SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT02124044

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Safety, Tolerability, and Efficacy of Daclatasvir and Asunaprevir, With or Without BMS-791325, in Subjects Coinfected With HIV-HCV

Chronic hepatitis C virus (HCV) infection is a major public health problem with an estimated 180 million people infected worldwide. In the United States an estimated 4.1 million people are infected and HCV is the principal cause of death from liver disease and leading indication for liver transplantation. Within HIV/HCV co-infected patients, liver disease due to Hepatitis C progresses even more rapidly. While combination of ribavirin (RBV) and pegylated interferon (PEG) in combination with boceprevir/telaprevir is the currently recommended therapy for chronic HCV infection and has superior cure rates compared to PEG+RBV alone in HCV monoinfected patients, treatment is still associated with a high incidence of adverse events (AEs), discontinuations and poor cure rates in several populations. Within the HIV/HCV co-infected population treatment for HCV remains complicated given drug interactions between anti-retrovirals and HCV protease inhibitors, in addition to the extensive side-effects due to PEG +RBV alone. Recent studies have demonstrated that the use of a combination of anti-virals which target HCV without interferon (IFN) can cure HCV, without additional toxicities. These novel therapies that do not rely on an IFN backbone may additionally enhance cure rates in HIV/HCV co-infected, a population which has historically been difficult to cure. The findings from this study will aid in the understanding of antiviral and host responses and determinants of response to an IFN free regimen in HIV/HCV co-infected patients.

NCT02124044 HIV-HCV

2 Interventions

Name: Asunaprevir and Daclatasvir

Description: Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients

Type: Drug

HIV/HCV GT-1b, 24 wks ASV/DCV

Name: Asunaprevir and Daclatasvir with BMS-791325

Description: Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients

Type: Drug

HIV/HCV GT-1a/1b, 12 wks ASV/DCV with BMS-791325


Primary Outcomes

Description: The primary outcome was the percentage of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.

Measure: The Percentage of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs

Time: 12 weeks after stop of treatment

Purpose: Treatment

Allocation: Non-Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 L31M

Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis) 2. Positive nucleotide sequence analyses of the NS5A gene for Y93H or L31M/V polymorphisms for the 2DAA arm only. --- Y93H --- --- L31M ---


2 Y93H

Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis) 2. Positive nucleotide sequence analyses of the NS5A gene for Y93H or L31M/V polymorphisms for the 2DAA arm only. --- Y93H ---



HPO Nodes