Australian Trial in Acute Hepatitis C

Conditions

Hepatitis C

Keywords

Acute Hepatitis C

Brief summary

Australian Trial in Acute Hepatitis C (ATAHC) A prospective non-randomised dual arm longitudinal cohort of newly acquired hepatitis C infection into which participants will be enrolled and then followed at 3 monthly intervals over a 3 year period. All participants will be offered a 24 week course of pegylated interferon alfa 2a which will be commenced within 12 weeks of screening (patients coinfected with HIV will be offered 24 weeks with pegylated interferon alfa 2a plus ribavirin).

Detailed description

The main purposes of the study are: * To enrol and follow-up a large group of people with acute hepatitis C infection to examine why some people naturally clear hepatitis C and some don't. * To examine how many people become re-infected after having cleared hepatitis C and to look at why this happened. The study will also offer everyone taking part the option of undergoing a 6 month course of pegylated interferon alfa 2a (plus ribavirin if HIV coinfected) as treatment for hepatitis C. The purpose of this part of the study is: 1\. To examine whether treatment is effective in clearing the virus.

Joseph Doyle, Jason Grebely, Tim Spelman, Maryam Alavi, Gail Matthews et al. (9 authors)

PLoS ONE2016-06-2919 citations

10.1371/journal.pone.0150655

HIV infection is associated with higher levels of monocyte chemoattractant protein-1 and eotaxin among people with recent hepatitis C virus infection.

Lamoury FM, Hajarizadeh B, Keoshkerian E, Feld JJ, Amin J, Teutsch S, Matthews GV, Hellard M, Dore GJ, Lloyd AR, Applegate TL, Grebely J, ATAHC Study Group.

2016-06-016 citations

10.1186/s12879-016-1567-2

Naturally Occurring Dominant Drug Resistance Mutations Occur Infrequently in the Setting of Recently Acquired Hepatitis C

Tanya Applegate, Silvana Gaudieri, Anne Plauzolles, Abha Chopra, Jason Grebely et al. (10 authors)

Antiviral Therapy2014-08-0823 citations

10.3851/imp2821

Patterns and characteristics of hepatitis C transmission clusters among HIV-positive and HIV-negative individuals in the Australian trial in acute hepatitis C.

Matthews GV, Pham ST, Hellard M, Grebely J, Zhang L, Oon A, Marks P, van Beek I, Rawlinson W, Kaldor JM, Lloyd A, Dore GJ, White PA, ATAHC Study Group.

2011-01-3178 citations

10.1093/cid/ciq200

Interventions

DRUGPegylated Interferon alfa 2a

PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly

DRUGRibavirin (HIV conifected patients only)

* genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg) * Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Male and female patients \>16 years of age; Anti-HCV antibody positive within the previous 6 months; Anti-HCV antibody negative in the two years prior to the anti-HCV antibody positive result OR acute hepatitis (jaundice or ALT \> 10 XULN) within the 12 months prior to the anti-HCV antibody results (where other causes of acute hepatitis are excluded); HCV RNA positive (for treatment group); Negative urine or blood pregnancy test (for women of childbearing potential; treated arm only); Informed consent

Exclusion criteria

* Women with ongoing pregnancy or breast feeding;Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) \<6 months prior to the first dose of study drug; Any investigational drug \<6 weeks prior to the first dose of study drug; Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab; History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures); History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease; Neutrophil count \<1500 cells/mm3 or platelet count \<90,000 cells/mm3 at screening; Serum creatinine level \>1.5 times the upper limit of normal at screening; Hgb\< 12g/dL in women or \< 13g/dL in men at screening (for patients who receive combination therapy with Pegylated interferon and ribavirin only); Male partners of women who are pregnant (for patients who receive combination therapy with Pegylated interferon and ribavirin only); History of a severe seizure disorder or current anticonvulsant use; History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study; History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease; Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration); Inability or unwillingness to provide informed consent or abide by the requirements of the study

Design outcomes

Primary

Measure	Time frame
Efficacy of peg-interferon alpha 2a (and ribavirin for HIV/HCV coifection)	24 weeks

Secondary

Measure	Time frame
Natural history of acute hepatitis C	5 years

Countries

Australia

Outcome results

None listed