Z Gastroenterol 2020; 58(05): e99
DOI: 10.1055/s-0040-1712311
Hepatologie

Directly observed therapy for hepatitis C with sofosbuvir/velpatasvir alongside opioid substitution as an effective micro elimination strategy in PWIDs at high risk of non-adherence to antiviral therapy - real world data from Vienna, Austria

C Schmidbauer
1   Wilhelminenspital, 4. Med. Abteilung, Vienna, Austria
2   Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie, Vienna, Austria
3   Vienna HIV & Liver Study Group, Vienna, Austria
,
R Schubert
4   Suchthilfe Wien gGmbH, Ambulatorium Suchthilfe Wien, Vienna, Austria
,
A Schütz
4   Suchthilfe Wien gGmbH, Ambulatorium Suchthilfe Wien, Vienna, Austria
,
C Schwanke
4   Suchthilfe Wien gGmbH, Ambulatorium Suchthilfe Wien, Vienna, Austria
,
E Gutic
1   Wilhelminenspital, 4. Med. Abteilung, Vienna, Austria
,
M Schwarz
1   Wilhelminenspital, 4. Med. Abteilung, Vienna, Austria
2   Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie, Vienna, Austria
3   Vienna HIV & Liver Study Group, Vienna, Austria
,
R Pirker
1   Wilhelminenspital, 4. Med. Abteilung, Vienna, Austria
,
T Lang
1   Wilhelminenspital, 4. Med. Abteilung, Vienna, Austria
,
T Reiberger
2   Medizinische Universität Wien, Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie, Vienna, Austria
3   Vienna HIV & Liver Study Group, Vienna, Austria
,
H Haltmayer
4   Suchthilfe Wien gGmbH, Ambulatorium Suchthilfe Wien, Vienna, Austria
,
M Gschwantler
1   Wilhelminenspital, 4. Med. Abteilung, Vienna, Austria
5   Sigmund Freud Universität, Vienna, Austria
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Background We evaluated the effectiveness of sofosbuvir/velpatasvir (SOF/VEL) in difficult-to-treat persons who inject drugs (PWIDs) with presumed “borderline compliance” using an innovative concept involving their opioid substitution therapy (OST) facility.

Methods N = 273 patients (m/f: 201/72; median age: 44.7 (IQR 17.0) years; HCV-genotype (GT) 1/2/3/4: 134/6/115/10, GT3: 42.1 %; cirrhosis: n = 96; 35.2 %) treated with SOF/VEL were included. PWIDs at high risk for non-adherence to DAA therapy received HCV treatment together with their OST under the supervision of medical staff (“directly observed therapy”, DOT). The effectiveness of SOF/VEL given as DOT in PWIDs with presumed “borderline compliance” was compared to patients with presumed “sufficient compliance” in the “standard setting” (SS) of SOF/VEL prescription at a tertiary care center and self-managed SOF/VEL intake at home. Treatment duration was 12 weeks according to the SOF/VEL drug label.

Results DOT-patients (n = 168) were younger than SS-patients (n = 105) (median: 41.3 (IQR 13.5) vs. 53.8 (IQR 14.7) years), all had psychiatric co-morbidities and most had a poor socioeconomic status. 91/168 (54.2 %) reported ongoing intravenous drug use (IDU). By time of abstract submission, SVR was achieved in 100 % according to mITT analysis (n = 94/94), while n = 74/273 (44.0 %) remain under surveillance. 6 patients showed HCV reinfection during follow-up.SS-patients achieved SVR in 93.8 % according to mITT analysis (n = 76/81) with n = 10/105 patients being lost to FU and n = 14/105 remaining under surveillance. 3 patients experienced HCV relapse during treatment with SOF/VEL and n = 2 died for reasons not related to therapy. No reinfections were recorded in the SS-group.

Conclusion SOF/VEL given as DOT along with OST in PWIDs at high risk of non-adherence to antiviral therapy resulted in excellent SVR rates. Despite some reinfections, DAA treatment using the concept of DOT represents an effective HCV-elimination strategy among PWIDs on OST.



Publication History

Article published online:
26 May 2020

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