Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to evaluate the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian participants infected with HCV GT4.
Egyptian participants infected with HCV GT4 were classified into two groups: group 1 (easy to treat) was treated with a dual therapy of SOF/DCV daily for 12 weeks and group 2 (difficult to treat) was treated with a triple therapy of SOF/DCV/RBV daily for 12 weeks.
SOF dose was 400 mg/day given orally DCV was given in a dose of 60 mg/day, orally. RBV was given as oral tablets in the morning and in the evening based on patient's weight and tolerability (starting dose 600 mg/day to reach 1200 mg/day.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF/DCV | Active Comparator | Easy to treat arm: Participants were treated with a dual therapy (SOF and DCV) for 12 weeks. This arm included non-cirrhotic treatment-naïve patients |
|
| SOF/DCV/RBV + Cirrhosis | Active Comparator | This difficult-to-treat arm included 111 cirrhotic participants who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks. |
|
| SOF/DCV/RBV + Non-Cirrhosis | Active Comparator | This difficult-to-treat arm included treatment-experienced non-cirrhotic participants (77 participants) who were treated with a triple therapy (SOF, DCV, and RBV) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (SOF and DCV) | Drug |
|
|
| 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) 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 | up for 12 weeks after planned End of Treatment (EOT). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Viral relapse | Viral relapse was HCV RNA level ≤ 15 IU/ml at EOT, but detectable HCV RNA level > 15 IU/ml 12 weeks after planned EOT. | 12 weeks after last dose |
| Percentage of Participants With On-treatment Virologic Failure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29754329 | Result | Abdel-Moneim A, Aboud A, Abdel-Gabaar M, Zanaty MI, Ramadan M. Efficacy and safety of sofosbuvir plus daclatasvir with or without ribavirin: large real-life results of patients with chronic hepatitis C genotype 4. Hepatol Int. 2018 Jul;12(4):348-355. doi: 10.1007/s12072-018-9868-8. Epub 2018 May 12. |
| Label | URL |
|---|---|
| This link describes the efficacy and safety of DCV plus sofosbuvir (SOF) with or without ribavirin (RBV) for treatment of Egyptian patients infected with HCV GT4. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C549273 | daclatasvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| (SOF, DCV, and RBV) | Drug |
|
|
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 |