Viral Hepatitis Poster Session – Monday Nov 3: 8 AM
HCV Treatment - PegIntron
1216. Impact
of Advanced Fibrosis and Cirrhosis on Sustained Virologic Response of HCV
G1-Infected Patients: Results of The Canadian
POWeR Program.
P. Marotta; C. Cooper;
D. K. Wong; J. Farley; M. Elkashab; K. M. Peltekian; N. Abadir; R. N.
Woolstencroft; R. J. Bailey
Purpose:
To evaluate the impact of advanced fibrosis/cirrhosis on
Methods:
The POWeR program was a prospective, non-interventional
observational study conducted at 138 community and academic centers in
Results:
This
Overall
Conclusions:
Advanced liver disease diminished genotype 1
HCV Treatment – General
1220.
Anti-viral therapy in haemodialyzed HCV patients: efficacy, tolerance and
treatment strategy.
P. Deltenre; D.
Thabut; A. Tran; H. Castel; M. El Nady; V. Canva; A. Louvet; H. Ben Ali; F.
Provot; F. Glowacki; S. Dharancy; F. Stanke; J. Henrion; C. Noel; P. Mathurin
Introduction:
In haemodialyzed HCV patients (HDP), viral eradication is an
attractive option because HCV has a deleterious impact on survival after renal
transplantation.
Aim:
In this prospective study of HDP treated with PegIFN and
ribavirin (
1. analyse virological response (VR);
2. evaluate tolerance and propose a
strategy for erythropoietin (EPO) use;
3. compare
Methods and study
design:
In the first part of the study, EPO was increased when HB was
<10g/dl (strategy 1). As interim analysis observed a drastic increase in EPO
need and a high rate of transfusion, a new strategy was defined: EPO was
doubled from the start of the treatment and then adapted to HB level (strategy
2). Treatment duration was 6-12 months (M) according to genotype (G).
Results:
31 HDP (21 G1/4, 10 G2/3) waiting for renal transplantation
were included. Median viral load was 350,000 IU/ml (95%CI: 146,100-2,200,000).
Fibrosis was ≤F2 in 27 HDP.
Median PegIFNα2a/α2b doses were 150 (95%CI:
135-180) and 50µg/week (95%CI: 35-50). Median
1. 31% of HDP had rapid VR (G1/4: 17%, G2/3: 62%, p=0.02),
79% early VR (G1/4: 74%, G2/3: 89%, p=0.4), and 48% sustained VR (G1/4: 40%,
G2/3: 60%, p=0.3). One HDP died from cerebral haemorrhage unrelated to
treatment as HB and platelets were within normal ranges.
2. When compared to strategy 1, HDP treated with strategy 2
had higher median EPO doses during M1 (20000 vs. 6000U/week, p=0.0001), higher
median HB levels at week 2 (12.7 vs. 11.4mg/dl, p=0.04), M1 (12.8 vs. 11.2,
p=0.01), M2 (12.2 vs. 10.0, p=0.01) and M3 (10.8 vs. 9.8, p=0.03). There was a
trend for less patients transfused with strategy 2 (18 vs. 40%, p=0.2), and for
less packed red blood cells transfused per patient and per month of treatment
(0.02 vs. 0.17 p=0.14).
3. Median
Conclusions:
50% of HDP treated with PegIFN and adapted doses of
HCV Treatment – PegIntron
1222. Impact of the use of drugs and
substitution treatments on the antiviral treatment of chronic hepatitis C
(HCV): analysis of compliance, virological response and quality of life
(Cheobs).
P. Melin; J. Lang ; D. Ouzan; M. Chousterman ; M. Varastet; M. Rotily ;
T. Fontanges ; P. Marcellin; P. Cacoub
Purpose:
Cheobs is a French, multicentric and
prospective study which aimed to analyse the factors associated with the
compliance with treatment by Peginterferon alpha-2b and Ribavirin in HCV+
patients. The present analysis focuses on the compliance with antiviral dual
therapy, the virological response and the quality of life (SF-36) during
treatment according to whether the patients were active drug users or under
substitution treatment (ADU), ex-drug users (EDU) or non drug users (NDU).
Methods:
Between 2003 and 2006, 184 clinicians included 2,001 HCV+
patients, evaluated on Day 0, then every three months (M3, M6, M9, M12) during treatment,
and 6 months after end of treatment. Among these 2,001 patients, 141 were
excluded from the analysis (prescription of an antiviral single agent therapy,
date of the end of treatment or virological response unavailable). The studied
population included 1,860 patients : 244 ADU, 578 EDU
and 1,038 NDU. Good compliance was defined by >80% of the dose and duration
of the antiviral dual therapy prescribed. The sustained virologic response was
defined by a negative
Results:
The patient profile of the EDU group was between those of the
ADU and NDU groups for mean age,
Conclusion:
The rate of sustained virologic response was similar in the
active or substitution drug users and in the ex- or non-users. Excess
consumption of alcohol, a precarious socio-economic situation, and the
psychiatric diseases observed in drug users in this study did not have a
negative impact on the studied factors. On the contrary, young age, recent
contamination, high prevalence of genotype 3, lower
HCV Treatment – PegIntron
T. Oze; N. Hiramatsu;
T. Yakushijin; M. Kurokawa; T. Igura; K. Mochizuki; K. Imanaka; A. Yamada; M.
Oshita; H. Hagiwara; E. Mita; T. Ito; Y. Inui; T. Hijioka; H. Yoshihara; E.
Hayashi; A. Inoue; Y. Imai; M. Kato; Y. Yoshida; T. Tatsumi; K. Ohkawa; S.
Kiso; T. Kanto; A. Kasahara; S. Tamura; T. Takehara; N. Hayashi
Background & Aim:
Chronic hepatitis C genotype 1
patients with late viral response (LVR) to peginterferon (Peg-IFN) alfa-2b and
ribavirin (
Patients & Methods:
This study, conducted at
Results:
Among the patients with LVR, the relapse rate with 72-week
treatment (37%, 29/78) was lower than that with 48-week treatment (66%, 57/86)
(p < 0.001). The relapse rate in aged patients ≥ 65 y.o., which was
higher than in younger patients with 48-week treatment (85%, 15/20 vs. 61%,
40/66; p = 0.06) markedly decreased with 72-week treatment (85% vs. 39%, 11/28;
p < 0.001). With extended treatment of 72 weeks, the timing of the HCV RNA
disappearance showed a strong correlation with relapse. The relapse rate was
16% (6/38) in patients with undetectable HCV RNA at week 16, 53% (10/19) at
week 20, 75% (9/12) at week 24 (p < 0.001). Analysis of the relationship of
relapse and drug exposure for patients given 72-week treatment showed the
relapse rate to be lower in those receiving ≥ 1.0 µg/kg/week of Peg-IFN
(Peg-IFN ≥ 1.0 µg/kg/week, 32%, 20/63 vs. Peg-IFN < 1.0 µg/kg/week,
60%, 9/15; p < 0.05), and also for those receiving ≥ 8 mg/kg/day of
Conclusion:
Extended treatment of Peg-IFN alfa-2b and
HCV Treatment – Pegasys
M. Waizmann; K. Wolle; F. Ackermann
Aim:
To evaluate safety and efficacy of early and directly observed therapy
with peginterferon alfa-2a and ribavirin (
Methods:
Retrospective open label study
conducted in an outpatient center. Observation and analysis
period January 2005 to May 2008.
Inclusion criteria:
·
Treatment-naďve
HCV-infected IDUs (≥ 18 years) on stable L-polamidone or buprenorphine
treatment.
Exclusion criteria:
·
HIV-coinfection,
non-adherence to substitution drug and alcohol treatment, suicidal
behaviour.
Directly Observed Therapy:
·
Patients
received directly observed therapy with peginterferon alfa-2a (40KD) 180µg/week
plus fixed-dosed
·
Treatment
duration: 48 weeks in genotype 1/4 and 24 weeks in genotype 2/3 patients. No
liver biopsies were conducted. Plasma HCV RNA was quantified by real time
Results:
·
To
date, 50 subjects were enrolled, 49 patients were dosed and 48 completed
treatment. 1 subject was excluded due to massive concomitant drug abuse prior
to start of HCV treatment.
·
33
males/16 females. Mean age 30.1 years, mean duration of injection drug use 6.4
years, HCV infection known since 3.4 years (mean).
·
HCV genotype 1 (n=20), genotype 2/3 (n=28),
genotype 4 (n=1). Median baseline HCV RNA was 132,465 IU/ml (range 1.407 –
22.146.587).
·
1
patient (genotype 1) discontinued due to non-response.
·
Overall
Conclusions:
·
Successful
treatment of HCV-infected IDUs with peginterferon alfa-2a and
·
Directly
observed therapy delivering 100% of antiviral dosages and ensuring completion
of full length of treatment (100%) resulted in
·
Once
daily observed intake of fixed-dose
HCV Treatment – PegIntron
M. Pawlowska; M.
Pilarczyk; W. Halota; E. Jendryczka
Introduction:
Treatment of chronic hepatitis C in children with recombinant
IFN alpha and ribavirin has efficacy above 50%. The aim of the study was an
assessment of the efficacy and safety of treatment of chronic hepatitis c in
children with pegylated IFN alpha and ribavirin.
Methods:
Investigations were performed in 53 children (16 girls and 37
boys) with chronic hepatitis C in the age 8 – 17 years (mean age 13,6+2,4 years). HCV genotypes were as follow: genotype1 HCV
(n=27), genotype 3 HCV (n=2) and genotype 4 (n=24).
Mean duration of HCV infection was 8,5 + 4,6 years, main
route of HCV transmission were nosocomial infections. Examined children were
divided on 2 groups (A and B). Children from group A (n=29) were naďve and they
administered combined therapy with pegylated IFN alpha-2b (PegIntron) in the
dose 1,5mcg/kg/week and ribavirin 15mg/kg/daily during 48 weeks. Patients from
group B (n=24) were treated firstly with recombinant IFN alpha-2b (Intron A)
3MU three times a week and ribavirin 15mg/kg/day during 12 months and as
retherapy they administered combined therapy with pegylated IFN alpha-2b
(PegIntron) in the dose 1,5mcg/kg/week and ribavirin 15mg/kg/daily during 12 months.
Mean baseline viral load was 0,456x10^6 IU/mL, mean
During the study serum HCV RNA in TW 12 - EVR, TW 48 -
Results:
Sustained viral response achieved in 47% of children (62 %
naďve and 33% from group of retherapy). Prevalence of relapses was 7,5%, respectively 5,6% in group A and 33% in group B.
The most important predictor of
In responders from both groups baseline
Conclusions.
1. Pegylated IFN and ribavirin are
efficient in treatment of chronic hepatitis C in children.
2. cEVR is the predictor of sustained viral
response.
3. High rate of relapses in retreated
patients may suggest longer duration of retherapy.
HCV Treatment – General
1232.
Re-infection following successful treatment for Hepatitis C virus Infection.
J. Farley; Y. Al-Khafaji
Introducation
Guidelines for treatment of chronic hepatitis C Virus (HCV)
infections in Intravenous Drug Users (IDUs) do not recommend counseling,
testing, monitoring, or follow-up beyond six months after End Of Treatment (
Method:
We reviewed the database of all patients (IDUs and non-IDUs)
treated at our clinic between August 1999 and April 2008. We assumed that
re-infection happened halfway between the date of the last negative test result
and the date of the first subsequent positive test result for HCV.
Results:
Of 180 individuals with complete data, we identified 18 IDU
patients who were reinfected after successful treatment (HCV RNA was
undetectable at least six months after completing the recommended treatment
(Sustained Virological Response (
Conclusion:
Overall, we have demonstrated that IDUs can be suscessfully
treated for HCV infections; however, reinfection may decrease the effectiveness
of such treatment programs.
We recommend that any effective treatment program for
treating HCV in IDUs must include pre treatment counseling as well as on going
follow up and testing after successfully treating the HCV infection. Harm
reduction strategies should also be continually reinforced.
HCV Treatment – Acute
Infection
C. E. Birch; A. Y. Kim;
L. L. Reyor; M. J. Bowen; E. H. Nagami; B. McGovern
Background:
Rapid virologic response (RVR) is a strong predictor of a
sustained virologic response (
Methods:
Two cohorts were examined to determine the proportion of
patients who attained RVR in the setting of acute HCV infection. Retrospective
chart reviews were conducted in community patients treated at a tertiary care
medical center. Patients who did not have HCV RNA testing at four weeks were
excluded from analysis. Four week HCV RNA levels were obtained prospectively in
a cohort of incarcerated patients undergoing treatment for acute HCV infection
in state correctional facilities in
Results:
Twenty-six patients were analyzed, including 15 men and 11
women; mean age is 32 years (IQR 24-36). Twenty-one were white, two were
Hispanic, and three were other. Risk factors included injection drug use
(n=21), sexual transmission (n=2), needle stick injury (n=1), and unknown
(n=1). Genotype distribution was as follows: genotype one (n=16), genotype 2
(n=3), genotype 3 (n=4), genotype 4 (n=2), and unknown genotype (n=1). RVR was
achieved in 25 of 26 patients.
Conclusions:
In contrast to chronic disease, the proportions of patients
who achieve RVR are much higher in the setting of acute HCV infection. Although
many of these patients underwent therapy outside the 12-16 week window period
traditionally used to treat patients with acute HCV infection, the high rates
of RVR suggest that a sustained virologic response may still be achieved,
regardless of genotype.
HCV Treatment – Pegasys
S. Bruno; S. J.
Hadziyannis; M. L. Shiffman; D. Messinger; P. Marcellin
Background:
It has been previously shown that among patients infected
with genotype 2 or 3 HCV treated with pegIFN alfa-2a 180µg/wk plus ribavirin (
Methods:
G2/3 patients with advanced fibrosis/cirrhosis included in
this analysis were those assigned to 16 or 24wks of treatment with pegIFN
alfa-2a 180μg/wk plus
Results:
Data were available for 380 patients with advanced fibrosis/cirrhosis
(G2 16wks=107; G2 24wks=99; G3 16wks=84; G3 24wks=90). Among patients treated
for 16wks of therapy,
Conclusions:
Among patients with advanced fibrosis/cirrhosis treated with
pegIFN alfa-2a plus ribavirin, those infected with G2 HCV had higher rates of
RVR and
|
Response at wk 4/12 |
G2 |
G3 |
|
RVR, n (%) |
132 (64.1) |
88 (50.6) |
HCV treatment – General
T. Goto; H. Yoshida; R.
Tateishi; K. Enooku; E. Goto; H. Yoshida; T. Sato; T. Ohki; R. Masuzaki; J.
Imamura; N. Yamashiki; F. Kanai; K. Hamamura; S. Shiina; T. Kawabe; M. Omata
Aim:
Because of very frequent recurrence of hepatocellular
carcinoma (
Method:
From January 1992 through September 2006, a total of 1344
HCV-related
Result:
The
·
88%
interferon treated group vs. 60% untreated group
Conclusion:
·
The
·
Among
70 naive
HCV Treatment – General
L. N. Cavalcante; K.
Abe-Sandes; A. D. Angelo; D. C. Lemaire; L. S. Souza; E. S. Azevedo; J. d. Carvalho;
T. M. Machado; P. S. Brandăo; N. P. Santana; L. G. Lyra; A. C. Lyra
Several studies have suggested that ethnical background
influences antiviral therapy response to chronic hepatitis C (
Aims:
To evaluate the influence of ancestry determined by genetic
polymorphisms analysis and by phenotype classification in antiviral therapy
response of subjects with
Methods:
This is a case-control study. We evaluated HCV mono-infected
patients who had been treated with combination of interferon and/or
peg-interferon and ribavirin and divided them into two groups: A–patients who
were non-responders/relapsers; and B–patients with
Results:
So far, 169 subjects who attended the outpatient clinic
between February 2007 and April 2008 were consecutively included; 106 subjects
were non-responders/relapsers; (78% were infected by HCV genotype 1; 3 of them
were not classified according to phenotype), 63 had achieved
Conclusions:
Whites and non-white patients with
HCV Treatment – Pegasys
M. L. Shiffman; F. M.
Hamzeh; R. T. Chung
Aim
This retrospective analysis assessed the breakthrough and
relapse rates based on the time to HCV-RNA negativity in patients with HCV
genotype 1.
Methods
Patients from 4 clinical trials, 2 of which were enriched
with difficult to treat patients, who were infected with HCV genotype 1 were
treated for 48 wks with pegIFNα-2a 180 µg/wk and ribavirin 1000/1200 mg/d.
Patients were grouped according to the time at which HCV-RNA negativity was
first achieved: Wks 4 (RVR), 12 (cEVR), 24 (negative at Wks 13–24), 48 (negative
at Wks 25–48), and 72 (
Results
Of 1243 patients analyzed, 67% were non-Latino whites, 23%
were Latino whites, and 9% were African Americans. At baseline, 67% of patients
were men, 71% were aged >40 yrs, 63% weighed >75 kg, 51% had a
Conclusion
Longer time to HCV-RNA negativity and lower ribavirin
exposure tended to be associated with higher breakthrough and relapse rates which resulted in lower
|
|
|
Breakthrough % |
|
Relapse % |
|
|
||
|
Response group |
N |
TP |
TR |
|
TP |
TR |
Dropout %† |
|
|
RVR |
195 |
5 |
6 |
81 |
2 |
2 |
18 |
75 |
|
cEVR |
505 |
7 |
7 |
81 |
18 |
23 |
12 |
63 |
|
24-wk neg |
194 |
12 |
13 |
84 |
45 |
58 |
10 |
33 |
|
48-wk neg |
39 |
- |
- |
100 |
72 |
76 |
5 |
23 |
|
Total |
933 |
7 |
8 |
82 |
22 |
29 |
13 |
58 |
*End
of treatment response †While responding
HCV Treatment – Predictors of Treatment
Response
1249. Effect
of obesity on interferon stimulated genes expression in chronic HCV
infection.
V. Aggarwal; C. S.
Palmer; A. R. Lloyd; A. Zekry
Introduction:
Obese subjects with chronic HCV infection respond poorly to
antiviral therapy with pegylated interferon and ribavirin. We utilized paired
PBMCS prospectively collected at baseline and 12 weeks post commencing
antiviral therapy, to compare interferon stimulated genes (ISGs) expression and
signaling in obese and lean subjects with chronic HCV genotype 1 infection. We
correlated the ISGs in each group with the response to treatment at 12 weeks of
therapy (HCV
Methods:
RT2-
Results:
PBMCS from 12 subjects; 6 obese (
Conclusions:
Obese subjects with chronic HCV genotype 1 infection
displayed increased expression of several ISGs in response to antiviral
therapy. However, the magnitude of ISGs induction in obese subjects was
significantly less robust to that observed in lean subjects. In parallel, the
expression of negative regulators of interferon signaling including SOCS1,
HCV Treatment – Pegasys
1251. Very
Low Viral Load (VLVL) Relapse after Treatment for HCV: A unique group
with High Sustained Virologic Response (
J. C. Hoefs; V. S.
Aulakh
Introduction:
A sustained virological response (
Methods:
Five patients with VLVL relapse (RNA < 5000 IU/ml at 3
months post treatment) were compared to 30 relapse patients whose RNA levels
returned to baseline post treatment. Serial blood tests, quantitative liver
spleen scan (QLSS) and liver biopsies (LBx) were reviewed.
Results:
Five patients with VLVL relapse were all genotype 1 (compared
to 12/21 of the other relapse patients),
had > 12 months of initial therapy, had a spike of high RNA level in blood
within 3 months of end-of-treatment (
·
3
patients 180 ug week pegylated interferon/ plus 800 mg/day ribavirin
·
2
patients 90 ug weekly pegylated interferon alpha 2a plus 600-800 mg/day
ribavirin
Conclusion:
Patients with VLVL relapse after HCV treatment:
·
Were
unique: cirrhosis, low baseline HCV RNA,
genotype 1
·
Very
responsive to low dose, short treatment with 100%
·
Tolerant
of retreatment despite high incidence of cirrhosis.
HCV Treatment – General
1252.
Determinants of HCV Antiviral Treatment in a Managed Care Setting.
M. Manos; V. Shvachko;
W. Zhao; R. C. Murphy
Introduction:
Little is known about how hepatitis C patients are selected
for antiviral treatment in community settings. Among HCV patients in a
comprehensive managed care program, we identified the predictors of having
received treatment.
Methods:
We studied adult HCV patients in the Northern California
Kaiser Permanente Medical Care Program in December 2007 who had race/ethnicity
data available (82%). Electronic records were extracted for years 1995-2007.
For medical history we assessed the period prior to therapy in treated
patients, and “ever” in the untreated.
Results:
Of 15,979 HCV patients included, mean age (in 2007) was 54
yr; 59% were male; 61% were white non-Hispanic, 16% Hispanic, 14% black and 9%
Asian/PI; HIV co-infection 2.4%; chronic HBV 1.7%. Based on pharmacy records
since 1995, a total of 3,494 (22%) were dispensed at least one HCV treatment
(an interferon and/or ribavirin).
HCV genotype was available for 50% overall, and 88% of
treated cases. Of patients ever treated, 32% had genotype 2 or 3, and 56% had
type 1 or another type. Percent of HCV patients ever
treated varied significantly among the 15 medical centers (12 - 31%). HIV
status, or diagnoses of active alcohol/drug use, was not predictive of
treatment.
The table shows, for significant factors, crude and adjusted
(logistic regression) odds ratios for ever receiving treatment. When limited to patients with genotype, the model gave similar
results; and the adjusted OR for genotypes 2/3 vs. 1/other was 1.77 (1.60 -
1.97). When Blacks and Hispanics were each assessed separately,
residence in a high poverty area was no longer significant; and genotype
remained predictive.
Conclusion:
In this comprehensively insured population, Blacks and
Hispanics were less likely than other groups to have been treated, after
adjustment for multiple confounding variables. This may reflect the anticipated
lower response rates in these patients. Factors predictive of treatment
included abnormal
Correlates of Being Treated for HCV
|
|
Crude OR |
(95% CI) |
Adj OR^ |
(95% CI) |
|
Women |
0.86 |
(0.80-0.93) |
1.14 |
(1.05-1.24) |
|
Age 60+ |
0.69 |
(0.63-0.76) |
0.63 |
(0.57-0.69) |
|
Asian/PI* |
1.09 |
(0.96-1.24) |
1.03 |
(0.90-1.19) |
|
Black* |
0.49 |
(0.43-0.55) |
0.58 |
(0.50-0.67) |
|
Hispanic* |
0.95 |
(0.86-1.06) |
0.82 |
(0.73-0.92) |
|
Poor area** |
0.60 |
(0.52-0.71) |
0.78 |
(0.66-0.92) |
|
|
3.26 |
(2.99-3.56) |
3.23 |
(2.95-3.54) |
|
Cirrhosis |
2.05 |
(1.84-2.28) |
1.62 |
(1.45-1.82) |
|
Depression hx |
0.65 |
(0.60-0.71) |
0.62 |
(0.56-0.67) |
^Adjusted for all
factors listed, plus medical facility; *versus non-Hispanic white; **resides in
high poverty area
HCV Treatment – General
1253. Assessment
of serum HCV RNA at week 12 post-treatment is as relevant as week 24 to predict
M. Martinot-Peignoux;
M. Ripault; S. Maylin; L. Leclere; N. Boyer; P. Marcellin
Introduction.
Sustained Virologic response (
Aim.
The aim of our study was to evaluate if 12 weeks
post-treatment serum HCV RNA assessment could be as relevant as 24 weeks to
identify patients with
Methods:
137 patients, consecutively treated with standard of care
regimens of
Results.
At the end of the 24 weeks-post treatment follow-up 108/139
(78%) of the patients demonstrated a
Conclusions.
Our results show that the assessment of serum HCV RNA at week
12 post-treatment follow-up (PPV 100%) is as effective as week 24 to predict
HCV Treatment – Pegasys
1256. Higher
Response Rate from Peginterferon Alpha 2a Plus Ribavirin in
Chronic Hepatitis C Patients with Hemophilia.
H. Sul; H. Kim; S.
Chung; Y. Lee; S. Park; H. Lee; K. Yoo;
Background and Aims:
Chronic hepatitis C (
Methods:
90
Results:
Characteristics of the 90 patient included in this study are
shown in the table 1. 6 patients (2%) were withdrawn from treatment. In 89
patients who treated more than 4 weeks, RVR was achieved in 51 patients (57%,
G1=35%, G2/3=94%). In 86 patients who treated more than 12 weeks, EVR was
achieved in 81 patients (94%, G1=93%, G2/3=97%). In 48 patients who completed
the treatment schedule,
Conclusion:
PegIFN alpha-2a and ribavirin treatment showed higher
response rate in
HCV Treatment – IDUs
S. Manolakopoulos; O. Anagnostou;
M. Deutsch; E. Tiniakou; G. V. Papatheodoridis; E. K. Manesis; D.
Tzourmakliotis; A. J. Archimandritis
Introduction:
Intravenous drug use (IVDU) is the main transmission route of
hepatitis C virus. NIH expert panel states that IVDUs should not be excluded
from treatment, however, active IVDUs are difficult to
treat and are often denied treatment for hepatitis C due to concerns about
adherence.
Aim:
The present study evaluates HCV treatment adherence and
response rates among active and past IVDUs with or without methadone
maintenance and the possible factors that may influence their outcome.
Patients and methods:
We have retrospectively studied 146 IVDUs (37% on methadone
maintenance therapy, 12% with active substance use and 51% with a history of
substance abuse who had disrupted > 1 year) with chronic HCV infection who had started treatment (interferon or Peginterferon
α-2α or 2b with or without ribavirin) between 2000 and 2007. Data
base included: gender, age, history of alcohol abuse (>50g/day), smoking
habits, duration of drug use, histology when available, HCV genotype, baseline
serum HCV RNA, data about patients follow up, treatment adherence, and
treatment outcome. The end points of the analysis included treatment adherence
and treatment outcome.
Results:
Among the 146 patients, 108 were males and 38 females with a
mean age of 40.5 years SD + 8 (range 20-60). The mean duration of IVDU was
9+7.3 years, 65% of the patients reported >50g/day alcohol consumption and
93% were smokers. The mean baseline HCV RNA was 1.9x106, 36,4%
had genotype 1-4 and 11,5% advanced fibrosis.
Overall, 110 patients (75, 4%) were adherent to anti-HCV
therapy. Adherence was independent of treatment duration and was not
significantly different between the patients with active use, methadone
substitution or past use. 36/146 patients (24,6%)
discontinued treatment prematurely, after a mean of 3±2 months (17% due to side
effects and 14% by their own decision)
Among the 81 patients who fulfilled treatment schedule
overall
Conclusion:
·
Our
data clearly show that in active or past IVDUs with chronic hepatitis C
adherence is significantly associated with
·
·
Therefore
our results reinforces recent recommendations and
support that IVDUs with HCV infection should not be excluded from antiviral
treatment.
HCV Treatment – Predictors of Treatment
Response
1259.
Steatosis, Insulin resistance, Iron overload, Fibrosis and Viral load as negative
factors affecting Early (EVR) and Sustained (
E. F. Georgescu; R.
Ionescu; G. Florescu; G. Mateescu; L. Vancica
Introduction:
Since the relation between hepatitis C virus infection,
insulin resistance and iron overload is not fully understood in genotype 1
HCV-infected patients, our aim was to evaluate the impact of several
biochemical (serum ferritin, uric acid, HOMA-IR), histological (fibrosis,
necroinflammation, steatosis, and hepatic iron scores) and viral factors (HCV
viraemia) on both EVR and
Patients and Methods:
We evaluated retrospectively 188 naďve
Results:
EVR was achieved in 115/188 pts (61.17%) while
Conclusion:
Fibrosis, steatosis and iron scores, as well as viral load
are independent parameters that can affect both EVR and
HCV Treatment – Predictors of Treatment
Response
1260.
Monitoring virologic on treatment response to predict treatment outcome in
patients with chronic hepatitis C treated with pegylated interferon plus
ribavirin: realtime
M. Martinot-Peignoux;
S. Maylin; H. Khiri; L. Leclere; M. Ripault; P. Marcellin; P. Halfon
Introduction:
It well established that measurements of baseline HCV RNA and
early virologic response are the key parameters for tailoring treatment outcome
in patients with chronic hepatitis C. Different assays have been developed for
the quantification of HCV RNA in routine clinical practice.
Aim:
Our aim was to compare the clinical performance of 3
commercially available assays to evaluate the positive predictive value (PPV)
and the negative predictive value (NPV) of baseline viral load (BVL), rapid
virologic response at week 4 (RVR) and early virologic response at week 12
(EVR).
Methods:
283 patients consecutively treated with standard of care
regimens of pegylated interferon alpha 2b + ribavirin were studied (155 naďves;
128 non-naives). Serum HCV RNA was measured at baseline, week 4, week 12, end
of treatment and 6 months after the end of treatment
Low BVL was < 400 000 IU/ml (PPV), RVR was defined as
undetectable serum HCV RNA or ≥2 log drop decline of BVL at week 4 (PPV)
and non-EVR was defined as detectable serum HCV RNA or log drop < 2 log decline
of BLV at week 12 (NPV) of therapy.
Results.
Overall
Conclusions.
1.
Monitoring
of therapy should include both, detection of serum HCV RNA at week 4 to predict
2.
Both
3 assays show the same performance to evaluate RVR or non-EVR. However, assays
show viral load discrepancy according to HCV genotype, it is therefore
important to consistently use the same HCV RNA assay throughout treatment
patient follow-up.
|
|
PPV |
PPV |
PPV |
NPV |
NPV |
|
|
Baseline |
Week 4 |
week 4 |
Week 12 |
Week 12 |
|
Viral Load |
<5.602 log UI/ml |
Undetectable |
≥ 2log drop |
Detectable |
<2log drop |
|
bDNA/ |
59% |
97% |
68% |
85% |
93% |
|
|
57% |
91% |
70% |
92% |
84% |
|
|
55% |
94% |
70% |
81% |
74% |
HCV Treatment – General
1261. The
Impact Of A Multi-Disciplinary Support Program On
Adherence And The Efficacy Of Hepatitis C Treatment.
M. Garcia-Retortillo;
I. Cirera; M. Giménez; C. Marquez; J. Galeras; P. Castellví; R. Navinés; E.
Clot; E. Salas; F. Bory; R. Martín-Santos; R. Solŕ
Introduction:
Adherence to antiviral treatment has been cited as a
potentially important factor in determining the outcome of therapy in hepatitis
C patients.
Aim:
To evaluate the impact of a
multi-disciplinary support program (MSP) on the fulfilment and efficacy of
hepatitis C treatment.
Methods:
We included 278 hepatitis C naive patients treated
consecutively from June 2001 to June 2006. All patients were treated with
Peg-IFN alfa-2a 180 µg/week and ribavirin (
Results:
No differences were observed between groups in terms of age,
gender, HCV-genotype, viral load and fibrosis degree. Anti-depressives or
anxiolytics were prescribed in 45 (34.3%) and 34 (23.1%) patients in each
group, respectively (P 0.04). Haemoglobin levels decreased during treatment in
17.6 and 22.4% in both groups (P: NS) even though erythropoietin was used only
in 5.3 and 4.1%, respectively.
Conclusions:
The multi-disciplinary attention program improved the
adherence to treatment and increased its effectiveness, particularly among
genotype 1 patients.
|
|
Group 1 |
Group 2 |
|
Adherence (%) |
94.6 |
78.9 |
|
Withdrawal/drop-out (%) |
4.4 |
6.2 |
|
Drug dosages <80% (%) |
0 |
13.4 |
|
Peg-IFN dosage 100% (%) |
94.6 |
76.2 |
|
|
90.8 |
68.7 |
|
Sustained virological response (%) |
77.1 |
61.9 |
|
Genotype 1 |
66.7 |
48.1 |
|
Genotype 2/3 |
87.7 |
81.4 |
HCV Treatment – Side Effects
1263.
Prospective Analysis of Depression During Antiviral
Treatment for Hepatitis C: Results of the VIRAHEP-C Study.
D. M. Evon; D.
Ramcharran; S. H. Belle; N. Terrault; R. J. Fontana; M. W. Fried
Background:
Peginterferon and ribavirin therapy for chronic hepatitis C
is commonly associated with depressive symptoms, which may affect quality of
life and the outcome of treatment.
Aims:
To assess the frequency and factors associated with depression
occurring before and arising during treatment, and examine the relationship
between depression and sustained virological response (
Methods:
Prospectively collected data from the VIRAHEP-C study were
analyzed. 196 African Americans and 205 Caucasian Americans with chronic
hepatitis C were treated with peginterferon and ribavirin for up to 48 weeks.
In this analysis, depression was defined as a score of >23 on the Center for
Epidemiologic Studies Depression (CES-D) scale, collected before treatment and
at weeks 4,12,and 24. Study personnel were blinded to
CES-D scores, which were not part of the overall depression detection and
management guidelines for the study. Other markers of depression analyzed
included antidepressant use, psychiatric adverse events, a single item of
depression on a visual analog scale, and two depression detection questions
which assessed “feeling depressed, sad, or blue” and “feeling helpless about
the future”. Results: Before treatment, 47 (12%) participants endorsed CES-D
scores >23, which was associated with 10 factors, including younger age,
female sex, poor social support, use of antidepressants, and endorsement of
other markers of depression. Compared to those with CES-D scores <23, these
47 participants had higher rates of treatment discontinuation (13% vs 38%,
respectively, p<0.0001), psychiatric adverse events (17% vs 30%, p=0.04),
and new antidepressant medication use after starting antiviral therapy (27% vs
58%, p=0.0003); however, there were no differences in
Conclusions:
Participants with pre-existing depression, as measured by
CES-D, were at greater risk for psychiatric adverse events, need for
antidepressants, and treatment discontinuation, although
HIV/HCV Coinfection
1265.
Treatment Rates of Hepatitis C Virus (HCV) Infection Among Patients Co-Infected
With HIV Over The Past Decade In An Urban
P. Suwandhi; K. Gopal;
P. Benias; C. Wong; D. Meyer; H. C. Bodenheimer; A. D. Min
Introduction:
HIV related mortality in HCV/HIV co-infected patients had
decreased with advent of antiretroviral therapy (
Aim:
The aim of this study was to investigate HCV treatment rates
in HCV/ HIV co-infected patients and treatment barriers at our center.
Methods:
We reviewed charts of all HCV/HIV co-infected patients
referred for HCV treatment from 1998-2007.
Results:
There were 326 HCV/HIV co-infected patients with majority
male (227;70%). 196 (60%) had HCV genotype 1. Mean CD4
count was 458 cells/mm3 (range 4-1532). HIV viral load
was undetectable in 157(48%) patients with 266(82%) patients on
Conclusions:
·
Number
of co-infected patients referred for HCV treatment has plateaued over the past
several years.
·
Only
a minority of HCV/HIV co-infected patients were deemed eligible for and
received HCV treatment over the past decade.
Thirty percent of the patients were deemed ineligible for
treatment and 10% discontinued treatment due to patient control factors.
Development of patient focused educational program may impact these factors and
increase treatment rates and compliance.
HCV Treatment – General
E. Collin; S. Fratté;
A. Baudu; M. Thévenot; T. Thévenot; E. Monnet; V. Di Martino
Introduction:
Poor tolerance to anti-HCV therapies may lead to decreased
compliance, more frequent dose reductions of and/or treatment discontinuations,
then reducing the
Since 2003, a education program (EP)
dedicated to patients undergoing anti-HCV therapy was implemented in two
centers, involving three trained nurses. An educational program has been systematically proposed to
the patients on starting treatment.
Aim:
The aim of this study was to evaluate the impact of an educational
program on
Methods:
From March 2003 to October 2006, we collected data from all
patients undergoing antiviral therapy for chronic hepatitis C. The impact of an
educational program on
Results:
258 patients (149 males; 48yrs) were included. 19 (7.4%) were
HIV positive, 128 (58.4%) had high viral load, 84 (32.6%) were infected by
HCV-genotype 2 or 3, 66 (29.7%) had F3/F4 fibrosis. As compared with patients
not receiving an educational program , the 97 patients
(37.6%) who received an educational program
were similars regarding genotype, histology, or HIV status.
Conclusion:
1.
After
adjustment on well-known non response factors, an educational program
substancially improves
2.
This result was not explained by a decrease in
prescribed treatment discontinuation or doses reductions. It may be the
consequence of a better adherence to anti-HCV therapies, suggesting that
standard medical follow-up is associated with more frequent lack of compliance.
Liver Transplantation – HCV Treatment
C. Ortiz; F. Lopez-Labrador;
R. Canada; B. Risalde; V. Aguilera; M. Prieto; M. Berenguer
Introduction:
Antiviral therapy post-liver transplantation (LT) has a
limited efficacy. There is an interest in determining factors associated with
sustained virologic response (
Aim:
To assess whether the kinetics of viral response in LT
recipients treated with pegIFN-ribavirin differ depending on the baseline
immunosuppression (tacrolimus-Tac- vs cyclosporine-CsA-) and type of IFN
(pegintron vs pegasys).
Methods:
Ongoing prospective randomized study of LT patients
randomized to pegintron vs pegasys in combination with ribavirin started in
2006. A detailed kinetic study was performed in 16 LT patients (Tac-pegasys,
n=4, Tac-pegintron, n=4; CsA-pegasys, n=4; CsA-pegintron, n=4) and 4
immunecompetent patients (2 Pegintron and 2 Pegasys).
Results:
Of 65 patients randomized during 2006-2007, complete
follow-up (6 months post-treatment) is available in 25 patients (pegasys, n=13;
pegintron, n=12). There were 21 men, with a median age of 58 years (range:
39-69). Baseline immunosuppression consisted of Tac in
17, cyclosporine in 8. The overall
Conclusions:
In recurrent hepatitis C, there are no differences in early
viral kinetics between pegIFN alfa-2a and 2b regardless of baseline
immunosuppression (Tac vs CsA).
HIV/HCV Coinfection
1269.
Antiretrovirals reduce Ribavirin exposure in HIV-HCV coinfected patients.
J. Quioc; V. Jullien;
V. Mallet; B. Nalpas; S. Pol
Introduction and Aim:
Response rates under treatment with Peg-interferon and
ribavirin are lower in HIV-HCV-co-infected than in HCV-mono-infected patients.
A lower exposition to
Patients and Methods:
Serum
Results:
Among baseline characteristics, medians of age (41 vs. 48
years, P=0.001) and of body mass index (22.6 vs. 24.7, P=0.04) were lower in
co-infected patients. Median CD4 count was 430/mm3 in HIV-infected patients and
five of them did not receive any antiretrovirals (ARV).
There was no difference in
There was no association between serum
Median
Conclusion:
Despite a comparable intake of
HCV Treatment – Predictors of Treatment
Response
R. Moucari; M.
Ripault; M. Martinot-Peignoux; H. Voitot; S. Maylin; A. Cardoso; T. Asselah; N.
Boyer; M. Vidaud; D. Valla; P. Bedossa; P. Marcellin
Background & Aim:
Insulin-Resistance (IR) has been previously shown to impair
sustained virological response (
The aim of this study was to assess the independent impact of
IR after adjustment to major predictors of
Patients and Methods:
167 consecutive non-diabetic treatment-naďve
Results:
Baseline characteristics were: male gender (66%), mean age
(46±9 years), mean
By univariate analysis,
By logistic regression,
Conclusion:
1.
Insulin-Resistance
is a major negative predictor of
2.
Impact
of IR is independent of HCV genotype and liver fibrosis stage.
HCV Treatment – General
1271. Insulin
Resistant Chronic Hepatitis C (
W. Soliman; M.
Kuczynski; N. Perez-Gutierrez;
Introduction & Aim:
Methods:
Hepatic IR was determined using the homeostatic model
assessment (HOMA). Those with a HOMA ≥ 2.1 i.e., hepatic IR pretreatment
were initiated on peg IFNα 2a 180 mcg/wk plus ribavirin (weight based).
Serum glucose and insulin, HOMA, ISI and disposition index (measure of
pancreatic insulin secretion) were assessed at baseline, 12 weeks into therapy
and 6 months post-therapy by performing the oral glucose tolerance test. Serum
adiponectin and lipid profile were measured at baseline and 6 months
post-therapy.
Results:
In patients with non-cirrhotic
Conclusion:
HCV Treatment – Predictors of Treatment
Response
1273. Asian
Ethnicity is a Significant Predictor of Sustained Virologic Response (
P. Vutien; N. H. Nguyen; R. T. Garcia; H. N. Trinh; L.
H. Nguyen; E. B. Keeffe; G. Garcia; K. K. Nguyen; H. A. Nguyen; B. S. Levitt;
M. H. Nguyen
Introduction:
Chronic hepatitis C (
Methods:
We performed a cohort study of 219 consecutive patients
(AA=136, NA=83) with treatment-naďve
Results:
There were no statistically significant differences in age,
sex, and baseline
Conclusions:
Asian ethnicity is a significant predictor of
Diagnostic Tools – Biopsy – General
D. J. Weinerman; R. Chadalavada; K. D. Mullen
Aim:
Hepatitis C is the most common cause of cirrhosis and is the
foremost reason for liver transplantation in the
Methods:
An online survey was created and emailed to 2,203 members of
a national liver association, of whom 85% are physicians (N=1,865).
Results:
A total of 421 completed surveys were received, 89% from
physicians (N=375): 73% academic or university affiliated and 27% private
practitioners. The most common situations for performing a biopsy always or
most often were concern for other causes of liver disease (90%), genotype 1
(85%), concern for advanced liver disease (67%), African American race (66%),
history of significant alcohol abuse (65%), a high viral load (over 850,000)
(58%), and a normal
Conclusion:
There is currently a variety of opinions regarding the role
of LB in patients with HCV. This study supports LB in patients with genotype 1
or when there is concern for other causes of liver disease. When the imaging
meets criteria for cirrhosis or after successful treatment of HCV, LB may be
rarely indicated. It is possible that recent advances in HCV treatment and new
modalities for assessing fibrosis may affect decisions pertaining to liver
biopsies. This study shows the current range of perspectives among practicing
hepatologists across the nation and may be helpful in the formulation of future
guidelines.
Frequency of Liver Biopsy prior to treatment in HCV (%)
|
|
Never |
Rarely |
Some- |
Most |
Always |
|
Genotype 1 |
0 |
2 |
13 |
45 |
41 |
|
Genotype 3 |
3 |
28 |
38 |
19 |
12 |
|
Normal |
2 |
10 |
37 |
30 |
21 |
|
Imaging |
18 |
40 |
22 |
12 |
8 |
HCV Treatment – PegIntron
M. Kurokawa; N.
Hiramatsu; T. Takehara; T. Oze; T. Yakushijin; T. Igura; K. Mochizuki; K.
Imanaka; M. Oshita; H. Hagiwara; E. Mita; T. Hijioka; Y. Inui; K. Katayama; H.
Yoshihara; Y. Imai; M. Kato; S. Kiso; T. Kanto; A. Kasahara; N. Hayashi
Background & Aim:
IFN therapy is effective in reducing hepatocarcinogenesis and
in improving survival rate of patients infected with hepatitis C virus (HCV).
The combination therapy using IFN alfa-2b plus ribavirin is a more effective
treatment to eradicate HCV than IFN monotherapy. However, it has not been
accurately evaluated whether the combination therapy could reduce
Patients & Methods:
This study was conducted at
Results:
One hundred thirtynine patients (34%) of all achieved a
sustained virological response (
Conclusions:
·
The
attainment of
·
Old
age, severe fibrosis and non-
HCV Treatment – Side Effects
1284. Central
Hypothyroidism in patients with chronic hepatitis C.
D. E. Zantut-Wittmann ; M. P. Pavan; E. J. Pavin; F. L. Gonçales Junior
Introduction:
Thyroid dysfunction is described during the treatment of
virus C chronic hepatitis (HCV) with Interferon (IFN). Some authors referred panhypopituitarism
or central hypothyroidism during this therapy.
Objective:
The objective was to relate the prevalence of central
hypothyroidism in HCV patients before and after IFN therapy.
Methods:
We evaluated the thyroid function of 328 HCV patients,
followed from 2001 to 2007 in a Brazilian reference center to HCV and treated
with standard IFN (IFN) and/or pegylated-interferon (
Results:
Among the 308 patients evaluated, with mean of age of 43.9
years, 72.7% were men; 87.0% were Caucasoid. Eighteen patients (5.8%) presented
central hypothyroidism (11 men; 7 women) before-treatment. During the treatment
12 patients maintained laboratorial changes, 3 became
euthyroid (2 women; 1 man) and 3 women developed primary hypothyroidism. During
treatment, 17 new patients (12 men; 5 women) developed central hypothyroidism.
Of the 29 patients (9.4%) (22 men, 7 women) with central hypothyroidism, 11
used IFN; 6
Conclusion:
In conclusion, this preliminary study suggests that the HCV
patients may develop central hypothyroidism due the viral infection, because in
some cases the diagnosis was made before treatment. In accordance to the
literature, the treatment with interferon triggered central hypothyroidism.
Additionally, in this study, these patients presented 3.83 times more chance to
not obtain sustained viral response. Panhypopituitarism must be investigated
for the proper hormone replacement.
HCV treatment – IDUs
G. Anne; G. Laurent;
B. Vincent; A. Jean-Pierre; B. Celine; J. Jacques
Background:
Since 2002 in
Methods:
The medical files of 176 consecutive patients, who consulted
for hepatitis C between September 2006 and March 2007, were retrospectively
assessed. Baseline information on demographic patterns, sources of infection,
biological, virological and histological parameters were collected. Type of
treatment, outcomes, tolerance and compliance were analyzed.
Results:
Among the 176 patients, 85 were infected through drug-injecting
materials (IDU group) and 91 through other sources (non-IDU). The groups were
comparable in terms of demography, but 64/85 patients in IDU group were
co-infected with HIV versus 31/91 in non-IDU group. Mean serum HCV RNA was at
6.2 log UI/ml in IDU group versus 5.8 log UI/ml in
non-IDU group. In IDU group, HCV was genotype 1 in 53% (45 pts) patients,
genotype 2 or 3 in 27% (23 pts), genotype 4 in 6% (5 pts), not known in 14% (12
pts). In non-IDU group, HCV was genotype 1 in 52% (47 pts), genotype 2 or 3 in
10% (9 pts), genotype 4 in 31% (28 pts), not kwon in 6% (7 pts), one patient
was infected by HCV genotype 5 in the non-IDU group. In IDU group 37/85 (43%)
had a severe liver disease (metavir score F3 or F4) versus 31/91 (34%) in non
IDU group. 28 IDU patients were medically managed by joint hepatology–addiction
follow-up (IDU-J), 22 required treatment, 21 accepted it. IDU-J and non-IDU had
similar treatment response with, respectively, 53% and 52% end of treatment
response and 45% and 38% sustained virological response. In contrast, among 57
IDU patients not benefiting from joint follow-up for their hepatitis C
(IDU–non-J), 43 required anti-HCV treatment, 34
accepted it. Outcome was poorer : 20% of sustained
virological response. IDU-non-J were more likely not
to complete treatment and not to have adherence to treatment.
Discussion:
·
Despite
poorer predicting factors of virological response in IDU patients than non-IDU
(HIV infection and severe liver disease), IDU-J but not IDU-non-J had similar
adherence to treatment and virological response.
·
This
result suggests that hepatology-addiction joint follow up could improve access
and success of anti-HCV treatment.
HCV Treatment – General
O. T. Tsang; J. Zee;
J. Chan; R. S. Li; J. Lai; T. S. Lai
Introduction:
The predominant genotypes for HCV infected persons in
Methods:
All patients with chronic hepatitis C genotype 1 and 6
treated with subcutaneously pegylated interferon (IFN) injection (Pegylated IFN
alpha-2a at dose 180 µg or pegylated IFN alpha-2b at 1.5 µg per Kg body weight
weekly) and oral Ribavirin at dose 800-1200mg daily for 48 weeks at the
Infectious Diseases clinic in the Princess Margaret Hospital in Hong Kong is
conducted. Inclusion criteria include Antibody to HCV with detectable serum HCV
RNA, HCV genotypes 1 or 6, and persistently elevated
Assessment of efficacy:
HCV genotypes were determined prior to treatment and HCV
quantitation tests were checked prior to, at 12 weeks into treatment, end of 48
weeks treatment and 24 weeks after completion of treatment. The end of
treatment response (
Results:
A total of 65 patients were included with 36 male and 29 female.
Their mean age was 52 with range from 26 to 69. HCV infection was acquired by
blood transfusion in 76.5%. There were 44 patients having genotype 1 and 24
patients with genotype 6. The mean alanine transaminase levels were 136.7 U/L
and 120U/L for genotype 1 & 6 respectively. The mean initial HCV RNA levels
were 1819193 & 936200 IU/ml for genotypes 1 & 6 respectively. By
intention-to-treat analysis, the EVR for genotype 1 and 6 were 58.5% & 79.2% (p =
0.09) and the
Conclusion:
In
HIV/HCV Coinfection
A. Osinusi; J. J. Rasimas; R. Bishop; M.
McLaughlin; M. A. Polis; H. Masur; S. Kottilil
Introduction:
HIV/HCV coinfected patients have higher rates of substance
abuse, psychiatric disorders, HAART toxicities
including anaemia at baseline than HCV monoinfected patients, rendering these
patients at higher risk of interferon [IFN] related side effects. We evaluated
the relationship between IFN related side effects and HCV virologic response in
HIV/HCV coinfected individuals on therapy.
Methods:
55 HIV/HCV coinfected patients treated for 48 weeks with peg
IFN α-2b or peg IFN α-2a in combination with ribavirin were
prospectively studied. HCV RNA [Bayer bDNA v.3], safety labs and immune
profiles were measured frequently. Psychiatric and ophthalmologic evaluations
[visual acuity and fields, color vision and indirect opthalmoscopy] were
performed at baseline and at regular intervals. Psychiatric toxicities were
defined as emergent or worsening psychiatric symptoms from baseline
incorporating DSM-IV criteria, BDI scores and medication changes. The t-test
was used for comparisons between groups while a mixed model analysis was used
to evaluate the relationship between HCV viral load decline and CD4 counts.
Results:
HCV responders were more likely to have IFN related
psychiatric toxicities than non-responders, 63% vs. 7.7%, (p-value =0.009). The
Table shows relationships for other parameters. A mixed model analysis produced
a highly significant positive slope for the relationship between HCV viral load
decline and changes in CD4 counts (slope 1.12, p-value=0.0001). Overall 56% of
responders compared to 35% of nonresponders had at least 2 classes of IFN
related toxicities( p-value =0.227). Ten patients
discontinued study medications between Day 5 and Week 16; 40% had achieved
viral suppression or >2 log HCV viral load decline at the time of discontinuation.
Conclusions:
HIV/HCV co-infected patients responding to HCV therapy were
more likely to experience IFN related side effects, particularly psychiatric
symptoms. These data emphasize the need for patients with IFN-related side
effects to be supported through treatment in a multidisciplinary setting as
these patients are more likely to achieve a cure. Future studies will evaluate
the relationship between occurrence of serious IFN-related adverse events and
HCV virologic response as well as factors that predict the development of
IFN-dependent adverse events.
Table: Prevalence of side effects
|
Toxicity |
All patients |
Responders |
Non responders |
p-value |
|
Psychiatric toxicities attributed to IFN |
50% |
63% |
7.7% |
0.009 |
|
Opthalmologic toxicities attributed to IFN |
38.2% |
41% |
28.6% |
0.528 |
|
Anaemia [Hgb <10] or use of erythropoeitin |
36.4% |
36% |
35.7% |
0.748 |
|
Neutropenia [ANC<1000] or use of G-CSF |
43.6% |
41.5% |
50% |
0.756 |
HCV Treatment – Pegasys
M. von Wagner; W. Hofmann; G. Teuber; T. Berg; T.
Goeser; U. Spengler; H. Hinrichsen; H. Weidenbach; G. Gerken; M. P. Manns; P.
Buggisch; E. Herrmann
Background and aims:
Chronic hepatitis C is associated with impairment of quality
of life (QOL). In the present study, QOL was frequently assessed before, during
and after antiviral treatment with amantadine or placebo, administered in
combination with peginterferon alfa and ribavirin. Aim of the study was to
evaluate the impact of amantadine and virologic response on QOL.
Methods:
Seven-hundred-four untreated HCV 1-infected patients received
amantadine-sulphate or placebo in combination with 180µg peginterferon alfa-2a
once weekly and ribavirin (1000-1200mg/day) for 48 weeks in a multicenter,
placebo-controlled trial (Hepatology, in press). End of treatment (
Results:
Conclusion:
·
In
the present large multicenter study, in patients who achieved
·
At
the end of follow up, QOL was found to be significantly better in patients who
achieved
HCV Treatment – IDUs
1297. Impact
of Recent Substance Use on Antiviral Treatment for Chronic Hepatitis C.
A. Knott; E.
Dieperink; J. Durfee; S. B. Ho
Introduction:
Substance use is a common problem among patients with chronic
hepatitis C virus infections (HCV). However, few studies have determined the
impact of integrated care mental health/medical care on antiviral treatment
outcome in patients with recent drug use and HCV.
Purpose:
To determine the impact of recent
substance use on antiviral treatment initiation in patients with chronic
hepatitis C in an integrated hepatitis clinic.
Methods
Retrospective chart review of 300 consecutive veteran patients with
chronic hepatitis C with an initial appointment in the hepatitis clinic between
Results:
Most patients were male (96.6%), mean age was 53.3 years,
mean BDI was 13.7 (BDI≥10 mild depression), mean AUDIT-C was 4.0 (≥4
hazardous alcohol use), 92.8% reported lifetime drug use with 33.9% reporting
misuse of prescribed medications and 33.9% reported substance use in the last 6
months. The
Conclusions:
·
Lifetime
drug use is common in this cohort and1/3 of patients report misuse of
prescribed narcotics, benzodiazepines or stimulants in their lifetime
indicating that clinicians should closely monitor narcotic prescribing.
·
Despite
the high rate of recent substance use, many patients started antiviral therapy
and
·
Integrated
care services provided in a hepatitis clinic may enhance access and antiviral
treatment outcomes in this difficult to treat population.
HIV/HCV Coinfection
E. Veitsman; S.
Edoardo; G. Hassoun; M. Lorber; K. Maor; R. Kramskay; S. Pollack; Y. Baruch
Background and aim:
Recently with the emergence of highly effective
Patients and methods:
Consecutive HIV-HCV co-infected patients were completely
evaluated in the liver clinic. Liver needle biopsy as a part of the evaluation
was performed in 100% of the patients. The patients were treated by
multidisciplinary team consisting of immunologists, hepatologists, social
workers, nurses with close follow- up. 48 weeks duration of Peg-Interferon and
Ribavirin combination was used for all genotypes according to the recent
Guidelines. Weight adjusted Ribavirin doses were applied for all genotypes. The
treatment was started after stabilization of HIV parameters and successful
weaning from drug and alcohol addiction.
Results:
Out of 122 HIV HCV coinfected patients, 64 were fully evaluated . Six patients had spontaneous viral clearance and
9 are still under treatment. 28 (75 % male) completed treatment. Of those 18
(64%) achieved
Overall adherence to the treatment was high.
Conclusions:
·
Measures,
such as the use of multidisciplinary approach, high adherence of physicians to
the Guidelines, weight based Ribavirin dose, and selecting patients who are
ready to start therapy can significantly improve
HCV Treatment – Side Effects
F. Morisco; M.
Tartaglione; A. De Luna; P. Andreone; C. Coppola; N. Passariello; C. Carella;
A. Scuteri; C. Iannacone; M. Sarracino; N. Caporaso
Background:
Autoimmune thyroid disorders have been reported as side
effects of interferon therapy in patients with chronic hepatitis C, although
there are still controversial data regarding the incidence, the risk factors
and the correlation with therapeutic response.
Methods:
4498 naives patients were consecutively enrolled in the PROBE : an observational study involving 167 Italian centers
consisting of a retrospective and a prospective phase designed to assess the
efficacy and safety of pegylated interferons plus ribavirin in a non selected
population of patients with chronic hepatitis C. All were tested for clinical,
biochemical and virological parameters and for thyroid antibodies (TgAb and
TPOAb) before, 6 and 12 months after the beginning of treatment (
Results:
274/4498 (6,1%) patients were
positive for antithyroid antibodies before antiviral therapy. During treatment
248/4224 (5,9%) patients showed de novo appearance of
antibodies. On the whole, 522 patients (11,6%) were
affected by autoimmune thyroid disease (ATD). The principal demographic,
virological and histological characteristics were not statistically different
in patients with and without ATD whereas the prevalence of female and
From a clinical point of view the overall percentage of
sustained virological response was similar in patients with (53,8%) and without (52,1%) ATD.
Conclusions:
Incidence of ATD in HCV patients, who were exposed to
HCV Treatment – Predictors of Treatment
Response
1301.
Relationship between insulin resistance (IR) and sustained virologic response (
W. M. Cassidy; R.
Horswell
Purpose:
To determine if a relationship exists between central obesity
and/or insulin resistance (IR) and sustained virologic response (
Methods:
Four-hundred Hepatitis C positive patients were enrolled in a
multi-center study to evaluate the relationship between IR (measured by the
HOMA score), waist hip ratio and sustained virologic response (
Results:
In the final analytical sample of 2890 subjects, 33% were
female and 33% were African-American; a median age of 46 years. The table shows
both unadjusted and adjusted odds ratio (OR) estimates for HOMA score terciles
from logistic regression analyses in which
In the adjusted model, race had a clear relationship to
Conclusion:
·
·
·
Insulin
resistance and race independently influenced the likelihood of virological
reasponse.
