Posters – Tuesday May 23, 2006  8:00AM  Hepatitis C

 

Liver Disease

 

Abstract T1045 – Impact Of Alcohol Dependence On The Health Values Of Patients Infected With HCV

M. Atiq; S. N. Sherman; K. E. Sherman

 

Background:

The CAGE questionnaire is a simple instrument used to assess alcohol dependence. The relationship between CAGE outcomes, health utilities and quality of life measures have not been previously assessed in HCV infected subjects.

 

Materials and Methods:

This cross-sectional study was carried out at the University of Cincinnati Medical Center. One hundred twenty-four patients with chronic HCV infection were administered a disease-specific version of the SF-36 Health Survey, the Beck Depression Inventory, and 3 direct health value measures, including the Rating Scale, Time Trade-off (TTO), and Standard Gamble (SG). Correlation among measures and factor analysis was performed for the patients who were positive by CAGE criteria defined as > 2 variables.

 

Results:

There were a total of 124 patients including 80 (64 %) males and 44 (36 %) females. Mean age was 46.59 +/- 8.78 years. Sixty patients (48.4 %) patients were found to have alcohol dependence by CAGE criteria. Alcohol dependence was associated with a history of depression (p=0.036), consumption of >20 grams/day of alcohol (p=0.01), history of IV drug abuse (p<0.001), nasal cocaine use (p=0.007) and tattoos (p=0.001); whereas it was gender, ethnicity, marital status or sexual orientation. Alcohol dependence did not correlate with the presence of cirrhosis or decompensated liver disease.

 

Mean RS, TTO and SG scores were not different between the two groups. Composite mental function QOL (MCS) scores were lower in patients with alcohol dependence (P<0.01). Social Functioning (SF), Role emotional (RE) and Mental Health (MH) scores on the SF-36 questionnaire were lower amongst patients with alcohol dependence (p<0.02; p<0.04 and p<0.08 respectively). There was a strong correlation between RS and MCS (r-0.81; p<0.01) in the subset of patients with alcohol dependence whereas SG (r=0.44; p-0.02) and TTO (r=0.56; p<0.01) were only weakly correlated with MCS. There was a very strong correlation between SG and TTO (R-value 0.77; p-value<0.01). The TTO and SG scores were significantly greater than the RS score (P<0.01) and did not differ from each other.

 

Conclusion:

·       Alcohol dependence significantly affects the QOL in HCV infected individuals; however the health utility indices are not affected.

·       CAGE positive response is not associated with alteration of patient behavior related to medical decision making compared to those not meeting criteria for alcohol abuse.

 

This study was funded by a grant from NIH AHRQ (grant number HS10366-01)..

 


Abstract T1046 – Outcome of Screening for Hepatitis C Virus Infection in the Veteran Population C.

Mallette; K. Promrat; M. Flynn

 

Purpose:

Screening for hepatitis C virus (HCV) infection in high risk individuals is currently recommended by most, but not all, health authorities. There is a lack of data on the outcomes of screening. This study identifies clinical characteristics and outcomes of patients diagnosed with HCV through a screening program targeting patients with increased risk.

 

Methods:

Veterans presenting for care in VA facilities are assessed for HCV risk factors by a self-administered questionnaire. Those who answer ‘yes’ to one of the following risk factors are offered an anti-HCV test:

·       Vietnam-era veteran

·       Blood transfusion or blood products before 1993

·       Past or present intravenous drug use (even once)

·       History of snorting cocaine

·       Drank 5 or more drinks/day for ten or more years any time in your life

·       History of multiple (10 or more) sexual partners in your lifetime

·       Man who has sex with men

·       Exposure to blood or kin or mucous membranes

·       Required chronic hemodialysis

·       Had a tattoo or body piercing

·       Positive blood test for HIV (AIDS) or hepatitis B

·       Have been told that you have unexplained liver disease

 

Results

Review of the local HCV registry from October 1998 through May 2004 identified 25,701 patients who were assessed for risk factors. Of those with a risk factor were tested for HCV antibody.  260 patients were diagnosed with HCV infection through this screening program.

 

Summary

·       The prevalence of a positive anti-HCV was 7.3% among veterans who identified a risk fact for HCV infection

·       34% of individuals tested positive for anti-HCV had negative HCV RNA

·       34% of individuals with chronic hepatitis C (HCV RNA pos) had persistently normal ALT

·       18% of screen-detected patients with chronic hepatitis C had clinical evidence of advanced liver disease or advanced fibrosis on biopsy

·       Two-thirds of patients with liver biopsies had mild liver disease (minimal or no fibrosis)

·       43% of screen-detected patients with chronic hepatitis C were not immediate treatment candidates

 

Conclusion:

·       We found higher prevalence of HCV infection (7.3%)  in veterans with identified risk factors compared to the general US population (1.8%) or general veteran population (5.4%)

·       Screening for HCV infection among persons at high risk can lead to early identification of individuals which may benefit from counselling, medical evaluation, and treatment to prevent liver-related morbidity and mortality

·       All screening test-positive results must be verified with a supplemental test to eliminate false positive results and to determine status of infection (chronic vs. cleared)

·       A support program to provide adequate counselling and medical evaluation of screen-detected individuals plays a major role in the success of a screening program.

 


Abstract T1047 – Initial HCV Response in Patients with End Stage Renal Disease treated with Combination Pegylated Interferon α-2a and Ribavirin

W. Hakim; S. Sheikh; I. Inayat; M. Bia; C. Caldwell; D. Jain; D. Smith; F. Lakkis; A. Friedman; M. Lorber; R. Formica; W. Mehal

 

Background.

Treatment of hepatitis C virus (HCV) with pegylated interferon and ribavirin has been widely studied, but there is little data on combination treatment of patients with HCV and end-stage renal disease (ESRD). We designed a pilot study to determine the initial and sustained viral response of combination treatment of these patients.

 

Methods.

A non-randomized, prospective observational study of combination therapy with low dose pegylated interferon α-2a and ribavarin. 20 patients who met the criteria for inclusion (age over 18yrs, viremic for HCV, any genotype, on dialysis) were enrolled for the study. Exclusion criteria were decompensated liver disease, immunosuppressive therapy, hepatocellular cancer, and use of antiviral therapy in the last 6 months. After undergoing liver biopsies, patients began PEG-IFN at 135 microgram/week sc, and 4 weeks later ribavarin was started at 200mg PO weekly, increasing gradually to three times a week for a total of 48 weeks.

 

Results.

20 patients: M:F 18:2; mean age 52.4 yrs; African American 15, Caucasian 3, Hispanic 2; genotype 1: 18, non-1: 2. All patients underwent liver biopsy (stage I: 4; stage II: 9; stage III 7). Of the 20 patients, 4 withdrew from the study prior to starting treatment. 2 patients discontinued before three months of treatment (1 for moderate fatigue and 1 patient moved out of state). 11 patients have reached the three-month time point to determine initial viral response, while 3 have not. Of the 11, 5 patients have had initial viral response, defined as at least a two log drop in their HCV viral count (45%). Of the 3 patients that have not reached 3 months on treatment 1 has had a viral response. Side effects included 2 cases of anemia (Hgb less than 9.5g/dl) requiring temporary withholding of ribavirin, and one patient with headaches not requiring stopping treatment.

 

Conclusions.

Low-dose pegylated interferon and ribavirin therapy of patients with HCV and ESRD in this study has not been associated with any serious adverse effects. The response rate in individuals taking three months of treatment is comparable to studies in non-ESRD patients. These results demonstrate that combination therapy with low dose pegylated interferon α-2a and ribavirin is a safe therapeutic option in the ESRD population with HCV infection. Conclusive results will be obtained once all patients complete the treatment and the follow-up period for determining a sustained response.

 

This study was supported by Roche Pharmaceuticals.

 


Abstract T1048 – The Positive Impact of a Multi-Faceted Educational Intervention on Physician Knowledge and the Actual Practice of Primary Care Physicians Regarding Hepatitis C.

A. Daniel; A. M. Jankowski; N. T. Gunaratnam; T. M. Shehab

 

Background:

The majority of hepatitis C (HCV) patients remain undiagnosed. Multiple studies have shown knowledge and practice deficits among primary care physicians (PCPs). In addition, previous interventions have failed to improve patient care.

