ledipasvir/sofosbuvir / Generic mfg. 
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 54 Diseases   8 Trials   8 Trials   2662 News 


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  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  HIV Coinfection Predicts Failure of Ledipasvir/Sofosbuvir in Treatment-Naïve Noncirrhotic Patients With HCV Genotype 1. (Pubmed Central) -  May 30, 2019   
    A multivariable logistic regression model including age, sex, liver stiffness, G1 subtype, HCV-RNA, HIV, and treatment duration showed the factors associated with treatment failure to be male sex (adjusted odds ratio [aOR], 2.49; 95% confidence interval [CI], 1.27-4.91; P = .008) and HIV infection (aOR, 2.23; 95% CI, 1.13-4.38; P = .020). The results of this large prospective study analyzing outcomes for LDV/SOF against HCV G1 in treatment-naïve noncirrhotic patients suggest that HIV infection is a predictor of treatment failure in patients with chronic hepatitis C.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion, Adherence:  Evaluation of HepCure Toolkit to Improve Harvoni Adherence (clinicaltrials.gov) -  May 13, 2019   
    P=N/A,  N=71, Completed, 
    TDF was not associated with an increase in renal toxicity. Recruiting --> Completed
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Journal:  Treatment of HCV in the Department of Corrections in the Era of Oral Medications. (Pubmed Central) -  May 7, 2019   
    Multiple logistic regression of GT1 patients identified lower FIB-4 ( p = .008) and treatment clinic ( p = .01) as independent predictors of SVR12. HCV treatment in the DOC by telemedicine with DAA is not only feasible but has a very high SVR12 similar to published trials.
  • ||||||||||  NN1213 / Novo Nordisk
    Trial completion:  Extrahepatic Insulin Resistance in Chronic Hepatitis C (clinicaltrials.gov) -  May 1, 2019   
    P=N/A,  N=17, Completed, 
    Patients with HCV infection suspected of having herpesvirus infection should be treated promptly. Active, not recruiting --> Completed
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Enrollment change, Trial completion date, Trial primary completion date:  APOSTLE: Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection (clinicaltrials.gov) -  May 1, 2019   
    P2,  N=25, Recruiting, 
    Active, not recruiting --> Completed N=10 --> 25 | Trial completion date: Nov 2019 --> Feb 2020 | Trial primary completion date: May 2019 --> Nov 2019
  • ||||||||||  NN1213 / Novo Nordisk
    Trial completion date, Trial primary completion date:  Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia (clinicaltrials.gov) -  Apr 23, 2019   
    P2/3,  N=10, Recruiting, 
    Treatment with LDV/SOF with/without RBV for 12-24 weeks was very well tolerated and resulted in high SVR 12 rates (96%) in HCV GT1 relapsers to SMV + SOF treatment. Trial completion date: Dec 2018 --> Apr 2019 | Trial primary completion date: Dec 2018 --> Apr 2019
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Ledipasvir/Sofosbuvir Effectively Treats Hepatitis C Virus Infections in an Underserved Population. (Pubmed Central) -  Apr 12, 2019   
    This finding also highlights the need for additional measures to prevent loss to follow-up and overdose-related deaths among PWID. Our results suggest that direct-acting antivirals, particularly ledipasvir/sofosbuvir, are generally effective for achieving SVR among underserved patients with HCV infections and may help reduce inequalities in HCV prevalence and outcomes for this vulnerable population.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Olysio (simeprevir) / J&J, Medivir, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Journal:  No difference between direct-acting antivirals for hepatitis C in hepatocellular carcinoma risk. (Pubmed Central) -  Apr 11, 2019   
    There are no significant differences between DAA regimens in HCC risk after antiviral treatment. This suggests that DAAs do not have direct carcinogenic effects as it would be unlikely that different DAAs would have identical carcinogenic effects.
  • ||||||||||  sofosbuvir/velpatasvir/voxilaprevir (GS-7977/GS-5816/GS-9857) / Gilead, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Journal:  Identification of 19 Novel Hepatitis C Virus Subtypes-Further Expanding HCV Classification. (Pubmed Central) -  Apr 6, 2019   
    Despite the presence of polymorphisms at resistance-associated substitution positions, 18 of the 19 patients treated with sofosbuvir-containing therapy achieved SVR12. Nineteen novel HCV subtypes were identified, suggesting an even greater genetic diversity of HCV subtypes than previously recognized.