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Data regarding hepatocellular carcinoma (HCC) recurrence after directly acting antivirals (DAAs) given for hepatitis C virus treatment are contradictory. Surprisingly, some studies reported that DAAs are accompanied with higher HCC recurrence. But, other studies showed no rise or even decrease in HCC recurrence. Most of these studies were retrospective and some were non-randomized prospective studies. Here investigators aim to perform a randomized controlled trial to study this issue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAAs group | Active Comparator | Those with complete HCC ablation who will start sofosbuvir / velpatasvir aiming to eradicate HCV. |
|
| Postponed DAAs group | Active Comparator | Those who will not start DAAs within the 12 months follow up from HCC ablation procedure. Patients of this group will receive DAAs provided that there is no HCC recurrence after the end of 1 year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Velpatasvir/Sofosbuvir | Drug | sofosbuvir / velpatasvir will be given for 12 weeks aiming to eradicate HCV. Ribavirin will be added for Child-Pugh B patients or treatment will be extended for 24 weeks for those who are Ribavirin intolerant. |
| Measure | Description | Time Frame |
|---|---|---|
| HCC recurrence | 1 year after HCC ablation procedure |
| Measure | Description | Time Frame |
|---|---|---|
| changes in Child-Pugh scores over time | 1 year from HCC ablation procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed Kamal, MD, PhD | Lecturer of Internal Medicine and Hepatology, Faculty of Medicine, Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University, Faculty of Medicine | Alexandria | 21131 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38436921 | Derived | Kamal A, Metawea M, Omar H, Ghallab M, Kassem A, Naguib H. Hepatitis C Virus-Related One-Year Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial. J Gastrointest Cancer. 2024 Jun;55(2):913-923. doi: 10.1007/s12029-024-01035-5. Epub 2024 Mar 4. |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| D006526 | Hepatitis C |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C000611331 | sofosbuvir-velpatasvir drug combination |
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masking for radiologists who assess HCC recurrence only. Patients and physicians: not masked.
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |