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enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.
Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level < 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cirrhotic Participants | Active Comparator | The experienced participants(113 participants) who failed prior DAA treatments. They were allocated to cirrhotic (30 participants) and treated for 12 weeks. |
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| Non-cirrhotic Participants | Active Comparator | The experienced non-cirrhotic participants(83 participants) who failed prior DAA treatments. They were treated for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF plus (OBV/PTV/r) plus RBV | Drug | They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body 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/ml 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni-Suef University | Banī Suwayf | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29546644 | Result | Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty M, Ramadan M. Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients. Dig Dis Sci. 2018 May;63(5):1341-1347. doi: 10.1007/s10620-018-5005-8. Epub 2018 Mar 15. |
| Label | URL |
|---|---|
| This link clarify the retreatment efficacy and safety of the SOF with OBV/PTV/r + RBV, for chronic HCV GT4-experienced patients who failed treatment with DAA-based regimens. | View source |
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| ID | Term |
|---|---|
| C585405 | paritaprevir |
| C586094 | ombitasvir |
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