buprenorphine and Hepatitis-C--Chronic

Hepatitis C virus (HCV) infected patients often take multiple co-medications to treat adverse events related to HCV therapy, or to manage other co-morbidities. Drug-drug interactions associated with this polypharmacy are relatively new to the field of HCV pharmacotherapy. With the advent of the direct-acting antivirals telaprevir and boceprevir, which are both substrates and inhibitors of the cytochrome P450 (CYP) 3A iso-enzyme, knowledge and awareness of drug-drug interactions have become a cornerstone in the evaluation of patients starting and continuing HCV combination therapy. In our opinion, an overview of conducted drug-drug interaction studies and a list of contraindicated medications is not enough for the clinical management of these drug-drug interactions. Knowledge of pharmacokinetic profiles and concentration-effect relationships is key for the interpretation of these data, and insight into how to manage these interactions (e.g., dose adjustments, safe alternatives and therapeutic drug monitoring) is of equal importance. This review provides a practical overview of the safe and effective management of these clinical challenges.

Topics: Anti-Infective Agents; Antidepressive Agents; Antiviral Agents; Buprenorphine; Cardiovascular Agents; Drug Interactions; Drug Therapy, Combination; Hepatitis C, Chronic; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypnotics and Sedatives; Hypoglycemic Agents; Immunosuppressive Agents; Methadone; Opiate Substitution Treatment

People who inject drugs (PWID) constitute 60% of the approximately 5 million people in the U.S. infected with hepatitis C virus (HCV). Treatment of PWID is complex due to addiction, mental illness, poverty, homelessness, lack of positive social support, poor adherence-related skills, low motivation and knowledge, and poor access to and trust in the health care system. New direct-acting antiviral medications are available for HCV with high cure rates and few side effects. The life expectancy and economic benefits of new HCV treatments will not be realized unless we determine optimal models of care for the majority of HCV-infected patients. The purpose of this study is to evaluate the effectiveness of directly observed therapy and group treatment compared with self-administered individual treatment in a large, urban opioid agonist therapy clinic setting in the Bronx, New York.. In this randomized controlled trial 150 PWID with chronic HCV were recruited from opioid agonist treatment (OAT) clinics and randomized to one of three models of onsite HCV treatment in OAT: 1) modified directly observed therapy; 2) group treatment; or 3) control - self-administered individual treatment. Participants were age 18 or older, HCV genotype 1, English or Spanish speaking, treatment naïve (or treatment experienced after 12/3/14), willing to receive HCV treatment onsite, receiving methadone or buprenorphine at the medication window at least once per week, and able to provide informed consent. Outcomes of interest include adherence (as measured by self-report and electronic blister packs), HCV treatment completion, sustained virologic response, drug resistance, and cost-effectiveness.. This paper describes the design and rationale of a randomized controlled trial comparing three models of care for HCV therapy delivered in an opioid agonist treatment program. Our trial will be critical to rigorously identify models of care that result in high adherence and cure rates. Use of blister pack technology will help us determine the role of adherence in successful cure of HCV. Moreover, the trial methodology outlined here can serve as a template for the development of future programs and studies among HCV-infected drug users receiving opioid agonist therapy, as well as the cost-effectiveness of such programs.. This trial was registered with ClinicalTrials.gov ( NCT01857245 ). Trial registration was obtained prospectively on May 20th, 2013.

Topics: Adult; Antiviral Agents; Buprenorphine; Directly Observed Therapy; Drug Users; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Informed Consent; Male; Medication Adherence; Methadone; New York; Opiate Substitution Treatment; Research Design; Self Report

The combination of glecaprevir (formerly ABT-493), a nonstructural protein 3/4A (NS3/4A) protease inhibitor, and pibrentasvir (formerly ABT-530), an NS5A protein inhibitor, is being developed as treatment for HCV genotype 1 to 6 infection. The pharmacokinetics, pharmacodynamics, safety, and tolerability of methadone or buprenorphine-naloxone when coadministered with the glecaprevir-pibrentasvir combination in HCV-negative subjects on stable opioid maintenance therapy were investigated in a phase 1, single-center, two-arm, multiple-dose, open-label sequential study. Subjects received methadone (arm 1) or buprenorphine-naloxone (arm 2) once daily (QD) per their existing individual prescriptions alone (days 1 to 9) and then in combination with glecaprevir at 300 mg QD and pibrentasvir at 120 mg QD (days 10 to 16) each morning. Dose-normalized exposures were similar with and without glecaprevir and pibrentasvir for (

