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Depression Due to Treatment with Pegylated Interferon plus Ribavirin May Be Under-diagnosed by Clinicians

The occurrence of depression has been reported in 20%-30% of cases that evaluated psychiatric side effects in chronic hepatitis C patients using pegylated interferon alfa plus ribavirin. However, the diagnosis of depression in these studies was determined solely based on the impression of the study investigators.
In the current French study, supported by Roche Laboratories, manufacturer of pegylated interferon alfa-2a (Pegasys), investigators assessed the incidence of depression during treatment with Pegasys plus ribavirin under “real life” circumstances using the Mini-International Neuropsychiatric Interview (MINI).

MINI is a short, structured diagnostic interview to assess psychiatric disorders that makes a correlation between the MINI results and the diagnosis made by a clinician and with the Beck Depression Inventory score (BDI).

The multicenter study is expected to enroll 150 HCV monoinfected patients treated with Pegasys plus ribavirin. The incidence of depression will be assessed at baseline, at weeks 4, 12, and 24, at the end of the treatment, and at the end of follow up using MINI, clinician observations, and BDI scores.

Interim study results from baseline through week 12 for the 123 first patients enrolled were presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases in Boston (November 2-6, 2007).
 
Results

Baseline patient characteristics were as follows:

  • Mean age: 48 years

  • Sex: 73 (59%) male;

  • HCV genotype 1: 67 (54%);

  • Advanced (stage F3-F4) fibrosis: 45 (37%);

  • Previously treatment-naive patients: 73 (59%).

  • History of injection drug use: 53 (43%);

  • History of alcohol abuse: 29 (24%);

  • At baseline, MINI revealed current major depression in 9 patients (7%).

  • 7 received anti-depressant therapy before (n=5) or after (n=2) the beginning of Pegasys plus ribavirin treatment.

  • Between baseline and week 12, 21 (18%) cases of major depression were diagnosed by MINI.

  • In 16 of these cases (76%), clinicians assessed was no depression.

  • Conversely, in 7 cases (6%) the diagnosis of major depression was made by the clinician but not confirmed by the MINI.

  • Anti-depressant therapy was started in 17 cases (81%).

  • The correlation between MINI and BDI score was poor.

  • Conclusion

    Based of these results, the investigators concluded, “The incidence of depression between baseline and week 12 was 18%.”

    Furthermore, they stated, “Major depression [in patients using Pegasys plus ribavirin] seems to be under-diagnosed by clinicians.”

    Finally, they concluded, “The systematic use of the Mini-International Neuropsychiatric Interview (MINI)…may be useful during peginterferon therapy.”

    Hepato-gastroenterology, CHU de Nancy, Vandoeuvre les Nancy, France; CHG Saint Dizier, Saint Dizier, France; CHG Tourcoing, France; CHU Amiens, France; CHR Metz, France; CHU Besancon, France; CHU Lille, France; CHR Colmar, France; CH Saint Philibert, Lille, France. CH Belfort, France.


    J Bronowicki, P Melin, N Talbodec, and others. The depression induced by peginterferon alfa-2a and ribavirin in the treatment of chronic hepatitis C is under-diagnosed by the clinician. 58th Annual Meeting of the American Association for the Study of Liver Diseases. Boston, MA, November 2-6, 2007. Abstract 337.

     


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