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

Hepatitis C Clinical Trial

— DARE-C II  

Official title:

An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02156570
• Other study ID #: VHCRP1206
• Status: Completed
• Phase: Phase 4
• Start date: October 2014
• Est. completion date: December 2017

Study information

• Verified date: September 2018
• Source: Kirby Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Alfred Hospital	Melbourne	Victoria
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Australia	St Vincent's Hospital	Sydney	New South Wales
New Zealand	Auckland City Hospital	Auckland	Grafton

Sponsors (1)

Lead Sponsor	Collaborator
Kirby Institute

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	End of treatment response	Proportion of patients with undetectable HCV RNA at end of therapy (ETR - week 6)	End of treatment week 6
Other	SVR 4	Proportion of patients with undetectable HCV RNA by TaqMan 4 weeks after therapy completion (SVR 4 - Week 10)	4 weeks post treatment
Other	Follow up 1 year	Proportion of patients with undetectable HCV RNA at end of study follow-up (FU1 - Week 58)	1 year post treatment
Other	Undetectable HCV RNA	Proportion of patients with undetectable HCV RNA at weeks 1, 2, 3 and 4	Week 1, 2, 3 and 4 of treatment
Other	Indicators of toxicity (ALT, HB, Neutrophils, Platelets)	To evaluate indicators of toxicity (ALT, HB, Neutrophils, Platelets) during therapy	Baseline until week 4 of treatment
Other	Plasma ribavirin levels and haemoglobin	To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy	Baseline to week 4 of treatment
Other	Incidence of reinfection	Incidence of reinfection after documented SVR	End of treatment until follow up 1 year
Primary	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	SVR 24	Proportion of patients with undetectable HCV RNA by TaqMan 24 weeks after therapy completion (SVR 24 - Week 30)	24 weeks post treatment

External Links

•   UNSW Kirby Institute for infection and immunity in society Homepage