Directly observed therapy at opioid substitution facilities using sofosbuvir/velpatasvir results in excellent SVR12 rates in PWIDs at high risk for non-adherence to DAA therapy.

Background & Aims: We evaluated the effectiveness of sofosbuvir/velpatasvir (SOF/VEL) in difficult-to-treat PWIDs with presumed high risk for non-adherence to antiviral therapy using an innovative concept involving their opioid agonist therapy (OAT) facility.
Methods: N = 221 patients (m/f: 168/53; median age: 44.7 years (IQR 16.9); HCV-genotype 3: 45.2%; cirrhosis: 33.9%) treated with SOF/VEL were included. PWIDs at high risk for non-adherence to DAA therapy (n = 122) received HCV treatment alongside OAT under the supervision of medical staff ("directly observed therapy", DOT). These patients were compared to patients with presumed excellent drug compliance, who were treated in a "standard setting" (SS) of SOF/VEL prescription at a tertiary care center (n = 99).
Results: DOT-patients (n = 122/221; 55.2%) were younger than SS-patients (median age: 41.3 vs. 53.0 years), all had psychiatric comorbidities and most had a poor socioeconomic status. 83/122 (68.0%) reported ongoing intravenous drug use. Within the DOT-group, SVR12 was achieved in 99.1% (95% CI: 95.0-100; n = 109/110) with one patient experiencing treatment failure, while n = 12/122 (9.8%) patients were excluded due to loss of follow-up (FU). 5 patients showed HCV reinfection after achieving SVR12. SS-patients achieved SVR in 96.6% (95% CI: 90.3-99.3%; n = 84/87) after exclusion of 10/99 (10.1%) patients who were lost to FU and 2 patients who died prior to SVR12 due to reasons not related to DAA therapy.
Conclusions: SOF/VEL given as DOT along with OAT in PWIDs at high risk of non-adherence to antiviral therapy including those with ongoing intravenous drug use resulted in excellent SVR rates similar to patients with presumed "excellent compliance" under standard drug intake.
Competing Interests: C. Schmidbauer (schmidbauer.c@gmail.com): received travel support from Gilead, Abbvie and Gebro; and speaking honoraria from Abbvie. M. Schwarz (michael.schwarz@wienkav.at): received travel support from MSD, Sandoz, BMS and Abbvie; and speaking honoraria from BMS. A. Schütz (angelika.schuetz@suchthilfe.at): is employed by Suchthilfe Wien gGmbH and has no conflicts of interest. R. Schubert (raphael.schubert@outlook.at): is employed by Suchthilfe Wien gGmbH and received travel support from Gilead. C. Schwanke (cornelia.schwanke@suchthilfe.at): is employed by Suchthilfe Wien gGmbH and has no conflicts of interest. E. Gutic (enisa.gutic@extern.wienkav.at): received travel support from Gilead and Abbvie. R. Pirker (roxana.pirker@aon.at): no conflicts of interest. T. Lang (tobiaslang1904@gmail.com): no conflicts of interest. T. Reiberger (thomas.reiberger@meduniwien.ac.at): received grant support from Abbvie, Boehringer- Ingelheim, Gilead, MSD, Philips Healthcare, Gore; speaking honoraria from Abbvie, Gilead, Gore, Intercept, Roche, MSD; consulting/advisory board fees from Abbvie, Bayer, Boehringer-Ingelheim, Gilead, Intercept, MSD, Siemens; and travel support from Boehringer-Ingelheim, Gilead and Roche. H. Haltmayer (hans.haltmayer@suchthilfe.at): is employed by Suchthilfe Wien gGmbH and has no conflicts of interest. M. Gschwantler (michael.gschwantler@wienkav.at): received grants from Abbvie, Gilead, MSD; speaking honoraria from Abbvie, Gilead, MSD, Janssen, Roche, Intercept; consulting/advisory board fees from Abbvie, Gilead, MSD, Janssen, Roche, Intercept. This does not alter our adherence to PLOS ONE policies on sharing data and materials.