Directly observed therapy for HCV with glecaprevir/pibrentasvir alongside opioid substitution in people who inject drugs-First real world data from Austria

PLoS One. 2020 Mar 10;15(3):e0229239. doi: 10.1371/journal.pone.0229239. eCollection 2020.

Abstract

Background: Directly acting antivirals (DAA) against hepatitis C virus (HCV) infection have facilitated sustained virologic response (SVR) rates >90% in clinical studies. Yet, real life data regarding DAA treatment in people who inject drugs (PWIDs) are scarce. We evaluated the effectiveness of glecaprevir/pibrentasvir (G/P) in difficult-to-treat PWIDs with presumed high risk of non-adherence to DAA therapy using the concept of directly observed therapy involving their opioid substitution therapy (OST) facility.

Methods: N = 145 patients (m/f: 91/54; median age: 41.1 (IQR 19.5) years; HCV-genotype (GT) 1/2/3/4: 82/1/56/5, GT3: 38.6%; cirrhosis: n = 6; 4.1%) treated with G/P 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 G/P given as DOT in PWIDs with presumed high risk of non-adherence to DAA therapy was compared to patients with suspected "excellent compliance" in the "standard setting" (SS) of G/P prescription at a tertiary care center and self-managed G/P intake at home. Treatment duration was 8-16 weeks according to the G/P drug label.

Results: DOT-patients (n = 74/145; 51.0%) were younger than SS-patients (median 38.7, IQR 12.5 vs. median 50.6, IQR 20.3 years), all had psychiatric co-morbidities and most had a poor socioeconomic status. 50/74 (67.6%) reported ongoing intravenous drug use (IDU). SVR was achieved in n = 70/74 (94.6%) patients with n = 3 being lost to follow-up (FU) and n = 1 showing nonresponse to therapy. SS-patients achieved SVR in 97.2% (69/71) with n = 1 patient being lost to FU and n = 1 patient with GT3 showing HCV relapse.

Conclusion: G/P given as DOT along with OST in PWIDs with high risk of non-adherence to DAA therapy resulted in similarly high SVR rates (94.6%) as in patients with presumed "excellent compliance" under standard drug intake.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Austria
  • Benzimidazoles / administration & dosage*
  • Benzimidazoles / therapeutic use
  • Directly Observed Therapy / methods*
  • Drug Combinations
  • Female
  • Hepatitis C, Chronic / drug therapy*
  • Humans
  • Male
  • Medication Adherence
  • Middle Aged
  • Opiate Substitution Treatment / methods*
  • Patient Compliance
  • Pyrrolidines / administration & dosage*
  • Pyrrolidines / therapeutic use
  • Quinoxalines / administration & dosage*
  • Quinoxalines / therapeutic use
  • Social Class
  • Substance Abuse, Intravenous / drug therapy*
  • Sulfonamides / administration & dosage*
  • Sulfonamides / therapeutic use
  • Sustained Virologic Response
  • Treatment Outcome
  • Young Adult

Substances

  • Benzimidazoles
  • Drug Combinations
  • Pyrrolidines
  • Quinoxalines
  • Sulfonamides
  • glecaprevir and pibrentasvir

Grants and funding

There was no specific funding for this study. However, the following authors are employed by Suchthilfe Wien gGmbH: • Raphael Schubert • Angelika Schütz • Cornelia Schwanke • Julian Luhn • Hans Haltmayer Suchthilfe Wien gGmbH represents a governmental non-profit organization financed by the City of Vienna and the Austrian Ministry of Health. Suchthilfe Wien gGmbH did not play a role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript and only provided financial support in the form of authors’ salaries. This does not alter our adherence to PLOS ONE policies on sharing data and materials. Suchthilfe Wien gGmbH provided support in the form of salaries for authors [Raphael Schubert, Angelika Schütz, Cornelia Schwanke, Julian Luhn, Hans Haltmayer], but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.