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Hepatitis C virus (HCV) infection is associated with significant morbidity and mortality owing to progression of a high percentage (85%) of HCV infected patients to chronic hepatitis, which might lead to the development of liver cirrhosis or hepato cellular carcinoma..
Egypt has possibly the highest HCV prevalence in the world, 10-20% of the general population .
Currently, second-generation direct-acting antiviral agents have been used for chronic hepatitis C treatment. The association of sofosbuvir with daclatasvir or simeprevir , with or without ribavirin , directly inhibits viral replication .
Sofosbuvir (400 mg once per day) and daclatasvir (60mg once per day) or simeprevir (150 mg once per day) for 3 months treatment regimens.
Sofosbuvir-based antiviral therapy guarantees efficacy in HCV eradication in approximately 90% of cases and is associated with mild to moderate adverse effects.
Overall, studies describe an increase in serum cytokine levels in chronic hepatitis C patients, when compared with healthy individuals. ,interleukin-6(IL-6) is produced mainly by kupffer cells and induces the production of the acute phase proteins, C-reactive protein and haptoglobin .
Previous studies reported that serum Interleukin-6 levels were increased, compared with healthy individuals, in patients with some liver diseases.Previous results suggest that baseline levels of Interleukin, as well as their decrease during treatment .Transforming growth factor beta (TGF-β) is a cytokine that has been assigned a key role in epithelial repair. Injury to the liver elicits a rapid increase in its expression. HCV -infected hepatocytes produce (TGF-β) which may stimulate T-regulatory cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group1 (naive) | No Intervention | Assess serum level of interleukin-6 and transforming growth factor beta before the course of treatment | |
| group2 (sustained responder) | Active Comparator | Assess serum level of interleukin-6 and transforming growth factor beta after three months from the end of treatment Sofosbuvir (SOF) (400 mg once per day) and daclatasvir (DCV)(60mg once per day) or simeprevir (SIM) (150 mg once per day) for 3 months treatment regimens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sofosbuvir and daclatasvir | Drug | oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| mean difference in level of interleukin-6 and transforming growth factor beta after treatment | serum level of interleukin-6 and transforming growth factor beta will be measured before and after treatment | three months from the end of treatment |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Salwa Sayed Ahmed, proffessor | Contact | 01013318344 | salwaegy@yahoo.com | |
| Aliaa Mahmoud Ali, lecturer | Contact | 01006199196 | aliaaghandour@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| hayam hamdy, master deree | faculty of medicine,medical microbiology department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university | Recruiting | Asyut | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11164741 | Background | Rahman El-Zayadi A, Abaza H, Shawky S, Mohamed MK, Selim OE, Badran HM. Prevalence and epidemiological features of hepatocellular carcinoma in Egypt-a single center experience. Hepatol Res. 2001 Feb;19(2):170-179. doi: 10.1016/s1386-6346(00)00105-4. | |
| 24428467 | Background | Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, Lawitz E, Lok AS, Hinestrosa F, Thuluvath PJ, Schwartz H, Nelson DR, Everson GT, Eley T, Wind-Rotolo M, Huang SP, Gao M, Hernandez D, McPhee F, Sherman D, Hindes R, Symonds W, Pasquinelli C, Grasela DM; AI444040 Study Group. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014 Jan 16;370(3):211-21. doi: 10.1056/NEJMoa1306218. |
| Label | URL |
|---|---|
| related info | View source |
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Serum concentrations of(IL-6 and TGF-β) will be measured before treatment and after three months from the end of the course of treatment with sofosbuvir 400 mg once daily plus daclatasvir 60 mg for three months using a commercially available Quanti kine ELISA (Enzyme linked Immune sorbent Assay ).
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D003966 | Camurati-Engelmann Syndrome |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C549273 | daclatasvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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assess serum level of interleukin-6 and transforming growth factor beta before intervention and after intervention with sofosbuvir and daclatasvir.
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| 28433893 | Background | Baskic D, Vukovic VR, Popovic S, Djurdjevic P, Zaric M, Nikolic I, Zelen I, Mitrovic M, Avramovic D, Mijailovic Z. Cytokine profile in chronic hepatitis C: An observation. Cytokine. 2017 Aug;96:185-188. doi: 10.1016/j.cyto.2017.04.008. Epub 2017 Apr 21. |
| 1689567 | Background | Heinrich PC, Castell JV, Andus T. Interleukin-6 and the acute phase response. Biochem J. 1990 Feb 1;265(3):621-36. doi: 10.1042/bj2650621. No abstract available. |
| 22024524 | Background | Ueyama M, Nakagawa M, Sakamoto N, Onozuka I, Funaoka Y, Watanabe T, Nitta S, Kiyohashi K, Kitazume A, Murakawa M, Nishimura-Sakurai Y, Sekine-Osajima Y, Itsui Y, Azuma S, Kakinuma S, Watanabe M; Ochanomizu-Liver Conference Study Group. Serum interleukin-6 levels correlate with resistance to treatment of chronic hepatitis C infection with pegylated-interferon-alpha2b plus ribavirin. Antivir Ther. 2011;16(7):1081-91. doi: 10.3851/IMP1864. |
| 7615817 | Background | Bissell DM, Wang SS, Jarnagin WR, Roll FJ. Cell-specific expression of transforming growth factor-beta in rat liver. Evidence for autocrine regulation of hepatocyte proliferation. J Clin Invest. 1995 Jul;96(1):447-55. doi: 10.1172/JCI118055. |
| 22933833 | Background | Liaskou E, Wilson DV, Oo YH. Innate immune cells in liver inflammation. Mediators Inflamm. 2012;2012:949157. doi: 10.1155/2012/949157. Epub 2012 Aug 9. |
| 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 |
| D010009 | Osteochondrodysplasias |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |