ledipasvir/sofosbuvir / Generic mfg. 
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  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Clinical, Journal:  Use of sofosbuvir-based regimens in the treatment of adolescents and children with chronic hepatitis C (Pubmed Central) -  Feb 14, 2021   
    Available clinical trial data show that sofosbuvir with ribavirin and ledipasvir/sofosbuvir are highly efficacious and safe in CHC patients aged 3-17 years old; therefore, they can meet the unmet medical needs of adolescents and children with CHC in China. Furthermore, the pan-genotypic sofosbuvir/velpatasvir is being investigated in adolescents and children with CHC, which is expected to make the treatment in such patients more convenient upon approval.
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    Clinical, Journal:  Hepatitis C direct-acting antiviral outcomes in patients 75 years and older. (Pubmed Central) -  Feb 9, 2021   
    Ribavirin-free DAA therapy is safe and achieves SVR rates in older adults comparable to those described in the general population. RBV inclusion frequently results in complications, often leads to treatment modification or interruption, and does not improve SVR rates in those with advanced age.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    [VIRTUAL] Retrospective review of real world on-treatment HCV RNA values and cure rates () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_2928;    
    Due to the high rate of SVR, correlations between on-treatment viral loads and achievement of SVR were not evaluated. This research further supports that on-treatment viral loads may not be a valuable indicator of treatment failure but may be helpful to engage patients in care and ensure treatment adherence and ultimately cure.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    [VIRTUAL] Impact of clinical pharmacist driven hepatitis C care in gastroenterology within a safety net institution () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_2763;    
    Within our safety net institution, a large number of patients were treated successfully, with genotype 1A being most common and ledipasvir-sofosbuvir being one of the most used DAAs. SVR rates are lower compared to clinical trials, as many patients are lost to follow-up post-treatment; thus, further work is needed to optimize SVR rates within the safety net setting.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    [VIRTUAL] Regional variation in Ledipasvir/Sofosbuvir use, cost, and prescribers of medicare beneficiaries () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_1634;    
    Some of the regional variation may be due to the fact that patients need to meet certain requirements to receive these drugs such as a specialist referral and proof of cessation of alcohol or illicit drugs, which may differ by region. Increasing the availability of specialty providers in more rural areas such as the Midwest may help to address access issues.
  • ||||||||||  [VIRTUAL] Determining treatment for hepatitis C refractory to multiple direct-acting antivirals () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_1266;    
    In early 2017, the patient was initiated on elbasvir/grazoprevir, a combination NS5A inhibitor and NS3/4A protease inhibitor, for twelve weeks and again experienced treatment failure...The patient was initiated on sixteen weeks of glecaprevir/pibrentasvir in November 2018 and had an undetectable viral load at treatment completion in February 2019...After consideration of his resistance test and previous treatment failures, the plan was made to proceed with treatment with sofosbuvir/velpatasvir/voxilaprevir plus ribavirin for 12 weeks...This case illustrates the complicated nature of treating patients with refractory HCV infection and the potential for multiple treatment failures, even on agents with very high rates of sustained virologic response. In order to determine an option that will produce a sustained virologic response, it is vitally important to consider the data and evidence to guide treatment decisions after failure on previous options.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead
    Clinical, Journal, Real-World Evidence:  High efficacy of Resistance-guided retreatment of HCVpatients failing NS5A inhibitors in real world. (Pubmed Central) -  Dec 23, 2020   
    We hypothesize that SVR rates may even be improved if resistance data are discussed between experienced virologists and treating clinicians. We believe that our data may be relevant for countries where the access to new DAA combination regimens is limited.
  • ||||||||||  Trial completion, Trial completion date:  PRIORITIZE: Study of Oral Treatments for Hepatitis C (clinicaltrials.gov) -  Dec 23, 2020   
    P4,  N=1275, Completed, 
    We believe that our data may be relevant for countries where the access to new DAA combination regimens is limited. Active, not recruiting --> Completed | Trial completion date: Feb 2022 --> Sep 2020
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Journal:  Hepatitis C Virus Infection in Pregnancy: An Update. (Pubmed Central) -  Dec 18, 2020   
    Direct acting antiviral agents are interferon-free, and many are also ribavirin-free. Based on animal studies, sofosbuvir plus ledipasvir may be the best safety profile during pregnancy for now; however, it is too early to recommend treating hepatitis C virus-infected pregnant women with these direct acting antiviral agents currently.
