Direct acting antiviral therapy of hepatitis C in Denmark: treatment response, adverse events and resistance associated variants

Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre.0 sites111 target enrollmentJune 10, 2015

ConditionsPatients with chronic hepatitis C MedDRA version: 19.1Level: LLTClassification code 10074391Term: Chronic hepatitis C virus genotype 1System Organ Class: 100000004862 Therapeutic area: Diseases [C] - Virus Diseases [C02]

DrugsHarvoni Sovaldi Viekirax PAK Daklinza Rebetol Epclusa

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with chronic hepatitis C
Sponsor: Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre.
Enrollment: 111
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 10, 2015

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Department of Infectious Diseases, Copenhagen University Hospital, Hvidovre.

Eligibility Criteria

Inclusion Criteria

•Patients of both sexes between 18\-70 years
•Patients are followed at one of the 18 departments affiliated with DANHEP, diagnosed with chronic HCV infection (verified by real\-time PCR as the presence of HCV RNA in two blood samples taken 6 months apart).
•Treatment\-naïve or previous treatment with pegylated interferon / ribavirin or discontinuing treatment with pegylated interferon / ribavirin / telaprevir / boceprevir due to side effects.
•Treatment demanding chronic hepatitis C virus infection.
•Liver biopsy or Fibroscanning showing moderate to severe fibrosis (Metavir \=F2 score) or cirrhosis. Liver fibrosis or cirrhosis examined by liver biopsy ranked by the Danish scoring system based on the Metavir scoring system, where stage F2 indicate moderate fibrosis stage F3; severe fibrosis and stage F4; cirrhosis. If the diagnosis is made with Fibroscanning; values\> 7 kPa and \<17kPa indicate moderate to severe fibrosis and values \=17 kPa indicate cirrhosis.
•\- Clinically diagnosed cirrhosis in the absence of liver biopsy or Fibroscanning, defined as overt cirrhosis at ultrasound (\+/\- spleen enlargement), low platelet count \=110 \* 109 cells / L, PT\=75 / INR\> 1\.7 (increased clotting of the blood) , serum albumin \<6g / L or the presence of complications: ascites confirmed by ultrasound, esophageal varices diagnosed by gastroscopy or hepatic encephalopathy.
•Infected with genotype 1 or genotype 3\.
•Women of childbearing potential must use effective contraception defined as copper or progesten spiral and condom must be used by partner throughout the treatment period.
•Men who are treated in the trial must use condoms throughout treatment and for at least 7 months after completion of treatment.
•Must be able to read and understand Danish.

Exclusion Criteria

•Hypersensitivity to any of the ingredients in the medicine.
•Severe untreated psychiatric illness which the investigator believe may affect treatment.
•Severe mental illness; schizophrenia, psychosis, bipolar disorder, post\-traumatic stress disorder, mania.
•Current alcohol (\> 25 objects weekly), intravenous drug or other drug abuse.
•Decompensated cirrhosis.
•Diagnosed with hepatocellular carcinoma or are being investigated for this.
•Severe heart failure NYHA class III and IV
•Previous stroke, TIA or AMI.
•Severe angina pectoris, cardiomyopathy, pulmonary hypertension, uncontrolled hypertension or significant arrhythmia diagnosed by ECG.
•Severe chronic lung disease; COPD, pulmonary fibrosis or sarcoidosis defined as; GOLD stage 3: FEV1 / FVC \<0\.7 and FEV1 between 30\-50% predicted and GOLD stage 4: FEV1 / FVC \<0\.7 and FEV1 between the 30% predicted.