Olysio (simeprevir) / J&J, Medivir 
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 36 Diseases   5 Trials   5 Trials   637 News 


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  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Biomarker, Clinical, Journal:  Remodeling of immunological biomarkers in patients with chronic hepatitis C treated with direct-acting antiviral therapy. (Pubmed Central) -  Dec 16, 2021   
    We sought to analyze the kinetics profiles of serum biomarkers (LuminexTM) in fifty patients with chronic hepatitis C enrolled in a longitudinal investigation carried out before (baseline), during (W2-4 and W8-12 weeks) and post-treatment (W12-24 weeks) with sofosbuvir plus daclatasvir or simeprevir...High ALT (>69U/L), low platelet (≤150,000/mm) and cirrhosis status at baseline were factors related to delayed immune response shift, as well as, in the kinetics of baseline fold changes in serum biomarkers. These findings added novel evidences for the immunological restoration process triggered by DAAs.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Biomarker, Journal:  Effectiveness of direct-acting antiviral drugs against hepatitis C virus: predictive factors of response to the treatment. (Pubmed Central) -  Oct 30, 2021   
    Presence of diabetes and complications related to liver disease (splenomegaly, portal hypertension, portal hypertensive gastropathy), body mass index ≥30, greater liver fibrosis, receiving simeprevir and higher baseline levels of glucose, aspartate-aminotransferase, alanine-aminotransferase and alkaline-phosphatase, have been identified as predictive factors of non-response (p < 0.05)...The effectiveness and safety of direct-acting antivirals against hepatitis C virus have been maintained in routine clinical practice. Further research on predictive factors of response is required in order to develop more reliable and reproducible predictive models.
  • ||||||||||  [VIRTUAL] TRENDS IN HEPATOCELLULAR CARCINOMA AND ANTIVIRAL HEPATITIS TREATMENT IN OLDER AMERICANS () -  Oct 21, 2021 - Abstract #AASLD2021AASLD_913;    
    Despite a marked increase in the effectiveness and frequency of HCV treatment in 2014 and 2015, HCV-attributable HCC continued to rise through 2015. Future studies should examine the incidence of HCV-attributable HCC among older Americans in subsequent years to assess the effect of the introduction of DAA therapies for HCV in this population .
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Trial termination:  Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis (clinicaltrials.gov) -  Sep 13, 2021   
    P3,  N=9, Terminated, 
    This study highly recommends researchers to screen these potential drugs in vitro and in vivo against SARS-CoV-2 for further validation of utility. Active, not recruiting --> Terminated; Study stopped due to low accrual and availability of other treatment options
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Extranodal Liver, Pancreas and Spleen Diffuse Large B Cell Lymphoma After Successful Treatment for Chronic Hepatitis C Infection Using Direct Acting Antiviral Therapy (Shoreline Exhibit Hall) -  Sep 8, 2021 - Abstract #ACG2021ACG_2604;    
    The relationship for HCV infection and development of lymphomas is well established,but pathophysiology is not well understood.One of the most accepted hypotheses is chronic viral antigen stimulation and genetic mutations to lymphocytes arising from HCV‐induced replication proteins.Physicians need to be aware that DAA therapy is clearly effective for intra- and extrahepatic manifestations of the virus, but these patients are still at risk for malignancy regardless HCV serologic status.Figure: PET-CT SCAN showing in the lower half of the right liver lobe three large foci of increased tracer uptake, the larger lesion located on the anterolateral aspect of segment VIII measuring 4.3cm AP, also shows a soft tissue mass in pancreatic head with caudal extension that measures 3.7cm AP. There is no main pancreatic duct dilation (b), and a small lesion on superior-posterior aspect subcapsular area of the spleen (c).
  • ||||||||||  Trial completion date, Trial primary completion date:  SWITCH-1: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (clinicaltrials.gov) -  Aug 30, 2021   
    P2,  N=160, Recruiting, 
    There is no main pancreatic duct dilation (b), and a small lesion on superior-posterior aspect subcapsular area of the spleen (c). Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Oct 2020 --> Oct 2022
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Clinical, Journal:  Anti-rod and ring antibodies in patients with chronic hepatitis C using direct-acting antivirals. (Pubmed Central) -  Aug 25, 2021   
    Only one of the 29 naïve patients (3.44%) developed anti-RR during the current treatment. Anti-RR was present in patients previously treated with interferon/ribavirin and can emerge after DAA treatment probably at a lower frequency than after interferon/ribavirin treatment.
  • ||||||||||  Preclinical, Journal:  Hepatitis C Virus Protease Inhibitors Show Differential Efficacy and Interactions with Remdesivir for Treatment of SARS-CoV-2 in Vitro. (Pubmed Central) -  Aug 25, 2021   
    Acyclic PIs asunaprevir and faldaprevir had ECs of 72 and 23 μM, respectively...Viral suppression was achieved with 3- to 8-fold EC50 boceprevir or 1-fold EC50 simeprevir or grazoprevir, but not boceprevir, in combination with 0.4- to 0.8-fold EC50 remdesivir; these concentrations did not lead to viral suppression in single treatments. This study could inform development and application of protease inhibitors for optimized antiviral treatments of COVID-19.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Clinical, Journal:  Remission of long-term hepatic and renal disease induced by HCV after direct-acting antivirals therapy. (Pubmed Central) -  Aug 20, 2021   
    In these two cases, previously experienced to peg-interferon plus ribavirin, the sofosbuvir plus simeprevir therapy was effective, without significant side effects, and interrupted the evolution of at least 20 years of both hepatic and renal diseases. These cases join the seven previously described cases that were treated with this DAAs association.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Clinical, Journal, Real-world evidence:  Cost and Effectiveness of the Treatment of Chronic Hepatitis C in Brazil: Real-World Data. (Pubmed Central) -  Jul 22, 2021   
    The costs of the medicines were still deemed too high for the Brazilian reality, however. Therefore the results contribute to support the formulation and review of public policies based on strong evidence and on real-world data for the treatment of hepatitis C.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir, Tasigna (nilotinib) / Novartis, Inhibikase
    Journal:  Computational investigation of possible inhibitors of the winged-helix domain of MUS81. (Pubmed Central) -  Jun 22, 2021   
    The van der Waals free binding energy majorly modulates the ligand-binding mechanism. The two conserved residues Leu189 and Arg196 are likely important in monitoring the interacting process of simeprevir to wMUS81.
  • ||||||||||  imatinib / Generic mfg.
    Preclinical, Journal:  Antiviral drug design based on the opening mechanism of spike glycoprotein in SARS-CoV-2. (Pubmed Central) -  Jun 16, 2021   
    FDA approved drug molecules were screened by their capabilities of blocking the formation of the key pair of salt bridges, achieved by their positional stabilities in the cavity containing the side chains of K537 and E619 formed in the interface between SD1 and SD2. Simeprevir, imatinib, and naldemedine were identified to possess the desired capability with the most favorable interaction energies.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Journal:  Simeprevir Potently Suppresses SARS-CoV-2 Replication and Synergizes with Remdesivir. (Pubmed Central) -  Jun 3, 2021   
    Mechanistically, we showed that simeprevir not only inhibits the main protease (M) and unexpectedly the RNA-dependent RNA polymerase (RdRp) but also modulates host immune responses. Our results thus reveal the possible anti-SARS-CoV-2 mechanism of simeprevir and highlight the translational potential of optimizing simeprevir as a therapeutic agent for managing COVID-19 and future outbreaks of CoV.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Journal:  Antivirals virtual screening to SARS-CoV-2 non-structural proteins. (Pubmed Central) -  May 6, 2021   
    Moreover, the results suggest that simeprevir is a strong inhibitor of Mpro (-37.2 kcal mol), which is an interesting finding because Mpro plays an important role in viral replication. In addition to drug-receptor affinity, hot spot residues were characterized to facilitate the design of new drug derivatives with improved biological responses.
  • ||||||||||  Olysio (simeprevir) / J&J, Medivir
    Preclinical, Journal:  In vitro susceptibility of human Blastocystis subtypes to simeprevir. (Pubmed Central) -  May 4, 2021   
    Ultra-structurally, SMV induced rupture of Blastocystis cell membrane leading to necrotic death, versus the reported apoptotic death caused by MTZ. In conclusion, 150 µg/ml SMV for 72 h proved its efficacy against ST1, ST2, and ST3 Blastocystis, thus sparing the need for pre-treatment molecular subtyping in developing countries.
  • ||||||||||  Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
    Clinical, Journal:  A real-life study of the positive response to DAA-based therapies for hepatitis C in Brazil. (Pubmed Central) -  Apr 10, 2021   
    This study is the first of this magnitude to be held in a Latin-American country with high SVR results, supported by a free-of-charge universal and public health system. The high performance found in this study gives support to the Brazilian public health policy decision of adopting DAA-based therapies as a strategy to eliminate HCV by 2030.