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Psych Disorders Caused 4 Times Higher HCV Therapy Withdrawal Rates; Quality of Life Before Therapy Lower in HCV+ with Psych Disorders
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Reported by Jules Levin
EASL April 2006, Vienna, Austria
"A Prospective, Multicenter, Observational Study on Compliance
to Hepatitis C Treatments (CHEOBS): Characteristics of
HCV-Infected Patients with Psychiatric Disorders"
J.-P. Lang1, P. Melin2, D. Ouzan3, L. Cattan4, M. Chousterman5, M. Rotily6, T. Fontanges7, P. Marcellin8, P. Cacoub9
1Psychiatric Department, Centre Hopitalier Erstein, Erstein; 2Internal Medicine Department, Hopital General, Saint Dizier; 3Institut Arnaud Tzanck, Saint Laurent du Var, Paris ; 42 rue Robert Lecoin, 75016, Paris, France;
5Hepato-gastro-enterology Department, Hopital de Creteil, Creteil; 6Clinsearch, Bagneux; 7Centre de l'Appareil Digestif, Bourgoin Jallieu; 8Hepato-gastro-enterology Department, Hopital Beaujon, Clichy, France; 9Internal Medicine Department, Hopital Pitie Salpetriere, Paris, France
AUTHORS CONCLUDED
- There was a high prevalence of psychiatric disorders in HCV-infected patients who started anti-viral treatment
in this cohort
- Current psychiatric disorders negatively influence the QOL (psychiatric and physical scores) at
initiation of anti-viral treatment
- CHEOBS should be very informative for the management of patients with chronic HCV and psychiatric disorders
ABSTRACT
Background and Aims: CHEOBS is a French multicenter prospective observational study designed to analyse the factors associated with compliance to combination treatment with peginterferon alfa-2b and ribavirin in patients with
chronic hepatitis C virus (HCV). In this analysis we report the proportion of HCV-infected patients with psychiatric disorders and the impact of psychiatric disorders on the quality of life of patients with chronic hepatitis C.
Methods: From January, 2003 to December, 2004, 1,945 patients with chronic HCV infection, were prospectively included in the CHEOBS study. All patients received a single subcutaneous injection of peginterferon alfa-2b (1.5 mg/kg/wk) plus oral ribavirin (800-1,200mg) once daily.
Results:
432/1,945 (22%) patients were identified with psychiatric disorders, but only 251/406 (61%) had been evaluated by a psychiatrist before starting antiviral treatment (26 responses not reported).
Patients with a past history of psychiatric disorders (764, 39%) had depression (476), and/or attempted suicide (128) and/or psychiatric hospitalisation (160).
Distribution of current psychiatric disorders appeared similar to that of the general population:
-- patients suffered from depression (54.5%, 218/432), anxiety (54.5%, 218/432), chronic psychosis (5.6%, 23/406), or bipolar depression (2.4%, 9/406).
--Most patients (72%) with a current psychiatric disorder had never been treated
for HCV.
Among those patients for whom HCV treatment was stopped early, the percentage of patients with psychiatric disorders (36%, 43/121) was similar to the percentage of patients without psychiatric disorders (30%, 130/430).
However, premature withdrawal from treatment due to psychiatric reasons was significantly more frequent in the patients with psychiatric disorders than in those without such disorders (16%, 7/43 versus. 4%, 5/130; p=0.01).
Quality of life scores (SF36 scale) were negatively influenced by the existence of psychiatric disorders; the psychiatric and physical scores were significantly lower for patients with psychiatric disorders compared with those without such disorders (Psychiatric score:35+/-10 versus 43+/-10, p<0.001; Physical score:45+/-10 versus 48+/-9, p<0.001).
Conclusions: In this observational study, patients who start HCV treatment frequently have psychiatric disorders which negatively influence their quality of life scores.
BACKGROUND
Combination therapy with peginterferon alfa and ribavirin is the standard of care for patients with hepatitis C.
However, because side effects, such as depressive symptoms, are associated with pegintron and ribavirin therapy, tolerance is often poor.
Depression may jeopardize patient safety (suicide attempts) or result in dose reductions or discontinuation of therapy.
As a result, compliance with medical treatment, which is critical to successful outcomes, may be compromised, particularly in patients with co-morbid psychiatric disorders.
STUDY AIMS
To analyse the baseline profile of patients chronically infected with hepatitis C virus (HCV) who also had co-morbid psychiatric disorders.
To evaluate the impact of psychiatric disorder on the quality of life (QOL) of patients with chronic hepatitis C.
METHODS
Patients
Patients (N = 1945) with chronic HCV infection were recruited from 96 sites throughout France and treated from January 2003 to December 2004.
Study Design
In this prospective, multicentre, observational study (CHEOBS), patients received peginterferon alfa-2b (PegIntron, 1.5 mg/kg/week) and ribavirin (800-1200 mg/day) for 24 weeks (genotypes 2 and 3) or 48 weeks (genotypes 1 and 4)
and were followed up for 24 weeks after treatment. Almost half the patients also participated in a therapeutic education program.
Assessments
Patients were assessed at day 0 and at weeks 12, 24, 36, and 48, as well as 24 weeks after the end of treatment.
- A generic QOL tool, the short form-36 (SF-36), was completed at each evaluation time
- Only the day 0 results are presented here
RESULTS
Patient demographics
Psychiatric Disorders and Previous Anti-viral Treatment
- Of the 1945 patients enrolled in the study, 432 (22%) had current psychiatric disorders
- Most of these patients (72%) had never been treated for HCV
- A similar proportion of patients with current psychiatric disorders and without psychiatric disorders prematurely stopped treatment (36% and 30%, respectively)
- However, premature withdrawal from treatment because of psychiatric reasons was significantly more frequent in the patients with psychiatric disorders than in those without such disorders (16% versus 4%, P = .01)
Psychiatric Disorders
- 39% of patients had previous psychiatric disorders and 22% currently have one or more
- Only 251 (61%) of 406 patients with psychiatric disorders had been evaluated by a psychiatrist before starting anti-viral treatment; 26 responses were not reported
Only 61% of the 22% were evaluated by a psychiatrist before the initiation of treatment.
Anxiety/depression was the most common psychiatric disorder in the overall patient population
QOL Scores at Day 0
- QOL scores were negatively influenced by a history of psychiatric disorders
- Psychiatric and physical scores were significantly lower for patients with psychiatric disorders than for those without such disorders
Summary of Psychiatric Score of QOL at Day 0 for
Different Patient Profiles
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