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Since first being identified in 1989, HCV has quickly gained attention as a public health concern due to its intense proliferation and negative consequences associated with chronic infection. In comparison with other blood-borne illnesses, HCV is now far more common than HIV/AIDS; and unlike HBV, HCV lacks available vaccines. Because injection drug use is by far the most significant risk factor for contracting HCV, and continued substance use among infected persons raises the risk for developing complications, as well as spreading the infection, this study sought to better understand the risk factors associated with HCV among patients enrolled into medication-assisted therapy for opioid dependence. Patients (N=1039) were randomized as part of a larger, multisite clinical trial sponsored by the National Drug Abuse Treatment Clinical Trials Network (CTN-0027) assessing liver function in opioid-dependent participants randomized to medication condition (buprenorphine/naloxone or methadone). HCV status was first assessed with an antibody screen; if positive, then current infection was determined with an antigen screen testing for detectable virus. Patients were classified as HCV negative, HCV positive but have cleared the virus, or as having chronic HCV. Logistic regression analysis was used to examine demographic and behavioral correlates of the three groups.
Thirty-four percent of patients were classified with chronic infection and 14% had evidence of prior infection with apparent clearing of the virus. Chronic infection was associated with recent injection drug use and cocaine use. Chronic HCV infection was also associated with being older and Hispanic.
Conclusions: Age, ethnicity, and current drug use increase the likelihood of being chronically infected with HCV. Strategies targeting high risk subgroups can aid in preventing further disease escalation. Further research would benefit from better understanding the role of ethnicity in transmission and/or spontaneous remission. Early intervention and continuous monitoring of IDUs should be the primary focus for addressing this epidemic.
Related protocols: CTN-0027
This is the primary outcomes article for CTN-0027.
Buprenorphine/naloxone (BUP) and methadone (MET) are efficacious treatments for opioid dependence, although concerns about a link between BUP and drug-induced hepatitis have been raised. This study, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0027 (Starting Treatment with Agonist Replacement Therapies (START)), was a randomized controlled trial of 1269 opioid-dependent participants seeking treatment at 8 federally licensed opioid treatment programs and followed up for 32 weeks between May 2006 and August 2012. Participants were randomly assigned to receive BUP or MET for 24 weeks. Shift table analyses determined how many evaluable participants moved between categories of low and elevated transaminase levels. Predictors of moving from low to high transaminase levels were identified.
Results determined that changes in transaminase levels did not differ by medication condition. Baseline infection with hepatitis C or B was the only significant predictor of moving from low to high transminase levels; 9 BUP and 15 MET participants showed extreme liver test elevations and were more likely than those without extreme elevations to have seroconverted to both hepatitis B and C during the study, or to use illicit drugs during the first 8 weeks of treatment. MET participants were retained longer than the BUP participants, however the 24-week retention rates for the BUP group in this study were in the range seen in prior studies. In fact, because of its superior safety profile and excellent clinical responses to BUP in previous studies, BUP could be considered a first line treatment agent, with MET reserved for those who do not respond well to BUP.
Conclusions: This study demonstrated no evidence of liver damage during the initial 6 months of treatment with either BUP or MET, providing further encouragement to physicians to use buprenorphine as an effective treatment option for opioid addiction.
Related protocols: CTN-0027
Currently in the United States, pharmacological treatment of opioid addiction most commonly consists of replacement therapy with either methadone or buprenorphine/naloxone (bup/nal). Several clinical trials from the NIDA Clinical Trials Network have demonstrated the effectiveness of bup/nal in a variety of treatment settings and populations. Most recently a multi-site, open label, Phase IV study randomized 1269 participants in federally licensed opioid treatment programs to receive either six months of methadone or six months of bup/nal (CTN-0027, “START”).
The primary outcomes of the study focused on parameters of liver function; 731 participants completed the study. Worsening of indices of liver health was rare and did not differ by medication condition. Participants in the bup/nal group had poorer treatment retention than did participants on methadone. Adoption of bup/nal treatment in licensed opioid treatment programs will require additional efforts towards treatment retention.
Related protocols: CTN-0027
The purpose of this study was to explore changes in transaminase values associated with buprenorphine treatment and hepatitis C status among opioid dependent subjects aged 15-21. One-hundred-and-fifty-two subjects seeking treatment for opioid dependence were randomized to 2-week detoxification with buprenorphine/naloxone (DETOX) or 12 weeks buprenorphine/naloxone (BUP). Liver chemistries including transaminases were obtained at baseline and 4, 8, and 12 weeks. One-hundred-and-eleven patients had at least one set of transaminases during treatment and were included in analyses of treatment effects. Overall, 8/60 BUP participants vs. 12/51 DETOX participants had at least one elevated ALT value during follow-up. Five BUP participants vs. eleven DETOX participants had at least one elevated ALT value. Twenty-eight out of 152 participants were hepatitis C (HCV) positive at baseline, and 4 seroconverted within 12 weeks, 2 in each group. HCV status was significantly associated with transaminase abnormalities (p=.009 and p=.006 for ALT and AST, respectively). HCV status had a strong effect on transaminase abnormalities among participants assigned to DETOX, but not among those assigned to BUP. No evidence was found for hepatotoxicity of buprenorphine in this exploratory analysis. HCV was present in a significant minority of participants and was a significant predictor of transaminase elevation. Results suggest that stabilization on buprenorphine may decrease the frequency of transaminase abnormalities associated with HCV in opioid dependent young people. The high rate of seroconversion underscores the importance of effective treatment and prevention.
Related protocols: CTN-0010
This study aimed to determine whether buprenorphine treatment was associated with changes in liver function among opioid dependent subjects aged 15-21. Baseline data was available for 152 subjects who participated in protocol CTN-0010 (“Buprenorphine/Naloxone-Facilitated Rehabilitation for Opioid Dependent Adolescents/Young Adults”), seeking treatment for opioid dependence. The subjects were then randomized to 2 weeks of detoxification with buprenorphine/naloxone (DETOX) or 12 weeks of buprenorphine/naloxone (BUP), each with weekly individual and group drug counseling. Liver function tests (LFTs) were evaluated at 4, 8, and 12 weeks, including ALT, AST, GGT, LDH, Total Bilirubin, and alkaline phosphatase. 111 patients had at least one set of LFTs during treatment and were included in analyses of treatment effects. 24.8% of participants had one or more abnormal LFTs at baseline, with 31.5%, 29.1%, and 24.1% at 4, 8, and 12 weeks respectively. Two individuals in the DETOX group and 2 in the BUP group developed markedly elevated LFTs. 19% of participants were Hep C positive at baseline and 4 seroconverted within 12 weeks, 2 in each group. No significant differences were found between treatment groups on total LFT abnormalities, but patients in the BUP group had fewer elevated transaminase values during treatment (p = .041). There were highly significant differences in rates of Hep C by site. Hep C status was weakly associated with total LFT abnormalities, but more strongly associated with transaminase abnormalities. When logistic regression was used with any abnormal transaminase as the dependent variable, Hep C status was highly significant, but treatment group lost significance. In conclusion, no evidence was found for hepatotoxicity of buprenorphine in this sample. Hep C was present in a significant minority of participants and was a significant predictor of transaminase elevation. The high rate of seroconversion points to the importance of effective treatment and prevention in this population.
Related protocols: CTN-0010
This brochure, intended for participants thinking about joining the CTN-0027 clinical trial (Starting Treatment with Agonist Replacement Therapies), answers questions about who can participate and what happens if you join, and provides information about the medication used in the project, buprenorphine naloxone (Suboxone).
Related protocols: CTN-0027