A prospective, randomized, multicenter acceptability and safety study of direct buprenorphine/naloxone induction in heroin-dependent individuals.

AIMS: To provide controlled data on direct induction with buprenorphine/naloxone (BNX) versus indirect buprenorphine (BPN)-to-BNX induction. DESIGN: Phase 4, prospective, randomized, active-drug controlled, parallel-group trial consisting of a 2-day, double-blind, double-dummy induction phase followed by 26 days of open-label treatment with BNX. SETTING: Nineteen sites in 10 European countries from March 2008 to December 2009. PARTICIPANTS: A total of 187 opioid-dependent men and women ≥ 15 years of age. MEASUREMENTS: The primary objective was assessment of patient response to direct and indirect BNX induction [proportion of patients receiving the scheduled 16-mg BNX dose on day 3 (i.e. first day post-induction)]. Secondary assessments included illicit drug use, treatment retention and compliance, withdrawal scale scores, and safety. FINDINGS: Patient response to direct- versus indirect-BNX induction was similar [direct 91.4% (85/93) versus indirect 90.4% (85/94); 95% confidence interval (CI): -7.3%, 9.2%]. Rapid dose induction (16 mg of BPN equivalent on day 2) was acceptable and 72% of patients completed treatment (day 28). There were no significant differences in secondary measures across groups. An average BNX maintenance dose of 15.3 mg across groups was associated with substantial reductions in illicit opioid use and no self-reported intravenous misuse. Treatment compliance and retention rates were similar (98.5% and 81.3%, respectively). Treatment-emergent adverse event rates were comparable: 75% versus 74% for direct- versus indirect-induction groups, respectively. CONCLUSIONS: Direct buprenorphine/naloxone induction was a safe and effective strategy for maintenance treatment of opioid dependence. Response to high-dose direct buprenorphine/naloxone induction appears to be similar to indirect buprenorphine-to-buprenorphine/naloxone induction and was not associated with reports of intravenous buprenorphine/naloxone misuse.

Intravenous Drug Users Can Achieve a High Sustained Virological Response Rate: experience From Croatian Reference Center for Viral Hepatitis.

BACKGROUND: Hepatitis C virus (HCV) is one of the major infectious disease agents among injecting drug users (IVDUs). However, most of the IVDUs are not still treated. OBJECTIVES: To examine the treatment course, adherence, tolerability and safety profiles and SVR rates in IVDUs compared to non-IVDUs. PATIENTS AND METHODS: Demographic and clinical data were collected from medical records of 345 adult patients diagnosed with chronic hepatitis C (CHC) who were treated with a PEG-IFN-α and ribavirin in Croatian Reference Center for Viral Hepatitis in Zagreb between January 2003 and January 2010. Efficacy, safety and tolerability treatment profiles were analyzed in IVDUs vs. non-IVDUs. Positive predictors for treatment outcome were evaluated by univariate and multivariate logistic regression. RESULTS: A total of 106 (30.46%) IVDUs were identified. The IVDUs were mainly male (81.13% vs. 52.30%, P = 0.0001), young (mean ± SD age: 32.46 ± 5.33 y vs. 46.12 ± 11.48 y, P = 0.0001), had lower fibrosis and HAI score (measured by ISHAK) and shorter duration of infection (mean ± SD: 8.98 ± 5.87 vs. 16.79 ± 8.99 y, P = 0.0001) compared to non-IVDU group. In IVDUs, genotype 1a (24.52%) and 3a (38.68%) were predominant. There were no differences in completion rate between the two studied groups. IVDUs achieved a significantly higher rate of overall SVR (70.75% vs. 51.04%, P < 0.0009) and in genotypes 1 and 4 (65.08% vs. 48.73%, P = 0.0294) vs. non-IVDUs. Treatment discontinuation rates due to side-effects were not significantly different in IVDUs and non-IVDUs (2.83% vs. 7.11%, P = 0.1390). IVDU group had a higher rate of lost to follow-up (13.21% vs. 4.60%, P = 0.0071). There were no statistically significant differences in SVR rate between IVDUs with, or without substitution therapy (55.55% vs. 74.62%, P = 0.0866). Independent predictors of SVR were age < 40 years and genotypes 2 and 3. Type of PEG-IFN-α used was not associated with SVR. CONCLUSIONS: Treatment of CHC in IVDUs should strongly be encouraged as they have positive predictors for achieving SVR such as younger age, shorter duration of infection, and consequently favorable histological stage of the disease, and good adherence to treatment. There is no difference in safety and tolerability profiles of treatment in IVDUs compared to patients with no history of drug abuse.

[Viral hepatitis. Croatian consensus conference--2009]. / Virusni hepatitis. Hrvatska konsenzus konferencija 2009.

Summarized text of Croatian Consensus Conference on Viral Hepatitis of 2009 comprises the following chapters: 1) Epidemiology, 2) Clinical Picture, 3) Diagnostic Procedure, 4) Aims of Treatment of Viral Hepatitis, 5) Terminology, 6) Medicaments (6.1. Interferon, 6.2. Analogues of Nucleozides and Nucleotides), 7) Hepatitis B (7.1. Serologic and Molecular HBV Diagnostics, 7.2. Terminology, 7.3.Whom to Treat? 7.4. Therapy), 8) Hepatitis C (8.1. Serologic and Molecular HCV Diagnostics, 8.2. Terminology, 8.3. Whom to Treat? 8.4. Therapy). Clinical, laboratory and histologic assessment of patients with chronic viral hepatitis (algorythm of pretherapeutic treatment; histologic evaluation) and notions related to therapy of viral hepatitis (category of the patient and category of the response to treatment) are presented in related tables.

[Prevention and treatment of hepatitis C in illicit drug users]. / Prevencija i lijecenje hepatitisa C kod ovisnika o drogama.

Drug use is a complex behavior with multidimensional determinants, including social, psychological, cultural, economic, and biological factors. Blood borne viral infections including hepatitis C virus are transmitted when an uninfected intravenous drug user (IVDU) uses injection equipment, especially syringes, that have previously been used by an infected person. The transmission can also result from sharing other injection equipment such as 'cookers' and 'cottons'. Recent studies have shown that the prevalence and incidence of drug abuse have declined substantially since the introduction of needle exchange. Infection with hepatitis C may spontaneously resolve during the acute stage and never progress to chronic infection, or the infection may become chronic without medical complications, or the infection may become chronic with progressive medical complications. Regular testing for infection is an important strategy for secondary prevention of chronic hepatitis C infection. Care for hepatitis C is a vital component of a comprehensive health program for persons using illicit drugs. Such care includes screening for transmission risk behavior, prevention counseling and education, testing for HCV antibody and RNA. IDUs found to have chronic HCV infection should be assessed for the presence and degree of liver disease and evaluated for treatment for HCV Hepatitis C care also requires providing access to treatment for substance use and abuse. Therapy with opioid agonists, including methadone maintenance treatment, has been shown to diminish and often eliminate opioid use and reduce transmission of infection. Approval of buprenorphine makes office-based pharmacotherapy for opioid addiction possible. When considering treatment for hepatitis C, particular attention must be paid to mental health conditions. As a group, IDUs exhibit higher rates of comorbid psychiatric disorders than the general population. IFN-based regimens for hepatitis C are often complicated by neuropsychiatric adverse effects, including depression, insomnia, and irritability. Strong linkages with mental health services, whether on-site or within the community, are a vital component of comprehensive health programs for IDUs and are particularly important during treatment for hepatitis C. Past episodes of depression or other psychiatric disorders are not absolute contraindications for the treatment for HCV infection. Some authors recommend prophylactic antidepressant therapy before initiating treatment for HCV in patients thought to be at a high risk of depression.

Perceived parental acceptance-rejection, family-related factors, and socio-economic status of families of adolescent heroin addicts.

AIM: To compare adolescent heroin addicts and non-addicts with respect to their perceived parental acceptance and rejection, family factors (structure of the family, parents' marital status, and psychopathological disorders in the family), socio-economic status, and subjective appraisal of their family relations. METHODS: Fifty-two heroin addicts aged between 17 and 21, were compared with a group of 52 non-addicts of the same age. The comparison group was selected from an ad-hoc sample of high-school juniors and seniors and first- and second-year university students. Only participants who reported never to have taken any drugs were selected for the group of non-addicts. The perceived parental behavior of mothers and fathers was assessed by the 32-item version of Rohner's Parental Acceptance-rejection Questionnaire. Three other questionnaires were constructed to collect information on family factors, socio-economic status, subjective appraisal of family relations, and drug usage. RESULTS: The addicts perceived their mothers as more rejecting (p=0.018 for total score), more aggressive (p=0.007), and showing more undifferentiated rejection (p=0.001) than non-addicts. The addicts perceived their fathers as more rejecting then their mothers (p=0.002 for total score), less warm and accepting (p<0.001), and more neglecting (p=0.001). In comparison with non-addicts, the addicts evaluated the relationships with their mothers (p=0.001) and general satisfaction with their families (p=0.021) as poorer. Adolescent addicts mostly came from intact families. In the addicts' primary families (mother, father, and siblings), there was significantly higher incidence of addiction (p=0.041), schizophrenia (p=0.022), and suicide or attempted suicide (p=0.012). Addicts' families belonged to higher income groups then non-addicts (p=0.021). Addicts' fathers were on average less educated than non-addicts' fathers (p=0.040); typically to a high school level. The education level of addicts' mothers was similar to that of non-addicts' mothers (p=0.091), typically they were educated to a high school level. CONCLUSION: The results of this research indicate the importance of parental rearing practices, especially mothers', on adolescent drug abuse and addiction. As addicts perceived their mothers as more rejecting than non-addicts, mothers' rejection could be one of the major risk factors for developing drug addiction.