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The purpose of the study is to determine if statin can affect the clinical outcome of chronic hepatitis C patients receiving Sofosbuvir/Daclatasvir/Ribavirin combination
Aim of the work
To determine the benefits of statin use in CHC patients treated with Sofosbuvir/Daclatasvir/Ribavirin through :
Primary Outcome: Assessment of therapeutic SVR12
Seconadry Outcome
1. assessment of Chronic hepatitis C(CHC) infection risk on development of metabolic syndrome through assessment of lipid profile , fasting glucose test , HgbA1C and C-reactive protein(CRP).
2- Evaluation of CHC related complications such as fibrosis and cirrhosis
Patients will be followed up for the whole study period and will be subjected to assessment of the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Experimental | low dose of simvastatin10 mg plus sofosbuvir 400mg / daclatasvir 60 mg daily for 12 weeks. |
|
| Group II | Active Comparator | sofosbuvir plus daclatasvir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin 10mg | Drug | tablets |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| SVR 12 | sustained virological response 3 months after the end of therapy | 3 months after end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid marker | lipid profile | three months |
| Glycemic status marker | fasting glucose test | three months |
| Measure | Description | Time Frame |
|---|---|---|
| CHC related complications | fibrosis and cirrhosis | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nagwa Ali Sabri, Professor | Professor of clinical pharmacy , ASU | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kobri El koba Armed Forces Hospital | Cairo | Egypt |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D000069474 | Sofosbuvir |
| C549273 | daclatasvir |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| sofosbuvir plus daclatasvir |
| Drug |
sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks. |
|
|
| inflammatory marker | C-reactive protein(CRP). | three months |
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |