Treatment for chronic hepatitis C in a cohort of opiate substitution therapy recipients in three Swedish cities - completion rates and efficacy.

OBJECTIVES: Opiate substitution treatment (OST) programs could provide opportunities for management of comorbidities, such as hepatitis C virus (HCV) infection, in people who inject drugs. We aimed to prospectively evaluate the real-life feasibility of interferon/ribavirin-based HCV treatment in OST recipients, with a special focus on psychiatric status and health-related quality of life. METHODS: Patients from a cohort of OST recipients from three cities in Sweden were selected for HCV treatment on the basis of structured investigation for HCV-related liver disease. Therapy was delivered in collaboration between infectious disease and OST clinics, with monitoring for completion and adherence, treatment response, adverse events, health-related quality of life (HRQoL) (SF-36) and signs of depression (MADRS-S), or relapse into drug abuse. The primary endpoint was completion of prescribed treatment; the secondary endpoints were sustained virological response (SVR), adherence, and incidence of depression. RESULTS: Among 69 patients with an indication for antiviral therapy, 41 initiated treatment; 34/41 (83%) completed treatment and 19/41 (46%) achieved SVR. Adequate adherence was observed in 29/41 patients (71%). Two serious adverse events occurred, including one death because of liver failure. Baseline scores for self-assessed health were low, with a significant reduction during treatment. Seventy-one percent of patients (29/41) fulfilled the criteria for clinically significant depression at some time point during treatment. Baseline scores for HRQoL/MADRS-S were associated with treatment completion, SVR, and depression during treatment. CONCLUSION: Despite the low HRQoL and the high occurrence of depression, HCV treatment was feasible and showed satisfactory rates of completion in this cohort of unselected OST recipients.

Chronic hepatitis C in Swedish subjects receiving opiate substitution therapy--factors associated with advanced fibrosis.

BACKGROUND: Opiate substitution therapy (OST) reduces the risk of death from directly drug-related causes in heroin users, allowing other chronic health problems to emerge. People who inject drugs (PWID) are exposed to hepatitis C virus (HCV), with an associated risk of chronic liver disease. We investigated HCV prevalence and liver-related morbidity in a cohort of OST recipients, and analyzed factors associated with significant hepatic fibrosis. METHODS: All patients registered on 1 April 2008 in 4 clinics providing OST in the 3 largest cities in Sweden were eligible for inclusion. HCV viremic subjects were evaluated for fibrosis stage by liver biopsy, transient elastometry (TE), and/or a biochemical fibrosis index (Göteborg University Cirrhosis Index; GUCI). Factors associated with severity of fibrosis were determined by logistic regression analysis. RESULTS: Out of 524 eligible patients, 277 consented to enrolment. Two hundred and thirty-six subjects (88%) were anti-HCV-positive, and 162 of these were viremic (69%). Significant liver fibrosis (defined as Ishak stages F3-F6, TE value ≥ 8.85 kPa, or GUCI > 0.33) was found in 69 out of 103 (67%) tested viremic patients, and was associated with alcohol intake (p = 0.03), higher body mass index (BMI; p = 0.04), and the presence of anti-HBc antibodies (indicating exposure to hepatitis B virus (HBV); p = 0.02). CONCLUSIONS: Significant liver fibrosis was detected in two-thirds of HCV viremic OST recipients in this cohort, and was associated with alcohol use, high BMI, and exposure to HBV. These findings indicate that the management of HCV and associated risk factors should be emphasized in Swedish OST programs.

Dose patterns among patients using low-dose buprenorphine patches.

OBJECTIVE: The objective of this study was to investigate the dose pattern of low-dose buprenorphine patches among patients in Swedish clinical practice. The clinical experts among the coauthors interpreted the results in relation to possible indications of development of tolerance and/or dependence/addiction. DESIGN AND SETTING: This was a nationwide, observational study using data from the Swedish Prescribed Drug Register. SUBJECTS: Individuals who were dispensed the low-dose buprenorphine patches continuously for more than 24 weeks during July 1, 2005 to February 28, 2011 were included. METHODS: The dose pattern was analyzed as the change in dose over time for each patient: 1) the dose at baseline compared with each of the following 8-week intervals, and 2) the dose at baseline compared with the dose during the patients' last treatment period. RESULTS: The majority of the patients were female (74%), and most were 75 years and older (69%). The median treatment duration was 260 days, and 4% and 1% of patients remained on continuous treatment for 2 and 3 years, respectively. The mean dose was 11 µg/h at baseline, and 15 µg/h during the patients' last treatment period. The average dose increased by 4 µg/h during the patients' entire treatment course. CONCLUSIONS: The average dose increased by 4 µg/h during the patients' treatment course, which lasted on an average of 260 days. From a clinical perspective, the dose increase of 4 µg/h is low and does not suggest dependence/addiction, as also supported by the low proportion of patients remaining on continuous treatment.