buprenorphine--naloxone-drug-combination and Hepatitis-C

Suboxone(®) is a sublingual tablet of buprenorphine/naloxone, approved for the treatment of opioid dependence. The objective of this study was to quantify the impact of hepatic impairment or hepatitis C virus infection on the pharmacokinetics of buprenorphine or naloxone and their major metabolites.. Forty-three subjects received a single dose of a Suboxone 2.0/0.5-mg tablet. Blood samples were collected up to 168 h and pharmacokinetic parameters were calculated using non-compartmental analysis. Statistical analysis was performed using analysis of covariance.. Pharmacokinetic parameters were derived from 33 subjects. Compared with healthy subjects, for patients with severe hepatic impairment, total and peak exposures increased to 281.4 % [90 % confidence interval 187.1-423.3] and 171.8 % [117.9-250.2] for buprenorphine, 1401.9 % [707.6-2777.5] and 1129.8 % [577.2-2211.4] for naloxone. For moderate hepatic impaired subjects, naloxone total and peak exposure increased to 317.6 % [164.9-611.5] and 270.0  % [141.9-513.9]. For buprenorphine, only total exposure increased to 163.9 % [110.8-242.3]. Changes in maximum observed plasma concentration, area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration, and area under the plasma concentration-time curve from time zero to infinity of buprenorphine or naloxone in subjects with mild hepatic impairment or with hepatitis C virus infection were within twofold of those of healthy subjects. Serious adverse events were not observed.. Severe and moderate hepatic impairment significantly increased exposure of naloxone and to a lesser extent of buprenorphine. Therefore, buprenorphine/naloxone combination products should generally be avoided in patients with severe hepatic impairment and may not be appropriate for patients with moderate hepatic impairment. However, buprenorphine/naloxone products may be used with caution for maintenance treatment in patients with moderate hepatic impairment who have initiated treatment on a buprenorphine product without naloxone [Registered at ClinicalTrials.gov as NCT01846455].

Topics: Adult; Buprenorphine, Naloxone Drug Combination; Case-Control Studies; Female; Hepatitis C; Humans; Liver Diseases; Male; Middle Aged; Opioid-Related Disorders; Young Adult

In 2018, the Baltimore City Health Department launched a mobile clinic called Healthcare on The Spot, which offers low-threshold buprenorphine services integrated with health care services to meet the needs of people who use drugs. In addition to buprenorphine management, The Spot offers testing and treatment for hepatitis C, sexually transmitted infections, and HIV, as well as pre-exposure prophylaxis for HIV, wound care, vaccinations, naloxone distribution, and case management.. This cohort analysis includes clinical service data from the first 15 months of The Spot mobile clinic, from September 4, 2018, to November 23, 2019. The Spot co-located with the Baltimore syringe services program in five locations across the city. Descriptive data are provided for patient demographics and services provided, as well as percent of patients retained in buprenorphine treatment at one and three months. Logistic regression identified factors associated with retention at three months.. The Spot mobile clinic provided services to 569 individuals from September 4, 2018, to November 23, 2019, including prescribing buprenorphine to 73.8% and testing to more than 70% for at least one infectious disease. Patients receiving a prescription for buprenorphine were more likely to be tested for HIV, hepatitis C, and sexually transmitted infections, as well as receive treatment for hepatitis C and preventive services including vaccination and naloxone distribution. The Spot initiated HIV treatment for four patients and HIV pre-exposure prophylaxis for twelve patients. More than 32% of patients had hepatitis C; nineteen of these patients initiated treatment for hepatitis C with eight having a documented cure. Buprenorphine treatment retention was 56.0% at one month and 26.2% at three months. Patients who were Black or receiving treatment for hepatitis C were more likely to be retained in buprenorphine treatment at three months.. Increasing access to integrated medical services and drug treatment through low-threshold, community-based models of care can be an effective tool for addressing the effects of drug use.

Topics: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Hepatitis C; Humans; Mobile Health Units; Naloxone; Opiate Substitution Treatment; Opioid-Related Disorders

Patients who present to the hospital for infectious complications of intravenous opioid use are at high risk for against-medical-advice discharge and readmissions. The role of medication-assisted treatment for inpatients is not clear. We aimed to assess outcomes prior to and after rollout of an inpatient buprenorphine-based opioid use disorder protocol, as well as to assess outcomes in general for medication-assisted therapy.. This was a retrospective observational cohort study at our community hospital in New Hampshire. The medical record was searched for inpatients with a complication of intravenous opioid use. We searched for admissions 11 months prior to and after the November 2018 buprenorphine protocol rollout.. Rates of medication-assisted therapy usage and buprenorphine linkage increased significantly after protocol rollout. Rates of against-medical-advice discharge did not decrease after protocol rollout, nor did readmissions. However, when evaluating the entire group of patients regardless of date of presentation or protocol use, against-medical-advice discharge rates were substantially lower for patients receiving medication-assisted therapy compared with those receiving supportive care only (30.0% vs 59.6%). Readmissions rates were lower for patients who were discharged with any form of ongoing medication-assisted therapy compared with those who were not (30-day all-cause readmissions 18.8% vs 35.1%; 30-day opioid-related readmissions 10.1% vs 29.9%; 90-day all-cause readmissions 27.3% vs 42.7%; 90-day opioid-related readmissions 15.1% vs 33.3%).. There is a strong association between medication-assisted therapy and reduced against-medical-advice discharge rates. Additionally, maintenance medication-assisted therapy at time of discharge is strongly associated with reduced readmissions rates.

Topics: Abscess; Acute Disease; Adult; Arthritis, Infectious; Bacteremia; Buprenorphine, Naloxone Drug Combination; Cellulitis; Cohort Studies; Discitis; Endocarditis; Female; Hepatitis C; HIV Infections; Hospitalization; Humans; Infections; Male; Myositis; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Osteomyelitis; Patient Discharge; Patient Readmission; Substance Abuse, Intravenous; Treatment Refusal

Untreated opioid use disorder (OUD) affects the care of HIV/HCV co-infected people who inject opioids. Despite active injection opioid use, there is evidence of increasing engagement in HIV care and adherence to HIV medications among HIV/HCV co-infected persons. However, less than one-half of this population is offered HCV treatment onsite. Treatment for OUD is also rare and largely occurs offsite. Integrating buprenorphine-naloxone (BUP-NX) into onsite care for HIV/HCV co-infected persons may improve outcomes, but the clinical impact and costs are unknown. We evaluated the clinical impact, costs, and cost-effectiveness of integrating (BUP-NX) into onsite HIV/HCV treatment compared with the status quo of offsite referral for medications for OUD.. We used a Monte Carlo microsimulation of HCV to compare two strategies for people who inject opioids: 1) standard HIV care with onsite HCV treatment and referral to offsite OUD care (status quo) and 2) standard HIV care with onsite HCV and BUP-NX treatment (integrated care). Both strategies assume that all individuals are already in HIV care. Data from national databases, clinical trials, and cohorts informed model inputs. Outcomes included mortality, HCV reinfection, quality-adjusted life years (QALYs), costs (2017 US dollars), and incremental cost-effectiveness ratios.. Integrated care reduced HCV reinfections by 7%, cases of cirrhosis by 1%, and liver-related deaths by 3%. Compared to the status quo, this strategy also resulted in an estimated 11/1,000 fewer non-liver attributable deaths at one year and 28/1,000 fewer of these deaths at five years, at a cost-effectiveness ratio of $57,100/QALY. Integrated care remained cost-effective in sensitivity analyses that varied the proportion of the population actively injecting opioids, availability of BUP-NX, and quality of life weights.. Integrating BUP-NX for OUD into treatment for HIV/HCV co-infected adults who inject opioids increases life expectancy and is cost-effective at a $100,000/QALY threshold.

Topics: Adult; Buprenorphine, Naloxone Drug Combination; Coinfection; Cost-Benefit Analysis; Delivery of Health Care, Integrated; Female; Hepatitis C; HIV Infections; Humans; Male; Middle Aged; Monte Carlo Method; Opiate Substitution Treatment; Opioid-Related Disorders; Quality of Life; Quality-Adjusted Life Years; Substance Abuse, Intravenous

There is limited data on hepatitis C (HCV) treatment uptake among people who inject drugs including individuals receiving opioid substitution treatment (OST). We aimed to calculate cumulative HCV treatment uptake, estimate annual treatment rates, and identify factors associated with HCV treatment among individuals who have received OST in Norway.. This observational study was based on linked data from The Norwegian Prescription Database and The Norwegian Surveillance System for Communicable Diseases between 2004 and 2013. Both registries have national coverage. From a total of 9919 individuals who had been dispensed OST (methadone, buprenorphine or buprenorphine-naloxone), we included 3755 individuals who had been notified with HCV infection. In this population, dispensions of HCV treatment (pegylated interferon and ribavirin), benzodiazepines, selective serotonin reuptake inhibitors and antipsychotics were studied.. Among 3755 OST patients notified with HCV infection, 539 (14%) had received HCV treatment during the study period. Annual HCV treatment rates during OST ranged between 1.3% (95% confidence interval [CI] 0.7-2.2) in 2005 and 2.6% (95% CI 1.9-3.5) in 2008 with no significant changes over time. HCV treatment uptake was not associated with age or gender, but associated with duration of active OST (adjusted odds ratio [aOR] 1.11 per year; 95% CI 1.07-1.15), high (> 80%) OST continuity (aOR 1.62; 95% CI 1.17-2.25), and heavy benzodiazepine use (aOR 0.65; 95% CI 0.49-0.87).. Cumulative HCV treatment uptake among OST patients notified with HCV infection in Norway between 2004 and 2013 was 14%. Annual treatment rates during OST remained unchanged below 3% per year. High continuity of OST over time and absence of heavy benzodiazepine use predicted HCV treatment uptake. Increased awareness for HCV among OST patients is needed as tolerable and efficient directly acting antiviral treatment is being introduced.

Topics: Adult; Antipsychotic Agents; Antiviral Agents; Benzodiazepines; Buprenorphine, Naloxone Drug Combination; Disease Notification; Female; Hepacivirus; Hepatitis C; Humans; Interferon alpha-2; Interferon-alpha; Methadone; Middle Aged; Norway; Opiate Substitution Treatment; Polyethylene Glycols; Recombinant Proteins; Registries; Ribavirin; Selective Serotonin Reuptake Inhibitors; Substance Abuse, Intravenous