuable input on the manuscript.",

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AU - Lucas, Gregory M.

AU - Beauchamp, Geetha

AU - Aramrattana, Apinun

AU - Shao, Yiming

AU - Liu, Wei

AU - Fu, Liping

AU - Jackson, J. Brooks

AU - Celentano, David D.

AU - Richardson, Paul

AU - Metzger, David

N1 - Funding Information: This study was approved by Chiang Mai University Research Institute for Health Sciences, Thailand; Ministry of Public Health Ethical Review Committee for Research in Human Subjects, Nonthaburi, Thailand; Guangxi Centre for Disease Prevention and Control Institutional Review Board (IRB), China; Xinxiang Uighur Autonomous Region Bureau of Health Disease Control and Treatment IRB, China; The Chinese National Centre for AIDS/STD Control and Prevention IRB; and Johns Hopkins Medicine IRB, United States. This study was supported by the HIV Prevention Trials Network (HPTN) and sponsored by the National Institute of Allergy and Infectious Diseases, National Institute on Drug Abuse, National Institute of Mental Health, and Office of AIDS Research, of the National Institutes of Health, U.S. Department of Health and Human Services under award number UM1 AI068619. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health. The buprenorphine/naloxone (Suboxone) used in the safety phase of this trial was donated by Reckitt Benckiser Pharmaceuticals, Inc. We want to acknowledge Marek Chawarski, David Burns, Deborah Donnell, and Scott Rose for their valuable input on the manuscript.

PY - 2012/3

Y1 - 2012/3

N2 - Background: Buprenorphine/naloxone (BUP/NX) is not licenced for use in China or Thailand and there was little clinical experience with this drug combination in these countries at the inception of HIV Prevention Trial Network (HPTN) 058, a randomized trial comparing risk reduction counselling combined with either short-term or long-term medication assisted treatment with BUP/NX to prevent HIV infection and death amongst opioid-dependent injectors. Methods: We conducted a safety phase that included the first 50 subjects enrolled at each of the three initial study sites (N= 150). Clinical and laboratory assessments were conducted at baseline and weekly for the first 4 weeks. Changes in laboratory parameters were estimated with random effects models. Results: BUP/NX was well tolerated by study subjects and opioid withdrawal scores decreased substantially during the 3-day induction. Two participants experienced grade 3 clinical adverse events, which were categorized as probably not related to the study drug. Grade 2 or 3 increases in alanine aminotransferase (ALT) occurred in 25 (17%) subjects. The magnitude of ALT increase over 4-week follow-up was strongly associated with baseline ALT elevation. Conclusions: In Chinese and Thai opioid-dependent injectors, we found BUP/NX to be effective in reducing opioid withdrawal symptoms and safe during short-term use. ALT increases were observed over 4-week-follow-up, which are consistent with reports from Western populations. Long-term safety and efficacy evaluations are indicated.

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KW - HIV prevention

KW - Hepatic toxicity

KW - Injection drug use

KW - Opioid dependence

KW - Risk reduction counselling

KW - Safety

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Short-term safety of buprenorphine/naloxone in HIV-seronegative opioid-dependent Chinese and Thai drug injectors enrolled in HIV Prevention Trials Network 058

Abstract

Bibliographical note

UN SDGs

Keywords

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