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Introduction

Treating hepatitis C virus (HCV) infection among people who inject drugs (PWID) on opioid agonist therapy (OAT) according to the concept of directly observed therapy (DOT) with direct-acting antiviral agents (DAA) is a highly effective approach to HCV microelimination. The principle behind DOT is DAA prescription via a low-threshold facility (LTF) and supervised OAT/DAA ingestion at a pharmacy or the LTI. In individuals with good adherence to OAT, the intervals for OAT/DAA dispensation may be extended from daily to once weekly.
However, the effect of these alterations in OAT/DAA dispensation schedules on sustained virologic response (SVR) rates remains unclear. We present an individualized approach to DAA DOT for PWID that was used throughout the COVID19 pandemic and thereby represents one of only few HCV elimination programs that were successfully continued during the pandemic.

Aims & Methods

Two groups of Viennese PWID were compared regarding DOT distribution intervals, SVR rates, and socioeconomic characteristics: The "COVID period" was defined as 15.3.2020-2.5.2023 and comprised 239 PWID starting DAA treatment within that time frame. The "pre-COVID period" was defined as 26.9.2014-14.3.2020 and consisted of 441 PWID who began DAA therapy during that period.

Results

Daily DOT was the most frequent OAT/DAA distribution schedule pre-COVID (348 PWID, 78.9%) while 19 (4.3%) were on 2-3 times weekly and 74 (16.8%) on once weekly distribution. By comparison, during COVID, only 75 (31.4%) PWID were on daily DOT, 60 (25.1%) underwent 2-3 times weekly and 104 (43.5%) once weekly dispensation regimens (p<0.001). SVR rates, however, were comparably high between the two treatment periods (167/168 [99.4%] COVID vs. 402/405 [99.3%] pre-COVID according to modified intention-to-treat analysis; p=0.849) and no significant difference concerning missed visits (59 [0.8%] COVID vs. 84 [0.4%] pre-COVID; p=0.239) was recorded.
During COVID, socioeconomic status among the study population was equal or worse as compared to pre-COVID (unemployment: 83.7% vs. 67.3%, p=0.967; homelessness: 38.5% vs. 35.1%, p=0.227; harmful alcohol use: 29.3% vs. 10.7%, p<0.001; ongoing intravenous drug use: 64.0% vs. 57.8%, p=0.616). No treatment interruptions or COVID19-related deaths were observed among the study population.

Conclusion

Individualized DOT featuring extended OAT/DAA distribution intervals resulted in similarly high SVR rates as traditional daily DOT. Hence, the effectiveness of DOT seems to primarily result from the streamlined approach to HCV care comprising low-barrier access to healthcare and DAA treatment via an LTI and is not mainly linked to strict supervision.

Disclosure

C.S. received travel support from Gilead, Abbvie, and Gebro; speaking honoraria from Abbvie and Gilead; and payments for consulting from Gilead.
D.B. received travel support from Gilead and AbbVie; speaking honoraria from AbbVie and Siemens and grant support from Gilead and AbbVie.
E.G. received travel support from Gilead, Abbvie.
T.R. received grant support from Abbvie, Boehringer- Ingelheim, Gilead, MSD, Philips Healthcare, Gore; speaking honoraria from Abbvie, Gilead, Gore, Intercept, Roche, MSD; consulting/advisory board fee from Abbvie, Bayer, Boehringer-Ingelheim, Gilead, Intercept, MSD, Siemens; and travel support from Boehringer-Ingelheim, Gilead, and Roche.
M.G. received grant support from Abbvie, Gilead and MSD; speaking honoraria from Abbvie, Gilead, Intercept, Janssen, BMS, Roche, Norgine, AstraZeneca, Falk, Shionogi, and MSD; consulting/advisory board fees from Abbvie, Gilead, Intercept, Janssen, BMS, Roche, Alnylam, Norgine, AstraZeneca, Falk, Shionogi and MSD; and travel support from Abbvie and Gilead.

