Hepatitis C Virus Prevalence and Incidence in a Large Nationwide Sample of Patients in Opioid Substitution Treatment in Germany: A Prospective Cohort Study.

BACKGROUND: Hepatitis C virus (HCV) infection is highly prevalent among people who inject drugs (PWID). Accurate data on HCV prevalence and incidence rates among patients receiving opioid substitution treatment (OST) are needed to estimate the current and future burden of HCV infections in this high-risk population. METHODS: Baseline data from routine care were collected between October 2014 and June 2016 from randomly selected OST facilities in Germany. The primary outcome measure was the HCV status (antibody and RNA prevalence). Patients who were HCV antibody-negative at baseline were followed up after 12 months to calculate the HCV incidence rate. RESULTS: Sixty-three facilities from 14 German Federal States provided clinical data for a total of 2466 OST patients. HCV antibody and HCV RNA prevalence were 58.8% (95% confidence interval [CI], 56.8%-60.8%) and 27.3% (95% CI, 25.5%-29.2%), respectively. At baseline, a total of 528 patients (21.4%) had previously undergone antiviral treatment. Moreover, lower HCV RNA prevalence was associated with female gender, employment, younger age, and shorter duration of OST and opioid dependence. The HCV incidence rate was 2.5 cases per 100 person-years. CONCLUSIONS: The low HCV RNA prevalence and HCV incidence rates confirm that OST in Germany is an effective setting both for treating chronic HCV infections and for preventing new infections among PWID. Scaling up the provision of OST, HCV testing, and HCV treatment among OST patients are important public health strategies for reducing HCV infections in this high-risk population.

Measuring quality of life in opioid-dependent people: a systematic review of assessment instruments.

PURPOSE: Opioid dependence is a chronic relapsing disorder. Despite increasing research on quality of life (QOL) in people with opioid dependence, little attention has been paid to the instruments used. This systematic review examines the suitability of QOL instruments for use in opioid-dependent populations and the instruments' quality. METHODS: A systematic search was performed in the databases Medline, PsycInfo, The Cochrane Library, and CINAHL. Articles were eligible if they assessed QOL of opioid-dependent populations using a validated QOL instrument. Item content relevance to opioid-dependent people was evaluated by means of content analysis, and instrument properties were assessed using minimum standards for patient-reported outcome measures. RESULTS: Eighty-nine articles were retrieved, yielding sixteen QOL instruments, of which ten were assessed in this review. Of the ten instruments, six were disease specific, but none for opioid dependence. Two instruments had good item content relevance. The conceptual and measurement model were described in seven instruments. Four instruments were developed with input from the respective target population. Eight instruments had low respondent and administrator burden. Psychometric properties were either not assessed in opioid-dependent populations or were inconclusive or moderate. CONCLUSIONS: No instrument scored perfectly on both the content and properties. The limited suitability of instruments for opioid-dependent people hinders accurate and sensitive measurement of QOL in this population. Future research is in need of an opioid dependence-specific QOL instrument to measure the true impact of the disease on people's lives and to evaluate treatment-related services.

Development of OSTQOL: A Measure of Quality of Life for Patients in Opioid Substitution Treatment.

BACKGROUND: Quality of life (QOL) of patients in opioid substitution treatment (OST) is increasingly being addressed in research. However, no disease- or treatment-specific instrument is available to assess the QOL of this target population. The purpose of this project was to develop the first QOL instrument for OST patients. METHODS: Focus groups with 60 OST patients were analyzed using thematic analysis to elicit key QOL themes as perceived by patients. Identified themes were developed into items and refined through pilot testing and cognitive debriefing. The resulting 82 items were tested in a large sample of OST patients (n = 577). Principal component analysis with varimax rotation was performed to explore a possible factor structure and reduce the number of items. Psychometric properties were assessed. RESULTS: Factor analysis revealed 6 subscales accounting for 46.1% of the variance: Personal Development, Mental Distress, Social Contacts, Material Well-being, Opioid Substitution Treatment, and Discrimination. The 38-item instrument demonstrated good to acceptable internal consistency reliability for all subscales (Cronbach's alpha = 0.75-0.88), and good convergent and discriminant validity. CONCLUSION: The Opioid Substitution Treatment Quality of Life scale (OSTQOL) is a multidimensional instrument with low respondent and administrator burden. A thorough validation is needed to assess its validity.

Epidemiology of hepatitis C virus infection among people receiving opioid substitution therapy (ECHO): study protocol.

BACKGROUND: Hepatitis C virus infection is highly prevalent among people who inject drugs. Opioid substitution therapy, the standard treatment for opioid dependence, provides an excellent opportunity for the treatment of hepatitis C virus infection due to the close and regular contact between patients and clinicians. However, there is little research on the impact of opioid substitution therapy on the prevalence of the hepatitis C virus at a national level. This paper describes the protocol for the Epidemiology of Hepatitis C Virus Infection among People Receiving Opioid Substitution Therapy (ECHO) study. The aim of this study is to estimate the national prevalence and incidence of hepatitis C virus infection among people receiving opioid substitution therapy in Germany and to describe factors associated with hepatitis C treatment uptake and seroconversion. METHODS/DESIGN: An observational, longitudinal, multicentre study is being conducted between 2014 and 2016 in a representative sample of approximately 2500 people receiving opioid substitution therapy from about 100 clinicians providing opioid substitution therapy in Germany. Data will be collected during routine patient care and by means of patient and clinician questionnaires at baseline and 12-month follow-up. Stratified sampling will be performed to obtain a representative sample of clinicians providing opioid substitution therapy. The strata will be constructed based on the distribution of the total sample of clinicians providing opioid substitution therapy in Germany according to German Federal State and the number of patients per clinician. DISCUSSION: Opioid substitution therapy may be an important strategy to prevent the spread of hepatitis C virus in opioid dependent populations, but its effectiveness may be diminished by our limited understanding of factors associated with treatment uptake and seroconversion. The present study will provide important information for developing strategies to address hepatitis C virus-related disease burden in people receiving opioid substitution therapy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02395198.

Clinical and Patient-Reported Outcomes of Direct-Acting Antivirals for the Treatment of Chronic Hepatitis C Among Patients on Opioid Agonist Treatment: A Real-world Prospective Cohort Study.

BACKGROUND: Patient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs. METHODS: HCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs). RESULTS: We found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients. CONCLUSIONS: This real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment.

Factors associated with health-related quality of life in a large national sample of patients receiving opioid substitution treatment in Germany: A cross-sectional study.

BACKGROUND: Knowledge of health-related quality of life (HRQOL) of patients receiving opioid substitution treatment (OST) is limited and fragmented. The present study examines the HRQOL of a large national sample of OST patients in Germany and sociodemographic and clinical correlates. METHODS: Cross-sectional data on the HRQOL of 2176 OST patients was compared with German general population norms. Patients were recruited from 63 OST practices across Germany. To identify correlates of HRQOL, as measured with the SF-12, we performed bi- and multivariate analyses with sociodemographic and clinical variables, including patient- and clinician-reported outcomes on physical and mental health. RESULTS: Patients' HRQOL was significantly poorer than in the general population, especially their mental HRQOL. Factors associated with lower physical HRQOL were older age, longer duration of opioid dependence, hepatitis C virus infection, and HIV infection. Benzodiazepine use was associated with lower mental HRQOL, and amphetamine use with higher physical HRQOL, compared to non-use of these substances. For both mental and physical HRQOL, the factor with the strongest positive association was employment and the factors with the strongest negative associations were physical and mental health symptom severity, psychiatric diagnosis, and psychopharmacological medication. CONCLUSIONS: Compared to the general population, we found substantially lower HRQOL in OST patients, especially in their mental HRQOL. OST programs can benefit from further improvement, particularly with regard to mental health services, in order to better serve their patients' needs. Clinicians may consider the use of patient-reported outcome measures to identify patients' subjective physical and psychological needs. Further research is needed to determine if employment is a cause or consequence of improved HRQOL. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02395198 , retrospectively registered 16/03/2015.

Non-prescribed use of opioid substitution medication: Patterns and trends in sub-populations of opioid users in Germany.

BACKGROUND: Non-prescribed use of opioid substitution medication (NPU) appears to represent a relevant source of opioids among European drug users. Little is known about the prevalence of NPU in Germany and possible differences between subgroups of opioid users. The present study examines NPU and other drug use patterns among drug consumption room (DCR) clients, opioid substituted DCR clients, and patients recruited in opioid substitution treatment (OST) practices. METHODS: Cross-sectional data was collected in 2011 from 842 opioid users in 10 DCRs and 12 OST practices across 11 German cities. Structured interviews comprised indicators for socio-demographics, health status, drug use, motives for NPU, and the availability and price of illicit substitution medication. Group differences were examined with one-way ANOVAs, chi-square tests, or t-tests, and factors for NPU were included in a multivariate model. Over-time comparisons were performed with similar data collected in 2008. RESULTS: Lifetime, 30-day and 24-h NPU prevalence for the total sample was 76.5%, 21.9%, and 9.3%, respectively, with methadone being the most frequently used substance. NPU, poly-drug use and injection drug use were more common among DCR clients, especially among DCR clients not in OST. The three groups featured distinct socio-demographic characteristics, with substituted patients being more socially integrated, while few differences in health parameters emerged. Motives for NPU were mostly related to potential shortcomings of OST, such as insufficient dosages, difficulties with transportation, and lack of access. NPU prevalence was found to be higher than in 2008, while injection rate of substitution medication was similarly low. Main factors associated with NPU were not being in OST, past 24-h use of other drugs, and younger age. CONCLUSION: Although diverted methadone or buprenorphine are rarely used as main drugs, NPU is prevalent among opioid users, particularly among DCR clients not in OST. OST reduces NPU if opioid users' needs are met.

Factors associated with uptake, adherence, and efficacy of hepatitis C treatment in people who inject drugs: a literature review.

INTRODUCTION AND METHODS: Hepatitis C virus (HCV) infections are highly prevalent amongst people who inject drugs (PWID). Despite well documented evidence of its effectiveness, suggested cost-effectiveness, and potential to reduce HCV prevalence rates, the uptake of antiviral HCV treatment by PWID is low. This nonsystematic literature review describes factors associated with the uptake, adherence, and efficacy of HCV treatment among PWID and discusses strategies to increase their uptake of treatment. RESULTS: Low HCV treatment uptake among PWID is associated with a number of patient-related and provider-related barriers. Beliefs and fears about low efficacy and adverse effects on the patient's part are common. A substantial number of factors are associated with the chaotic lifestyle and altered social functioning of PWID, which are often associated with decompensation or relapsing into drug addiction. This may lead to perceived low adherence with treatment and low efficacy on the provider's part too, where lack of support, inadequate management of addiction, and other drug-related problems and poor treatment of side effects have been described. Practical issues such as the accessibility of treatment and finances also play a role. Strategies to improve the HCV treatment rate among PWID involve pretreatment management and assessment, a multidisciplinary approach, management of side effects, and enhanced education and counseling. CONCLUSION: Specific factors are associated with poorer treatment outcomes in PWID on the side of both the patient and the treatment system. However, given that PWID can achieve treatment adherence and sustained virologic response rates comparable with those in nondrug users, drug use per se should not be considered a criterion for exclusion from treatment. Further development of measures leading to higher uptake of treatment and adherence in PWID and appropriate adaptation of HCV treatment guidelines represent important tools in this regard.