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A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).
A total of 201 participants, treatment-naïve and experienced, with chronic HCV GT4 infection were allocated into two groups based on the type of the regimen used. All eligible participants were treated orally with SOF plus daily oral weight-based RBV (24 weeks; group 1), or SOF plus daily oral SMV (12 weeks; group 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF + RBV (Naive) | Active Comparator | For treatment-naive participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg). |
|
| SOF + RBV (Experienced) | Active Comparator | For treatment-experienced participants, SOF was given in a dose of 400 mg/day + RBV was given orally in the morning and in the evening (total daily dose was based on body weight:<75 kg, 1000 mg; >75 kg, 1200 mg). |
|
| SOF + SMV (Naive) | Active Comparator | For treatment-naive participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule. |
|
| SOF + SMV (Expereined) | Active Comparator | For treatment-experienced participants, SOF was given in a dose of 400 mg/day + SMV orally as a single 150 mg q.d. capsule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofosbuvir + Simeprevir + Ribavirin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With HCV 12 | HCV 12 is HCV RNA level <15 IU/mL at 12 weeks after planned end of treatment (EOT). | 12 weeks after last dose |
| Number of Participants With Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation administered the drugs of the study. A serious adverse event (SAE) is an event that results in death, life-threatening, participant hospitalization, or disability/incapacity | up for 12 weeks after planned EOT. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virologic relapse | Viral relapse was HCV RNA level <15 IU/mL at EOT, but >15 IU/mL levels through 12 weeks after planned EOT | 12 weeks after the last dose |
| Percentage of Participants With Virologic null response |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30598598 | Result | Abdel-Moneim A, Aboud A, Abdel-Gabbar M, Zanaty MI, Elbary AAA, Ramadan M. Sofosbuvir in combination with ribavirin or simeprevir: real-life study of patients with hepatitis C genotype 4. Ann Gastroenterol. 2019 Jan-Feb;32(1):93-98. doi: 10.20524/aog.2018.0327. Epub 2018 Nov 24. |
| Label | URL |
|---|---|
| This link describes the effectiveness and safety of two regimens sofosbuvir (SOF) in combination with either ribavirin (RBV) or simeprevir (SMV) in chronic hepatitis C (CHC) genotype (GT) 4 patients in Egypt. | View source |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| D000069616 | Simeprevir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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Virologic null response is defined as HCV RNA >15 IU/mL levels throughout the entire treatment period
| 24 or 36 weeks stating from the first dose |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |