Direct observed therapy of chronic Hepatitis C with an interferon-free all-oral regimen at a low-threshold drug treatment facility – a new concept for treatment of patients with borderline compliance receiving Opioid substitution therapy

Background: Patients receiving opioid substitution therapy represent an important subgroup of patients with chronic hepatitis C. Many of these patients suffer from psychiatric comorbidities and thus have contraindications against interferon-based treatment. Furthermore, a significant number of them have a borderline compliance and hence are reluctant to go to specialized hepatitis centers.

Patients and Methods: In patients with borderline compliance receiving their opioid substitution therapy at a low-threshold drug treatment facility on a daily basis, modern direct acting antivirals against hepatitis C are applied together with the opioid substitution therapy under direct observation of a physician or nurse.

Results: So far, three patients, including one female (age: 41 years) and two male (age: 46 and 37 years, respectively), have started treatment with an all-oral regimen. All three patients had liver cirrhosis (CHILD-PUGH class A) and were infected with genotype 3. One of the male patients was coinfected with HIV. Treatment consisted of sofosbuvir 400 mg o.d. plus daclatasvir 60 mg o.d. (two patients) or daclatasvir 30 mg o.d. (in the HIV-coinfected patient, because of drug-interactions with the comedication). The planned treatment duration was 24 weeks. So far the patients have completed 24, 21 and 14 weeks of treatment, respectively. The first negative PCR was obtained after one week of treatment in the female patient and after six and seven weeks in the two male patients, respectively. Not one single scheduled date for ingestion of the antiviral therapy in combination with the substitution therapy was missed by any of the patients.

Conclusions: Direct observed therapy of chronic hepatitis C with an interferon-free all-oral regimen at a low-threshold drug treatment facility seems to be a promising new concept for treatment of patients with borderline compliance receiving opioid substitution therapy. A project to test this approach in a larger cohort of patients is planned.