All rights reserved.
COVID-19 is an emerging, rapidly evolving situation.
Although they do result in a further shift in the ECThere are several possible explanations for the better than expected activity of ledipasvir in patients with genotype 3 infection. Study drug was resumed 3 days later and this patient completed the course of therapy.
Search for other works by this author on:
, Stedman, C.A. Search for other works by this author on:
We conducted an open-label trial to evaluate the safety, tolerability, and efficacy of ledipasvir and sofosbuvir plus ribavirin in patients with genotype 3 HCV infection.We enrolled treatment-naive patients with and without compensated cirrhosis at 15 sites in Canada.
In this study, high SVR rates were achieved in treatment-naive patients with genotype 3 infection with the use of coformulated sofosbuvir and ledipasvir combined with weight-based ribavirin for 12 weeks.Sofosbuvir is a pangenotypic nucleotide polymerase inhibitor with potent activity against all 6 HCV genotypes in both in vitro replicon assays and extensive clinical use.
In cohort 3, 18 patients received ledipasvir once daily for 12 weeks in combination with sofosbuvir (90 mg ledipasvir and 400 mg sofosbuvir).
SVRIn this multicenter trial involving treatment-naive patients with genotype 3 HCV, 12 weeks of ledipasvir-sofosbuvir provided a high level of SVR in those without cirrhosis.Genotype 3 hepatitis C virus (HCV) accounts for an estimated 30% of HCV infections, making it the second-most prevalent HCV genotype worldwide, following only genotype 1 [Ledipasvir is a potent, well-tolerated NS5A inhibitor with picomolar potency against HCV genotype 1a and 1b [At the time the study was undertaken, the only approved interferon-free treatment for genotype 3 was sofosbuvir plus ribavirin, which resulted in very low SVR rates, particularly in those who had been previously treated and those with cirrhosis [In the current study, we further evaluated the efficacy, tolerability, and safety of 12 weeks of ledipasvir and sofosbuvir plus weight-based ribavirin for treatment-naive patients infected with HCV genotype 3, with or without cirrhosis.We conducted this phase 2, open-label, single-cohort study from 1 May 2015 to 23 December 2015 at 15 sites in Canada. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection.
Search for other works by this author on:
Search for other works by this author on:
All patients were treated with ledipasvir-sofosbuvir (90 mg and 400 mg) plus weight-based ribavirin for 12 weeks.
Although ledipasvir and sofosbuvir plus ribavirin is not a recommended treatment for genotype 3 HCV infection by international guidelines, these data suggest that it could be an alternative treatment in settings where preferred treatments are not available.Oxford University Press is a department of the University of Oxford. Listing a study does not mean … For cohort 3, statistical comparisons of sofosbuvir, GS-331007, and ledipasvir plasma pharmacokinetic parameters AUC tau and C max were made between patients with HCV with stage 4–5 chronic kidney disease receiving ledipasvir plus sofosbuvir in this study and those with HCV and with normal renal function (CL cr ≥90 mL/min) who participated in the ledipasvir plus sofosbuvir phase 2 … Search for other works by this author on:
Patients with hepatocellular carcinoma, clinically significant laboratory abnormalities (alanine aminotransferase >10 times the upper limit of normal [ULN], aspartate aminotransferase [AST] >10 × ULN, direct bilirubin >1.5 × ULN, platelet counts <50000 cells/µL, hemoglobin A1c >10%, creatinine clearance by Cockroft-Gault equation <60 mL/minute, hemoglobin <10 g/dL, albumin <3 g/dL, or an international normalized ratio >1.5 × ULN), decompensated liver cirrhosis, or coinfection with hepatitis B virus or human immunodeficiency virus were ineligible for enrollment.Up to 40% of patients enrolled could have compensated cirrhosis, as demonstrated by liver biopsy (with a Metavir fibrosis score of 4 or Ishak score of at least 5), Fibroscan (showing cirrhosis defined as a score of at least 12.5 kPa), or a Fibrotest score of at least .75 and an AST-to-platelet ratio index of at least 2.