 

Hypothesis

A multifaceted intervention will improve primary care physician knowledge and therefore change their practices with regard to hepatitis C management.

 

Study Design

Prospective clinical trial assessing impact on both knowledge and practice

·       Survey & chart review

·       Multi-modality Intervention

·       Survey & chart review

·       Physician knowledge & practice

 

Study End Points

Physician Knowledge:

·       Risk factors

·       Diagnosis

·       Treatment Efficacy

 

Physician Practice:

·       Risk factor inquiry

·       Risk factor identification

·       Hepatitis C testing

 

Methods

Subjects – Physicians

·       Two intervention clinics

o      Academic internal medicine faculty & resident clinic

o      Faculty only clinic (different faculty from other intervention clinic)

·       Control group

o      Primary care clinic with no access to the intervention (faculty only)

 

Assessment of Pre-intervention Knowledge and Practice

o      Validated survey was administered to all of the physicians

o      Chart reviews were performed to assess baseline practice in both group

o      Almost 2000 random charts

§       Approximately 50% per, 50% post-intervention

§       Goal of 30 charts/ physician

o      Intervention duration:  8 weeks

§       Educational material, chart prompts and incentives

§       No intervention in control clinic

 

Components of Intervention

o      Chart prompts, weekly emails, 2 noon conferences, 1 morning report, 2 journal articles

 

Post-Intervention

o      Cohorts re-surveyed with the same validated survey

o      Charts were reviewed post-intervention in all three clinics

 

Results:

Demographics

o      72/79 (91%) physicians completed survey

o      56%% were female;         22% were teaching faculty

Baseline Knowledge Pre-Intervention

o      62% of physicians had not made a new diagnosis of HCV in the past year

o      56% reported testing for HCV in patients with high-risk behaviour

o      42% significantly underestimated the current of efficacy of multi-drug regime.

Knowledge Post-Intervention

o      Significant improvement in knowledge of hepatitis C risk factors, testing and management

Pre-intervention Physician Practice

o      0.4% of patients were asked about common HCV risk factors

o      0.1% were identified as having a risk factor

o      <0..1% were tested

o      No difference at baseline between intervention clinics and the contron clinic

Impact of this study on patient population

o      5-fold increase in new hepatitis C diagnosis during the study period.

o      New patient visits:  pre-intervention inquiry 0.1%, post intervention 80%

Conclusion

o      Our multifaceted intervention showed impact in virtually all areas of physician knowledge and lead to significant improvement in practice

o      Increased screening (inquiry)

o      Increased testing for HCV

o      Increased diagnosis of new hepatitis C cases

o      This is the first study reported where a significant improvement in knowledge and physician practice was seen in hepatitis C management

 


Abstract T1049 – Percutaneous Radio-frequency Ablation versus Surgical Resection in the Treatment of Small Hepatocellular Carcinoma

S. Nakamura; Y. Kobayashi; H. Tanaka; Y. Miyake; R. Terada; H. Ohnishi; B. Shoji; S. Iwadou; K. Miyoshi; H. Miyatake; K. Nouso; K. Sakaguchi; Y. Shiratori

 

PURPOSE:

The purpose of this study was to compare the effectiveness of percutaneous radio-frequency ablation (RFA) and that of surgical resection for the treatment of small hepatocellular carcinoma (HCC).

 

STUDY DESIGN:

Retrospective cohort study.

 

METHODS:

Between July 1997 and June 2005, consecutive 623 patients who were diagnosed with HCC for the first time were enrolled from our institute and Okayama Hepatocellular Carcinoma group. Two hundred and ninety-three patients received RFA (RFA group) and 330 patients received surgical resection (resection group). RFA was performed percutaneously using a 17-gauge internally cooled-tip electrode under real-time US guidance. All survival probabilities were estimated by means of the Kaplan-Meier method. Patients were stratified based on JIS score and CLIP score, and clinical outcomes in terms of survival and recurrence rates were compared. Furthermore, the multivariate analysis of factors affected to survival or recurrence rates were done using the Cox proportional hazards model.

 

RESULTS:

Clinical characteristics of patients were shown in Table 1. Four-year survival rates and recurrence rates were summarized in Table 2. Adjusted with age, gender, tumor number, Child-Pugh grade, tumor diameter, vascular invasion and serum level of alpha-fetoprotein, the relative risk of death and recurrence of RFA compared to resection was 1.58 (95% C.I.: 0.79-3.18) and 1.26 (95% C.I.: 0.87-1.82), respectively.

 

CONCLUSION:

No significant differences were found between the therapeutic outcome of RFA and surgical resection, even stratified according to JIS score or CLIP score.

 

 

No. of patients

4-year survival rate (%)

4-year recurrence rate (%)

 

RFA

Resection

RFA

Resection

P value

RFA

Resection

P value

All patients

293

330

85

82

0.74

48

45

0.49

JIS 0

105

64

98

91

0.28

42

38

0.07

JIS 1

117

158

84

82

0.62

33

43

0.24

JIS 2

54

86

71

82

0.07

55

48

0.09

JIS ≥3

17

22

73

63

0.80

59

49

0.51

CLIP 0

146

184

98

88

0.08

39

44

0.79

CLIP 1

119

99

76

82

0.21

40

52

0.54

CLIP ≥2

28

47

63

63

0.55

61

37

0.09

 

Characteristics

RFA group

Resection group

P value

Age, yr (median, range)

69 (35-87)

65 (24-83)

<.0001

Male: female

2.1 : 1

3.5 : 1

0.0029

Anti-HCV Ab positive (%)

80

62

<.0001

HBsAg positive (%)

11

22

<.0001

Child-Pugh grade A/B/C (%)

72.2/27.4/0.4

90.2/9.8/0

<.0001

Maximum tumor diameter, mm (median, range)

15 (5-47)

36 (10-150)

<.0001

Mean tumor number

1.35

1.26

0.090

Follow-up period, Mo (median, range)

29 (8-57)

54 (7-98)

<.0001

 


Abstract T1050 – The treatment of malignant ascites in patient with advanced cancer: peritoneovenous shunt versus paracentesis

M. Seike; I. Maetani; T. Endo; H. Shigoka; T. Tada; T. Ukita; Y. Sakai

 

Background:

Malignant ascites often appears in the end-stage patients with advanced cancer, and such patients must be admitted to the hospital due to refractory ascites. Malignant ascites is difficult to treat and effective palliation is often not achieved.

 

Methods:

We performed peritoneovenous shunt (PVS) placement in patients with malignant ascites, who were admitted to our institution between January 2000 and March 2005. The outcome of PVS placement was compared with the outcome in patients who underwent paracentesis to drain ascites during the same period. Comparison included changes in abdominal girth, hematocrit (Hct), blood urea nitrogen (BUN), and creatinine (Ct) measurements before and up to seven days after PVS placement. The changes in performance score after the procedure, the median survival from the time of PVS placement and the first paracentesis, possibility of discharge, and complications were compared in the 2 groups. Furthermore, the median survival in PVS group was compared between patients who had malignant cells identified in their ascites cytology and those who did not have malignant cells in their ascites.

 

Results:

Twenty patients underwent PVS placement and 49 patients were subjected to paracentesis. After PVS placement, abdominal girth and Hct decreased significantly. BUN and Cr also tended to decrease. The postoperative performance score showed a significant improvement following PVS placement (p = 0.0026). The median survival for PVS group was significantly longer than that for paracentesis group (42 days vs. 18 days; p = 0.003). The rate of possible discharge was significantly higher in PVS group (p = 0.0076). Severe complications associated with mortality were observed in 1 patient in the PVS group and in 7 patients in the paracentesis group. Patients with positive and negative ascites cytology evaluation for malignant cells had a median survival of 35 days and 54 days, respectively, and there was no statistically significant difference between them (p = 0.9655).

 

Conclusions:

PVS placement decreased ascites in advanced cancer patients and improved circulating blood volume. The performance score, the median survival time, and possibility of discharge were better for the PVS group than for the paracentesis group. PVS was found to be a safe and effective treatment to improve the patient’s quality of life.