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
·
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.
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.
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
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.