DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral)

NCT02156570 | Completed Phase 4 DMC

• 1 other identifier: VHCRP1206
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of the study is to examine whether patients who have acute or early chronic hepatitis C virus (HCV) infection can be treated effectively and safely with an interferon-sparing regimen that combines a new direct acting antiviral drug (sofosbuvir) with one of the standard treatments for chronic hepatitis C (ribavirin). In particular, this study will investigate whether treatment of acute or early chronic HCV can be shortened. The study will assess efficacy by looking at the proportion of people who clear the virus (have no virus detectable in their blood) at the end of treatment, and 1, 3 and 6 months after treatment. The hypothesis is that short course (6 weeks) dual therapy using sofosbuvir and RBV will result in successful virological eradication in the majority (≥80%) of subjects treated for recently acquired HCV.

Conditions

Hepatitis C

Keywords

Hepatitis C; Acute/early chronic; Recently acquired; Directly acting antiviral therapy; Sofosbuvir; Ribavirin

Outcome Measures

Primary Outcomes (1)

• SVR 12

  Proportion of patients with undetectable HCV RNA by TaqMan 12 weeks after therapy completion (SVR 12 - Week 18)

  12 weeks post treatment

Secondary Outcomes (1)

• SVR 24

  24 weeks post treatment

Other Outcomes (7)

• End of treatment response

  End of treatment week 6

• SVR 4

  4 weeks post treatment

• Follow up 1 year

  1 year post treatment

Study Arms (1)

Sofosbuvir and ribavirin

EXPERIMENTAL

Sofosbuvir tablet 400 mg daily Ribavirin tablet weight based dosing (1000mg \<75 kg, 1200mg \>/= 75kg) daily Treatment will be for 6 weeks in all participants.

Drug: Sofosbuvir and ribavirin

Interventions

Sofosbuvir and ribavirin DRUG

Sofosbuvir 400mg daily plus weight-based dosing ribavirin (1000mg \<75kg, 1200mg \>/= 75 kg) Treatment will be for 6 weeks in all participants.

Also known as: Sovaldi, Copegus

Sofosbuvir and ribavirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• Male and female patients aged 18 years and above
• Willing to use two effective methods of contraception during the treatment period and 24 weeks post.
• HBsAg negative
• Detectable HCV RNA at screening (\>10,000 IU/ml), and in the opinion of the investigator is unlikely to demonstrate spontaneous viral clearance
• Compensated liver disease (Child-Pugh A)
• Negative pregnancy test at screening and 24 hours prior to first dose of study drugs
• Medically stable on the basis of physical examination, medical history and vital signs
• Adequate English to provide reliable responses to the study questionnaires
• Recent hepatitis C infection, as defined by: A) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV Ab negative within the 24 months prior to anti-HCV antibody positive result, OR B) i) First anti-HCV Ab or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT\> 10 X ULN) within the previous 12 months prior to first positive HCV antibody or HCV RNA, with no other cause of acute hepatitis identifiable
• If co-infection with HIV is documented, the subject must meet the following criteria:
• Antiretroviral (ARV) untreated for \>8 weeks preceding screening visit with CD4 T cell count \>500 cells/mm3 OR
• On a stable ARV regimen for \>8 weeks prior to screening visit, with CD4 T cell count \>200 cells/mm3 and an undetectable plasma HIV RNA level.

You may not qualify if:

• Pregnancy/lactation or male subjects whose female partners are pregnant
• Subject has a history of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding oesophageal varices, and/or any of the following screening laboratory results: a.INR of ≥1.5; Serum albumin \<3.3 g/dL; Serum total bilirubin \>1.8 times upper limit of normal, unless isolated in subjects with Gilbert's syndrome.

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (5)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Auckland City Hospital

Auckland, Grafton, 1023, New Zealand

Location

Related Links

• UNSW Kirby Institute for infection and immunity in society Homepage

MeSH Terms

Conditions

Hepatitis C; Bronchiolitis Obliterans Syndrome

Interventions

Sofosbuvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Study Officials

• Gail Matthews, MbChB FRACP

  Kirby Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2014
• First Posted: June 5, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2017
• Study Completion: December 1, 2017
• Last Updated: September 21, 2018

Record last verified: 2018-09

Locations

NZ (1); AU (4)