Theme: Clinical Research Year: 2019
Background: A subgroup of people who inject drugs (PWID) receiving opioid agonist therapy (OAT)
cannot be treated at hepatological centers. In these patients, chronic hepatitis C might ideally be
managed at low-threshold facilities and if direct-acting antivirals (DAA) were administered together
Method: 300 PWID on stable OAT with chronic hepatitis C and high risk for non-adherence to DAAtherapy (male/female: 228/72; mean age: 38.0 ± 8.3 years; genotype (GT) 1/2/3/4: 178/3/109/7
(unknown: n=3); HIV-coinfection: n=18; liver cirrhosis: n=60) started antiviral treatment. Patients
received antiviral therapy together with OAT under direct observation of a pharmacist, physician or
nurse at a pharmacy or low-threshold facility. The DAA-regimen was selected according to GT,
fibrosis stage, pretreatment and current reimbursement policy of insurances.
Results: Following this concept, adherence to therapy was excellent: Only 0.15% of scheduled dates
for ingestion were missed by the 300 patients. Till now, 214 patients have completed treatment and
a 12-week follow-up period. Virological cure of hepatitis C infection (SVR12) could be confirmed in
213/214 patients (SVR12 rate: 99.5%; 95% CI: 97.3-99.9). One patient died 8 weeks after end of
therapy for reasons not related to treatment. During follow-up, reinfections occured in 12/214 (5.6%)
patients. The cumulative rate of reinfection 24 and 48 weeks after end of therapy was 5.3% and
Conclusion: Directly observed therapy of chronic hepatitis C is highly effective in PWID with ongoing
intravenous drug use and a high risk for non-adherence to DAA. By this concept, a group of difficultto-treat patients can be cured, who could not have been treated in settings of studies published so
Disclosure of Interest Statement: Michael Gschwantler has received lecture fees from AbbVie, MSD,
Bristol-Myers Squibb, Gilead and Janssen and is an advisory board member of AbbVie, MSD, BristolMyers Squibb, Gilead and Janssen; he has received grants from AbbVie, Gilead and MSD.
All other authors have no conflicts of interest.