HIV Risk Reduction With BuprenorphineNaloxone or Methadone: Findings From a Randomized Trial

Woody, George E. MD*; Bruce, Douglas MD; Korthuis, P. Todd MD; Chhatre, Sumedha PhD*; Poole, Sabrina MS*; Hillhouse, Maureen PhD§; Jacobs, Petra MD; Sorensen, James PhD; Saxon, Andrew J. MD#; Metzger, David PhD*; Ling, Walter MD§

JAIDS Journal of Acquired Immune Deficiency Syndromes: 1 July 2014 - Volume 66 - Issue 3 - p 288–293
doi: 10.1097/QAI.0000000000000165
Clinical Science

Objectives: Compare HIV injecting and sex risk in patients being treated with methadone (MET) or buprenorphine–naloxone (BUP).

Methods: Secondary analysis from a study of liver enzyme changes in patients randomized to MET or BUP who completed 24 weeks of treatment and had 4 or more blood draws. The initial 1:1 randomization was changed to 2:1 (BUP:MET) after 18 months due to higher dropout in BUP. The Risk Behavior Survey measured HIV risk before 30 days at baseline and weeks 12 and 24.

Results: Among 529 patients randomized to MET, 391 (74%) were completers; among 740 randomized to BUP, 340 (46%) were completers; 700 completed the Risk Behavior Survey. There were significant reductions in injecting risk (P < 0.0008) with no differences between groups in mean number of times reported injecting heroin, speedball, other opiates, and number of injections; or percent who shared needles; did not clean shared needles with bleach; shared cookers; or engaged in front/back loading of syringes. The percent having multiple sex partners decreased equally in both groups (P < 0.03). For males on BUP, the sex risk composite increased; for males on MET, the sex risk decreased resulting in significant group differences over time (P < 0.03). For females, there was a significant reduction in sex risk (P < 0.02) with no group differences.

Conclusions: Among MET and BUP patients who remained in treatment, HIV injecting risk was equally and markedly reduced; however, MET retained more patients. Sex risk was equally and significantly reduced among females in both treatment conditions, but it increased for males on BUP and decreased for males on MET.

*Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania and Treatment Research Institute, Philadelphia, PA;

Department of Medicine, Yale University School of Medicine, New Haven, CT;

Department of Medicine, Oregon Health and Science University, Portland, OR;

§Department of Psychiatry, University of California, Los Angeles, Los Angeles, CA;

National Institute on Drug Abuse, Bethesda, MD;

Department of Psychiatry, University of California, San Francisco, San Francisco, CA; and

#Department of Psychiatry, Veterans Affairs Puget Sound Health Care System, Seattle, WA.

Correspondence to: George E. Woody, MD, Treatment Research Institute, 150 South Independence Mall (W), Philadelphia, PA 19106 (e-mail: woody@tresearch.org).

Supported by NIDA grants: U10-DA 13045 (W.L.); U10-DA013714 (D.D.); U10 DA-13043, KO5 DA-17009 (G.W.).

Authors disclosing relevant financial interests, activities, relationships, and affiliations are A.S.: Paid consultant to Reckitt Benckiser Pharmaceuticals; W.L.: Paid consultant to Reckitt Benckiser Pharmaceuticals; R.D.B.: Research grant support from Gilead Sciences, Inc., Merck & Co., Bristol Myers Squibb, Boehringer Ingelheim, Reckitt Benckiser Pharmaceuticals, Abbott Laboratories, Pfizer, Inc., and honorarium from Reckitt Benckiser Pharmaceuticals; Y.L.: Paid consultant to Johnson & Johnson. The remaining authors have no funding or conflicts of interest to disclose. Reckitt Benckiser Pharmaceuticals and personnel provided suggestions for the study design and supplied Suboxone.

Trial registration of the parent study was initiated and maintained on clinicaltrials.com (NCT00315341).

Received August 28, 2013

Accepted March 13, 2014

© 2014 by Lippincott Williams & Wilkins