Theme: Clinical Research Year: 2016
DIRECT OBSERVED THERAPY OF CHRONIC HEPATITIS C WITH INTERFERON-FREE ALL-ORAL REGIMENS AT A LOW-THRESHOLD DRUG TREATMENT FACILITY – A NEW CONCEPT FOR TREATMENT OF PATIENTS WITH BORDERLINE COMPLIANCE RECEIVING OPIOID SUBSTITUTION THERAPY
Haltmayer H1, Schütz A1, Marchart K1, Ambrosch S1, Moser S2, Gutic E2, Gschwantler M2.
1Suchthilfe Wien gGmbH, Ambulatorium Suchthilfe Wien and 2Wilhelminenspital, Department of Internal Medicine IV, Vienna, Austria.
Background: An important subgroup of people who inject drugs (PWID) receives opioid substitution therapy (OST) under direct observation of a physician or nurse at a low-threshold drug treatment facility or pharmacy at a daily basis. Most of these patients suffer from psychiatric comorbidities and because of their borderline compliance they are reluctant to go to specialized hepatitis centers. Our hypothesis was that chronic hepatitis C in these difficult-to-treat patients could perfectly be managed if modern, interferon-free regimens were applied together with OST therapy under direct observation of a physician or nurse at a low-threshold drug treatment facility.
Methods: Forty-three PWID with chronic hepatitis C and borderline compliance (male/female: 33/10; mean age: 39.2 ± 9.8 years; genotype (GT) 1/3/4: 32/10/1) started interferon-free treatment of chronic hepatitis C at the “Ambulatorium Suchthilfe Wien” – a low-threshold drug treatment facility in Vienna, Austria. Four patients were coinfected with HIV and 12 had liver cirrhosis. Patients received antiviral treatment together with OST under direct observation of a physician or nurse. For each patient the individual treatment regimen was selected according to current guidelines.
Results: Following this concept of direct observed therapy adherence to antiviral therapy was excellent: Not one single scheduled date, out of 3.034 dates, for ingestion of the antiviral therapy in combination with OST was missed by any of the 43 patients. Till now, 17 patients (male/female: 15/2; mean age: 40.2 ± 7.1 years; GT1/3/4: 12/4/1; liver cirrhosis present in 6 patients) have completed treatment and a 12-week follow-up period. Virologic healing of hepatitis C infection (sustained virologic response, SVR12) could be confirmed in all 17 patients (SVR12-rate: 100%).
Conclusion: Direct observed therapy of chronic hepatitis C with interferon-free all-oral regimens at a low-threshold drug treatment facility represents a promising new concept for treatment of patients with borderline compliance receiving OST.
Disclosure of interest statement:
Michael Gschwantler has participated in advisory boards for Janssen, MSD, BMS, AbbVie and Gilead. He has also served as speaker for Janssen, MSD, BMS, AbbVie and Gilead. All other authors have nothing to disclose.
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