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Page 1: 830 CHOLESTEROL LEVELS AND PRESENCE OF DIABETES PREDICT EARLY VIROLOGICAL RESPONSE TO TRIPLE THERAPY WITH TELAPREVIR, PEG-INTERFERON alfa-2a 180 μg AND RIBAVIRIN IN CHRONIC HEPATITIS

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Methods: We examined 15 patients, nine male and six female, aged

between 24 and 66 years. The patients have been treated with Peg-

IFN (180mg/week), Ribavirin and in some cases with Boceprevir

or Telaprevir. During the treatment the patient’s weight has been

monitored. Also the patients have been interviewed about other

side effects and their general well-being. In order to find out wether

patients lose rather fat, water or muscles our approach was to run

a bioelectrical impedance analysis. For our analysis Akern BIA 101/s

was used. The patients have been examined in the beginning, in

week 4 and in week 12 of the therapy.

Results: Within all tested patients we found a loss of weight. The

medial weight of 76.8 kg was reduced to 74.4 kg which equates 3.2%

weight loss. The phase angle decreases due to the catabolic stimulus

we found as a result of the bioelectrical impedance analysis (PA

7.08 to PA 6.85) which means patients lose rather muscle-cells

than fat-cells. In 3 patients with a telaprevir based triple therapy

the reduction however was much higher. In the first four weeks of

the treatment the phase angle in the Peg-IFN and Ribavirin group

stays almost the same (medial PA 7.01 to PA 7.0), in the group with

Telaprevir the phase angle decreases (PA 7.4 to PA 6.6).

Conclusion: A IFN-based HCV treatment results in a median weight

loss of 3.2% in the first 12 weeks. The weight loss is due to a loss

of muscle mass. In a telaprevir based triple therapy the muscle

loss seems to be heigher. Sports or a protein rich diet may reduce

muscle loss.

830

CHOLESTEROL LEVELS AND PRESENCE OF DIABETES PREDICT

EARLY VIROLOGICAL RESPONSE TO TRIPLE THERAPY WITH

TELAPREVIR, PEG-INTERFERON alfa-2a 180mg AND RIBAVIRIN

IN CHRONIC HEPATITIS C

E. Jaeckel1, E. Zehnter2, C. John3, R. Heyne4, G. Teuber5,

W. Schiffelholz6, S. Christensen7, C. Antoni8, S. Pape9, M. Roessle10,

H. Loehr11, S. Stoll12, U. Alshuth12, D. Hueppe13, S. Mauss14,

M.P. Manns1, BNG Study Group. 1Dept. of Gastroenterology,

Hepatology & Endocrinology, Hannover Medical School, Hannover,2Center of Gastroenterology, Dortmund, 3Center of Gastroenterology,4Center of Gastroenterology and Liver Center, Berlin, 5IFS,

Interdisziplinaeres Facharztzentrum Sachsenhausen, Frankfurt/M,6Center of Gastroenterology, Augsburg, 7Center for Interdisciplinary

Medicine, Muenster, 8II. Medizinische Universitaetsklinik,

Universitaetsmedizin Mannheim, Mannheim, 9Center of

Gastroenterology, Paderborn, 10Gastrointestinal and Endocrinological

Center, Freiburg, 11Center of Gastroenterology, Wiesbaden, 12Virology,

Roche Pharma AG, Grenzach-Wyhlen, 13Center of Gastroenterology,

Herne, 14Center for HIV and Hepatogastroenterology, Duesseldorf,

Germany

E-mail: [email protected]

Background: We previously reported data that markers of the

metabolic syndrome such as BMI, blood sugar, hypertension and

lipid markers influence the SVR to dual therapy with PEG-

interferon alfa-2a 180mg/ribavirin. These data were generated by

a German-wide, observational study conducted by the German

gastroenterologists in private practice in cooperation with Roche

since 2003. Since 2011 the German gastroenterologists in private

practice are conducting another German-wide, observational study

in cooperation with Roche. Within this observational study

metabolic risk factors are investigated in patients receiving triple

therapy of telaprevir, PEG-interferon alfa-2a 180mg/ribavirin.Results: Within this interim analysis data of 881 patients were

evaluated for metabolic risk markers. 64.6% were male, median age

was 49.2 years, median BMI 26.2 kg/mm2, 27.5% of patients had an

BMI>28. Duration of infection was 17.1 years, 27.8% of patients had

blood glucose levels >100mg/dL. Early virological response was

defined as HCV-RNA negative or <10IU/mL at week12. EVR was

achieved by 58.7% of patients under triple therapy of telaprevir,

PEG-interferon alfa-2a 180mg, ribavirin. In contrast to dual therapy

markers of the metabolic syndrome such as BMI, hypertension,

blood glucose, HbA1c and HDL were not associated with non-

response in this group. Neither gender nor duration of infection

or viral load were predictive for non EVR. Only diabetes, baseline

cholesterol and LDL levels were predictive of achieving an EVR.

Patients with cholesterol >190mg/dl experienced an EVR in 65.7%

compared to just 55.4% EVR in patients with lower cholesterol

(p = 0.05). Likewise patients with LDL >160mg/dl had an EVR in

92.3% compared to just 53.2% with lower LDL levels (p = 0.006).

In contrast to results in dual therapy where presence of diabetes

predicted non-response, patients with diabetes achieved an EVR in

70.3% of patients compared to 57.8 in patients without diabetes

(p = 0.05).

Conclusions: None of the classical viral and host markers like viral

load and duration of infection did predict EVR in telaprevir based

triple therapy. The better treatment response with increased LDL

and cholesterol levels could highlight their importance in viral

replication. In contrast to dual therapy diabetes seems to predict a

better treatment response in telaprevir based triple therapy.

831

DELAYED DECLINE OF ON-TREATMENT HEMOGLOBIN

WAS ASSOCIATED WITH BETTER SUSTAINED VIROLOGICAL

RESPONSES IN GENOTYPE-2 CHRONIC HEPATITIS C PATIENTS

RECEIVING PEG-IFN/RBV TREATMENT

W.-J. Jeng, C.-Y. Lin, C.-W. Huang, C.-H. Huang, W.-T. Chen,

T.-C. Chang, I.-S. Sheen. Division of Hepatology, Chang Gung

University College of Medicine, Chang Gung Memorial Hospital, Lin

Kou, Taipei, Taiwan R.O.C.

E-mail: [email protected]

Background: Anemia is a troublesome adverse effect during

the PegIFN/RBV treatment for patients with chronic hepatitis C.

Recently, some evidence had shown that the occurrence of anemia,

especially the late anemia is associated with better sustained

virological responses (SVR) in genotype 1 patients.

Aim: To assess the impact of on-treatment hemoglobin decline on

SVR rate in patients with genotype-2 (GT-2) chronic hepatitis C

(CHC) who received PegIFN/RBV treatment.

Method: This is a retrospective analysis of our CHC cohort. HCV

genotyping and quantification were performed. The hemoglobulin

(Hgb) concentrations were measured on week 2, week 4 and

subsequent every 4 weeks during treatment. Blood transfusion,

administration of erythropoietin (EPO) or adjustment of RBV dosage

were used according to the preference of the patients when the

Hb below 10g/ml. The timing of the initial Hgb decline 3 g/ml was

recorded.

Results: There were 309 GT2 CHC patients who received

PegIFN/RBV treatment in this study. There were 236 (76.4%) patients

whose Hgb had decline more than 3g/ml during the treatment.

Those Hgb decline >3 after week 2 on treatment were easier to

achieved SVR (93.7%) than those without decline of Hgb or decline

before week 2 (86.3%). The predictor of SVR by logistic regression

are patients whose Hgb decline more than 3g/ml after 2 weeks on

treatment (OR: 2.93, 95%CI: 1.13–7.64, p = 0.028), those with RVR

(OR: 5.36, 95%CI: 2.1–13.66, p < 0.001), and with baseline higher

platelet count (OR: 1.01, 95%CI: 1.00–1.02, p = 0.01). By comparison

of baseline characteristics between those on-treatment decline of

hemoglobin <3 and ≥3, there were no differences in terms of age,

baseline viral load, fibrosis status, and RVR rate. However, men

are easier to have the decline of hemoglobin during treatment

rather than women (p =0.001). Other factors related to decline

of hemoglobin >3 during treatment are baseline creatinine and

baseline hemoglobin.

Conclusion: The decline of hemoglobin >3 after 2 weeks on

treatment, as well as higher baseline platelet count and RVR would

S340 Journal of Hepatology 2013 vol. 58 | S229–S407