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Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)
Experienced participants, who had chronic infection with HCV GT4 , and failed prior DAA treatments, SOF/DCV (71/92) or SOF/SMV (15/92) or SOF/pegylated interferon/RBV (2/92) or SOF/RBV (4/92) were enrolled in the current study.
In the present study, the regimen used was designed by the combination of triple DAAs with different mechanisms of action and non-overlapping resistance profiles, SOF/SMV/DCV, plus RBV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Cirrhotic | Active Comparator | SOF plus DCV/SMV/RBV regimen was administered to Egyptian non-cirrhotic experienced HCV GT4 participants for 12 weeks |
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| Cirrhotic | Active Comparator | SOF plus DCV/SMV/RBV regimen was administered to Egyptian cirrhotic experienced HCV GT4 participants for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/SMV/DCV/RBV | Drug | SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/m 12 weeks after the last dose of drugs. | 12 weeks after last dose |
| Number of Participants With Adverse Events in Each Treatment Arm | An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity | Screening up to 12 weeks after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Viral relapse | Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT. | Up to 12 weeks after last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammed Abdel-Gabbar, Ass. Prof | Biochemistry Dep., Faculty of Science, Beni-Suef University, P.O. Box 52621 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Administration at Beni-Seuf | Bani Sweif | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29625827 | Result | Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Ramadan M. A sofosbuvir-based quadruple regimen is highly effective in HCV type 4-infected Egyptian patients with DAA treatment failure. J Hepatol. 2018 Jun;68(6):1313-1315. doi: 10.1016/j.jhep.2018.03.010. Epub 2018 Apr 3. No abstract available. |
| Label | URL |
|---|---|
| This link shows the investigation performed in the retreatment with SOF plus DCV/SMV/RBV regimen in EgyptianHCV GT4 participants | View source |
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