icon-folder.gif   Conference Reports for NATAP  
  AASLD (American Association for the Study of Liver Diseases)
Nov 2-5, 2002, Boston, MA
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IVDUs, Depression & Mental/Emotional Issues in HCV Therapy Can Be Successfully Addressed
Reported by Jules Levin
  Many HCV-infected patients, particularly HCV/HIV coinfected patients also have emotional or psychiatric concerns. IVDUs also have issues related to alcohol and drug use. These problems, if serious, can prompt care providers to exclude these patients from HCV therapy; or these types of patients may have more difficulty in tolerating and adhering to therapy, so they may be more inclined to discontinue therapy. In the end this reduces response rates to HCV therapy, increases costs, and prevents treatment for perhaps the most at-risk group of patients including IVDUs, persons with mental or emotional problems, and persons with HIV. Below are several studies reported at AASLD in which methods to address these problems showed promising success. Various techniques were used and appear to improve the adherence and success rates in treating such patients. These studies present several different techniques. Diana Sylvestre (OASIS Clinic, Oakland, CA) studied IVDUs on methadone maintenance in her clinic, who were treated with HCV therapy, and received intense support services. David Bernstein (North Shore University Hospital, Manhasset, NY) reported on study using standardized test to identify depression and consider anti-depressive therapy. Richard Goldsmith (University of Cincinnati VA Medical Center) reports on using a team of experts in managing HCV therapy for patients with behavioral, emotional and psychiatric problems.
The Impact of Negative Prognostic Factors Impact on Hepatitis C Treatment Outcomes in Recovering IVDUs: treatment can be successful
Diana Sylvestre (OASIS Clinic, Oakland, CA) studied IVDUs on methadone maintenance in her clinic, were treated with HCV therapy, and received intense support services. She finds such individuals can be treated successfully under the right circumstances. Although the majority of new and existing cases of hepatitis C (HCV) are related to injection drug use, little is known about HCV treatment in this population. IDUs have many barriers to HCV treatment including psychiatric disease, relapse to drug use, and comorbid alcoholism. The quantitative impact of these barriers is unknown. Sylvestre examined the individual and cumulative impact of pre-existing psychiatric illness, intervening drug or alcohol use, and limited length of drug sobriety on sustained virologic response rates in recovering IDUs who received HCV treatment in a setting that could address their special needs.
Recovering heroin users stabilized on methadone maintenance (MM) were offered treatment if they had active HCV and reliably attended at least 75% of scheduled visits. Sixty-six elected to undergo therapy and were treated with standard interferon/ribavirin combination therapy. The average age of the 66 patients was 50, 39 (59%) were male, and 48 (73%) were Caucasian, 10 (15%) were African-American, and 8 (12%) were Latino. The average length of infection was 28 years, and 37 (56%) had genotype 1. Forty-one (62%) reported a preexisting psychiatric diagnosis, 14 (21%) drank alcohol during treatment, 20 (30%) used hard drugs during treatment, and 20 (30%) were sober for <6months.
Overall, the dropout rate was 24% and the SVR was 29%. The SVR of patients who had no negative prognostic factors (n=15) was 40%. Patients with psychiatric disease (n=41) showed an SVR of 24%, compared with 36% in the non-psychiatric patients (p=0.4). A minority of patients (14/66), drank alcohol; their SVR was 36% vs 27% in the alcohol-free patients (p>0.5). Those with < 6mo drug sobriety had a reduction in SVR compared with those with more lengthy sobriety, 20% vs 32%, respectively, but this was not statistically significant (p=0.38). Patients using drugs during treatment also showed a nonsignficant reduction in SVR, 20%, vs. 33% in the sober population (p=0.38). Drug use during treatment was highly correlated with limited length of sobriety (p<0.001). Occasional drug users (n=13) showed outcomes similar to those who abstained (n=46), 31% vs 33%, but none of the 7 patients who used drugs regularly showed a virologic response (p=0.17).
The negative impact of these prognostic factors was cumulative: none of the patients with psychiatric illness who used both drugs and alcohol (n=4) showed a virologic response. Multiple logistic regression analysis reveals that only psychiatric disease is independently correlated with negative outcome in this population (p=0.02).
Sylvestre concluded that psychiatric illness, drug use, and alcohol use during HCV treatment is relatively common in a real-world sample of recovering IDUs stabilized on methadone maintenance. Although regular drug use may be problematic, these negative prognostic factors do not individually have a substantial impact on HCV outcomes, and reasonably successful outcomes can be expected in a setting where the special needs of this population can be accommodated. However, the cumulative impact of multiple risk factors may substantially reduce treatment outcomes, and therefore consideration should be given to delaying HCV therapy until these issues can be appropriately addressed.
BDI Testing May Be Superior To Doctor Assessment In Identifying Depression and Improving HCV Therapy Response
David Bernstein (North Shore University Hospital, Manhasset, NY) reported on study using standardized test to evaluate depression and for initiating anti-depressive therapy. The development of depression on combination interferon and ribavirin therapy is one of the factors contributing to poor adherence, early discontinuation and lower sustained viral response rates. In addition, combination therapy related depression adversely affects patient quality of life. The evaluation of depression in the practice of clinical hepatology is often difficult and critical warning signs of severe depression may be missed. To facilitate the assessment of depression and suicidal ideation in patients started on combination therapy we administered an automated version of the Beck Depression Index (BDI) utilizing the Point of View (POV) 2000 hand-held survey unit.
Patients were administered the BDI test prior to starting therapy and within the first 3 months after starting therapy. 448 patients treated with either combination interferon alfa-2b plus ribavirin or pegylated interferon alfa-2b plus ribavirin were evaluated with a POV 2000 BDI within the first three months of therapy. BDI scores obtained on all patients included in the study prior to initiation of therapy were classified as minimal depression. All POV 2000 BDI were administered in the office waiting room prior to any contact with a physician, nurse or physicians assistant. Patients were unaware of their virologic status at the time of the BDI.
BDI revealed the following: 293 patients (65.4%) had minimal depression, unchanged from baseline. 82 patients (18.3%) developed mild depression. 43 patients (9.3%) developed moderate depression. 30 patients(6.7%) developed severe depression. 40 (9%) patients stated they had thought of suicide but would not carry it out. 11 (2.4%) patients responded that they would like to kill themselves. 6 (1%) patients responded that they would kill themselves if they had the chance. 391 (87%) patients did not have any thoughts of suicide. Anti-depressive therapy was initiated on all patients who reported moderate depression or greater.
All patients with moderate depression or less were continued on therapy, unless suicidal ideation was present. 22/30 patients with severe depression completed therapy. Therapy was stopped on the 17 patients who considered suicide. Standard physician questioning did not reveal suicide ideation in any of the 17 patients with suicidal ideation.
Bernstein concluded that the POV 2000 BDI is a useful tool in the evaluation and detection of treatment related depression. It appears to be more sensitive than standard physician interviews in determining the presence and degree of depression. Widespread use of this instrument may allow for earlier detection of depression and earlier intervention leading to greater patient adherence to therapy and improved sustained viral response rates. The discordance between depression and suicidal ideation is important as many patients considering suicide did not report severe depression.
Multidiscipline Team For Psychiatric Disturbances Improves HCV Therapy Response
Richard Goldsmith (University of Cincinnati VA Medical Center) reports on using a team of experts in managing HCV therapy for patients with behavioral, emotional and psychiatric problems. Chronic HCV infections occur frequently in association with these issues. Treatment with interferon alpha 2b + ribaviron (IFN-R) exacerbates such disturbances which if unattended may terminate in death (suicide/homicide). Thus, these types of disturbances are typically considered an exclusionary condition for HCV treatment. This report describes one approach to the problem.
Patients at the Cincinnati VA Medical Center with HCV were evaluated for treatment by a multidiscipline team trained in Hepatology, Psychiatry, Pharmacy and Nursing. The decision to treat as well as follow-up management was by consensus. Treatment consisted of IFN a2b and weight based R (Rebetron).
67% of veterans treated had 1 or more axis 1 diagnoses (49% affective disorder, i.e. Major Depressive Disorder, Bipolar, Dysthymia, Schizoaffective); 28% an anxiety disorder i.e. Post Traumatic Stress, Panic Disorder]. 10% had both. 89% an addiction disorder i.e. alcoholism or drug addiction. Less than 5% had never experienced these types of disturbances.
Compliance was assessed by prescription refills and history. Approximately 90% completed 6 mo. of therapy and received >80% of their medication refills on time.
92 veterans had treatment initiated. Treatment is still in progress for 26 so response cannot be assessed. 66 (29%) were withdrawn or chose to drop out, 5% for medical adverse events (AE); 7% for psychiatric AE; 2% for alcohol or drug relapses. 6% disappeared and presumably due to an addiction relapse. 9% withdrew for personal problems.
71% completed treatment (n=47). 35% were non-responders (NR); 36% were end of treatment (EOT) HCV RNA negative. After 6 mo. off treatment 20% were sustained responders (SR). The best results were achieved in white males, SR 42% vs. African-Americans 10%. Goldsmith concluded: 1) Using a multidisciplinary team approach to treatment, patients with serious mental/emotional disturbances and chronic HCV can be treated successfully without undue risk to the patient. 2) Treatment success based on HCV RNA clearance is comparable to that described in the literature in less complicated populations.