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

NCT ID: NCT02156570

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-12-31

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.

Detailed Description

To evaluate the efficacy, safety and acceptability of an interferon-sparing strategy with sofosbuvir and ribavirin for the treatment of recently acquired HCV infection.

An open label single arm multicentre study Treatment of participants: Sofosbuvir 400mg daily with weight based ribavirin (1000mg <75 kg, 1200mg >/= 75kg) Duration of treatment will be 6 weeks for all subjects followed by 52 weeks of observational follow-up Total study duration = 58 weeks Primary endpoint: SVR 12

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sofosbuvir and ribavirin

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.

Group Type: EXPERIMENTAL

Sofosbuvir and ribavirin

Intervention Type: DRUG

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

Interventions

Sofosbuvir and ribavirin

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

Intervention Type: DRUG

Other Intervention Names

Sovaldi; Copegus

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Standard exclusions to RBV therapy
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirby Institute

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Matthews, MbChB FRACP

Role: PRINCIPAL_INVESTIGATOR

Kirby Institute

Locations

St Vincent's Hospital

Sydney, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Victoria, Australia

Auckland City Hospital

Auckland, Grafton, New Zealand

Countries

Australia; New Zealand

Related Links

http://www.kirby.unsw.edu.au

UNSW Kirby Institute for infection and immunity in society Homepage

Other Identifiers

VHCRP1206

Identifier Type: -

Identifier Source: org_study_id