ORAL PRESENTATION POSTERS O122  Efficacy and safety of paritaprevir/r/ombitasvir/dasabuvir ± ribavirin in genotype 1 HCV infected patients treated in real life settings (AMBER study) R Flisiak1, E Janczewska2, M Wawrzynowicz-Syczew3, A Wiercinska-Drapalo4, D Zarebska-Mich5, B Bolewska6, K Fleischer-Stepniewska7, K Tomasiewic8, K Rostkowska9, K Karwowska10, A Piekarska11, O Tronina12, A Pisula2, M Lucejko1, E Karpinska3, K Nazzal4, W Kryczka5, I Mozer-Lisewska6, B Knysz7 1  Klinika Chorob Zakaznych i Hepatologii UM, Bialystok, Poland, 2ID Clinic, Myslowice, Poland, 3Klinika Chorob Zakaznych, Szczecin, Poland, 4Klinika Chorob Zakaznych, Warsaw, Poland, 5Klinika Chorob Zakaznych WSZ i UJK, Kielce, Poland, 6Katedra i Klinika Chorob Zakaznych UM, Poznan, Poland, 7Katedra i Klinika Chorob Zakaznych, Wroclaw, Poland, 8Katedra i Klinika Chorob Zakaznych UM, Lublin, Poland, 9I Oddzial Zakazny WSS im, Gromkowskiego, Wroclaw, Poland, 10Katedra i Klinika Chorob Zakaznych i Hepatologii CM UMK, Bydgoszcz, Poland, 11Klinika Chorob Zakaznych i Hepatologii UM, Lodz, Poland, 12Klinika Medycyny Transplantacyjnej i Nefrologii UM, Warsaw, Poland

O123 Daclatasvir plus sofosbuvir with or without ribavirin for the treatment of HCV in patients with severe liver disease: interim results of a compassionate use program T Welzel1, K Herzer2, P Ferenci3, J Petersen4, M Gschwantler5, M Cornberg6, T Berg7, U Spengler8, O Weiland9, M Van der Valk10, H Klinker11, J Rockstroh12, P Ingiliz9, M Peck-Radosavljevic3, MJ Jimenez-Exposito13, S Zeuzem1 1  Universitätsklinikum der Johann Wolfgang Goethe Universität, Frankfurt, Germany, 2Universitätsklinikum Essen (AöR), Essen, Germany, 3Medizinische Universität Wien, Vienna, Austria, 4IFI Institut für Interdisziplinäre Medizin, Hamburg, Germany, 5Wilhelminenspital, Vienna, Austria, 6Medizinische Hochschule Hannover, Hannover, Germany, 7Universitätsklinikum Leipzig, Leipzig, Germany, 8Universitätsklinikum Bonn, Bonn, Germany, 9Karolinska Institutet, Solna, Sweden, 10Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands, 11Universitätsklinikum Würzburg, Würzburg, Germany, 12Universitätsklinikum Bonn, Bonn, Germany, 13Bristol-Myers Squibb, Rueil-Malmaison, Paris, France

POSTER PRESENTATIONS In all author listings, the presenting author is underlined.

HEPATITIS C VIRUS – Diagnosis P1 Can simple easily reproducible biochemical tests replace the costly elastography in diagnosis of liver cirrhosis in chronic hepatitis C patients?

H Shabana (Mansoura, Egypt)

P2

Agreement of indirect serum markers of liver fibrosis with liver biopsy results in chronic hepatitis C patients



H Shabana, M Askar, M Elrakhawy, M Haras (Mansoura, Egypt)

P3 Noninvasive assessment of liver fibrosis in hepatitis C: acoustic radiation force impulse imaging (shear wave elastography) and liver fibrosis biomarkers versus liver biopsy

E Mostafa, N Makhlouf, S Hassany, A Helmy, A Nasr, M Othman, H Seif, M Darwish, H Hasan (Assiut, Egypt)

HEPATITIS C VIRUS – Natural history and epidemiology P5 Watch and wait – chronic hepatitis C patients before the era of interferon-free therapy in Germany

D Hueppe, P Buggisch, S Christensen, H Heiken, S Mauss, U Naumann, C Fischer, H Kleine (Wiesbaden, Germany)

P6

Prevalence and clinical outcome of post transfusion hepatitis C in young and adults



C Millbourn (Stockholm, Sweden)

P7

Viral load dynamics in patients with chronic hepatitis C



O Sandulescu, A Streinu-Cercel, A Negut, A Streinu-Cercel (Bucharest, Romania)

HEPATITIS C VIRUS – Treatment and late-stage clinical trials P8 A single tablet regimen of ledipasvir/sofosbuvir for 12 weeks in HCV genotype 1 or 4 infected patients with HIV-1 co-infection: the Phase 3 ION-4 study

J Rockstroh, C Cooper, S Naggie, M Saag, J Yang, L Stamm, P Pang, J McHutchison, D Dieterich, M Sulkowski (Bonn, Germany)

P9

Real-world effectiveness of ledipasvir/sofosbuvir 8 weeks chronic hepatitis C treatment



P Buggisch, K Wursthorn, A Gauthier, P Atanasov, J Petersen (Hamburg, Germany)

P10 Efficacy and safety of a 12-week simeprevir plus peginterferon/ribavirin regimen in treatment-naïve HCV genotype 4-infected patients with mild-to-moderate fibrosis

T Asselah, C Moreno, C Sarrazin, M Gschwantler, G Foster, A Craxi, P Buggisch, F Sanai, B Ryan, O Lenz, G Van Dooren, I Lonjon-Domanec, C Nalpas, M Schlag, M Buti (Paris, France)

Efficacy and safety of Paritaprevir/r/Ombitasvir/Dasabuvir ±Ribavirin in GT1 HCV infected patients treated in real life settings (AMBER study - interim analysis )

Robert Flisiak1, Ewa Janczewska2, Marta Wawrzynowicz-Syczewska3, Alicja Wiercinska-Drapalo4, Dorota Zarebska-Michaluk5, Beata Bolewska6, Katarzyna Fleischer-Stepniewska7, Krzysztof Tomasiewicz8, Karolina Rostkowska9, Kornelia Karwowska10, Anna Piekarska11, Olga Tronina12, Arkadiusz Pisula2, Mariusz Lucejko1, Ewa Karpinska3, Khalil Nazzal4, Wieslaw Kryczka5, Iwona MozerLisewska6, Brygida Knysz7. 1. Klinika Chorob Zakaznych i Hepatologii UM, Bialystok, Poland 2. ID Clinic, Myslowice, Poland 3. Klinika Chorob Zakaznych, Hepatologii i Transplantacji Watroby PUM, Szczecin, Poland 4. Klinika Chorob Zakaznych, Tropikalnych i Hepatologii UM, Warsaw, Poland 5. Klinika Chorob Zakaznych WSZ i UJK, Kielce, Poland 6. Katedra i Klinika Chorob Zakaznych UM, Poznan, Poland

Background:

Genotype 1 is the most common HCV genotype in Europe1 Almost 80% of HCV infections in Poland are caused by genotype 1b2 HCV infections have historically been more difficult to cure in patients with liver cirrhosis and non-responders to previous, IFN-based therapy. Clinical trials carried-out with interferon-free regimens containing directacting antivirals (DAA) have shown SVR rates exceeding 90% in this population irrespective of liver fibrosis and treatment history3-5 3-DAA regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir (PTV/OBV/r ±DSV ±RBV) for 12 weeks has demonstrated 99% SVR rates in HCV GT1b-infected patients with and without cirrhosis6-11 The most recent data demonstrate no need of RBV addition even in cirrhotics infected with genotype 1b12.

• •

Baseline disease characteristics

Safety and efficacy data of PTV/OBV/r+DSV ±RBV in HCV genotype 1 infected patients are available from clinical trials only. The aim of this multicenter study was to confirm safety and efficacy of this regimen in real-life settings.

AMBER study design • AMBER is a multicentre, investigator initiated, open-label study, carried out in Poland and based on medication provided by AbbVie in HCV Named Patient Program. • Patients infected with genotype 1 or 4 received coformulated OBV/PTV/r (25/150/100 mg QD) ±DSV (250 mg BID) ±RBV for 12 or 24 weeks according to current product information. • Patients visits were scheduled on day 0, EOT and FU week 12, but some centers decided to perform additional visits on day 1, day 7, week 4 or week 8.

All Genotypes, n=196 GT1 GT4 GT1a 11 1013

AMBER-GT1: baseline characteristics

GT1 n=186 162

Fibrosis in GT1, n=186 unknown F0 F1 33 16 F2 23 107

F4

Treatment history in GT1, n=186 unknown discont naive 16 39 11

GT1b

34

71

33 F3

(58%)

(38%)

null

15

relapse

partial

2

10 18%

80%

94 62%

8

60% 41

40%

TND 39 98%

123 98%

17

77

TD 2 IU/mL TD-102 4 IU/mL 2 102-104 6 IU/mL 4 104-106

31 20%

6 8 IU/mL 106-108

27 20 4

0% d0 n=186

d1 n=55

11 EOT n=125

6 d7 n=76

w4 n=152

1 FU w12 n=40

Any AE Serious AE* AE leading to study discontinuation AEs in ≥5% of patients Fatigue Nausea Headache Pruritus Jaundice Rash Insomnia

AMBER-GT1: on-treatment lab. abnormalities Bilirubin [mg/dL]

14

1,5

RBV+

1,0

RBV-

0,5

13

RBV+

12

RBV-

11 day 7

week 4

EOT

with RBV n=137 27 (20%)

10 day 0

day 7

without RBV n=49 1 (2%)

week 4

Bilirubin, 3-10xULN Hemoglobin 8-10 g/dL 5 (3.6%) 2 (4.0%) 6-8 g/dL 1 (0.7%) 0 RBV dose was reduced in 25 and discontinued in 8 subjects.

Conclusions:

140 120 100 80 60 40 20 0 day 0

ALT

max

22 18 0.0025 0.1 17 10 0.8 9.4 13 2.5 0.8 0.4 5 6

76 39 12.8 4.8 492 251 2.2 17.7 356 6.4 306 2.0 9 17

5 x ULN)

3 (0.8)o

0

Aspartate aminotransferase (> 5 x ULN)

2 (0.6)o

0

Total bilirubin (> 2.5 x ULN)

11 (3.1)p

9 (7.2)q

Creatinine (> 1.9 x ULN)

4 (1.1)r

1 (0.8)r

a Sepsis

(n = 2); multi-organ failure after surgery (n = 2); multi-organ failure (n = 1); esophageal varices bleeding (n = 1); liver-related (nonHCC; n = 1); hepatic encephalopathy (n = 1); hepatocarcinoma (n = 1); myelodysplastic syndrome (n = 1); extensive alcohol consumption (n = 1); unknown (n = 1). b Multi-organ failure due to haemorrhagic shock (n = 1); liver-related (non-HCC; n = 2); myocardial infarction (n = 1). c Reported as related to program therapy: n = 5 (1 pancytopenia, 1 abdominal pain, 1 diabetic coma, 1 hepatic encephalopathy, 1 real impairment, 1 pleural effusion). d Reported as related to program therapy: n = 1 (HCC). e Multi-organ failure (n = 3); sepsis (n = 2); pneumonia (n = 1); hepatic encephalopathy (n = 2); renal impairment (n = 1); acute cholecystitis (n = 1); cardiopulmonary failure (n = 1); cholangiocarcinoma (n = 1); HCC (n = 1); seborrhoeic dermatitis (n = 1); oesophageal varices hemorrhage (n = 1), unknown (n = 1). f Multiorgan failure (n = 1); general physical health deterioration (n = 2); bacterial peritonitis (n = 1); hepatic encephalopathy (n = 1); syncope (n = 1); acute renal failure (n = 3); hepatic failure (n = 2); myocardial infarction (n = 1); hypersensitivity vasculitis (n = 1). g Reported as related to program therapy: n = 2. h Reported as related to program therapy: n = 2. I Reported as related to program therapy: n = 5. j Reported as related to program therapy: n = 4. k Reported as related to program therapy: n = 8. l Reported as related to program therapy: n = 5. m Reported as related to program therapy: n = 15. n Reported as related to program therapy: n = 1. o Patients with worsening in toxicity grade. p Patients with worsening in toxicity grade. Abnormal value at baseline: n = 10 (1 missing value); q Patients with worsening in toxicity grade. Abnormal value at baseline: n = 8. r Patients with worsening in toxicity grade. All of them had abnormal value at baseline.

■ DCV + SOF ± RBV was generally well tolerated ■ Most of the AEs and serious AEs were considered not related to program treatment ■ The most common AEs were anemia, fatigue, nausea, and diarrhea; the majority of these were mild in intensity ■ 35/39 anemia events occurred in patients receiving DCV + SOF + RBV ■ There were few AEs that led to discontinuation of program therapy

3 3

No cirrhosis

a HCV RNA < LLOQ (TD or TND). b Observed values. c 9 patients on DCV + SOF and 2 patients on DCV + SOF + RBV had indeterminate cirrhosis status; all 11 achieved SVR12. d 10 patients on DCV + SOF had indeterminate cirrhosis status; all 10 achieved SVR12; 1 patient on DCV + SOF + RBV with indeterminate cirrhosis status did not achieve SVR12. e 1 relapse. f 1 relapse, 1 HCV RNA > LLOQ but discontinuation before week 12.

ACKNOWLEDGMENTS & DISCLOSURES

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/02/WC500160499.pdf

98

97

40

REFERENCES 1. World Health Organization. Hepatitis C key facts. WHO factsheet no 164. April 2014. 2. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol 2014;60:392–420. 3. Poordad F, et al. EASL 2015. Abstract LB-4291 (oral). 4. Wyles D, et al. N Engl J Med 2015; 373:714-725. 5. Nelson DR, et al. Hepatology 2015;61:1127–1135. 6. European Medicines Agency, summary on compassionate use of Daclatasvir, Bristol-Myers Squibb Pharma EEIG. 21 November 2013. Available at:

99

Grade 3/4 laboratory abnormalities,

95

95

SVR12, % a,b

57 (27–87) 387 (80) 95 (20) 321 (67)

80

SVR12 (%) a,b

Figure 2. Patient Disposition – Interim Analysis

56 (31–79) 105 (84) 20 (16) 88 (70)

Figure 3. Primary Efficacy Analysis – SVR12 Overall Cohort*

0

RESULTS

57 (27–87) 282 (79) 75 (21) 233 (65)

a Pakistani (2); Turkish (1), Egyptian (1). b Tattoo (1), mother to child transmission (1), job related exposure (1), injury during sport activities (1), surgery injury (1), early childhood infection (1), plasma donation (1). c HCV genotype was mixed or unknown for 11 patients. d Genotype 1 subtype was unrecorded or GT 1c (1 patient) in 41 patients overall (DCV+SOF, n=34; DCV+SOF+RBV, n=7). e Defined by the following algorithm: present, if liver biopsy shows cirrhosis (Metavir > F3, Ishak > 4, or the equivalent) at any time prior to screening ; or Fibroscan (FS) > 14.6 kPa at any time prior to screening, or FIB -4 score > 3.25 at baseline; absent if most recent liver biopsy (within 3 years of screening) shows absence of cirrhosis (Metavir F0-F3, Ishak 0-4, or equivalent); or Fibroscan ≤ 9.6 kPa within 1 year of baseline; or FIB-4 score of < 1.45 at baseline. In case of conflicting results, liver biopsy takes precedence over FS or FIB-4, and if not available, FS takes precedence over FIB-4. Patients who did not meet the criteria, did not have enough information for classification or had contradictory information recorded were classified as indeterminate for this interim analysis. f Includes interferon/ peginterferon monotherapy or in combination with RBV, protease inhibitors (PIs), SOF, or other agents. g Includes SOV + RBV and other regimens. h Dose adjustment in combination with antiretroviral therapy: boosted PIs (30 mg); NNRTI (90 mg).

100

Treatment Duration 100 100 100

100

SVR12, % a,b

GT 1–6 in vitro and GT 1–4 in clinical trials. nucleotide NS5B inhibitor with low potential for drug–drug interactions; safe and well tolerated; approved in combination with other HCV agents in the US, Europe, and Canada. c ALLY-1: Patients with cirrhosis or post-liver transplant (GT 1 to 6);3 ALLY-2: Patients with HIV co-infection (GT 1 to 6);4 ALLY-3: treatment-naive and -experienced patients with GT 3 infection.5 d ClinicalTrials.gov NCT02097966. a Pangenotypic:

All Patients (N = 482)

SVR12, % a,b

■ Daclatasvir (DCV) is a potent, pan-genotypica NS5A inhibitor with low potential for drug-drug interactions that have been studied in > 13,000 patients ■ DCV in combination with sofosbuvir (SOF)b with or without ribavirin (RBV) has demonstrated high response rates with minimal adverse events in phase 2 and 3 clinical trials, including in challenging populations (DCV ALLY programc,3-5) ■ An extensive early access program provided access to DCV before market authorization to > 7000 patients in urgent need of treatment ■ In Europe, in accordance with the recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)6, a compassionate use program (CUP) for the combination DCV + SOF ± RBV was opened where allowed by local regulations ■ Data from this CUP will provide clinically relevant information on the effectiveness and safety profile of this combination in a real-word setting ■ This analysis reports interim findings from the European CUP in 5 European countries (Germany, Austria, Netherlands, Sweden and Norway) (AI444-237)d

Demographics Age Median (range), years < 65 years, n (%) ≥ 65 years, n (%) Male, n (%) Race, n (%) White Black Asian Othera Not reported HCV-Related Factors Method of HCV transmission, n (%) Injection drug use Transfusion/receipt of blood products Sexual transmission Otherb Unknown Not reported HCV genotype, n (%)c 1ad 1bd 2 3 4 5 IL28B genotype, n (%) CC Non-CC Not available / not reported Baseline Disease Characteristics HCV RNA Median (range) ≥ 2,000,000 IU/mL, n (%) ≥ 6,000,000 IU/mL, n (%) Not done/not available, n (%) Cirrhosis statuse, n (%) Present Absent Indeterminate Child-Pugh category, n (%) A B C Not reported MELD category, n (%) =F3

TE using sh.wave Fib4 APRI

>=F4

TE using sh.wave Fib4 APRI

0.78 (0.67:0.89) 0.57 (0.44:0.7) 0.52 (0.39:0.65) 0.92 (0.83:1) 0.55 (0.39:0.72) 0.75 (0.6:0.89) 0.98 (0.96:1) 0.7 (0.57:0.83) 0.71 (0.57:0.84)

Sensiti Specif vity icity (%) (%)

PPV (%)

NPV Accur (%) acy

4.815

81.5

73.1

61.1

88.4

0.009

40.7

76.9

47.8

71.4

0.405

63.0

51.9

40.5

73.0

6.335

93.8

86.5

68.2

97.8

0.006

56.3

65.4

33.3

82.9

0.992

56.3

90.4

64.3

87.0

9.39

91.3

98.1

95.5

96.2

0.011

52.2

84.6

60.0

80.0

0.672

69.6

69.2

50.0

83.7

75.9 64.6 55.7 88.2 63.2 82.4

96.0 74.7 69.3

Fig3: Roc curve for estimate cutoff value between stage (F0-F1) and stage (F4)

Conclusion: Share Wave Elastography provides more accurate correlation with liver fibrosis stage compared with FIB-4 score and APRI as a non-invasive technique for assessment of liver fibrosis especially in advanced stages (F3 and F4). Acknowledgement: This study is supported and funded by Science & Technology Development Fund (STDF) in Egypt. The research team would like to acknowledge The Science and Technology Development Fund (STDF) in Egypt for the financial support to this study (Project ID: 3261).The research team would like also to thanks The Science and Technology Development Fund (STDF) for establishing scientific partnerships with scientists to keep track of quickly advancing technology

Watch and Wait – Chronic Hepatitis C-Patients before the Era of Interferon-free Therapy in Germany Hüppe D.1; Buggisch P.2; Christensen S.3; Heiken H.4; Mauss S.5; Naumann U.6; Fischer C.7; Kleine H.8 Gastroenterologische Gemeinschaftspraxis, Herne, Germany; 2 ifi Institut, Hamburg, Germany; 3 Zentrum für interdisziplinäre Medizin Münster GmbH, Münster, Germany; 4 Internistische Gemeinschaftspraxis, Hannover, Germany; 5 Medizinisches Versorgungszentrum, Düsseldorf, Germany; 6 Praxiszentrum Kaiserdamm, Berlin, Germany; 7 Consultant in Medical Affairs and Market Access/HEOR, Munich, Germany; 8 AbbVie GmbH & Co KG, Wiesbaden, Germany

1

Pretreatment

BACKGROUND Data on people living with chronic Hepatitis C (CHC) in Germany are limited. CURRENT-C is a crosssectional epidemiology study to elucidate the characteristics of the CHC population regarding route of infection, Hepatitis C genotypes, pretreatments and scheduled future treatments. The data presented here were obtained shortly before the direct acting anitviral (DAA) combination drugs were introduced into the treatment of CHC.

43.2 % (n = 636) of the patients had already received HCV treatment, most frequently dual therapy with pegylated interferon (PegIFN) + ribavirin (RBV; 60.8 %; n = 387) or triple therapy with telaprevir (TRV) or boceprevir (BOC) in 20.3 % (n = 129) of the pretreated patients (see Figure 2). Figure 2: Prior HCV treatment

METHODS Study Design Non-interventional, single country, multi-center epidemiology study.

Inclusion Criteria Age ≥18 years, CHC, treatment-naïve or non-successful treatment, informed consent.

Primary Objectives Assessment of the current patterns of HCV Genotype and -subtype distribution in diagnosed treatmentnaïve or treatment-experienced patients in Germany.

RESULTS Patient characteristics 1471 patients from 40 German centers specializing in viral hepatitis treatment were included in the analysis. Patients were enrolled from June through November of 2014 and were not actively receiving treatment. Baseline characteristics are shown in Table 1.

Mean age (years; mean ± SD) Age

< 50 years (%, n) ≥ 50 years (%, n)

Male

Female

Total

58.8 % (N = 865)

41.2 % (n = 606)

100 % (n = 1471)

50.1 ± 12.0

55.6 ± 13.9

52.4 ± 13.1

46.4 % (n = 401) 53.6 % (n = 464)

31.5 % (n = 191) 68.5 % (n = 415)

40.2 % (n = 592) 59.8 % (n = 879)

Duration of infection (years, median) Anamnesis

Treatment-naïve (%, n) Treatment-experienced (%, n)

15

18

15

57.6 % (n = 498)

55.6 % (n = 337)

56.8 % (n = 835)

42.4 % (n = 367)

44.4 % (n = 269)

43.2 % (n = 636)

Native language German (%, n)

72.0 % (n = 623)

72.4 % (439)

72.2 % (n = 1062)

Liver cirrhosis

17.1 % (n = 115)

13.7 % (n = 83)

15.7 % (n = 231)

Total (%, n) ≥ 50 years (%, n)

HCV treatment within the next 3 months To assess the urgency of therapeutical need for the patients, the data collection included the question whether a HCV treatment was planned within the next 3 months. This was true in 50.2 % (n = 739) of the patients (see Figure 3).

Table 1: Patient characteristics Patients (%, N)

Compared to treatment-naïve patients, treatment-experienced HCV patients were older (55.1 vs. 50.3 years) and had more frequently liver cirrhosis as clinical diagnosis (22.2 % vs. 10.8 %).

Figure 3: HCV treatment scheduled within the next 3 months

20.7 % (n = 182)

Route of infection Suspected route of infection in male patients was most frequently drug use (64.4 %; n = 400), in female patients blood products (40.0 %; n = 138). It was frequently unknown in 28.2 % (n = 244) of male and 43.1 % (n = 261) of female patients (see Figure 1). Figure 1: Suspected route of infection

CONCLUSIONS The current data carry forward the trend stated by Klass et al. in 2012 [2], when they compared their data to those reported by Hüppe et al. in 2008: The German CHC population is progressing in age, disease severity and parameters indicating poor treatment response. This is illustrated by the reported rate of cirrhosis from 3 % [1] to 8.8 % [2] up to 15.7 % observed in this study. The genotype distribution observed correlated with the route of infection, e.g. males frequently exhibit an infection via i.v. drug use and correspondingly showed a much higher rate of GT3. In line with the short time availability of newer treatment options, the most common prior HCV treatment was with PEG RBV dual therapy. Every other patient was not scheduled for treatment within the next three months, mainly to delay treatment until the availibility of further treatment options. The current data demonstrate CHC patient characteristics including age, disease severity and pretreatment history to underline the increasing trend towards more difficult to treat patients, indicating the urgent need for the now widely available new treatment options.

HCV genotype HCV genotype (GT) was known in 1,440 patients. GT 1 was found in 73.8 % (n = 1,063), GT 2 in 3.5 % (n = 50), GT3 in 18.3 % (n = 264), GT4 in 4.2 % (n = 60), GT5 in 0.2 % (n = 3) and GT 6 in 0.3 % (n = 4). The HCV genotype distributions of several subgroups are shown in Table 2. Table 2: Distribution of HCV genotypes Total

Male

Female

< 50 years

≥ 50 years

Therapy naïve

Pretreated

GT1

73.8 % (n = 1063)

69.5 % (n = 589)

80.1 % (n = 474)

61.9 % (n = 359)

81.9 % (n = 704)

66.9 % (n = 539)

82.6 % (n = 524)

GT1a

29.0 % (n = 418)

34.9 % (n = 296)

20.6 % (n = 122)

32.8 % (n = 190)

26.5 % (n = 228)

28.2 % (n = 227)

30.1 % (n = 191)

GT1b

38.4 % (n = 553)

30.1 % (n = 255)

50.3 % (n = 298)

25.0 % (n = 145)

47.4 % (n = 408)

32.3 % (n = 260)

46.2 % (n = 293)

GT2

3.5 % (n = 50)

3.5 % (n = 30)

3.4 % (n = 20)

4.1 % (n = 24)

3.0 % (n = 26)

5.3 % (n = 43)

1.1 % (n = 7)

GT3

18.3 % (n = 264)

21.2 % (n = 180)

14.2 % (n = 84)

28.1 % (n = 163)

11.7 % (n = 101)

23.2 % (n = 187)

12.1 % (n = 77)

GT4

4.2 % (n = 60)

5.5 % (n = 47)

2.2 % (n = 13)

5.9 % (n = 34)

3.0 % (n = 26)

4.1 % (n = 33)

4.3 % (n = 27)

100.0 % (n = 1440)

100.0 % (n = 848)

100.0 % (n = 592)

100.0 % (n = 580)

100.0 % (n = 860)

100.0 % (n = 806

100.0 % (n = 634)

Genotype known

References 1. Hüppe D, Zehnter E, Mauss S et al. Zeitschrift für Gastroenterologie. 2008, Bd. 46, S. 34-44. 2. Klass DM, Hinrichsen H, Boeker KH et al. Poster presented at the 63rd Annual Meeting of the American Association for the Study of Liver Diseases, Boston, USA : 958, 2012.

Acknowledgement We thank all the participating patients and physicians of the CURRENT-C study. The study was sponsored by AbbVie GmbH & CO KG. The authors wish to thank Prof. Dr. Michael Gutmann, e.factum GmbH, for providing medical writing in the development of this poster. The financial support for these services was provided by AbbVie.

Disclosures D. Hüppe has received research funding and has acted as a speaker or consultant for MSD, Janssen, Roche, BMS, Falk Pharma, Boehringer, Novartis, Norgine, Shire, AbbVie/Abbott, Gilead, Ferring Arzneimittel, Merckle Recordati, Merz Pharmaceuticals, and Echosens S.A.S.U. P. Buggisch has served as a consultant, advisor and speaker and received fees from AbbVie, BMS, Gilead, Janssen, MSD, and Roche. S. Christensen received payment for lectures and has served on advisory boards from Abbvie, BMS, Gilead, Hexal, Janssen, MSD, ReckittBenckiser, and ViiV. H. Heiken received fees for lectures and has served on advisory boards from Abbvie, BMS, Boehringer, Gilead, Janssen, Roche, and ViiV. S. Mauss has served as a consultant and advisor for or received payment for lectures from Abbvie, BMS, Boehringer, Gilead, Janssen, Roche, ViiV, Novartis, and MSD. U. Naumann received fees for lectures and advisor activity from AbbVie, BMS, ViiV, Gilead, Janssen, Roche, and MSD. C. Fischer is a former employee of Abbvie. H. Kleine is an AbbVie employee and may hold stock or options.

Patients with GT5 (n = 3) and GT6 (n = 4) are not shown.

PRESENTED AT THE VIRAL HEPATITIS CONGRESS, 10 –12 SEPTEMBER 2015, FRANKFURT, GERMANY

PREVALENCE AND CLINICAL OUTCOME OF POST TRANSFUSION HEPATITIS C IN YOUNG AND ADULTS Charlotta Millbourn 1, 2, Afrodite Psaros Einberg 3, 4, Gudrun Lindh 1,2, Ingegerd Hökeberg 5, Björn Fischler 3, 4, Karin Lindahl 1, 2 1Department of Medicine Huddinge, Unit of Infectious diseases Karolinska Institutet, 2 Department of Infectious Diseases,Karolinska University Hospital Huddinge, 3 Department of Pediatrics, Karolinska University Hospital, 4 CLINTEC, 5 Department of Communicable Disease Prevention and Control, Karolinska Institutet, Stockholm, Sweden

Conclusions

Total tested for anti-HCV n=7473 anti-HCV pos n=134 1.8% PCR pos n=102 1.4%

PCR neg n=26

Group 1 n=23

Lost to follow up n=6

This look-back study found an anti-HCV prevalence of 1.8%, which is higher than in other regions in Sweden. In this study, patients infected during childhood were more likely to receive antiviral treatment than patients with post transfusion hepatitis C contracted later in life. Additional data on the hepatitis C epidemic in Sweden are needed regarding prevalence and age distribution. If treatment coverage is higher in younger patients this population should be targeted for general screening.

Group 2 n=79

Anti-HCV tested subjects during the campaign in Stockholm area 2008-2010. Group 1: 19 years of age at transfusion. In group 2 three subjects were lost to follow up.

Introduction and aims

Results

The prevalence of chronic hepatitis C in Sweden is estimated to 0.5%. Before 1991 blood transfusion was a common route of transmission. The primary aim of this study was to estimate the anti-HCV prevalence in subjects receiving blood transfusions in Stockholm during that period. The secondary aim was to study the effect of age at transfusion on liver disease and treatment outcome.

•1.8% anti-HCV positive •1.4% HCV RNA positive •Obstetric or gynecological intervention were the most common causes of transfusion. •71% were female •45% of the patients were older than 61 years at diagnosis •18% (10/56) had advanced liver damage

Method This is a single center retrospective analysis of subjects found to be anti-HCV tested positive in Stockholm county during a national screening campaign in Sweden in 20082010. Subjects were informed through media and encouraged to perform anti-HCV testing by their general physician if they had received blood transfusions during the period 1965-91. All anti-HCV positive subjects were also HCV RNA tested and those positive were referred to Karolinska University Hospital for further investigation. Inclusion criterion for this study was blood transfusion as the most likely mode of HCV transmission. Subjects with ongoing, or a history of, drug abuse were excluded. The identified anti-HCV subjects were divided into two groups. Data on age at transfusion, age at HCV diagnosis, genotype, IL28B genotype, viral load, fibrosis score, liver histology and antiviral treatment was recorded.

Patients younger than 19 years of age at transfusion (group 1) were significantly more often started on antiviral treatment compared to those transfused as adults, 65% vs 29% p