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


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  • ||||||||||  paritaprevir/ritonavir (ABT-450/r) / AbbVie, Sovaldi (sofosbuvir) / Gilead
    DIRECTLY ACTING ANTIVIRALS ARE SAFE AND EFFECTIVE IN HCV ELDERLY PATIENTS (Poster Exhibition - Hall 7) -  Aug 18, 2019 - Abstract #UEGW2019UEGW_1311;    
    Our study shows that DAA treatment in HCV Patients older than 80 years of age is safe and effective. Due to high rate of comorbidities DDI need to be carefully assessed before starting treatment.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    OFF TRAIL TREATMENT OF HÉPATITIS C WITH HEMODIALYIS PATIENTS, RESULTS OF AN ALGERIAN COHORT (Poster Exhibition - Hall 7) -  Aug 18, 2019 - Abstract #UEGW2019UEGW_1305;    
    Due to high rate of comorbidities DDI need to be carefully assessed before starting treatment. The renal clearance of Sofosbuvir makes it difficult to handle in patients with IRCT, however our study shows that with close and strict monitoring we get a sustained viral response in more than 95% of patients with no significant side effects, however more exhaustive studies, with dosage of active metabolites should be conducted to support our results.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    TREATMENT OUTCOMES OF HEPATITIS C VIRUS RECOMBINANT FORM 2K/1B WITH SOFOSBUVIR BASED REGIMENS IN GEORGIA (Poster Exhibition - Hall 7) -  Aug 18, 2019 - Abstract #UEGW2019UEGW_1300;    
    Also we can conclude, that SVR12 rate was significantly higher in GT2 patients, confirmed by sequencing, treated with SOF/RBV 12 or 20 weeks than in unspecified GT2, who were treated with the same regimen (p < 0.05). Treatment of HCV RF_2k/1b with SOF/LDV regimen with or without RBV is as effactive as GT1 patients.
  • ||||||||||  Clinical, Review, Journal:  Treatment of hepatitis C: Results in real life. (Pubmed Central) -  Aug 15, 2019   
    Furthermore, because of the existing level of evidence, it is difficult to define optimal regimens based on real-world data (ie, treatment duration, when to include ribavirin and options for patients with cirrhosis). The real-life challenges of managing HIV-coinfected patients are also discussed showing the additional burden of avoiding drug-drug interactions between DAAs and antiretrovirals.
  • ||||||||||  Daklinza (daclatasvir) / BMS
    Clinical, Journal:  Generic sofosbuvir based direct-acting antivirals in hepatitis C virus infected patients with chronic kidney disease. (Pubmed Central) -  Aug 9, 2019   
    The real-life challenges of managing HIV-coinfected patients are also discussed showing the additional burden of avoiding drug-drug interactions between DAAs and antiretrovirals. Full dose sofosbuvir based DAA therapy using generics is highly effective for individuals with HCV infection and CKD including advanced CKD (CKD stage 4 or 5 with an e-GFR <30 mL/min or those on dialysis).
  • ||||||||||  daclatasvir+asunaprevir+BMS 791325 FDC / BMS, beclabuvir (BMS-791325) / BMS, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
    Clinical, Journal:  Limitations of daclatasvir/asunaprevir plus beclabuvir treatment in cases of NS5A inhibitor treatment failure. (Pubmed Central) -  Aug 9, 2019   
    Sustained virological response was achieved in a DAA-naïve patient and one of the DCV/ASV treatment failures through DCV/ASV/BCV therapy; however, HCV relapse occurred in the other patients with prior DCV/ASV and/or sofosbuvir/ledipasvir treatment failures. DCV/ASV/BCV therapy seems to have limited efficacy for patients with NS5A RAVs for whom prior DAA treatment has failed.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Acute Hepatitis C in an Elderly Woman With No Risk Factors: A Rare Presentation (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_2979;    
    She was then discharged and immediately started on sofosbuvir-ledipasvir and eventually achieved sustained virologic response...A biopsy aids in discerning these two entities with very different treatment strategies. Generally, a waiting period of 12 weeks is instituted to allow for spontaneous viral clearance, but immediate treatment can be initiated in cases of elderly patients with severe presentations.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Abdominal Aortic Aneurysm: An Uncommon Cause of Gastric Outlet Obstruction (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_2248;    
    Case Description/ A 65 year old male with past medical history of AAA, HCV treated with Harvoni, GERD with gastritis, and HTN presented with intractable nausea and non-bloody, bilious vomiting for 6 hours associated with sudden onset generalized abdominal pain...Previously, gastric bypass was the general treatment prior to the introduction of surgical aortic repair. Aortic aneurysm repair is the mainstay of therapy with endovascular repair becoming increasingly common.
  • ||||||||||  Trileptal (oxcarbazepine) / Novartis
    Treating Acute Hepatitis C Virus Infections: Is It Cost Effective? (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_2125;    
    Though the presence of the eosinophils and granulomas suggest Oxcarbazepine induced liver injury, the marked hepatocyte injury coincides with acute HCV...In high risk patients the QALY increased by 0.03 and decreased costs up to $3,655, substantiating this as a cost saving outcome. Although more studies are needed to demonstrate the effectiveness of DAAS,this particular study seemed to be promising.
  • ||||||||||  tacrolimus / Generic Mfg., Vemlidy (tenofovir alafenamide) / Gilead
    Multifocal Hepatocellular Carcinoma Masquerading as Cirrhosis (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_2115;    
    He also has chronic hepatitis B which is treated with tenofovir alafenamide...Secondary to this discovery, tacrolimus was decreased and everolimus was started in hopes to decrease risk for recurrent HCC...Studies have shown in animal models the potential positive effects of mTOR inhibitors in decreasing recurrence; however human data is controversial. There is some thought that the benefit of the mTOR inhibitor is to decrease the dose of calcineurin agents with known hepatoproliferative properties.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Direct-Acting Antivirals for the Treatment of Hepatitis C Genotypes 1 to 5 in Sub-Saharan Africa (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_2014;    
    The median age of patients was 52 years (IQR 42-60) and 55% of them were females. Seventy-six percent of individuals had genotype 4, 14% genotype 2, 6% genotype 1, 2.5% genotype 5 and 1.5% genotype 3.
  • ||||||||||  Lenvima (lenvatinib) / Eisai, Merck (MSD), Nexavar (sorafenib) / Bayer, Amgen, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Non-Cirrhotic Hepatocellular Carcinoma Presenting as Bleeding Rectal Varices (Exhibit Halls 3 and 4 (Street Level)) -  Aug 8, 2019 - Abstract #ACG2019ACG_1793;    
    Medical history was notable for prostate cancer status post radiation therapy, prior hepatitis B exposure and hepatitis C status post Harvoni with sustained virologic response...Patient would ultimately fail sorafenib and lenvatinib therapy due to liver toxicity and continued tumor growth without recurrence of LGIB...Given the low incidence, there are no established guidelines to define management strategies for bleeding rectal varices. Currently long term management is directed by physician expertise and available services.
  • ||||||||||  NN1213 / Novo Nordisk
    Trial completion, Trial completion date, Trial primary completion date:  Efficacy of All-Oral Anti-Viral Therapy for Symptomatic Hepatitis C Virus Infection-Related Cryoglobulinemia (clinicaltrials.gov) -  Aug 6, 2019   
    P2/3,  N=10, Completed, 
    There were 132 patients (36.0%) who had cirrhosis, and 28 patients (7.6%) who underwent liver transplantation. Recruiting --> Completed | Trial completion date: Apr 2019 --> Jul 2019 | Trial primary completion date: Apr 2019 --> Jul 2019
  • ||||||||||  Clinical, Journal:  Treatment of Hepatitis C Virus Infection in Dialysis Patients. (Pubmed Central) -  Aug 3, 2019   
    DAA therapy causes far fewer adverse reactions compared with IFN therapy and has been reported to be highly effective in treating HCV infection in hemodialysis patients. Key Messages: A remarkable progress in HCV treatment has allowed all patients with chronic hepatitis C to receive effective therapies to cure the disease.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion, Enrollment change, Trial completion date, Metastases:  Hepatitis C Virus(HCV) Heart and Lung Study (clinicaltrials.gov) -  Jul 24, 2019   
    P4,  N=15, Completed, 
    Provision of this 2-tablet daily HIV-HCV regimen is feasible, well tolerated, and safe, avoids drug-drug interactions between HIV and HCV medications, maintains HIV suppression in the absence of drug resistance, and is highly curative of HCV. Recruiting --> Completed | N=50 --> 15 | Trial completion date: Apr 2019 --> Jul 2019
  • ||||||||||  Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie
    Journal:  HCV compliance and treatment success rates are higher with DAAs in structured HCV clinics compared to general hepatology clinics. (Pubmed Central) -  Jul 23, 2019   
    Female patients (P = .02), older age (P < .0001), previous treatment (P = .03), treatment in SHC (OR 1.7, 95% CI 1.2, 2.3, P = .0008), and sofosbuvir/ledipasvir compared to sofosbuvir/velpatasvir, sofosbuvir, or elbasvir/grazoprevir had higher odds of treatment success. With 1:1 matching, the SHC group still had significantly higher odds than the GHC group of achieving treatment and compliance success.Our study shows that the effectiveness of HCV treatment could be improved by coordinating treatment in a structured HCV clinic.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Journal:  Hepatitis C Treatment with Sofosbuvir and Ledipasvir Accompanied by Immediate Improvement in Hemoglobin A1c. (Pubmed Central) -  Jul 19, 2019   
    With 1:1 matching, the SHC group still had significantly higher odds than the GHC group of achieving treatment and compliance success.Our study shows that the effectiveness of HCV treatment could be improved by coordinating treatment in a structured HCV clinic. This pilot study shows the possibility that HCV eradication by SOF/LED was accompanied by an improvement of glucose metabolism in the population with or without diabetes, and suggests further investigation.
  • ||||||||||  Daklinza (daclatasvir) / BMS
    Review, Journal:  Management of acute HCV infection in the era of direct-acting antiviral therapy. (Pubmed Central) -  Jul 17, 2019   
    The Review also discusses the 2016 AASLD-IDSA and EASL recommendations for acute HCV infection management in light of available evidence and highlights key differences in study populations and design that influence interpretation. We focus on populations at high risk of HCV transmission and acquisition, including people who inject drugs and HIV-positive men who have sex with men, and highlight the potential effects of diagnosis and treatment of acute HCV infection in contributing to HCV elimination.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Enrollment change, Trial completion date, Trial initiation date, Trial withdrawal, Trial primary completion date:  IFNL4 Genotype for Predicting Response to Ledipasvir/Sofosbuvir (clinicaltrials.gov) -  Jul 8, 2019   
    P=N/A,  N=0, Withdrawn, 
    More steps must be taken to increase access to treatment for this underserved, vulnerable population. N=600 --> 0 | Trial completion date: Sep 2026 --> Jul 2019 | Initiation date: Jul 2019 --> Jun 2018 | Not yet recruiting --> Withdrawn | Trial primary completion date: Sep 2026 --> Jul 2019
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Ledipasvir-Sofosbuvir for Treating Japanese Patients With Chronic Hepatitis C Virus Genotype 2 Infection. (Pubmed Central) -  Jul 4, 2019   
    These novel findings hold important implications for not only improving therapeutic outcomes, but also maximizing the clinical utility of LDV and SOF combination regimens. Among Japanese patients with HCV genotype 2, 12 weeks of treatment with ledipasvir-sofosbuvir resulted in high rates of SVR12 that were non-inferior to sofosbuvir + ribavirin.
  • ||||||||||  Rituxan (rituximab) / Roche, Biogen
    Journal:  Recurrence of malignant lymphoma immediately after treatment for hepatitis C virus using direct-acting antivirals (Pubmed Central) -  Jun 28, 2019   
    Seven years later, he received the direct-acting antivirals (DAAs) sofosbuvir/ledipasvir for hepatitis C virus (HCV) genotype 1b...However, the relationship between DAAs and hepatocellular carcinoma recurrence remains unclear. Nonetheless, possible cancer recurrence should be considered in patients with a history of lymphoma who are prescribed DAAs to treat HCV.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion date, Trial primary completion date:  Harvoni Treatment Porphyria Cutanea Tarda (clinicaltrials.gov) -  Jun 26, 2019   
    P2,  N=49, Recruiting, 
    Trial primary completion date: May 2019 --> Dec 2019 Trial completion date: Aug 2022 --> Aug 2024 | Trial primary completion date: Aug 2022 --> Aug 2023
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Is sofosbuvir/ledipasvir safe for the hearts of children with hepatitis C virus? (Pubmed Central) -  Jun 15, 2019   
    No adverse cardiovascular events were observed in this group of HCV infected children and adolescents treated with sofosbuvir/ledipasvir. None of the patients developed bradyarrhythmias during treatment.