HCV Treatment – RibaPak
V. K. Rustgi; I. Alam;
B. Cecil; A. D. Tice ; T. Stainbrook; K. D. Ingram; K. David
Background:
Hepatitis C virus (HCV) is the most common blood-borne
infection in the United States (US). Current standard of care treatment is
combination therapy of pegylated interferon (PIFN) plus ribavirin. Poor
compliance to treatment is an important cause of treatment failure. Treatment
compliance is complicated by the fact that traditional ribavirin (
Aims:
To evaluate if treatment compliance is improved in patients
prescribed RBP vs.
Methods:
Accurate Dosing in Hepatitis C: Examining the RibaPak®
Experience (ADHERE) is a multi-center, prospective, observational registry
capturing data on compliance with RBP vs.
Results:
As of June 2008, 508 patients have been enrolled from 38
sites; 95 patients (RBP = 67,
Conclusions:
These preliminary data suggest potential differences in
compliance between treatment with RBP and
HCV Treatment – IDUs
1305. Three year follow-up of a
multidisciplinary care and peer support model for the engagement of IDUs in
care and treatment for HCV infection.
J. Grebely; E. Knight;
T. Ngai; K. Genoway; F. Duncan; M. I. Viljoen; M. Storms; D. Elliott; J. D.
Raffa; B. Conway.
Purpose:
To evaluate engagement in HCV care and treatment for HCV
infection among IDUs attending a weekly peer-support group at a
multidisciplinary community health clinic.
Methods:
From March 2005 to March 2008, patients interested in
receiving HCV treatment were referred to a weekly peer-support group and
evaluated for treatment readiness/eligibility. Engagement in HCV care was
defined as being under evaluation for HCV treatment, treatment not being
medically indicated and having received HCV treatment, while subjects lost to
follow-up were considered not engaged in HCV care. Patients received directly
observed therapy with
Results:
Overall, 204 subjects were referred over 3 years. Of these,
94 (47%) were lost to follow-up, 14 (7%) initiated or completed treatment for
HCV infection prior to attending the group, 9 (4%) were under evaluation for
treatment and treatment was deferred or not indicated in 30 (15%). Uptake of
HCV treatment was 28% (n=57). The median number of group visits in subjects
engaged in HCV care (n=110, 20 visits) was significantly higher than that in
those not engaged (n=94, 1 visit, p<0.001). In multivariate analysis,
attendance to group was significantly associated with subsequent engagement in
HCV care; attended 2-4 visits (
Conclusion:
A high engagement in HCV care and response to therapy can be
achieved among IDUs attending a peer-support group. HCV support group
attendance provides an important predictor of individuals more likely to engage
in HCV care and may constitute a screening tool to identify those eligible for
therapy.
HCV Treatment – Side Effects
K. Kuhara; T. Ide; N. Uchimura; R. Kumashiro; T.
Arinaga; K. Ogata; R. Kuwahara; I. Miyajima; M. Sata.
Background and Aims:
In pegylated interferon (PegIFN) and ribavirin combination
therapy for chronic hepatitis C, various kinds of psychiatric side effects
often occur, and some patients discontinued the IFN therapy due to psychiatric
side effect. Therefore we performed many institutions collaboration research to
verify whether psychiatric consultation before PegIFN and ribavirin combination
therapy contributes to completion of that therapy.
Methods:
Five-hundred thirty five patients who started
PegIFN-α-2b and ribavirin combination therapy in six hospitals affiliated
with our hospital since January 2005 until August 2006 were included.
Patients were divided into two groups as follows, the group
who have received psychiatric consultation before therapy as consultation group
(N=223), the group who have not received psychiatric consultation before
therapy except with a history of psychiatric diseases as non-consultation group
(N=332).
We analyzed the rate of discontinuation by psychiatric side
effect in these two groups.
Results:
The rate of discontinuation by the psychiatric side effect of
the consultation group was significantly lower than that of the
non-consultation group (1.8% (4/223) vs. 6.1% (19/312), P=0.035).
As the reason for the discontinuation of the therapy, the
psychiatric side effect were 6.1% (4/65)in the
consultation group and 27% (19/68)in the non-consultation group (P=0.0004).
In the patients who presented with the psychiatric symptoms
during the PegIFN and ribavirin combination therapy, the rate of the therapy
completion of the consultation group was significantly higher than that of the
non-consultation group (69.2% (18/26) vs. 5.0% (1/20), P=0.0067).
In patients with a history of psychiatric symptom, the
discontinuation by psychiatric side effect has not shown in the consultation
group.
Conclusions:
Psychiatric consultation before PegIFN and ribavirin
combination therapy contributes to complete that therapy.
HCV Treatment – Infergen
1310.
Efficacy Of Daily Dose Consensus Interferon
Alfacon-1(CIFN) And Ribavirin In Previous Non Responders To Pegylated
Interferon and Ribavirin In Patients With Advanced Fibrosis From Chronic
Hepatitis C.
P.
S. Mantry; M. Barnes.
Background:
At present, there are very limited treatment options for
patients with Hepatitis C infection (HCV) who are non-responders or relapsers
to combination treatment with pegylated interferon (
Methods:
Charts of 35 consecutive patients with HCV who were
non-responders or relapsers after a course of pegylated interferon (alpha
2a/2b) combined with weight based ribavirin and were consequently treated with
daily CIFN/
Results:
Demographics: 83% male, 69% Caucasian, 23% were African
American, average age-55 years.
In terms of virologic characteristics, 91% patients had
genotype 1; 3 patients had genotype 3. 31% patients were relapsers after
In terms of disease severity, 74% (26) patients had complete
or incomplete cirrhosis on liver biopsy, 17% had moderate fibrosis and 5.7%
patients had mild fibrosis.
All patients were treated with CIFN 15mcg SQ daily with
weight based
6 patients discontinued treatment due to severe treatment
side effects. In 22 patients,treatment was
discontinued at various time points (3,6 or 9 months) due to inadequate
virologic response (failure to achieve 2log RNA drop at 3 months and
Growth factors (erythropoietin, fligrastim) were used in 18
(51%) patients to avoid dose reductions. Yet, dose reductions in CIFN/
Of the remaining 7 patients who completed 1 yr of treatment 5
patients achieved a sustained virologic response(
Discussion:
1. In our study, daily CIFN and weight
based ribavirin produced an overall
2. Majority of these patients (92%) had
significant fibrosis and even with growth factors, 37% required dose reductions
and 17% discontinued treatment due to side effects.
3. In our opinion, daily CIFN/
HCV Treatment – Substitute Opioid Therapy
1311.
Pegylated Interferon Alfa-2a (Peg-2a) Plus Ribavirin (
J. Sasadeusz; G. J. Dore; I. Kronborg; D. A.
Barton; M. Yoshihara; M. Weltman.
Background and Aims:
HCV treatment uptake has been limited in people on drug
dependency treatment due to concerns regarding efficacy, adherence and adverse
effects, especially psychological effects such as depression and the inherent
increased suicide risk. This study aimed to evaluate these parameters in
patients receiving opioid pharmacotherapy
Methods:
Fifty-three patients at four Australian sites received Peg-2a
180 ug/week and
Results:
Seventy-nine percent of patients were male, with a mean age
of 37.9 years, 75% were receiving methadone and 25% buprenorphine, and 36 % had
injected in the previous 6 months. Fifty one percent of patients had high viral
load (>400,000 IU/ml) and 27% had F3/4 fibrosis.
Sixty-eight percent of G1 patients achieved EVR.
Conclusions:
HCV treatment of patients undergoing opioid pharmacotherapy
has comparable efficacy to non-pharmacotherapy patients. There was good
treatment adherence, no significant increase in depression and similar levels
of withdrawals due to adverse events. Adherence was better in patients
receiving 24-week therapy and post-treatment reinfection rates were low. HCV
treatment should be considered suitable for patients on opioid pharmacotherapy
including selected active injectors.
HCV Treatment – General
K. Chang; C. Lee; J. Wang; C. Hung; T. Hu; S. Lu.
Background:
To clarify the risk factors for the development of
hepatocellular carcinoma (
Methods:
A total of 301 HCV- related advanced fibrosis patients
receiving peg-IFN and oral ribavirin for 24 or 48 weeks were analyzed.
Cumulative incidence of
Results:
180 (59.8%) achieved a sustained virological response (