ledipasvir/sofosbuvir / Generic mfg. 
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  • ||||||||||  ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    Clinical, Journal:  Real-life experience of ledipasvir and sofosbuvir single-tablet regimen among chronic hepatitis C patients in Turkey. (Pubmed Central) -  Oct 9, 2021   
    In conclusion, LDV/SOF±ribavirin yielded very high SVR12 rates, without any safety or tolerability concern in Turkey. The effectiveness of the LDV/SOF treatment was not affected by the patient demographics or medical characteristics such as fibrosis level, cirrhosis status, previous treatment status, HCV-RNA level or HCV genotype.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Clinical, Journal:  Experiences and Perspectives From Women Taking Investigational Therapy for Hepatitis C Virus During Pregnancy. (Pubmed Central) -  Oct 5, 2021   
    Describe the experiences and perspectives among pregnant people with chronic HCV infection receiving ledipasvir/sofosbuvir (LDV/SOF) therapy during pregnancy...Women stated that cure from HCV would be "life-changing," and described antepartum treatment for HCV with LDV/SOF as tolerable and desired, when provided by non-judgmental providers. Antepartum treatment was found to be acceptable by study participants and should be further evaluated to combat the increasing HCV epidemic among young persons, including pregnant people.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Journal:  An evaluation of ledipasvir + sofosbuvir for the treatment of chronic Hepatitis C infection. (Pubmed Central) -  Oct 2, 2021   
    The combination is not FDA approved for genotypes 2 and 3. Single-pill regimens, like LDV/SOF, are important to maintain the quality of life of children and other special populations infected with HCV by shortening treatment regimens, avoiding complex pill regimens, and eliminating injection therapies.
  • ||||||||||  Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie
    Clinical, Journal:  Direct-Acting Antiviral Use for Genotype 1b Hepatitis C Patients with Associated Hematological Disorders from Romania. (Pubmed Central) -  Sep 29, 2021   
    Our findings are consistent in evaluating the efficacy and tolerability of direct-acting antivirals for 1b genotype HCV infected patients with associated hematological malignancies under remission, and other hematological disturbances, that were previously unsuccessfully treated with a pegylated interferon regimen. Thus, paving a pathway for government-funded programs being implemented in this direction.
  • ||||||||||  Zepatier (grazoprevir/elbasvir) / Merck (MSD), Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
    Clinical, Journal:  Comedications and potential drug-drug interactions with direct-acting antivirals in hepatitis C patients on hemodialysis. (Pubmed Central) -  Sep 23, 2021   
    HCV-viremic patients on hemodialysis had a very high prevalence of comedications with a broad spectrum, which had varied DDIs with currently available DAA regimens. Elbasvir/grazoprevir had the fewest potential DDIs, and sofosbuvir/velpatasvir/voxilaprevir had the most potential DDIs.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    A Rare Case of an Incidental Finding of Sarcomatoid Hepatocellular Carcinoma (Shoreline Exhibit Hall) -  Sep 8, 2021 - Abstract #ACG2021ACG_3042;    
    We present a unique case of a 68 year old female with a prior history of hepatitis C who was treated with Harvoni and presented two years later with a liver mass that was found to be positive for primary sarcomatoid hepatocellular carcinoma...In the future, additional studies will be required to determine the impact of adjunctive chemotherapy with or without surgical resection on survival rates. Figure: Immunohistochemistry stain of the liver showing vimentin, magnified at 10x suggesting Sarcomatoid Hepatocellular Carcinoma
  • ||||||||||  ribavirin / Generic mfg.
    Metastatic Hepatocellular Carcinoma After Sustained Virologic Response to Hepatitis C in a Non-Cirrhotic (Shoreline Exhibit Hall) -  Sep 8, 2021 - Abstract #ACG2021ACG_2157;    
    Case Description/ A 71-year-old male with a history of tobacco use, hypertension, diabetes mellitus type 2, and chronic hepatitis C who completed Harvoni in 2017 was admitted due to unintentional weight loss of fifty-five pounds associated with early satiety, epigastric pain, and weakness...Clearance by DAAs had no impact on short term development of HCC but noted sofosbuvir-based treatment without Ribavirin as adding additional risk...Although abdominal ultrasound remains the gold standard, associating the development of HCC in patients with SVR and various SNPs could identify patients at increased risk. Our case further enforces the need for increased surveillance in this patient population.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Acute Renal Failure Caused by Tacrolimus Nephrotoxicity Due to Enhanced Absorption Mediated by Harvoni (Shoreline Exhibit Hall) -  Sep 8, 2021 - Abstract #ACG2021ACG_1901;    
    This drug-drug interaction (DDI) has been rarely reported in the literature before and Ledipasvir/sofosbuvir is generally considered safe in renal transplant patients. Close monitoring, dose titration of immunosuppressive medication, or switching to other safe immunosuppressants may be required in such patients.Figure: Timeline of tacrolimus trough, tacrolimus dose, serum creatinine and creatinine clearance of our patient
  • ||||||||||  benzylpenicillin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
    New Autoimmune Liver Disease or Immunologic Epiphenomenon? A Rare Case of Syphilitic Hepatitis Mimicking Autoimmune Liver Disease (Shoreline Exhibit Hall) -  Sep 8, 2021 - Abstract #ACG2021ACG_1544;    
    Case Description/ A 64-year-old male with hypertension, chronic kidney disease and Hepatitis C infection treated with ledipasvir and sofosbuvir in 2013 achieving SVR12 was admitted for orthostatic hypotension and acute right eye vision loss...The patient was diagnosed with SH and ocular syphilis, and treated with penicillin-G 24 million units/day for 14 days...The positive antibody levels were felt to be secondary to SH, an immunologic epiphenomenon that has not previously been reported. This case again highlights syphilis as the great masquerader.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Clinical, Journal:  Machine-learning-based predictions of direct-acting antiviral therapy duration for patients with hepatitis C. (Pubmed Central) -  Sep 7, 2021   
    The risk of antiviral resistance and the cost of DAA are strong motivators to ensure that first-round DAA therapy is effective. For the dominant DAA treatment during the course of this analysis, we present a model that identifies factors already captured in established guidelines and adds to those age, comorbidity burden, and type 2 diabetes status; patient characteristics that are predictive of extended treatment.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial primary completion date:  Harvoni Treatment Porphyria Cutanea Tarda (clinicaltrials.gov) -  Sep 5, 2021   
    P2,  N=25, Active, not recruiting, 
    For the dominant DAA treatment during the course of this analysis, we present a model that identifies factors already captured in established guidelines and adds to those age, comorbidity burden, and type 2 diabetes status; patient characteristics that are predictive of extended treatment. Trial primary completion date: Jan 2021 --> May 2022
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Clinical, Journal, Real-world evidence:  Real-world safety and effectiveness of ledipasvir/sofosbuvir for the treatment of chronic hepatitis C virus genotype 1 in Japan. (Pubmed Central) -  Sep 2, 2021   
    SVR12 rates were high overall (98.5%) and across subgroups investigated (≥94%), including patients who were elderly (98.2%), treatment-experienced (97.6%), advanced fibrotic (≥95.8%), had existing NS5A resistance-associated substitutions reported pre-treatment (95.0%), compensated cirrhosis (95.7%), HCC (94.0%), and other chronic liver diseases (96.1%). In this large, real-world observational study of Japanese patients with HCV GT1 infection, LDV/SOF treatment resulted in low incidence of adverse events, with high real-world effectiveness, even among patients with potentially higher risks of adverse safety outcomes and treatment failure.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Clinical, Journal:  Risk factors for difficult-to-treat Hepatitis C Virus genotype 4r in Rwanda and implications for elimination in sub-Saharan africa. (Pubmed Central) -  Sep 2, 2021   
    A secondary analysis was performed on data from 300 adults with HCV GT4 enrolled in a prospective trial assessing the safety and efficacy of sofosbuvir-ledipasvir in Rwanda in 2017...In the absence of advanced diagnostics to assess GT subtype, patients with these characteristics may warrant closer monitoring for treatment failure or alternative DAA regimens. More treatment experience with diverse DAA regimens is urgently needed for GT subtypes particular to this region.
  • ||||||||||  NN1213 / Novo Nordisk, Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) / AbbVie, Enanta Pharma, Exviera (dasabuvir) / AbbVie
    Trial completion, Trial completion date, Trial primary completion date:  DAAs Treatment for Chronic HCV/HBV Co-infection Patients(DASCO) (clinicaltrials.gov) -  Sep 1, 2021   
    P2/3,  N=23, Completed, 
    Antiviral therapy avoided the chronic progression of the infection and further spread in care units and in the family environment. Recruiting --> Completed | Trial completion date: Dec 2020 --> Aug 2021 | Trial primary completion date: Oct 2020 --> May 2021
  • ||||||||||  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, 
    Recruiting --> Completed | Trial completion date: Dec 2020 --> Aug 2021 | Trial primary completion date: Oct 2020 --> May 2021 Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Oct 2020 --> Oct 2022
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Enrollment change:  Harvoni Treatment Porphyria Cutanea Tarda (clinicaltrials.gov) -  Aug 30, 2021   
    P2,  N=25, Active, not recruiting, 
    Trial completion date: Dec 2020 --> Dec 2022 | Trial primary completion date: Oct 2020 --> Oct 2022 N=15 --> 25
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion, Trial completion date:  APOSTLE: Ledipasvir/Sofosbuvir for Hepatitis B Virus Infection (clinicaltrials.gov) -  Aug 25, 2021   
    P2,  N=21, Completed, 
    LDV/SOF±RBV proved to be highly efficient in our difficult to treat population with 85.1% SVR. Active, not recruiting --> Completed | Trial completion date: Apr 2021 --> Jun 2021
  • ||||||||||  Zepatier (grazoprevir/elbasvir) / Merck (MSD), Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
    Trial completion date, Trial primary completion date:  CHROME: Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication (clinicaltrials.gov) -  Aug 19, 2021   
    P4,  N=90, Recruiting, 
    ISRCTN Registration: 37915093 (11/04/2016). Trial completion date: Jul 2021 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2022
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion date:  Harvoni Treatment Porphyria Cutanea Tarda (clinicaltrials.gov) -  Aug 18, 2021   
    P2,  N=15, Active, not recruiting, 
    Trial completion date: Jul 2021 --> Jul 2023 | Trial primary completion date: Jul 2021 --> Jul 2022 Trial completion date: Jul 2021 --> May 2022