Topics: Adult; Aminoisobutyric Acids; Antiviral Agents; Benzimidazoles; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Cyclopropanes; Drug Interactions; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Lactams, Macrocyclic; Leucine; Male; Methadone; Middle Aged; Naloxone; Opiate Substitution Treatment; Opioid-Related Disorders; Proline; Protease Inhibitors; Pyrrolidines; Quinoxalines; Sulfonamides; Surveys and Questionnaires; Young Adult

Hepatitis C virus (HCV) infection is common in persons who inject drugs (PWID).. To evaluate elbasvir-grazoprevir in treating HCV infection in PWID.. Randomized, placebo-controlled, double-blind trial. (ClinicalTrials.gov: NCT02105688).. Australia, Canada, France, Germany, Israel, the Netherlands, New Zealand, Norway, Spain, Taiwan, the United Kingdom, and the United States.. 301 treatment-naive patients with chronic HCV genotype 1, 4, or 6 infection who were at least 80% adherent to visits for opioid agonist therapy (OAT).. The immediate-treatment group (ITG) received elbasvir-grazoprevir for 12 weeks; the deferred-treatment group (DTG) received placebo for 12 weeks, no treatment for 4 weeks, then open-label elbasvir-grazoprevir for 12 weeks.. The primary outcome was sustained virologic response at 12 weeks (SVR12), evaluated separately in the ITG and DTG. Other outcomes included SVR24, viral recurrence or reinfection, and adverse events.. The SVR12 was 91.5% (95% CI, 86.8% to 95.0%) in the ITG and 89.5% (95% CI, 81.5% to 94.8%) in the active phase of the DTG. Drug use at baseline and during treatment did not affect SVR12 or adherence to HCV therapy. Among 18 patients with posttreatment viral recurrence through 24-week follow-up, 6 had probable reinfection. If the probable reinfections were assumed to be responses, SVR12 was 94.0% (CI, 89.8% to 96.9%) in the ITG. One patient in the ITG (1 of 201) and 1 in the placebo-phase DTG (1 of 100) discontinued treatment because of an adverse event.. These findings may not be generalizable to PWID who are not receiving OAT, nor do they apply to persons with genotype 3 infection, a common strain in PWID.. Patients with HCV infection who were receiving OAT and treated with elbasvir-grazoprevir had high rates of SVR12, regardless of ongoing drug use. These results support the removal of drug use as a barrier to interferon-free HCV treatment for patients receiving OAT.. Merck & Co.

Topics: Adolescent; Adult; Aged; Antiviral Agents; Benzofurans; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Double-Blind Method; Drug Combinations; Drug Resistance, Viral; Female; Genotype; Hepatitis C, Chronic; Humans; Imidazoles; Male; Medication Adherence; Methadone; Middle Aged; Opiate Substitution Treatment; Opioid-Related Disorders; Quinoxalines; Recurrence; Substance Abuse, Intravenous; Young Adult

Hepatitis C virus (HCV)-infected patients with a history of injection drug use have low rates of initiation and completion of interferon-based therapies. This study evaluated efficacy, safety, and pharmacokinetics of a 12-week all-oral regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir+ribavirin in HCV genotype 1-infected patients on stable opioid replacement therapy.. This was a phase II, multicenter, open-label, single-arm study in treatment-naïve or peginterferon/ribavirin treatment-experienced HCV genotype 1-infected patients on methadone or buprenorphine±naloxone. Patients received 12weeks of co-formulated ombitasvir/paritaprevir/ritonavir (25mg/150mg/100mg once daily) and dasabuvir (250mg twice daily)+weight-based ribavirin. The primary efficacy endpoint was sustained virologic response 12 weeks post-treatment.. Thirty-eight non-cirrhotic patients on chronic methadone (n=19) or buprenorphine (n=19) were enrolled. A total of 37 patients (97.4%) had a sustained virologic response 12 weeks post-treatment. No patient had a viral breakthrough or relapse. One patient discontinued due to serious adverse events unrelated to study drug (cerebrovascular accident and sarcoma). The most frequent adverse events were nausea, fatigue, and headache. Eight patients had on-treatment hemoglobin concentrations <10g/dl. Pharmacokinetic analyses indicated no clinically meaningful impact of methadone or buprenorphine on ombitasvir, paritaprevir, ritonavir, dasabuvir, or dasabuvir M1 metabolite exposures. No dose adjustments of methadone or buprenorphine were required.. The interferon-free regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir+ribavirin for 12weeks was well tolerated and achieved sustained virologic response in 97.4% of patients on opioid substitution therapy in this study. This all-oral regimen may provide an effective alternative to interferon-based therapies for HCV-infected patients with a history of injection drug use.

Topics: 2-Naphthylamine; Adolescent; Adult; Aged; Analgesics, Opioid; Anilides; Antiviral Agents; Buprenorphine; Carbamates; Cyclopropanes; DNA, Viral; Drug Therapy, Combination; Female; Follow-Up Studies; Genotype; Hepacivirus; Hepatitis C, Chronic; Humans; Lactams, Macrocyclic; Macrocyclic Compounds; Male; Methadone; Middle Aged; Opioid-Related Disorders; Proline; Retrospective Studies; Ribavirin; Sulfonamides; Uracil; Valine; Young Adult

Topics: Adolescent; Adult; Antiviral Agents; Buprenorphine; Female; Hepatitis C, Chronic; Humans; Male; Methadone; Middle Aged; Pilot Projects; Prospective Studies; Substance Abuse, Intravenous; Treatment Outcome

Many physicians are still skeptic to treat opioid dependants, with or without maintenance treatment, for hepatitis C (HCV) because of concerns about psychiatric comorbidity, stability and adherence. In Norway, there are about 3,500 patients participating in the restrictive medication-assisted rehabilitation (LAR) programs in which all patients are given methadone or buprenorphine maintenance therapy. This study was undertaken to determine whether HCV combination therapy with pegylated interferon alpha-2a plus ribavirin is feasible, efficient and safe in this patient group.. Seventeen patients with HCV genotype 3a were treated for 24 weeks. To optimize compliance, the treatment was given from a department of infectious diseases in cooperation with an LAR center. All injections were given in the LAR center and the patients were given psychosocial support.. The compliance was 100%. All responded to the therapy and 16 (94%) were sustained responders.. This study indicates that compliance and treatment outcome of opioid dependants on methadone or buprenorphine maintenance after 24 weeks of HCV treatment corresponds to that for non-dependants if extra support is given. The treatment should be undertaken in collaboration with specialists in addiction medicine, hepatology and infectious diseases.

Topics: Administration, Oral; Adult; Antiviral Agents; Buprenorphine; Comorbidity; Drug Therapy, Combination; Feasibility Studies; Female; Hepatitis C, Chronic; Humans; Injections, Subcutaneous; Interferon alpha-2; Interferon-alpha; Male; Methadone; Middle Aged; Narcotics; Norway; Opioid-Related Disorders; Patient Compliance; Pilot Projects; Polyethylene Glycols; Recombinant Proteins; Ribavirin; Social Support; Substance Abuse, Intravenous

Although opioid use disorder (OUD) is common in patients with cirrhosis, it is unclear how medication treatment for OUD (MOUD) is used in this population. We aimed to assess the factors associated with MOUD and mortality in a cohort of Veterans with cirrhosis and OUD.. Within the Veterans Health Administration Corporate Data Warehouse, we developed a cohort of Veterans with cirrhosis and active OUD, using 2 outpatient or 1 inpatient International Classification of Diseases, ninth revision codes from 2011 to 2015 to define each condition. We assessed MOUD initiation with methadone or buprenorphine over the 180 days following the first OUD International Classification of Diseases, ninth revision code in the study period. We fit multivariable regression models to assess the association of sociodemographic and clinical factors with receiving MOUD and the associations between MOUD and subsequent clinical outcomes, including new hepatic decompensation and mortality.. Among 5,600 Veterans meeting criteria for active OUD and cirrhosis, 722 (13%) were prescribed MOUD over 180 days of follow-up. In multivariable modeling, MOUD was significantly, positively associated with age (adjusted odds ratio [AOR] per year: 1.04, 95% confidence interval (CI): 1.01-1.07), hepatitis C virus (AOR = 2.15, 95% CI = 1.37-3.35), and other substance use disorders (AOR = 1.47, 95% CI = 1.05-2.04) negatively associated with alcohol use disorder (AOR = 0.70, 95% CI = 0.52-0.95), opioid prescription (AOR = 0.51, 95% CI = 0.38-0.70), and schizophrenia (AOR = 0.59, 95% CI = 0.37-0.95). MOUD was not significantly associated with mortality (adjusted hazards ratio = 1.20, 95% CI = 0.95-1.52) or new hepatic decompensation (OR = 0.57, CI = 0.30-1.09).. Few Veterans with active OUD and cirrhosis received MOUD, and those with alcohol use disorder, schizophrenia, and previous prescriptions for opioids were least likely to receive these effective therapies.

Topics: Age Factors; Alcoholism; Analgesics, Opioid; Buprenorphine; Cohort Studies; Female; Hepatitis C, Chronic; Humans; Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Male; Methadone; Middle Aged; Mortality; Multivariate Analysis; Opiate Substitution Treatment; Opioid-Related Disorders; Proportional Hazards Models; United States; United States Department of Veterans Affairs; Veterans

Buprenorphine (BUP) is commonly used for opioid maintenance therapy in pregnancy. Our goal was to determine whether liver dysfunction related to hepatitis C virus (HCV) infection impacts BUP dosing requirements in pregnancy.. This was a retrospective cohort study of pregnant women with antenatal exposure to BUP to compare dosing between individuals positive versus negative for HCV infection. Spearman correlation tests were used to assess the relationship between BUP dose and HCV status.. Women with HCV infection required less of an increase in BUP dose throughout pregnancy compared with women without HCV infection. Severity of HCV infection, as measured by viral load and liver enzymes, was also associated with BUP dosing.

Topics: Adult; Alanine Transaminase; Analgesics, Opioid; Aspartate Aminotransferases; Buprenorphine; Female; Hepatitis C, Chronic; Humans; Liver; Opiate Substitution Treatment; Opioid-Related Disorders; Pregnancy; Pregnancy Complications; Pregnancy Complications, Infectious; Retrospective Studies; Viral Load

Chronic hepatitis C was until recently treated with a combined therapy of interferon and ribavirin. More recently, direct antiviral agents (DAA), are being introduced. They are more tolerable and have fewer side effects, with better treatment results. In the Federation of Bosnia and Herzegovina we have started using this new therapy, with a limited financial opportunity. Large numbers of patients with chronic hepatitis C are former or current addicts, some of them treat their addiction with methadone or buprenorphine. These patients often formerly have a depression disorder and during treatment of chronic hepatitis need supervision of a psychiatrist, due to one of the side effects of interferon being deterioration of depression. Using this research we wanted to valorize the depression disorder of our patients, to indicate the effects of interferon on depression deterioration and the need for a new therapy protocol.. Examinees were patients with chronic hepatitis C on interferon therapy, which we divided into three groups: those who were never addicts, then the group of patients who were earlier addicts and have a long abstinence and patients who treat their addiction with a replacement therapy of methadone or buprenorphine. All patients completed Beck's test, which determines the level of depression, before and after interferon therapy.. Patients who used to be addicts or were on replacement therapy had mild or moderate depression before interferon treatment in a large number. After interferon therapy, there was a statistically substantial increase of patients with serious depression, which was not noted before the therapy.. Interferon therapy deteriorates depression in patients with chronic hepatitis C and there should be a strive for new therapies with less side effects in treatment. No patients stopped therapy. That is a result of community work and supervision over patients from both hepatologists and psychiatrists.

Topics: Antiviral Agents; Bosnia and Herzegovina; Buprenorphine; Depression; Drug Therapy, Combination; Female; Hepatitis C, Chronic; Humans; Interferon-alpha; Male; Methadone; Ribavirin

Drug overdoses are the leading cause of accidental death in the United States. It is imperative to explore predictors of opioid overdose in order to facilitate targeted treatment and prevention efforts. The present study was conducted as an exploratory examination of the factors associated with having a past opioid overdose.. Participants (N = 244) from substance treatment facilities, inpatient services following ER admittance, or involved within the drug court system and who reported opioid use in the past 6 months were recruited in this study. Measures of opioid use and history were used to determine characteristics associated with previous experience of a non-fatal opioid overdose.. Opioid users who were Caucasian and used a combination of prescription opioids and heroin were more likely to have experienced a prior overdose. Opioid user characteristics associated with greater odds of experiencing a prior overdose included: witnessing a friend overdose (OR 4.21), having chronic hepatitis C virus (HCV) infection (OR 2.44), reporting a higher frequency of buprenorphine treatment episodes (OR 1.55), and having a higher frequency of witnessing others overdose (OR 1.42). Greater frequency of methadone treatment episodes was related to decreased odds of experiencing an overdose (OR 0.67).. Overall, this study demonstrated certain demographic and drug use factors associated with elevated risk for an overdose. Understanding the risk factors associated with drug overdose can lead to targeted naloxone training and distribution to prevent fatal overdoses.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Drug Overdose; Female; Friends; Hepatitis C, Chronic; Humans; Male; Methadone; Odds Ratio; Opiate Substitution Treatment; Opioid-Related Disorders; Risk Factors; United States

