SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03572140

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Safety of Sofosbuvir Plus Daclatasvir in Patients With Chronic Hepatitis c Virus and Assessment of Resistance Associated Variants in Resistant and Relapsed Cases

To identify side effects of Sofosbuvir/ Daclatasvir treatment regimen of chronic HCV GT-4 infection. - 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.

NCT03572140 HCV

1 Interventions

Name: RAVS In relapsed and resistent cases

Description: assessment of RAVS in relapsed and resistant cases after sofosbuvir plus daclatasvir regimen

Type: Diagnostic Test

group A group B


Primary Outcomes

Description: that may be used in the future to predict the response to Sofosbuvir and this will save a huge cost for Egypt .

Measure: relevance of HC RAVs to the outcomes of therapy with Sofosbuvir in treatment of egyptian patients infected with HCV genotype 4

Time: baseline

Time Perspective: Prospective

Cohort


There are 6 SNPs

SNPs


1 C316N

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. --- L159F --- --- C316N ---


2 L159F

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. --- L159F ---


3 L31M

NS5A RAVs can be very common, with Y93H detected in up to 15% of the population and L31M in up to 6.3%. --- Y93H --- --- L31M ---


4 S282R

Interestingly, this study also verified S282R mutation as associating with failure. --- S282R ---


5 V321A

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. --- L159F --- --- C316N --- --- V321A ---


6 Y93H

NS5A RAVs can be very common, with Y93H detected in up to 15% of the population and L31M in up to 6.3%. --- Y93H ---



HPO Nodes