  • ||||||||||  Copegus (ribavirin) / Bausch Health
    Retrospective data, Journal:  Successful use of generic direct acting antiviral medications to treat hepatitis C-a New Zealand-wide study. (Pubmed Central) -  Dec 15, 2020   
    In this large cohort of patients with various HCV genotypes managed in the real-world practice setting, daclatasvir plus sofosbuvir, ledipasvir/sofosbuvir, and sofosbuvir/velpatasvir achieved high SVR rates with good safety profile, comparable to those observed in clinical trials. Generic DAAs to treat hepatitis C are safe, efficient and a cheaper than branded medications option.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Sovaldi (sofosbuvir) / Gilead
    Clinical, Journal:  Assessment of Treatment Options for Patients with Hepatitis C Virus Recombinant Form 2k/1b. (Pubmed Central) -  Nov 21, 2020   
    DAA prices in most countries remain many times higher than estimated cost-based generic prices. SOF-based regimens are highly effective for treatment of RF 2k/1b patients, and with availability of new pan-genotypic direct-acting antivirals (DAAs), genotyping to identify RF 2k/1b patients may not be necessary.
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    Clinical, Journal:  Trends in Renal Function Among Heart Transplant Recipients of Donor-Derived Hepatitis C Virus. (Pubmed Central) -  Nov 19, 2020   
    In this first and largest reported case series to date of HT recipients with dd-HCV infection, we observed that neither the dd-HCV infection nor its treatment with Sofosbuvir-based DAAs increased the risk of RI. Sofosbuvir-based DAAs appear safe, tolerable, and effective for HCV treatment even in presence of severe RI.
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Journal, HEOR:  Drug Costs: What Can Infectious Diseases Physicians Do? (Pubmed Central) -  Nov 14, 2020   
    Sofosbuvir-based DAAs appear safe, tolerable, and effective for HCV treatment even in presence of severe RI. No abstract available
  • ||||||||||  Copegus (ribavirin) / Bausch Health
    Journal:  DIRECT-ACTING ANTIVIRALS FOR HEPATITIS C DO NOT AFFECT THE RISK OF DEVELOPMENT OR THE OUTCOME OF HEPATOCELLULAR CARCINOMA. (Pubmed Central) -  Nov 3, 2020   
    Since March 2016, ledipasvir/sofosbuvir (LDV/SOF) was prescribed to all patients with or without RBV depending on the HCV genotype, level of fibrosis, and previous treatment experience...Moreover, there are no significant changes in mortality rate due to HCC in these groups. Therefore, it can be concluded, that HCC status is not a contraindication for DAA treatment, especially at the early stages of cancer, when a tumor is curative.
  • ||||||||||  sofosbuvir/velpatasvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    Clinical, PK/PD data, Journal:  Pharmacokinetics, Safety, and Tolerability of Ledipasvir/Sofosbuvir and Sofosbuvir/Velpatasvir in Healthy Chinese Subjects. (Pubmed Central) -  Oct 21, 2020   
    Overall, ledipasvir/sofosbuvir and sofosbuvir/velpatasvir exhibited pharmacokinetic and safety profiles in healthy Chinese subjects similar to those in non-Chinese subjects in historical studies, supporting their use in the Chinese population with HCV infection. ChinaDrugTrials.org.cn identifiers: CTR20160149 (ledipasvir/sofosbuvir); CTR20160602 (sofosbuvir/velpatasvir).
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Enrollment closed:  APOSTLE: Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection (clinicaltrials.gov) -  Oct 20, 2020   
    P2,  N=25, Active, not recruiting, 
    The validated HPLC method was successfully used to analyze the abovementioned drugs in their pure and dosage forms without interference from common excipients present in commercial formulations. Recruiting --> Active, not recruiting
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Journal:  Shortened 8-Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents with Chronic Hepatitis C Infection. (Pubmed Central) -  Oct 16, 2020   
    Overall, the end of treatment response and SVR12 were 100%. No grade 3-4 adverse event or a serious adverse event was observed.Further studies are needed to confirm the optimal efficacy of the shortened 8-week treatment with sofosbuvir/ledipasvir for treatment-naïve, non-cirrhotic adolescents with chronic HCV genotype 1 infection and pre-treatment viremia level < 6 million IU/mL.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    [VIRTUAL] An Atypical Case of Fibrillary Glomerulonephritis (On-Demand) -  Oct 11, 2020 - Abstract #KIDNEYWEEK2020KIDNEY_WEEK_2070;    
    He was treated with ledipasvir/sofosbuvir and achieved a sustained virologic response however developed liver cirrhosis and underwent a liver transplant 2 years later...Case series reported positive HCV serology in around 15% of patients with FGN, but none reported FGN after HCV eradication. DNAJB9 staining is specific for FGN and helps establish the diagnosis especially when histology does not demonstrate the classical membranoproliferative or mesangioproliferative patterns of glomerular injury.