Topics: AIDS-Related Opportunistic Infections; Antiviral Agents; Buprenorphine; Comorbidity; Cooperative Behavior; Cross-Sectional Studies; Ethics, Medical; Follow-Up Studies; France; Health Services Accessibility; Hepatitis C, Chronic; Humans; Interdisciplinary Communication; Methadone; Patient Care Team; Prisoners; Recurrence; Substance Abuse Detection; Substance Abuse Treatment Centers; Substance Abuse, Intravenous; Utilization Review

Topics: Adult; Amphotericin B; Antifungal Agents; Buprenorphine; Candidiasis; Endocarditis; Endophthalmitis; Eye Infections, Fungal; Fatal Outcome; Flucytosine; Hepatitis C, Chronic; Heroin Dependence; Humans; Male; Mycoses; Pneumonia, Staphylococcal; Recurrence; Shock, Cardiogenic; Substance Abuse, Intravenous; Tricuspid Valve; Ultrasonography

Buprenorphine is associated with enhanced human immunodeficiency virus (HIV) treatment outcomes including increased antiretroviral therapy initiation rates, adherence, and CD4 cell counts among HIV-infected opioid-dependent individuals. Buprenorphine facilitates hepatitis C virus (HCV) treatment in opioid-dependent patients with HCV monoinfection. Less is known about buprenorphine's role in HIV/HCV coinfection.. We conducted a retrospective chart review to evaluate HCV care for HIV-infected buprenorphine patients in the first 4 years of buprenorphine's integration into a Rhode Island HIV clinic.. Sixty-one patients initiated buprenorphine. All had HCV antibody testing; 57 (93%) were antibody-positive. All antibody-positive patients underwent HCV RNA testing; 48 (84%) were RNA-positive. Of these, 15 (31%) were not referred to HCV care. Among chronically infected patients, 3 received HCV treatment after buprenorphine; all had cirrhosis and none achieved viral eradication. At buprenorphine induction, most patients had inadequately controlled HIV infection, with detectable HIV RNA (59%) or CD4 cell count less than or equal to 350/μL (38%).. Buprenorphine has shown limited success to date as a bridge to HCV treatment within an HIV clinic. Buprenorphine's stabilization of opioid dependence and HIV disease may permit the use of HCV therapy over time.

Topics: Adult; Antiretroviral Therapy, Highly Active; Antiviral Agents; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Comorbidity; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Combinations; Hepatitis C, Chronic; HIV Infections; Humans; Male; Middle Aged; Naloxone; Narcotics; Opiate Substitution Treatment; Opioid-Related Disorders; Retrospective Studies; Substance Withdrawal Syndrome

This retrospective study evaluated the efficacy and tolerability of directly observed therapy with peginterferon alfa-2a and once-daily ribavirin (RBV) for chronic hepatitis C in 49 opioid-addicted injection drug users (IDUs) participating in a drug treatment program at a specialized outpatient center. Patients also received prophylactic citalopram to minimize the risk of interferon-induced depression. Patients had daily access to and support from specialist physicians, nurses and counseling services at the center, and a 24-hour helpline. Sustained virological response was achieved by 48 of 49 patients (98%) overall, including 20 of 21 (95%) hepatitis C virus (HCV) Genotype 1/4-infected patients and 28 of 28 (100%) Genotype 2/3-infected patients. Treatment was well tolerated, and no unexpected side effects of peginterferon treatment were seen. The safety profile of once-daily RBV was not different from twice-daily dosing. Decline in hemoglobin levels was similar to those reported in clinical trials including once-daily RBV and did not lead to dose reduction or treatment withdrawal. Our data demonstrate that HCV-infected IDUs on stable L-polamidone (methadone) or buprenorphine maintenance can be successfully and safely treated with peginterferon alfa-2a and RBV in an optimal substitution setting.

Topics: Adult; Antidepressive Agents; Antiviral Agents; Buprenorphine; Citalopram; Depression; Directly Observed Therapy; Drug Administration Schedule; Female; Hemoglobins; Hepacivirus; Hepatitis C, Chronic; Humans; Interferon alpha-2; Interferon-alpha; Male; Methadone; Middle Aged; Narcotics; Polyethylene Glycols; Recombinant Proteins; Retrospective Studies; Ribavirin; Substance Abuse Treatment Centers; Substance Abuse, Intravenous; Treatment Outcome; Young Adult

In developed countries hepatitis C is prevalently transmitted by intravenous drug users (IDUs). The problems associated with management of HCV hepatitis in these patients have, in the past, discouraged treatment.. To evaluate efficacy, safety and tolerability of a standard Peginterferon (Peg-IFN) alpha-2b or alpha-2a plus Ribavirin treatment in IDUs who were receiving methadone or buprenorphine.. A multi-centre prospective observational study performed from September 2003 to September 2006 in Central Italy (Umbria and Marches regions). A shared care model of HCV management was used which integrated a multidimensional, multidisciplinary approach.. Sixty-five subjects were evaluated and 52 satisfied inclusion criteria. Forty-five completed treatment (25 with Peg-IFN alpha-2b, 20 with Peg-IFN alpha-2a), a total of 37 showed a biochemical/virological response at the end of treatment (ITT 71.1%), 26 had a sustained virological response (ITT 50%; 38.4% of cases genotype 1-4, 61.6% genotype 3-2).. The results indicate that patients on maintenance treatment with methadone/buprenorphine can be treated for HCV. The success rate was fairly good; tolerability and side effects were similar to those reported in non-IDU patients. Close cooperation with specialists in drug addiction and psychiatrists is however essential for success.

Topics: Adolescent; Adult; Antiviral Agents; Buprenorphine; Drug Therapy, Combination; Female; Hepatitis C, Chronic; Humans; Interferon alpha-2; Interferon-alpha; Male; Methadone; Middle Aged; Narcotics; Patient Compliance; Polyethylene Glycols; Prospective Studies; Recombinant Proteins; Recurrence; Ribavirin; RNA, Viral; Substance Abuse, Intravenous; Treatment Outcome; Young Adult

Topics: Antiviral Agents; Buprenorphine; Drug Therapy, Combination; Drug Users; Hepatitis C, Chronic; Humans; Interferon alpha-2; Interferon-alpha; Italy; Methadone; Narcotics; Patient Compliance; Polyethylene Glycols; Practice Guidelines as Topic; Practice Patterns, Physicians'; Recombinant Proteins; Refusal to Treat; Ribavirin; Substance Abuse, Intravenous; Treatment Outcome; United States

To examine among maintenance patients (methadone or buprenorphine) with and without hepatitis C virus (HCV) infection (i) the frequency of psychopathological symptoms at baseline and 1-year follow-up; (ii) the association between antiviral interferon (IFN) treatment and psychopathological symptoms; and (iii) to explore whether IFN therapy has an effect on 1-year outcome of maintenance treatment.. Naturalistic prospective longitudinal cohort design.. A total of 223 substitution centres in Germany.. A nationally representative sample of 2414 maintenance patients, namely 800 without and 1614 with HCV infection, of whom 122 received IFN therapy.. HCV infection (HCV+/HCV-), IFN (IFN+/IFN-) treatment status and clinical measures. Diagnostic status and severity (rated by clinician), psychopathology (BSI--Brief Symptom Inventory) and quality of life (EQ-5D--EuroQol Group questionnaire).. HCV+ patients revealed indications for a moderately increased psychopathological burden and poorer quality of life at baseline and follow-up compared to HCV- patients. HCV+ patients showed a marked deterioration over time only in the BSI subscale somatization (P = 0.002), and the frequency of sleep disorders almost doubled over time (12.8% at baseline; 24.1% at follow-up; P < 0.01). IFN treatment, received by 10% of HCV+ patients, did not impair efficacy or tolerability of maintenance therapy and was associated overall with neither increased psychopathological burden nor reduced quality of life.. Findings suggest no increased risk among HCV+ patients on maintenance therapy for depressive or other psychopathological syndromes. In our patient sample, IFN treatment was not associated with increased psychopathological burden, reduced quality of life or poorer tolerability and efficacy of maintenance treatment.

Topics: Adult; Antiviral Agents; Buprenorphine; Female; Germany; Hepatitis C, Chronic; Humans; Interferons; Longitudinal Studies; Male; Methadone; Narcotic Antagonists; Quality of Life; Substance Abuse, Intravenous; Surveys and Questionnaires; Viral Load

