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| Name | Class |
|---|---|
| Cairo University | OTHER |
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This is a prospective, cohort study in Faculty of Medicine, Zagazig University, Egypt. From June to December, 2016, investigators will follow up patients with chronic Hepatitis C virus genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of Egyptian ministry of health and population. The primary outcomes are safety of the treatment and the sustained virologic response 12 weeks after discontinuation of therapy. For the secondary outcomes, investigators will measure the change in health related quality of life and investigate the genetic sequence of viral RNA of resistant patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Easy to treat group |
This group will be receiving Sofosbuvir + daclatasvir for 12 weeks. |
| |
| Group 2: Difficult to treat group |
This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 12 weeks. |
| |
| Group 3: Sofosbuvir resistant cases | This is the group of patients who failed in previous Sofosbuvir treatment regiment. This group will be receiving Sofosbuvir + daclatasvir + ribavirin for 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daclatasvir 60 MG Oral Tablet [Daklinza] | Drug | Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy measured by Sustained Virologic Response Rate | 12 weeks posttreatment | |
| Incidence of grade 3/4 adverse events [Safety] | Within the treatment period (12 or 24 weeks according to the treatment regimen) | |
| Incidence of Neutropenia [Safety] | Neutropenia: Grade 3, 500-749/mm3; Grade 4, <500/mm3 | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of Lymphopenia [Safety] | Lymphopenia: Grade 3, 350-499/mm3; Grade 4, <350/mm3 | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of anaemia [Safety] | Anaemia: Grade 3, haemoglobin 7.0-8.9 g/dL; Grade 4, <7.0 g/dL | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of Thrombocytopenia [Safety] | Thrombocytopenia: Grade 3, 25 000-49 999/mm3; Grade 4, <25 000/mm3 | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of (Increased total Bilirubin) [Safety] | Bilirubin elevations: Grade 3, 2.6-5×ULN; Grade 4, >5×ULN | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of elevated Alanine Aminotransferase [Safety] |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life (HRQoL) | HRQoL will be assessed using the Arabic version of SF-36 questionnaire (SF-36™ Health Survey) | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include male or female patients ≥ 18 years, HCV RNA≥ 104 IU/mL, HCV genotype 4, screening ECG without clinically significant abnormalities.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Negida | Contact | +201125549087 | ahmed01251@medicine.zu.edu.eg | |
| Hussien Ahmed, MD | Contact | +201006037334 | hoseen011232@medicine.zu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Samah A Loutfy | National Cancer Institute, Cairo University, Cairo, Egypt | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25703086 | Background | Jensen D, Sherman KE, Hezode C, Pol S, Zeuzem S, de Ledinghen V, Tran A, Elkhashab M, Younes ZH, Kugelmas M, Mauss S, Everson G, Luketic V, Vierling J, Serfaty L, Brunetto M, Heo J, Bernstein D, McPhee F, Hennicken D, Mendez P, Hughes E, Noviello S; HALLMARK-QUAD Study Team. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol. 2015 Jul;63(1):30-7. doi: 10.1016/j.jhep.2015.02.018. Epub 2015 Feb 19. | |
| 26313445 |
| Label | URL |
|---|---|
| Related Info | 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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| ID | Term |
|---|---|
| C549273 | daclatasvir |
| D013607 | Tablets |
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
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| Sofosbuvir 400 MG Oral Tablet [Sovaldi] | Drug | Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor |
|
| Ribavirin Oral Product | Drug | Ribavirin (twice-daily) dosed according to body weight (<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily) |
|
Alanine Aminotransferase elevations: Grade 3, 5.1-10×upper limit of normal (ULN); Grade 4, >10×ULN |
| Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of Fatigue [Safety] | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of Headache [Safety] | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of Pruritus [Safety] | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of Insomnia [Safety] | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of Rash [Safety] | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of Nausea [Safety] | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Incidence of Myalgia [Safety] | Within the treatment period (12 or 24 weeks according to the treatment regimen) |
| Background |
| Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print. |
| 26196502 | Background | Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, Sherman KE, Dretler R, Fishbein D, Gathe JC Jr, Henn S, Hinestrosa F, Huynh C, McDonald C, Mills A, Overton ET, Ramgopal M, Rashbaum B, Ray G, Scarsella A, Yozviak J, McPhee F, Liu Z, Hughes E, Yin PD, Noviello S, Ackerman P; ALLY-2 Investigators. Daclatasvir plus Sofosbuvir for HCV in Patients Coinfected with HIV-1. N Engl J Med. 2015 Aug 20;373(8):714-25. doi: 10.1056/NEJMoa1503153. Epub 2015 Jul 21. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D011742 |
| Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |