Clinical trial NCT02156570: DAA-based Therapy for Recently Acquired Hepatitis C II (DAA = Directly Acting Antiviral)
Official title: An Interferon Sparing Strategy of Sofosbuvir Plus Ribavirin for the Treatment of Recently Acquired Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C
Keywords: Hepatitis C
Acute/early chronic
Recently acquired
Directly acting antiviral therapy
Sofosbuvir
Ribavirin
Lead sponsor: Kirby Institute
Sponsor class: OTHER_GOV
First posted: 2014-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: SVR 12
timeFrame: 12 weeks post treatment
Secondary outcomes:
measure: SVR 24
timeFrame: 24 weeks post treatment
Other outcomes:
measure: End of treatment response
timeFrame: End of treatment week 6
measure: SVR 4
timeFrame: 4 weeks post treatment
measure: Follow up 1 year
timeFrame: 1 year post treatment
measure: Undetectable HCV RNA
timeFrame: Week 1, 2, 3 and 4 of treatment
measure: Indicators of toxicity (ALT, HB, Neutrophils, Platelets)
timeFrame: Baseline until week 4 of treatment
measure: Plasma ribavirin levels and haemoglobin
timeFrame: Baseline to week 4 of treatment
measure: Incidence of reinfection
timeFrame: End of treatment until follow up 1 year
Locations:
city: Sydney
country: Australia
facility: St Vincent's Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Auckland
country: New Zealand
facility: Auckland City Hospital
state: Grafton
Study officials:
affiliation: Kirby Institute
name: Gail Matthews, MbChB FRACP
role: PRINCIPAL_INVESTIGATOR
References: