Interim Results Of An Ongoing Project To Eradicate HCV In People Who Inject Drugs At Risk For Non-Adherence To Direct-Acting Antivirals In Vienna

Author: Schubert R, Schütz A, Schwanke C, Luhn J, Gutic E, Lang T, Haltmayer H, Gschwantler M

Theme: Clinical Research Year: 2018

Background: An important subgroup of people who inject drugs (PWID) receiving opioid agonist therapy (OAT), cannot be treated in the setting of a hepatologic center and would not regularly ingest their medication when handed to them for self-administration at home. Our hypothesis was that chronic hepatitis C in these patients could be ideally managed if modern regimens were administered together with OAT under direct observation at a pharmacy or a low-threshold facility. Method: 208 PWID on stable OAT with chronic hepatitis C and high risk for non-adherence to DAAtherapy (male/female: 159/49; mean age: 38.4 ± 8.3 years; genotype (GT) 1/2/3/4: 126/2/73/6 (not definable: n = 1); HIV-coinfection: 14 patients; liver cirrhosis: 42 patients) started treatment. Patients received antiviral therapy together with OAT under direct observation 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 of directly observed therapy, adherence to antiviral therapy was excellent: Only 0.15% of scheduled dates for ingestion of antiviral therapy in combination with OAT were missed by the patients. Till now, 153 patients have completed treatment and a 12- week follow-up period. Virological cure of hepatitis C infection (SVR12) could be confirmed in all 153 patients (SVR12 rate: 100%, 95% CI: 97.6-100.0). During follow-up reinfections occurred in 10 patients. The cumulative rate of reinfection 12, 24 and 48 weeks after end of therapy was 2.0%, 5.6%, and 11.1%, respectively. Conclusion: Directly observed therapy of chronic hepatitis C at a pharmacy or a low-threshold facility is highly effective in PWID at risk for non-adherence to DAA. By this new concept, a group of difficult-to-treat patients can be cured, who could not have been treated in settings of studies published so far. In our cohort the rate of reinfection was relatively low. 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, Bristol-Myers Squibb, Gilead and Janssen; he has received grants from AbbVie, Gilead and MSD. All other authors have no conflicts of interest

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