Titre : New At Hepatitis C Online: Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi)
link : New At Hepatitis C Online: Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi)
New At Hepatitis C Online: Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi)
Hepatitis C Online is a free educational, web-based service that functions as a comprehensive resource for diagnosing, monitoring and managing the Hepatitis C virus infection. The service is produced at the University of Washington, through a partnership with the International Antiviral Society-USA, and funded by a grant from the Center for Disease Control and Prevention.Although Hepatitis C Online is aimed at clinicians, the site offers a wealth of information for people living with HCV as well. This interactive site offers easy to follow modules about the natural history of HCV, staging liver fibrosis, managing cirrhosis and treating HCV, click here to browse materials.
| Updates |
This week a bit of information on Gilead's newly FDA approved Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi) was added, make sure to check the website in the future for additional updates.
Here are a few links to get you started:
Summary
Start Here: Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi)
Links
View clinical trial data in either slide decks, in your browser or download PDF.
POLARIS-1
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In this phase 3 placebo-controlled trial, investigators enrolled patients with chronic hepatitis C genotype 1-6 who had previously received treatment that included an NS5A inhibitor. Genotype 1 patients were randomized in a 2:1 ratio to either the active arm, a fixed-dose combination of sofosbuvir-velpatasvir-voxilaprevir once daily for 12 weeks, or placebo arm (that received sofosbuvir-velpatasvir-voxilaprevir after follow-up). Patients with genotype 2-6 were all assigned to the active arm. Most patients were either ledipasvir- or daclatasvir-experienced (51% and 27% respectively) and compensated cirrhosis was present in 46% of patients in the active arm. The overall sustained virologic response (SVR) 12 rate was 96% by intent-to-treat analysis, with 6 viral relapses among those who failed sofosbuvir-velpatasvir-voxilaprevir. A SVR 12 occurred in 99% of those who were not cirrhotic and 93% of cirrhotic patients. The SVR rates were not associated with the presence of NS5A or other resistance-associated substitutions. Note: this study was published in tandem with the POLARIS-4 study.
POLARIS-2
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In this phase 3, open-labeled trial, patients with chronic hepatitis C genotype 1-4 infection who were naïve to direct-acting antiviral therapy (prior peginterferon and ribavirin allowed) were randomized to either 8 weeks of sofosbuvir-velpatasvir-voxilaprevir (SOF-VEL-VOX) or 12 weeks of sofosbuvir-velpatasvir (SOF-VEL). Patients with genotype 5-6 were assigned to the SOF-VEL-VOX arm. Compensated cirrhosis was present in 18% and genotype 1 infection in 49% of the 941 patients. Sustained virologic response (SVR) occurred in 95% and 98% in SOF-VEL-VOX and SOF-VEL arms respectively. Only 93% of genotype 1 patients achieved SVR in the 8-week arm; 92% among genotype 1A versus 97% among genotype 1B patients. Notably, SVR occurred in 90% of patients with cirrhosis in the 8-week arm compared with 99% in the 12-week arm. Note: this study was published in tandem with POLARIS-3.
POLARIS-3
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In this phase 3, open-labeled trial, patients with genotype 3 HCV infection and compensated cirrhosis who were DAA naïve (prior peginterferon and ribavirin experience permitted) were randomized to 8 weeks of sofosbuvir-velpatasvir-voxilaprevir (SOF-VEL-VOX) or 12 weeks of sofosbuvir-velpatasvir (SOF-VEL). Sixty-nine percent were treatment-naïve and 23% had platelet counts less than 100 x 103/μL. The rate of sustained virologic response (SVR) was 96% for both treatment arms. Neither of the two patients who relapsed in the SOF-VEL-VOX arm had treatment-emergent resistant substitutions whereas both patients who relapsed in the SOF-VEL arm developed the Y93H variant. All patients with baseline NS5A resistance-associated substitutions achieved an SVR. Note: this study was published in tandem with POLARIS-2.
POLARIS-4
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In this phase 3, active-comparator, open-labeled trial, 314 patients with chronic hepatitis C genotype 1-3 with prior direct-acting antiviral (DAA) therapy without an NS5A inhibitor were randomized to receive either sofosbuvir-velpatasvir-voxilaprevir (SOF-VEL-VOX) or sofosbuvir-velpatasvir (SOF-VEL) for 12 weeks; 19 patients with genotype 4 were assigned to the triple arm. Compensated cirrhosis was present in 46% and prior sofosbuvir exposure in 80% of patients. The overall sustained virologic response rates were 98% and 90% for the SOF-VEL-VOX and SOF-VEL arms respectively. Virologic relapse was confirmed at week 4 for one SOF-VEL-VOX patient and 14 SOF-VEL patients, of whom 8 had genotype 3a. Note: this study was published in tandem with POLARIS-1. Note: this study was published in tandem with POLARIS-1.
Thus articles New At Hepatitis C Online: Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi)
that is all articles New At Hepatitis C Online: Sofosbuvir-Velpatasvir-Voxilaprevir (Vosevi) This time, hopefully can provide benefits to you all. Okay, see you in another article post.
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