Pascal Melin

Adherence to treatment and quality of life during hepatitis C therapy: a prospective, real-life, observational study.

Background: Adherence is important for therapy of chronic diseases, but has still not been well studied in real life in chronic hepatitis C.

Effectiveness of chronic hepatitis C treatment in drug users in routine clinical practice: results of a prospective cohort study

Objective Injection drug users are often excluded from hepatitis C virus (HCV) treatment. This study compares sustained virological response, adherence, and quality of life in patients with or without a history of illicit drug use in routine clinical practice. Methods This is a post-hoc analysis of a prospective, observational study conducted in 1860 patients who received peginterferon α-2b/ribavirin combination therapy. Nondrug users (NDUs) were defined as patients without a history of drug addiction; former drug users (FDUs) as patients who had stopped using illicit drugs or opioid maintenance therapy and active drug users (ADUs) as patients using illicit drugs or on opioid maintenance therapy. Virological response, adherence, and the health-related quality of life were assessed by the measure of HCV RNA in the serum, self-report and 36-item short-form health survey Questionnaire, respectively. Results The analyzed population included 1038 (56%) NDUs, 578 (31%) FDUs, and 244 (13%) ADUs. About 85% of ADUs were on opioid maintenance therapy and 25% used illicit drugs. Although ADUs had a more chaotic lifestyle and more psychiatric disorders, sustained virological response of ADUs (58%) did not differ from that of NDUs (49%) and FDUs (51%) (P=0.133). Adherence rates were 39% in NDUs and FDUs, and 37% in ADUs (P=0.883). Health-related quality of life was improved in the three groups after the end of treatment. Conclusion Our study suggests that HCV therapy in ADUs on opioid maintenance therapy is as effective as in other HCV patients. The effectiveness of HCV therapy in illicit drug users needs to be evaluated in further studies.

Pegylated interferon-α2b plus ribavirin therapy in patients with hepatitis C and psychiatric disorders: results of a cohort study

BACKGROUND Hepatitis C antiviral therapies have significant psychiatric side effects. It is therefore believed that they might exacerbate mental illness in patients with pre-existing psychiatric disorders, resulting in poor adherence and response to antiviral treatment. We aimed to assess adherence to treatment, virological outcomes and mental safety in psychiatric patients, compared with non-psychiatric patients, treated for hepatitis C. METHODS A cohort study involved unselected hepatitis C patients on scheduled therapy with pegylated interferon-alpha2b and ribavirin, between 2002 and 2005 in France, and followed-up until 6 months after the end of treatment. Virological response was reported by the physician according to standard definitions and adverse events were monitored. Adherence to treatment was assessed by patient report. RESULTS Among 1,860 patients, 403 (22%) had pre-existing psychiatric disorders, mostly depressive and anxiety disorders. Strict adherence was similar in psychiatric and non-psychiatric patients (35% versus 39%; P=0.20) as was the rate of sustained virological response (52% versus 51%; P=0.75). Conversely the rate of mental adverse events was higher in psychiatric patients (78% versus 57%; P<0.001). Baseline characteristics independently associated with the risk of later mental adverse events were history of depression, initial pegylated interferon-alpha2b dose and female gender. CONCLUSIONS Antiviral therapy in hepatitis C patients with associated psychiatric disease appears as effective as in other patients but results in a higher rate of mental adverse events, emphasizing the need for close monitoring of these psychiatric patients.

Non-invasive assessment of liver fibrosis progression in hepatitis C patients retreated for 96 weeks with antiviral therapy: a randomized study.

Background: The efficacy of a maintenance therapy in non‐responder patients with chronic hepatitis C has been essentially evaluated by histological semiquantitative scores.

Management of psychiatric disorders and addictive behaviors in patients with viral hepatitis C in France.

INTRODUCTION Guidelines concerning the management of psychiatric disorders and addictive behaviors in patients with chronic hepatitis C and the conditions of collaboration between hepatogastroenterologists, infectiologists, psychiatrists and psychologists have not been published. This has a negative influence on optimal therapeutic management of chronic hepatitis C virus (HCV) infection. The aim of this study was to describe the current clinical practices for ambulatory management of psychiatric disorders and addictions, and the influence of a possible psychiatric and/or psychological collaboration. PATIENTS AND METHODS A retrospective survey was conducted among 101 clinicians treating patients with chronic hepatitis C. Data were collected from personal interviews with the managing clinicians and from the files of patients with chronic hepatitis C patients who presented psychiatric disorders. RESULTS Analysis of the 101 interviews and 598 patient files showed that 19% of patients had not received an optimal treatment for their HCV infection because of a psychiatric problem, and that less than 50% of the managing clinicians were working in collaboration with a psychiatrist or a psychologist. In conclusion, lack of collaboration between hepatogastroenterologists and psychiatrists could be deleterious for the optimal treatment of HCV infected patients. Improvement is required.

HEPACOM: multicenter, observational prospective study of outcome and monitoring of HCV positive antiviral-naïve patients managed in the French health care system.

OBJECTIVE To study management practices in the French health care system for antiviral-naïve patients with chronic hepatitis C virus (HCV) infection. METHODS AND PATIENTS Two groups of general practitioners, group I (special training and experience in drug addiction) and group II (other general practitioners) enrolled untreated HCV positive patients and noted management practices for a 12-month period. RESULTS Among 4660 enrolled patients, 2038 enrolled by 462 general practitioners in group I and 1756 enrolled by 588 general practitioners in group II were retained for analysis. These patients were adults, aged 42+/-14 years, who were naïve to antiviral treatment. The male/female ratio was 1: 7. Ten percent were coinfected with HIV, 12% had excessive alcohol intake, and 61% were current drug users, 75% of whom (45% of the total population) were taking replacement therapy. Minimal hepatic lesions (stageor=F2). At the end of the monitoring period, 64% of the patients had been referred to a specialist. Antiviral treatment had been started in 20%, i.e. 32% of the patients who consulted a specialist. Occupational activity (P<0.0001), young age (P=0.007), more recent diagnosis (P<0.0001), lack of HIV co-infection (P=0.015), male gender (P=0.006), lack of replacement treatment (P=0.006), previous liver histology with METAVIR A and F>or=2 (P<0.0001) and enrollment by a group I general practitioner (P<0.007) were the independent predictive factors of initiation of antiviral treatment. CONCLUSION Only one-third of patients with access to the French health care system started antiviral treatment and some categories of patients, including women, patients co-infected with HIV and patients on replacement therapy, were less likely to be treated than others. The recommendations of the French Consensus Conference, held in the middle of the study period (2002), might have been implemented (probably followed) by a minority of general practitioners.