sofosbuvir/velpatasvir / Generic mfg. 
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  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    Trial completion date, Trial primary completion date:  Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir (clinicaltrials.gov) -  Sep 5, 2021   
    P1,  N=10, Recruiting, 
    Trial completion date: Jun 2023 --> Dec 2023 | Trial primary completion date: Jun 2022 --> Dec 2022
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    Trial completion date:  Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil (clinicaltrials.gov) -  Aug 25, 2021   
    P=N/A,  N=144, Active, not recruiting, 
    It also supports the recommendations by the American Association for the Study of Liver Diseases to continue screening for HCC in decompensated cirrhotic patients who have achieved sustained virologic response. Trial completion date: Jun 2021 --> Nov 2021
  • ||||||||||  ribavirin / Generic mfg.
    [VIRTUAL] Management of DAA Failures in Asia () -  Aug 19, 2021 - Abstract #APDW2021APDW_385;    
    Trial completion date: Jun 2021 --> Nov 2021 The Taiwan HCV Registry (TACR) programme recently reported that the factors associated with DAA failure was DAA adherence 90% of patients with prior DAA failures can be successfully re-treated with sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir or glecaprevir/pibrentasvir if genotype, fibrosis, treatment history and RAS are taken into consideration.
  • ||||||||||  Zepatier (grazoprevir/elbasvir) / Merck (MSD), Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
    Review, Journal:  Virological Factors Associated with Failure to the Latest Generation of Direct Acting Agents (DAA) and Re-Treatment Strategy: A Narrative Review. (Pubmed Central) -  Aug 14, 2021   
    Although rare, the failure to the latest-generation regimens (grazoprevir/elbasvir, sofosbuvir/velpatasvir, pibrentasvir/glecaprevir) represents a serious clinical problem, since the data available in the literature on the virological characteristics and management of these patients are few. The aim of the present narrative review was to provide an overview of the impact of baseline RASs in patients treated with the latest-generation DAAs and to analyze the efficacy of the available retreatment strategies in those who have failed these regimens.
  • ||||||||||  ribavirin / Generic mfg.
    Clinical, Journal, Real-world evidence:  A real-world study of sofosbuvir-based drug treatment for hepatitis C virus genotype 6 infection in Hainan region of China (Pubmed Central) -  Aug 11, 2021   
    There were seven cases of adverse events, mainly including fatigue, anorexia, and mild anemia; however, no serious adverse events were reported. Sofosbuvir-based regimen combined with ribavirin or velpatasvir cannot only achieve high response rate to HCV subtype 6a, but also obtain a good sustained virological response to the rare prevalent sub-genotypes and special virus strains of HCV genotype 6, with mild adverse reactions and acceptable safety profile.
  • ||||||||||  Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
    Trial completion, Trial completion date, Trial primary completion date:  USE-Hep C: Utilization of Hepatitis C Positive Kidneys in Negative Recipients (clinicaltrials.gov) -  Aug 5, 2021   
    P2/3,  N=30, Completed, 
    In limited resource settings, reduction in drug acquisition costs may help achieve progress towards the goal of HCV elimination. Recruiting --> Completed | Trial completion date: Jan 2022 --> Apr 2021 | Trial primary completion date: Jan 2021 --> Apr 2021
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    Trial completion, Enrollment change, Trial completion date, Trial primary completion date:  HCV Seek, Test and Rapid Treatment for Young PWID (clinicaltrials.gov) -  Jul 28, 2021   
    P4,  N=39, Completed, 
    Despite this, a proportion of contraindicated drugs lower than that of GLE/PIB was registered. Recruiting --> Completed | N=72 --> 39 | Trial completion date: Jul 2022 --> Jun 2021 | Trial primary completion date: Jul 2022 --> Jun 2021
  • ||||||||||  ribavirin / Generic mfg.
    Trial completion:  MINMON: Monitoring SOF/VEL in Treatment Na (clinicaltrials.gov) -  Jul 16, 2021   
    P4,  N=400, Completed, 
    However, larger randomized clinical trials including more parameters are needed for accurate estimation of the efficacy of SOF/VEL. Active, not recruiting --> Completed
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    Clinical, Journal:  High Rates of Hidden HCV Infections among Hospitalized Patients Aged 55-85. (Pubmed Central) -  Jul 4, 2021   
    The overall rate of active infection was lower than the rate observed in the 1935-1954 cohort. The high rate of inpatients unaware of HCV infections and the high number of deaths among subjects with an active HCV infection born from 1935 to 1954, suggest that, at least in southern Italy, targeted screening of this birth cohort may be required to reduce the number of undiagnosed cases and hidden infections.
  • ||||||||||  Zepatier (grazoprevir/elbasvir) / Merck (MSD), Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
    Observational data, Retrospective data, Journal:  Factors Enhancing Treatment of Hepatitis C Virus-Infected Italian People Who Use Drugs: The CLEO-GRECAS Experience. (Pubmed Central) -  Jul 2, 2021   
    In addition, the method was successfully applied for determination of velpatasvir in spiked human plasma with adequate % recovery. The performance of DAAs in PWUD is excellent, if 2 conditions are met: (i) that the latest generation drugs are used and (ii) that the patients are managed within the SerDs.
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg.
    New trial, Real-world evidence, Real-world effectiveness, Real-world:  SOF/VEL (clinicaltrials.gov) -  Jul 1, 2021   
    P,  N=150, Recruiting, 
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    Clinical, Observational data, Journal:  Comparing direct acting antivirals for hepatitis C using observational data - Why and how? (Pubmed Central) -  Jul 1, 2021   
    This risk difference is evidence that SOF/LDV is not inferior to SOF/VEL for easy to treat patients with genotype 1 HCV. The approach is a template for comparing drugs when there are no data from comparative trials.
  • ||||||||||  ribavirin / Generic mfg., sofosbuvir/velpatasvir / Generic mfg.
    Clinical, Journal, HEOR, Real-world evidence:  Global real-world evidence of sofosbuvir/velpatasvir as simple, effective HCV treatment: analysis of 5552 patients from 12 cohorts. (Pubmed Central) -  Jun 22, 2021   
    A reasonable reduction in the price of DAAs will increase drug affordability and is of great significance as a global strategy to eradicate viral hepatitis. In this large cohort, representative of clinical practice, a simple 12-week regimen of SOF/VEL without ribavirin resulted in high SVR12/24 rates in diverse patient populations, even among those with compensated cirrhosis.