Injection drug users are at high risk for chronic hepatitis C virus infection (CHC). Opioid maintenance treatment (OMT) offers a unique opportunity to screen for CHC. This study proposed the hypothesis that a general practitioner (GP) with special interest in addiction medicine can achieve CHC screening rates comparable to specialized centres and aimed to investigate determinants for a successful CHC case finding in a primary care setting.. Retrospective medical record analysis of 387 patients who received opioid maintenance therapy between 1 January 2002 and 31 May 2008 in a general practice in Zurich, Switzerland.. Successful CHC assessment was defined as performance of hepatitis C virus (HCV) serology with consecutive polymerase chain reaction-based RNA and genotype recordings. The association between screening success and patient characteristics was assessed using multiple logistic regression. findings: Median (interquartile range) age and duration of OMT of the 387 (268 males) patients was 38.5 (33.6-44.5) years and 34 (11.3-68.0) months, respectively. Fourteen patients (3.6%) denied HCV testing and informed consent about screening was missing in 13 patients (3.4%). In 327 of 360 patients (90.8%) with informed consent a successful CHC assessment has been performed. Screening for HCV antibodies was positive in 136 cases (41.6%) and in 86 of them (63.2%) a CHC was present. The duration of OMT was an independent determinant of a successful CHC assessment.. In addicted patients a high CHC assessment rate in a primary care setting in Switzerland is feasible and opioid substitution provides an optimal framework.

Topics: Adult; Analgesics, Opioid; Buprenorphine; Family Practice; Female; Hepacivirus; Hepatitis C, Chronic; Humans; Male; Methadone; Morphine; Narcotics; Polymerase Chain Reaction; Regression Analysis; Retrospective Studies; Substance Abuse, Intravenous; Switzerland

Amongst people on opioid maintenance treatment (OMT), chronic hepatitis C (HCV) is common but infrequently treated. Numerous barriers, including misuse of alcohol may limit efforts at anti-viral treatment. The aim of this study was to define barriers, including alcohol misuse, to the effective treatment of HCV amongst OMT recipients. Ninety-four OMT patients completed the 3-item Alcohol Use Disorders Identification Test (AUDIT-C). A semi-structured interview was used in 53 subjects to assess alcohol use in detail, psychological health, discrimination and access to HCV treatment. Feasibility of brief intervention for alcohol misuse was assessed. Of the screening participants, 73% reported they were HCV positive. Of the detailed interview participants, 26% reported no drinking in the past month, but 53% scored 8 or more on AUDIT and 42% exceeded NHMRC drinking guidelines. Twenty subjects received brief intervention and among 17 re-interviewed at one month, alcohol consumption fell by 3.1 g/day (p = 0.003). Severe or extremely severe depression, stress and anxiety were found in 57%, 51% and 40% of interviewees respectively. Episodic heavy drinking, mental health problems, perceived discrimination, limited knowledge concerning HCV were all common and uptake of HCV treatment was poor. Brief intervention for alcohol use problems was acceptable to OMT patients, and warrants further study.

Topics: Adolescent; Adult; Alcoholism; Antiviral Agents; Anxiety Disorders; Australia; Buprenorphine; Comorbidity; Cross-Sectional Studies; Depressive Disorder, Major; Drug Therapy, Combination; Female; Follow-Up Studies; Health Knowledge, Attitudes, Practice; Health Services Accessibility; Hepatitis B, Chronic; Hepatitis C, Chronic; Humans; Male; Mass Screening; Methadone; Middle Aged; Narcotics; Opioid-Related Disorders; Patient Acceptance of Health Care; Patient Satisfaction; Psychotherapy, Brief; Substance Abuse, Intravenous

All over the world, Hepatitis C virus (HCV) accounts for an estimated 130 million chronic infections. Injection drug use has become one of the most important risk factors for HCV, and within the injection drug user population, the prevalence of HCV antibody ranges from 70 to 95 percent depending on an individual's length of use and the prevalence of infection in the community. This study was undertaken to determine the prevalence of and the risk factors for Hepatitis C antibodies in injecting drug users presenting to the Community Addictions Management Programme (CAMP) in Singapore.. Eligibility criteria for inclusion in this study were all intravenous buprenorphine users presenting to CAMP. 106 subjects, who consented to the study, completed an interviewer-administered questionnaire, and underwent a urine and blood analysis.. The prevalence rate for HCV was 42.5 percent among the subjects included in our study. The odds of seroprevalence in those sharing needles were 5.6 times that of those who were not, and the odds of seroprevalence among those using with others (peers or partners) were 6.3 times, as compared to among those who were individual users. Racial differences were also seen, but these could be accounted for by the sharing of needles.. This study provides important local data at the onset of an early buprenorphine-injecting epidemic in Singapore. This data is useful for disease prevention and healthcare planning.

Topics: Adult; Buprenorphine; Cross-Sectional Studies; Female; Hepacivirus; Hepatitis C; Hepatitis C Antibodies; Hepatitis C, Chronic; Humans; Male; Middle Aged; Narcotics; Risk Factors; Seroepidemiologic Studies; Singapore; Substance Abuse Treatment Centers; Substance Abuse, Intravenous

A 37-year-old man with a 19-years history of injection drug use (IDU) who had acquired a chronic hepatitis C virus (HCV-) infection 9 years ago, entered the German clinical study on heroine assisted treatment ("Modellprojekt zur heroingestützten Behandlung Opiatabhängiger"). Before study onset he received buprenorphine maintainance treatment, while at the same time engaging in illicit IDU (heroine, cocaine). He lived in a caravan and was on social welfare.. PCR revealed a genotype 2 and an HCV-viral load of 310,000 IU/ml. Liver biopsy showed a moderate chronic active hepatitis and a mild portal fibrosis without signs of liver cirrhosis.. Within the heroine-assisted treatment program the patient injected heroine under medical supervision several times a day and attended the standardized psychosocial program that comprised an intensive education on HCV-infection. Within a period of ten months of physical and social stabilization he managed to stop illicit drug use, found stable housing and started to work. We then initiated treatment of HCV-infection. Subcutaneous pegylated interferon alpha-2a, peroral ribavirin and intravenous heroine were administered as directly observed therapy. Based on the close mashed care of the heroine assisted treatment setting, side effects were well controllable and reversible after the end of antiviral therapy. A sustained response was obtained.. After careful indication, heroine-assisted treatment with particularly intensive medical and psychological care can offer appropriate conditions for a save and successful treatment of hepatitis C as well as for a sustained result.

Topics: Administration, Oral; Adult; Antiviral Agents; Buprenorphine; Cocaine-Related Disorders; Combined Modality Therapy; Comorbidity; Drug Therapy, Combination; Hepatitis C, Chronic; Heroin; Heroin Dependence; Humans; Injections, Intravenous; Injections, Subcutaneous; Interferon alpha-2; Interferon-alpha; Male; Polyethylene Glycols; Recombinant Proteins; Rehabilitation, Vocational; Ribavirin; Social Adjustment; Social Welfare; Substance Abuse, Intravenous

In France today, the treatment of opiate and notably heroin addiction with high-dose buprenorphine (HDB) is widespread. Although this treatment has been successful to some extent, problems persist. One is that some percentage (estimated at 17-47%) of patients "misuses" their HDB, either by intravenous injection or inhalation. This misuse presents a public health problem, since injecting drug users are more frequently infected by hepatitis C, and may even jeopardize the treatment's efficacy.. Our study compared a sample of 26 patients treated with sublingual HDB who reported injecting it on occasion and 27 patients under HDB who did not inject it.. There was no evidence of more psychiatric disorders in the population that injected HDB than in the population that did not. Conversely, the patients injecting HDB used more illicit products, more benzodiazepines and more alcohol.. Despite its efficacy, substitution treatment does not appear to provide relief for some patients. HDB injection may thus correspond to a search for a precarious balance: the disruption of the HDB kinetics induced by its injection would be aimed at enhancing the opiate effect. The consumption of other licit and illicit psychotropic agents indicates a further attempt to obtain relief from a persistent mental discomfort, over and above the substitution therapy and even its misuse. The reality of the psychological imbalance experienced with, induced by or pre-existing the heroin use requires rethinking the overall treatment. Future studies should lead to the identification of the disorders that lead these patients to seek relief in injections.

Topics: Administration, Sublingual; Adult; Alcoholism; Analgesics, Opioid; Antisocial Personality Disorder; Buprenorphine; Case-Control Studies; Cross-Sectional Studies; Female; France; Hepatitis C, Chronic; Humans; Interview, Psychological; Male; Opioid-Related Disorders; Prospective Studies; Psychotropic Drugs; Substance Abuse, Intravenous; Surveys and Questionnaires

Topics: Adult; Buprenorphine; Hepacivirus; Hepatitis C, Chronic; Humans; Male; Narcotic Antagonists; Nucleic Acid Amplification Techniques; Opioid-Related Disorders; RNA, Viral; Transcription, Genetic; Viral Load

Topics: Antiviral Agents; Buprenorphine; Hepatitis C, Chronic; Humans; Interferon alpha-2; Interferon-alpha; Naloxone; Narcotic Antagonists; Opioid-Related Disorders; Patents as Topic; Polyethylene Glycols; Recombinant Proteins; United States; United States Food and Drug Administration