Chronic Hepatitis C in patients with no or minimal liver fibrosis MedDRA version: 18.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Harvoni
Product Name: Harvoni
Pharmaceutical Form: Tablet
INN or Proposed INN: Sofosbuvir
CAS Number: 1190307-88-0
Other descriptive name: SOFOSBUVIR
Concentration unit: mg milligram(s)
Co
Sponsors
Department of infectious Diseases, Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Persons followed in a drug treatment center in the trial • Chronic hepatitis C (HCV RNA quantifiable by PCR testing on at least 2 occasions within the last 2 years) • Age 18-49 • Fibroscan =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria • Risk of noncompliance with study as judged by drug treatment center and study team. • Insufficient venous access • Clinical signs of cirrhosis (liver biopsy not required), or cirrhosis suspected by blood tests. • Contraindication to treatment with study drugs o Unstable psychiatric disease (Active psychotic or severe untreated depression) o Pregnancy o Breastfeeding o Refusal to use contraceptives o Use of medication which are strong P- Glycoprotein inducers ( see appendix 3 for Harvoni SmPC or section 6.3 on Harvoni)) o Unstable heart disease (heart failure or severe arythmia in last 3 months o Untreated or uncontrolled epilepsy ( seizure last 6 months) o Unstable thyroid disease ( TSH and T4 out of range) o Untreated Hypertension o Retinopathy o Allergy to study drug or components. • Autoimmune liver disease • Unable to understand Danish • Co-infection with Hepatitis B or HIV • Any other significant clinical illness deemed to interfere with response to treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the percentage of subjects achieving a 12-week sustained virological response, SVR 12 (HCV RNA below lower limit of quantification at week 12 after end of treatment) after 4 weeks of treatment with either Ledipasvir/Sofosbuvir and ribavirin or Ledipasvir/Sofosbuvir, ribavirin and interferon alpha 2a.;Secondary Objective: To compare the percentage of subjects achieving a 24-week sustained virological response at post treatment, SVR 12 (HCV RNA below LLOQ) after 4 weeks of treatment with Ledipasvir/Sofosbuvir and ribavirin with or without interferon alpha 2a. To evaluate the drop out rate due to non medical reasons Describe and compare the proportion of patients achieving HCV RNA < LLOQ by day 7, day 14, day 21, end of treatment (day 28) and post treatment week 4 and its relation to SVR 12. Describe the mean time to below LLOQ HCV RNA achieved by treatment group To demonstrate the feasibility of delivering HCV treatment at a Drug Treatment Center ;Primary end point(s): HCV RNA in serum measured by PCR at 12 weeks post treatment by intention to treat (ITT) analysis. ;Timepoint(s) of evaluation of this end point: 12 week after completed treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): HCV RNA in serum measured by PCR at 24 weeks post treatment by intention to treat (ITT) analysis. Dropout rate for nonmedical reasons (To demonstrate the feasibility of delivering HCV treatment at a Drug Treatment Center) SVR12 and 24 by per protocol analysis Proportion of patients with undetectable HCV RNA and HCVRNA< 25 IU/ml by day 7, day 14 and day 21, end of treatment (day 28) and 4 weeks post treatment ( SVR 4) Mean time to below LLOQ HCV RNA achieved by treatment group ;Timepoint(s) of evaluation of this end point: End of trial for all | — |
Countries
Denmark
Contacts
Public ContactAnne Øvrehus
Department of infectious Diseases, Odense University Hospital
Outcome results
None listed