HCV MICROELIMINATION THROUGH INDIVIDUALIZED INTERVALS FOR DIRECTLY OBSERVED THERAPY - A STREAMLINED APPROACH TO HCV CARE FOR PWID

Caroline Schwarz 1, Angelika Schütz 2, David Bauer 1, Enisa Gutic 3, Thomas Reiberger 4, Hans Haltmayer 2, Michael Gschwantler 5

1 Klinik Ottakring, Vienna, Austria|||Medical University of Vienna, Vienna, Austria

2 Suchthilfe Wien gGmbH, Vienna, Austria

3 Klinik Ottakring, Vienna, Austria

4 Medical University of Vienna, Vienna, Austria

5 Klinik Ottakring, Vienna, Austria|||Sigmund Freud University, Vienna, Austria

Conference

UEG Week Vienna 2024

Topics

Hepatobiliary

Submission format

Abstract

Session

LIVER (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

UEG Presentation

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INSIGHT FROM THE AUSTRIAN HEPATITIS D REGISTRY: INCREASING RESPONSE RATES TO BULEVIRTIDE-BASED REGIMENS DESPITE HIGH BURDEN OF CIRRHOSIS AND PORTAL HYPERTENSION

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Introduction

Chronic infection with the hepatitis D virus (HDV) may lead to rapid progression towards liver cirrhosis and portal hypertension. For this study, we characterized the cohort of Austrian HDV patients and their response to bulevirtide (BLV) treatment.

Aims & Methods

We included anti-HDV positive patients who visited one of six participating Austrian hepatology centers from 2020 onwards. At baseline (BL), demographic, clinical and laboratory data, endoscopy and imaging reports, liver stiffness measurement (LSM) and liver steatosis assessment (using controlled attenuation parameter, CAP) were recorded. If available, hepatic venous pressure gradient (HVPG) and histologic assessment of liver biopsies were included. In a subset of patients, single nucleotide polymorphisms (SNPs) in IL28B, PNPLA3, SERPINA1 and NTCP were assessed. Patients without BLV treatment were characterized at last contact. Patients who received treatment with BLV were evaluated for biochemical response (BR, defined by normalization of ALT), virological response (VR, negative HDV RNA PCR or ≥2log decline in viral load), or combined response (CR, meeting both BR+VR) every 24 weeks (W24, W48, W72, W96).

Results

Overall, 84 anti-HDV positive patients were included (median age 45.5 years [IQR 37-56), 58.3% male, median BMI 25.0 [IQR 21.4-29.0]), of which 59 (70.2%) had detectable HDV RNA. Nine (10.7%) patients reported daily alcohol intake. Eleven (13.1%) patients were coinfected with HIV and 17 (20.2%) had anti-HCV antibodies. A LSM ≥10 kPa was found in 36 (54.4% of 66) of patients and ≥25 kPa in 9 (13.6%). Liver biopsy showed F4 fibrosis in 19 (52.8% of 36) of patients. Esophageal varices were found in 15/61 (15.4%) in endoscopy and 12/50 (19.4%) had signs of portal hypertension on imaging reports. Median HVPG was 10 mmHg (IQR 6.75-15.5, n=28) and eleven (13.1%) patients were decompensated at baseline. Median MELD was 8 points (IQR 6-10). No polymorphisms were found regarding SERPINA1 or NTCP, while for PNPLA3 we found C/C n=15 (37.5%), C/G n=22 (55.0%) and G/G n=3 (7.5%); and for IL28B we found C/C n=17 [49.9%], C/T n=16 (43.2%) and T/T n=4 (10.8%).
Of 59 viremic patients, 50 were started on treatment with BLV (median treatment duration 17 [7.5-24] months). BR rates at W24, W48, and W96 were 27/46 (58.7%), 28/38 (73.7%), and 16/22 (72.7%). VR rates at M6, M12, and M24 were 15/46 (32.6%), 24/38 (63.2%), and 15/22 (68.2%). CR rates at M6, 12, and M24 were 10/46 (21.7%), 18/38 (47.4%), and 11/22 (50.0%). At W48 BLV treatment led to a decline of ALT (p<0.001), HDV RNA (p<0.001), and LSM (p < 0.006).
SNPs in either PNPLA3 or IL28B did not affect treatment outcomes. Ten patients who achieved clearance of HDV discontinued BLV, of which 4 relapsed and were restarted on BLV. Pegylated interferon alfa-2a was added to BLV treatment in 13 (26%) patients after a median of 10 (7-18) months. During follow-up, three (3.6%) patients – all without BLV treatment - were diagnosed with hepatocellular carcinoma and overall, five (6.0%) patients died, of which four deaths were liver-related.

Conclusion

Our Austrian HDV patient cohort showed a substantial burden of cirrhosis and signs of portal hypertension – still we observed high and steadily increasing rates of virologic and biochemical response to BLV treatment. Liver stiffness – as a surrogate of the risk for liver-related events – decreased significantly at W48.

Disclosure

M.P., M.Str., A.F.S., S.R., A.M., L.D., E.A. have nothing to disclose.
M.S. received travel support from MSD, Sandoz, BMS, AbbVie and Gilead; and speaking honoraria from BMS and Gilead.
C.S. received travel support from Gilead, Abbvie, Galápagos, and Gebro; speaking honoraria from Abbvie and Gilead; and payments for consulting from Gilead.
D.B. received travel support from Gilead and AbbVie; speaking honoraria from AbbVie and Siemens and grant support from Gilead and AbbVie.
A.M. received grant support from Abbvie and Gilead; speaking honoraria from Abbvie, Gilead, Janssen, Roche, Intercept, and MSD; consulting/advisory board fees from Abbvie, Gilead, Janssen, Roche, Intercept, Norgine, and MSD; and travel support from Abbvie, Gilead and Roche.
M.T. served as a speaker and/or consultant and/or advisory board member for Albireo, BiomX, Falk, Boehringer Ingelheim, Bristol-Myers Squibb, Falk, Genfit, Gilead, Intercept, Janssen, MSD, Madrigal, Novartis, Phenex, Pliant, Regulus, and Shire, and received travel support from AbbVie, Falk, Gilead, and Intercept, as well as grants/research support from Albireo, Alnylam, Cymabay, Falk, Gilead, Intercept, MSD, Takeda, and UltraGenyx. He is also co-inventor of patents on the medical use of 24-norursodeoxycholic acid filed by the Medical Universities of Graz and Vienna.
M.M. served as a speaker and/or consultant and/or advisory board member for AbbVie, Collective Acumen, Echosens, Gilead, Takeda, and W. L. Gore & Associates and received travel support from AbbVie and Gilead.
H.Z. has received grant support and honoraria for lecturing and consulting fees from Vifor, the manufacturer of ferric carboxymaltose.
M.G. received grant support from Abbvie, Gilead, and MSD; speaking honoraria from Abbvie, Gilead, Janssen, Roche, Intercept, and MSD; consulting/advisory board fees from Abbvie, Gilead, Janssen, Roche, Intercept, Norgine, AstraZeneca, Falk, Shionogi, and MSD; and travel support from Abbvie and Gilead.
T.R. served as a speaker and/or consultant and/or advisory board member speaking honoraria from AbbVie, Bayer, Boehringer-Ingelheim, Gilead, Intercept, MSD, Roche, Siemens, and W. L. Gore & Associates and received travel support from AbbVie, Boehringer-Ingelheim, Gilead, and Roche as well as grants/research support from AbbVie, Boehringer-Ingelheim, Gilead, Intercept, MSD, Myr Pharmaceuticals, Philips Healthcare, Pliant, Siemens, and W. L. Gore & Associates.
M.J. served as a speaker and/or consultant for Gilead.

INSIGHT FROM THE AUSTRIAN HEPATITIS D REGISTRY: INCREASING RESPONSE RATES TO BULEVIRTIDE-BASED REGIMENS DESPITE HIGH BURDEN OF CIRRHOSIS AND PORTAL HYPERTENSION

Michael Schwarz 1, Caroline Schwarz 2, David Bauer 2, Marlene Panzer 3, Michael Strasser 4, Silvia Reiter 5, Livia Dorn 6, Andreas Maieron 6, Alexander Moschen 5, Elmar Aigner 4, Michael Trauner 1, Albert Friedrich Stättermayer 1, Mattias Mandorfer 1, Heinz Zoller 3, Michael Gschwantler 7, Thomas Reiberger 1, Mathias Jachs 1

1 Medical University of Vienna, Vienna, Austria

2 Medical University of Vienna, Vienna, Austria|||Klinik Ottakring, Vienna, Austria

3 Medical University of Innsbruck, Innsbruck, Austria

4 Paracelsus Medical University, Salzburg, Austria

5 Johannes Kepler University, Linz, Austria

6 Karl Landsteiner University of Health Sciences, University Hospital of St. Pölten, Sankt Pölten, Austria

7 Klinik Ottakring, Vienna, Austria

Event

UEG Week Vienna 2024

Topics

Hepatobiliary Radiology & Imaging

Submission format

Abstract

Session

Trends in hepatology: From diagnosis to treatment

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

UEG Presentation

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Smart choices in systemic HCC therapy

Anna Saborowski 1

1 Hannover Medical School, Hannover, Germany

Event

UEG Postgraduate Teaching Programme Berlin 2025

Topics

Digestive Oncology Hepatobiliary

Session

Hepatocellular carcinoma: All you need to know

Citation

United European Gastroenterology Journal 2025; 13 (Supplement 8)

Published

2025

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Introduction

Despite the increased risk for hepatitis C virus (HCV) infection among people experiencing homelessness (PEH), tailored HCV elimination efforts are currently lacking as this population is often not covered by health insurance. We present the first Austrian HCV elimination project for PEH and people without health insurance (PHI).

Aims & Methods

"neunerhaus", a low-threshold facility providing health care, support by social workers, and housing for >5.000 PEH and PHI per year in Vienna, served as a platform for this project. From March 2020, all PEH and PHI using one of the services offered by neunerhaus had the opportunity to receive serological antiHCV screening directly on-site. AntiHCV(+) blood samples were automatically tested for HCV-RNA via PCR (reflex testing). Through the establishment of an on-site hepatology service at neunerhaus, HCV-viremic individuals received treatment with direct-acting antiviral agents (DAA). For the duration of DAA therapy, housing (PEH) was provided by neunerhaus while DAA treatment (PHI) was kindly provided by Abbvie and Gilead. Through social workers as well as at the neunerhaus housing facilities, PEH and PHI received support in DAA adherence.

Results

Serologic antiHCV screening was performed in 601 persons between March 2020 and July 2023, among whom 116 (19.3%) showed antiHCV(+). Negative HCV-RNA PCR results indicated HCV clearance in 24/116 (20.7%), while 92 (79.3%) individuals remained HCV viremic (HCV-RNA+). Among the 92 viremic patients, 36 (39.1%) already started DAA and 21/36 (58.3%) finished treatment. Sustained virologic response (SVR) was documented in 17/21 (81.0%) patients and in 4 (19.0%) post-treatment follow-up remains pending. No treatment interruptions were recorded among the study population.

Conclusion

Despite COVID19-related restrictions affecting most of the study period, a relevant number of underprivileged PEH and PHI underwent HCV screening through this project. HCV viremia was found in 15.3% of the overall cohort, underlining the need for specific HCV elimination strategies for PEH and PHI as an underserved population.
Furthermore, our data demonstrate the effectiveness of streamlined DAA therapy for PEH and PHI, provided that safe housing for the duration of therapy, support through social workers, and low-barrier health care are available.
Future HCV elimination strategies should include underserved populations such as PEH and PHI in whom HCV prevalence remains alarmingly high despite the availability of DAA treatment.

Disclosure

C.S. received travel support from Gilead, Abbvie, and Gebro; speaking honoraria from Abbvie and Gilead; and payments for consulting from Gilead.
E.G. received travel support from Gilead, Abbvie.
T.R. received grant support from Abbvie, Boehringer- Ingelheim, Gilead, MSD, Philips Healthcare, Gore; speaking honoraria from Abbvie, Gilead, Gore, Intercept, Roche, MSD; consulting/advisory board fee from Abbvie, Bayer, Boehringer-Ingelheim, Gilead, Intercept, MSD, Siemens; and travel support from Boehringer-Ingelheim, Gilead, and Roche.
M.G. received grant support from Abbvie, Gilead and MSD; speaking honoraria from Abbvie, Gilead, Intercept, Janssen, BMS, Roche, Norgine, AstraZeneca, Falk, Shionogi, and MSD; consulting/advisory board fees from Abbvie, Gilead, Intercept, Janssen, BMS, Roche, Alnylam, Norgine, AstraZeneca, Falk, Shionogi and MSD; and travel support from Abbvie and Gilead.

EXTENDING HCV ELIMINATION EFFORTS TO UNDERSERVED POPULATIONS - A VIENNESE APPROACH FOR HCV CARE AMONG HOMELESS PEOPLE WITHOUT HEALTH INSURANCE

Caroline Schwarz 1, Bernadette Becsi 2, Stephan Leick 2, Stephan Gremmel 2, Lena Wien 3, Enisa Gutic 4, Thomas Reiberger 5, Hans Haltmayer 6, Michael Gschwantler 7

1 Medical University of Vienna, Vienna, Austria|||Klinik Ottakring, Vienna, Austria

2 neunerhaus Health Care Center, Vienna, Austria

3 Sigmund Freud University, Vienna, Austria

4 Klinik Ottakring, Vienna, Austria

5 Medical University of Vienna, Vienna, Austria

6 Suchthilfe Wien gGmbH, Vienna, Austria

7 Klinik Ottakring, Vienna, Austria|||Sigmund Freud University, Vienna, Austria

Conference

UEG Week Vienna 2024

Topics

Hepatobiliary

Submission format

Abstract

Session

LIVER (Posters)

Citation

United European Gastroenterology Journal 2024; 12 (Supplement 8)

Published

2024

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Introduction

To achieve the WHO’s goal of eliminating hepatitis C by 2030, higher rates of detection of people infected with the hepatitis C virus (HCV) and of treatment uptake are needed. The ELIMINATE (ELIMINation of HCV in AusTria East) project is an Austrian HCV macroelimination program that utilized readily available hospital laboratory data to identify patients with a “last positive” HCV RNA PCR, who are thus potentially still viremic, to contact them and to allow re-linkage to medical care.

Aims & Methods

Ten major liver centers in Eastern Austria participated. A systemic readout of HCV RNA PCR tests obtained between 2008 and 2020 from the respective hospital’s database was conducted and between 2020 and 2023 identified people living with HCV were contacted by phone and, if unsuccessful, by letter. Patients were informed of the possibility of effective treatment via direct-acting antivirals (DAAs) and were offered a pre-treatment evaluation at the respective center.

Results

Overall, 5,695 individuals with „last positive” HCV RNA were identified (62.5% male, mean age 57.3±17.3 years). At the time of data acquisition, 1,931 (34%) had already died (33.8% liver-related deaths) and 759 (13%) had no valid contact information. At the time of recall, 1,171 (40.0%) of the 3,005 remaining patients had already achieved sustained virologic response (SVR). We successfully contacted 617 (20.5%) eligible patients, of whom 417 (67.6%) attended a pre-treatment evaluation visit. DAA therapy was started in 397 (64.3%) patients (median time from “last positive” PCR to initiation of DAA treatment: 59.8 months). As of now, SVR was confirmed in 258 patients (SVR rate 65.0%).

Conclusion

Through the ELIMINATE project we were able to identify 5,695 potentially still viremic individuals. Invalid contact information was a barrier to re-linkage to care and the amount of already diseased patients underlined the severity of the disease and the impact of potentially associated comorbidities. A systematic readout of hospitals’ HCV PCR records represents an effective macroelimination strategy to identify patients regardless of risk behavior.

Disclosure

L.D., M.J., L.H., L.W., N.P., B.H., A.S., R.S., A.V.-G., W.H., M.W., K.K., S.J.-S., S.T., W.K., C.M., L.A., L.Bu., G.W., F.R., H.L., J.H., C.W., J.W.-W., P.W., M.N., D.S., J.R. and S.R. have nothing to disclose outside of the submitted work.
L.B. received speaking honoraria from Chiesi, and Gilead.
M.S. received travel support from MSD, Sandoz, BMS, AbbVie and Gilead; and speaking honoraria from BMS and Gilead.
D.C. served as a speaker and/or advisory board member for Gilead, ViiV Healthcare and MSD and received travel support from MSD, ViiV Healthcare, and Gilead.
M.M. served as a speaker and/or consultant and/or advisory board member for AbbVie, Collective Acumen, Echosens, Gilead, Takeda, and W. L. Gore & Associates and received travel support from AbbVie and Gilead.
M.G. received grant support from Abbvie, Gilead, and MSD; speaking honoraria from Abbvie, Gilead, Janssen, Roche, Intercept, and MSD; consulting/advisory board fees from Abbvie, Gilead, Janssen, Roche, Intercept, Norgine, AstraZeneca, Falk, Shionogi, and MSD; and travel support from Abbvie and Gilead.
A.M. received grant support from Abbvie and Gilead; speaking honoraria from Abbvie, Gilead, Janssen, Roche, Intercept, and MSD; consulting/advisory board fees from Abbvie, Gilead, Janssen, Roche, Intercept, Norgine, and MSD; and travel support from Abbvie, Gilead and Roche.
T.R. served as a speaker and/or consultant and/or advisory board member speaking honoraria from AbbVie, Bayer, Boehringer-Ingelheim, Gilead, Intercept, MSD, Roche, Siemens, and W. L. Gore & Associates and received travel support from AbbVie, Boehringer-Ingelheim, Gilead, and Roche as well as grants/research support from AbbVie, Boehringer-Ingelheim, Gilead, Intercept, MSD, Myr Pharmaceuticals, Philips Healthcare, Pliant, Siemens, and W. L. Gore & Associates.
D.B. received travel support from Gilead and AbbVie; speaking honoraria from AbbVie and Siemens and grant support from Gilead and AbbVie.
C.S. received travel support from Gilead, Abbvie, Galápagos, and Gebro; speaking honoraria from Abbvie and Gilead; and payments for consulting from Gilead.