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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir and ribavirin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir and ribavirin | Drug | Sofosbuvir 400mg daily plus weight-based dosing ribavirin (1000mg <75kg, 1200mg >/= 75 kg) Treatment will be for 6 weeks in all participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| SVR 12 | Proportion of patients with undetectable HCV RNA by TaqMan 12 weeks after therapy completion (SVR 12 - Week 18) | 12 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| SVR 24 | Proportion of patients with undetectable HCV RNA by TaqMan 24 weeks after therapy completion (SVR 24 - Week 30) | 24 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| End of treatment response | Proportion of patients with undetectable HCV RNA at end of therapy (ETR - week 6) | End of treatment week 6 |
| SVR 4 | Proportion of patients with undetectable HCV RNA by TaqMan 4 weeks after therapy completion (SVR 4 - Week 10) |
Inclusion Criteria:
If co-infection with HIV is documented, the subject must meet the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gail Matthews, MbChB FRACP | Kirby Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Sydney | New South Wales | 2010 | Australia | ||
| Royal Adelaide Hospital |
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| Label | URL |
|---|---|
| UNSW Kirby Institute for infection and immunity in society Homepage | View source |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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|
| 4 weeks post treatment |
| Follow up 1 year | Proportion of patients with undetectable HCV RNA at end of study follow-up (FU1 - Week 58) | 1 year post treatment |
| 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 |
| Indicators of toxicity (ALT, HB, Neutrophils, Platelets) | To evaluate indicators of toxicity (ALT, HB, Neutrophils, Platelets) during therapy | Baseline until week 4 of treatment |
| 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 |
| Incidence of reinfection | Incidence of reinfection after documented SVR | End of treatment until follow up 1 year |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
| Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | 3050 | Australia |
| Auckland City Hospital | Auckland | Grafton | 1023 | New Zealand |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |