From the The Yale School of Medicine, New Haven, CT; and the New York Academy of Medicine, New York, NY.
Correspondence to: Gerald Friedland, Yale University School of Medicine, 135 College Street, Ste 323, New Haven, CT 06510-2483 (e-mail: firstname.lastname@example.org).
The worldwide epidemics of substance abuse, largely of opioids, and HIV/AIDS adversely affect tens of millions of people. The link between the expanding epidemic of drug use, particularly injection drug use and HIV has been well described. In the United States, injection drug use has been the second most frequent route of HIV acquisition. Both opioid dependence and HIV/AIDS are treatable, but availability of treatment has been limited and, even where available, those with substance-abuse disorders have not achieved their maximal benefit compared with other populations.
Recent advances in the treatment of opioid dependence have impacted favorably on clinical and public health outcomes of chemical dependence, HIV/AIDS and other associated comorbid conditions. Opioid agonist treatment with methadone has been long established as evidence-based therapy effective in reducing opiate use, criminal activity, and morbidity and mortality, and providing both primary and secondary HIV prevention. In the United States, limitations of methadone have included highly restricted and controlled requirements for administration, dangers of opioid excess and overdose and, with regards to HIV co infection, substantial concerns about medication interactions.
Buprenorphine/naloxone (bup/nx), a partial μ-receptor agonist with a plateau of its agonist effects at higher doses, has an improved safety profile compared with methadone. Recent studies also show fewer concerning medication interactions with antiretroviral therapies. Further, in the United States, buprenorphine can be prescribed within general medical settings, including HIV clinics and programs, allowing for the integration of HIV and substance-abuse treatment and prevention. Buprenorphine is becoming increasingly more available worldwide and was approved for use in the United States in 2002. Although clearly shown to be effective in controlled studies, larger population-based outcome data, including information on the implementation of buprenorphine and HIV treatment models, have been lacking. As such, there remains incomplete data regarding the utility of this integration strategy for opioid dependence and HIV infection.
To address this deficit, the Health Services and Resources Administration's organized a Special Program of National Significance project entitled “The Buprenorphine Initiative: An Evaluation of Innovative Methods for Integrating Buprenorphine Opioid Abuse Treatment in HIV Primary Care”. This program has created a national multisite demonstration project evaluating buprenorphine and HIV integrated treatment in 10 HIV primary care sites, involving over 300 patients and supported by an evaluation and technical assistance site. In this issue, the results of this, the largest study of the use of bup/nx to treat HIV-positive opioid-dependant patients are presented.
The process of study development, defining the issues to be examined, data collection and analysis and preparation of this supplement, has been remarkably collaborative. A wide and comprehensive array of issues is explored in individual but connected articles, ranging from the history of the project and its development, patients' characteristics, drug treatment outcomes, HIV treatment outcomes, side effects and toxicities, the importance of cocaine use, treatment effect on quality of life, cost, patient, and provider perspectives, and policy implications.
The overall results of the demonstration project clearly indicate that it is feasible to insert bup/nx treatment into ongoing HIV programs with resultant benefit in both drug and HIV treatment outcomes, particularly for those clinic patients not previously receiving antiretroviral therapy, that side effects appear to be minimal, and that although there are added costs and personnel requirements, there is both provider and patients satisfaction with and support for integrated models of care. The study results have important policy and practice implications.
As a demonstration project carried out in clinical care settings, there are clearly limitations to the study. Not all data collected were uniform and complete throughout (eg, differential rates of urine toxicology testing), the study protocol was not always rigorously followed (eg, treatment arm crossover), and there was an absence of a contemporaneous control population. Nevertheless, that the study was carried out in routine clinical care settings, where the results are likely to be widely applied, gives generalizability to the findings as those most reflective of what might be expected in the complicated, not always controllable but critically important real-world setting.
The providers and study team at each site and at the evaluation and support team which provided monitoring and analysis of the study data, and, of course, the study participants deserve great credit for performing a greatly needed operations research project. As a comprehensive document, available to both policy makers and practitioners, the study should have major effect on moving forward public policy in the direction of critically needed increased access and treatment for people with both opioid dependence and HIV infection.