Safety of Sofosbuvir ,Daclatasvir in HCV Patients and RAVS in Resistent and Relapsed Cases
NCT ID: NCT03572140
Last Updated: 2018-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
297 participants
OBSERVATIONAL
2018-07-01
2020-08-01
Brief Summary
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* To assess the occurrence and the prevalence of RAVs in patients with treatment failure and relapse after sofosbuvir and daclatasvir with assessment of their types .
* To examine the GT4 subtypes by phylogenetic analysis and baseline sequence variability among subtypes and their potential impact on treatment outcome and development of viral resistance in patients who received a regimen of Sofosbuvir/ Daclatasvir for treatment of chronic HCV GT-4.
* To assess the differences in patient demographics across GT4 subtypes.
Detailed Description
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Direct antiviral agents (DAAs) effectively eradicate HCV and rapidly improve residual liver functions. Current HCV eradication rates have exceeded 90% in a very short time .
Hepatitis C virus genotype 4 (GT4) is genetically diverse, with 17 confirmed subtypes, and comprises approximately 13% of infections worldwide \[3\]. In Egypt, GT4 accounts for approximately 90% of infections, with subtype 4a predominating .
Sofosbuvir and daclatasvir are generally well tolerated with only a few adverse effects reported.
Hepatitis C virus resistant associated variants (RAVs) are seen in most patients who do not achieve sustained virological response (SVR). These resistance-associated mutations depend on the class of direct-acting antiviral drugs used and also vary between hepatitis C virus genotypes and subtypes.
Donaldson et al performed an analysis on four phase III clinical trials in search of common RAVs against sofosbuvir, discovering L159F, C316N, and V321A were associated with virological failure. Interestingly, this study also verified S282R mutation as associating with failure.
NS5A RAVs can be very common, with Y93H detected in up to 15% of the population and L31M in up to 6.3%. Other RAVs tend to also be fairly common detected in approximately 0.3%-3.5% of the population
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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group A
RAVS IN resistent cases after daclatasvir plus sofosbuvir treatment
RAVS In relapsed and resistent cases
assessment of RAVS in relapsed and resistant cases after sofosbuvir plus daclatasvir regimen
group B
RAVS IN relapsed cases after daclatasvir plus sofosbuvir treatment
RAVS In relapsed and resistent cases
assessment of RAVS in relapsed and resistant cases after sofosbuvir plus daclatasvir regimen
Interventions
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RAVS In relapsed and resistent cases
assessment of RAVS in relapsed and resistant cases after sofosbuvir plus daclatasvir regimen
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Presence of malignancy before treatment.
* End-stage liver disease (Child score more than 9).
* Major co-morbid disease e.g heart failure
18 Years
75 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Rasha Maree Omar Ali
Principal investigator
Principal Investigators
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Ahlam Farghaly, Professor
Role: PRINCIPAL_INVESTIGATOR
Assiut University
haidi ramadan, Lecturer
Role: PRINCIPAL_INVESTIGATOR
Assiut University
Central Contacts
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References
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Ben Ari Z. [Chronic hepatitis C infection--eradication of the virus]. Harefuah. 2014 Jul;153(7):392-3, 433. Hebrew.
Conti F, Buonfiglioli F, Scuteri A, Crespi C, Bolondi L, Caraceni P, Foschi FG, Lenzi M, Mazzella G, Verucchi G, Andreone P, Brillanti S. Early occurrence and recurrence of hepatocellular carcinoma in HCV-related cirrhosis treated with direct-acting antivirals. J Hepatol. 2016 Oct;65(4):727-733. doi: 10.1016/j.jhep.2016.06.015. Epub 2016 Jun 24.
Reig M, Marino Z, Perello C, Inarrairaegui M, Ribeiro A, Lens S, Diaz A, Vilana R, Darnell A, Varela M, Sangro B, Calleja JL, Forns X, Bruix J. Unexpected high rate of early tumor recurrence in patients with HCV-related HCC undergoing interferon-free therapy. J Hepatol. 2016 Oct;65(4):719-726. doi: 10.1016/j.jhep.2016.04.008. Epub 2016 Apr 13.
Kamal SM, Nasser IA. Hepatitis C genotype 4: What we know and what we don't yet know. Hepatology. 2008 Apr;47(4):1371-83. doi: 10.1002/hep.22127.
Di Lello FA, Neukam K, Parra-Sanchez M, Plaza Z, Soriano V, Cifuentes C, Mira JA, Poveda E, Pineda JA. Hepatitis C virus genotype 4 in Southern and Central Spain does not originate from recent foreign migration waves. J Med Virol. 2013 Oct;85(10):1734-40. doi: 10.1002/jmv.23657. Epub 2013 Jul 16.
Donaldson EF, Harrington PR, O'Rear JJ, Naeger LK. Clinical evidence and bioinformatics characterization of potential hepatitis C virus resistance pathways for sofosbuvir. Hepatology. 2015 Jan;61(1):56-65. doi: 10.1002/hep.27375. Epub 2014 Nov 20.
Other Identifiers
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RAVS in HCV
Identifier Type: -
Identifier Source: org_study_id