SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03572140

Developed by Shray Alag, 2020.
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 Labels: 2

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