Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy

• Status: Unknown status
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with chronic hepatitis C that are under opiate substitution therapy are likely to have psychiatric comorbidities such as depression; hence an Interferon based therapy is contraindicated. Additionally many of these patients have a borderline compliance, which makes it impossible to treat them at specialized hepatological centers. An ideal opportunity to treat this patients is treatment with DAAs (Direct Acting Antiviral) which can be administered daily together with the opiate substitution therapy at a low threshold facility.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wilhelminenspital Vienna
• Collaborator: Gilead Sciences
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

Criteria

Inclusion Criteria:

• Chronic genotype 1 HCV infection

• Fibrosis F0-F3 (i.e. non-cirrhotic confirmed by Fibroscan <12.5kPa)

• Stable opiate substitution therapy

• Regular visits at the low threshold facility during the last month

Exclusion Criteria:

• Lack or unwillingness of safe contraception, pregnancy

• Liver cirrhosis (Fibroscan ≥12.5kPa)

• Coinfection with HBV (Hepatitis B Virus) or HIV (coinfection with HIV is excluded only because there are very few coinfected patients under care at the "Ambulatorium Suchthilfe Wien" and hence this subpopulation would be very small)

• Severe comorbidities resulting in a life expectancy of less than five years

• HCC (Hepatocellular carcinoma)