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To determine whether response guided treatment with pegylated interferon +/- ribavirin is effective for the treatment of recently acquired hepatitis C infection. Response guided treatment is when the length of treatment is determined by how quickly you respond to the treatment.
A prospective longitudinal study of natural history and treatment outcomes following response guided treatment of recent hepatitis C infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A - 8 weeks therapy | Experimental | 8 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 2 weeks of therapy. |
|
| Group B - 16 weeks therapy | Experimental | 16 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 4 weeks of therapy. |
|
| Group C - 24 weeks therapy | Experimental | 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 6 weeks of therapy. |
|
| Group D - 32 weeks (gt1) or 24 weeks (gt 2/3) | Experimental | 32 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 8 weeks of therapy (genotype 1) or 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 8 weeks of therapy. |
|
| Group E - 48 weeks (gt 1) or 24 weeks (gt 2/3) | Experimental | 48 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 12 weeks of therapy (genotype 1) or 24 weeks total of Pegylated interferon and ribavirin if undetectable HCV RNA after 12 weeks of therapy (genotype 2/3). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa-2a | Drug | PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and efficacy of response-guided pegylated interferon and ribavirin for the treatment of recent HCV infection. Response-guided means the duration of treatment will be determined by the subject's early response to treatment. | Treatment duration will be determined by time to undetectable HCV RNA. Undetectable at week 2=8 weeks of therapy; Undetectable at week 4=16 weeks of therapy; Undetectable at week 6=24 weeks of therapy; Undetectable at week 8=32 weeks of therapy (24 weeks for genotypes 2/3); Undetectable at week 12=48 weeks of therapy (24 weeks for genotypes 2/3); | 8-48 weeks |
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Inclusion Criteria:
A)
OR
B)
Exclusion Criteria:
All patients:
• Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples
Treatment group only:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory J Dore, MBBS, PhD | University of New South Wales | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia | ||
| Kirketon Road Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26867206 | Derived | Martinello M, Hellard M, Shaw D, Petoumenos K, Applegate T, Grebely J, Yeung B, Maire L, Iser D, Lloyd A, Thompson A, Sasadeusz J, Haber P, Dore GJ, Matthews GV. Short duration response-guided treatment is effective for most individuals with recent hepatitis C infection: the ATAHC II and DARE-C I studies. Antivir Ther. 2016;21(5):425-34. doi: 10.3851/IMP3035. Epub 2016 Feb 11. |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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|
| Untreated Group | No Intervention | Observation only. No treatment for hepatitis C administered. Subjects who have undetectable HCV RNA at baseline, do not wish to commence treatment or are ineligible for treatment. |
|
| Ribavirin | Drug | 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 |
|
| Darlinghurst |
| New South Wales |
| 2010 |
| Australia |
| St Vincent's Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| St Vincent's Hospital Melbourne | Melbourne | New South Wales | 3065 | Australia |
| Nepean Hospital | Penrith | New South Wales | 2751 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3065 | Australia |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |