DARE-C II: Direct Acting Antiviral (DAA) based therapy for rEcently Acquired hepatitis C - II

Date Commenced:
October 2014
Project Status
Ongoing
Expected Date of Completion:
Ongoing
Project Supporters

Gilead Sciences Inc

Currently recruiting
Yes
image -

About the Project

DARE-C II is an open label single arm multicentre study exploring the safety, efficacy and feasibility of the dual interferon-sparing combination of sofosbuvir plus ribavirin in patients with documented recently acquired HCV infection.

Rationale

The use of a highly potent pan-genotypic interferon sparing drug combination in the setting of recently acquired HCV infection is hypothesisedto result in the vast majority of patients achieving successful virological clearance. In this setting it is also anticipated that therapy can be shortened relative to that used in established chronic infection. A short course interferon free strategy is likely to be highly attractive to both patients and clinicians and if proven may further encourage early HCV testing and diagnosis.

In this pilot study, we plan to explore the safety, efficacy and feasibility of the dual interferon-sparing combination of sofosbuvir plus ribavirin in patients with documented recently acquired HCV infection. The established study recruitment network within the ATAHC studies in Australia is an ideal setting in which to explore the activity of interferon-free combinations for the treatment of subjects with recently acquired HCV infection. If successful such a strategy could offer significant individual and population level benefits.

Aims

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.

Design & Method

DARE-C II is an open label single arm multicentre study. A total of 20 subjects, with an estimated duration of infection ≤12 months, all HCV genotypes, will be treated with sofosbuvir 400 mg daily and weight-based ribavirin (1000 mg <75 kg, 1200 mg ≥ 75kg) for 6 weeks followed by 52 weeks of observational follow-up.

Progress/Update

St Vincent’s Hospital and Auckland City Hospital have started screening patients. The three other sites are expected to start in November 2014.

Benefits

The potential benefit of improving treatment outcomes for patients with recently acquired hepatitis C virus infection.

Output

Nil to date

Project Members
image - Dore
Professor and Program Head
Ph 02 9385 0900
image - Jason Grebely Replace
Senior Research Fellow (UNSW)
Ph +61 (2) 9385 0957
image - Marrianne Martinello
Research Associate
Ph +61 (0)2 9385 0900
image - Pip Marks
Clinical Trials Manager
Ph +61 (0)2 9385 0886
image - Laruence Maire
Mrs Laurence Maire
Clinical Project Coordinator
image - Danica Martinez2
Laboratory Coordinator
Ph +612 9385 0203
image - Mahshid Tamaddoni
Data Administrator
Ph +61 (0)2 9385 9978
Other Investigators
  • Dr Gail Matthews (Coordinating Investigator, Senior lecturer at the Kirby Institute)
  • Prof Gregory Dore (Principal Investigator, VHCRP Program Head at the Kirby Institute)
  • Dr Marianne Martinello (Co-investigator, the Kirby Institute)
  • Prof Ed Gane (Principal Investigator, Auckland City Hospital)
  • Prof Margaret Hellard (Principal Investigator, the Burnet Institute and the Alfred Hospital)
  • A/Prof. David Shaw (Principal Investigator, Royal Adelaide Hospital)
Project Collaborators: External

St. Vincent’s Hospital, Sydney, NSW

The Alfred Hospital, Melbourne, VIC

Royal Adelaide Hospital, Adelaide, SA

Royal Melbourne Hospital, VIC

Auckland City Hospital, New Zealand

Project Research Area

Project Contacts

  • image - Laruence Maire
    Mrs Laurence Maire
    Clinical Project Coordinator

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