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This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants
Between March 2015 and November 2015, 99 participants (59 naïve and 40 experienced) infected with HCV GT4 were enrolled in the study. Eligible participants received daily oral 400 mg SOF ( (Sovaldi, Gilead Sciences, Inc., USA), RBV (Copegus, Roche, Europe) based on body weight: < 75 kg, 1000 mg; ≥75 kg, 1200 mg), the dose modified according to participants tolerability, plus 180 μg PegINFα-2 once weekly for 12 weeks.
Experienced participants included participants with a prior relapse or a null response to PegINF/RBV therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-naive | Active Comparator | Naive Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2) |
|
| Treatment-experienced | Active Comparator | Experienced Egyptians having HCV GT4 received SOF, RBV, and PegINFα-2 once weekly for 12 weeks Intervention: 1 DDA: Sofosobuvir (SOF) plus Ribavirin (RBV) and pegylated-interferon (PegINFα-2) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF/RBV/PegINFα-2 | Drug | SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm SVR12 | SVR12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) < 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 or i 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 until 30 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Viral relapse | Viral relapse was HCV RNA undetectable at EOT, but detectable HCV RNA > 15 IU/ml levels 12 weeks after planned EOT. | 12 weeks after last dose |
| Percentage of Participants With On-treatment Virologic Failure |
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Inclusion Criteria:
The study population consisted of treatment-naïve and treatment-experienced adults patients aged 20-65 with HCV RNA level > 10,000 IU/ml.
Experienced participants included those with a prior relapse or a null response to PegINF/RBV therapy.
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Exclusion Criteria:Participants with one or more of
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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 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30324144 | Result | Abdel-Moneim A, Abood A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Effectiveness of sofosbuvir/pegylated-interferon plus ribavirin in treatment of hepatitis C virus genotype 4 patients. Clin Exp Hepatol. 2018 Sep;4(3):191-196. doi: 10.5114/ceh.2018.78123. Epub 2018 Sep 10. |
| Label | URL |
|---|---|
| The link clarify the effectiveness of sofosbuvir/pegylated-interferon plus ribavirin in treatment of hepatitis C virus genotype 4 patients | View source |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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On-treatment virologic failure was defined as quantifiable HCV RNA throughout the entire treatment period with HCV RNA greater than 15 IU/ml |
| up tp 24 weeks |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |