ledipasvir/sofosbuvir / Generic mfg. 
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  • ||||||||||  Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    EFFECT OF SOFOSBUVIR/LEDIPASVIR AND GLECAPREVIR/PIBRENTASVIR ON SERUM CREATININE (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_2444;    
    Treatment of chronic hepatitis C infection with SOF/LDV or GLE/PIB may result in an increase of creatinine at post treatment week-4 and week-24, and 6% will have an increase in serum creatinine of ≥ 0.3 mg/dL. The change in creatinine, however, was unrelated to the type of DAA combination.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    FACTORS ASSOCIATED WITH SUSTAINED VIRAL RESPONSE AMONG PATIENTS TREATED WITH DIRECT ACTING ANTIVIRALS, GEORGIA ELIMINATION PROGRAM (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_2314;    
    Treatment were provided by sofosbuvir/ribavirin (SOF/RBV) with or without interferon (IFN) and sofosbuvir/ledipasvir (LDV) with or without RBV. The presented study showed that by multivariate analysis age, gender, weight and liver enzymes were not associated with SVR, while genotype, fibrosis stage and treatment regimen were independent predictors of the treatment outcome.
  • ||||||||||  daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
    FACTORS ASSOCIATED WITH THE REDUCTION OF LIVER STIFFNESS AFTER THE TREATMENT OF DIRECT-ACTING ANTIVIRALS FOR CHRONIC HEPATITIS C (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_2313;    
    The significant reduction of LS at EOT was observed in patients with mild liver dysfunction and severe inflammation which were indicated by higher albumin levels and ALT levels, whereas the significant reduction of LS at 2Y was observed in patients with mild liver dysfunction and mild fibrosis which were indicated by lower bilirubin levels and LS. The reduction of LS at early times after EOT could be attributed to regression of liver inflammation.
  • ||||||||||  Ledipasvir (GS-5885) / Gilead
    HCV RESISTANCE PATTERNS IN A WORLDWIDE NETWORK OF COHORTS OF GT-3a INFECTED PATIENTS (Sheraton Boston Hotel, Constitution Ballroom) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_2166;    
    The frequency of the co-occurrence of Y93H with another RAS at position 30 (A30S, A30K) depended on the treatment regimen received (first versus last-generations DAAs). Multiple NS3 and NS5A RASs can challenge retreatment with last-generation NS5A inhibitors.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    HEPATITIS C SUSTAINED VIROLOGIC RESPONSE RATES IN AFRICAN AMERICANS (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_2096;    
    Fifty percent of patients had a drug-drug interaction at baseline, 38% had state-funded insurance (Medicaid), and 64% were treated with ledipasvir/sofosbuvir ± ribavirin. These findings demonstrate that DAA treatment is highly effective in AA patients and that AA race was not associated with decreased SVR rates after HCV treatment with DAAs compared to other races.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    MANAGEMENT OF HEPATITIS C IN PRIMARY HEALTHCARE IN THE COUNTRY OF GEORGIA (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_1681;    
    Our study reported the feasibility and effectiveness of integrating a simplified HCV diagnostic and treatment model in PHCs. Countrywide expansion of this model is warranted to bridge the gaps in the HCV care continuum and ensure high rates of treatment uptake towards achieving elimination targets.
  • ||||||||||  Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta
    MODELING-BASED RESPONSE-GUIDED THERAPY UNDER GLECAPREVIR/PIBRENTASVIR MAY OPTIMIZE DURATION OF THERAPY IN PATIENTS WITH COMPENSATED CIRRHOSIS (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_1623;    
    P=N/A
    Background: We recently showed in a proof-of-concept pilot study (NCT03603327) that real-time modeling-based response guided therapy (RGT) can shorten treatment duration with sofosbuvir/velpatasvir, elbasvir/grazoprevir and sofosbuvir/ledipasvir without compromising efficacy or patient safety (Hepatology 2018;68(6):1468-9A), which confirmed our retrospective modeling reports in more than 200 patients (Liver International 2019;39(5):815-817). Modeling underscores the utility of modeling-based RGT approach under P/G therapy.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    SAFETY, TOLERABILITY, AND ANTIVIRAL ACTIVITY OF LEDIPASVIR/SOFOSBUVIR FOR HEPATITIS B INFECTION. (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_1076;    
    Those with prior SOF/VEL treatment and with at least dual class resistance were less likely to achieve SVR with SVV, however strategies to improve SVR in these groups remain unclear. Ledipasvir/sofosbuvir when given for 12 weeks is safe and well tolerated by patients with monoinfected chronic HBV infection and appears to have a modest antiviral activity against hepatitis B.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    THE PREVALENCE AND IMPACT OF HEPATIC STEATOSIS ON RESPONSE TO DAA THERAPY IN HIV-HCV COINFECTION. (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_791;    
    In HIV-HCV coinfection, hepatic steatosis is common, correlates with increasing age and obesity, and cannot be readily identified by the HSI compared to CAP. SVR-12 rate with DAAs is high in HIV-HCV coinfected patients and not impacted by steatosis or the presence of the metabolic syndrome.
  • ||||||||||  Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
    THE ROAD TO ELIMINATION OF HEPATITIS C: COSTS PER CURE FALL TO US $32 PER PERSON. (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_782;    
    API costs for DAAs continue to fall, and, consequently, potential generic prices fall too. National Health departments need to be aware of these potential costs when negotiating lower prices for mass HCV elimination programs.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    USE OF ANTIVIRALS FOR HEPATITIS C GENOTYPES 1 TO 5 IN A SINGLE CENTER IN SUB-SAHARAN AFRICA (Hynes Convention Center, Hall B) -  Sep 29, 2019 - Abstract #AASLD2019AASLD_668;    
    The majority of patients were treated with Ledipasvir/Sofosbuvir (LDP/SOF) with or without Ribavirin (RBV) or Sofosbuvir with Ribavirin (SOF/RBV). Our study demonstrates e successful treatment of HCV with DAAs among different viral genotypes in Sub-Saharan Africa, demonstrating the feasibility of HCV elimination in resource-limited settings.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Journal, HEOR:  Comparative effectiveness of 8- and 12-week ledipasvir/sofosbuvir regimens for HCV infection. (Pubmed Central) -  Sep 28, 2019   
    Our real-world results suggest that 8- and 12-week ledipasvir/sofosbuvir have comparable effects on SVR among HCV-1 patients without cirrhosis or HIV. In addition, the comparable effectiveness of 8- and 12-week regimens among non-Hispanic Black individuals adds to the growing body of evidence that supports the removal of race-based treatment guidelines.
  • ||||||||||  Journal:  Direct-Acting Antivirals to Prevent Vertical Transmission of Viral Hepatitis C: When Is the Optimal Time to Treat? (Pubmed Central) -  Sep 26, 2019   
    In addition, we identified rare combinations of variants in HCV G3 that reduce response to sofosbuvir. Data to determine the best treatment point along the pregnancy-pediatric continuum are limited; however, given the lack of human data for use of DAAs during pregnancy, low rate of VT, high rate of spontaneous pediatric clearance, and recent approval of DAAs for pediatric patients, treatment of chronically infected children seems to be the optimal strategy currently.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    PULMONARY CRYPTOCOCCUS NEOFORMANS IN AN 'IMMUNOCOMPETENT' PATIENT RESULTS IN ACUTE RESPIRATORY FAILURE (Ernest N. Morial Convention Center - Exhibit Hall - Poster Area 1) -  Sep 25, 2019 - Abstract #CHEST2019CHEST_1606;    
    Data to determine the best treatment point along the pregnancy-pediatric continuum are limited; however, given the lack of human data for use of DAAs during pregnancy, low rate of VT, high rate of spontaneous pediatric clearance, and recent approval of DAAs for pediatric patients, treatment of chronically infected children seems to be the optimal strategy currently. We present a case of acute respiratory distress syndrome in an HIV seronegative patient likely secondary to cryptococcal pneumonia.Case Presentation:A 51 year old woman with a history of asthma on chronic inhaled steroids and Hepatitis C cirrhosis status post Harvoni presented with dysuria and was found to have a UTI with secondary E. Coli bacteremia...Her CT chest revealed bilateral airspace disease presumably from a hospital acquired pneumonia and she was treated with Vancomycin, Cefepime and Azithromycin...A more nuanced approach to immunological function may be needed to appropriately diagnose and treat such patients.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Olysio (simeprevir) / J&J, Medivir, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Safety and efficacy of ledipasvir/sofosbuvir with or without ribavirin in hepatitis C genotype 1 patients including those with decompensated cirrhosis who failed prior treatment with simeprevir/sofosbuvir. (Pubmed Central) -  Sep 18, 2019   
    We present a case of acute respiratory distress syndrome in an HIV seronegative patient likely secondary to cryptococcal pneumonia.Case Presentation:A 51 year old woman with a history of asthma on chronic inhaled steroids and Hepatitis C cirrhosis status post Harvoni presented with dysuria and was found to have a UTI with secondary E. Coli bacteremia...Her CT chest revealed bilateral airspace disease presumably from a hospital acquired pneumonia and she was treated with Vancomycin, Cefepime and Azithromycin...A more nuanced approach to immunological function may be needed to appropriately diagnose and treat such patients. Single tablet fixed-dose combination LDV/SOF ± RBV is efficacious and well tolerated in patients who previously failed treatment with SIM/SOF, including those with decompensated cirrhosis and recurrent hepatitis C following liver transplantation.
  • ||||||||||  Daklinza (daclatasvir) / BMS
    Journal:  Identification of a Novel Hepatitis C Virus Genotype from Punjab, India - Expanding Classification of Hepatitis C Virus into 8 Genotypes. (Pubmed Central) -  Sep 18, 2019   
    Despite presence of baseline RASs within the GT8 virus of all 4 patients (NS3: V36L, Q80K/R; NS5A: Q30S, Y93S), all patients achieved a sustained virologic response; two treated with sofosbuvir/velpatasvir/voxilaprevir for 8 weeks, one with sofosbuvir/ledipasvir plus ribavirin for 24 weeks and one with sofosbuvir plus daclatasvir for 12 weeks. The discovery of a novel HCV GT8 confirms the circulation of this newly identified lineage in the human population.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Journal, HEOR:  Cost-effectiveness of treating hepatitis C in Seychelles. (Pubmed Central) -  Sep 5, 2019   
    ...Treatment with Harvoni, a combination of sofosbuvir and ledipasvir (SOF/LDV), is now being offered on the condition that the patient does not, or has stopped, injecting drugs...treating hepatitis C cases in Seychelles is cost-saving. It is worth developing a treatment programme to include all cases of hepatitis C, regardless of status of drug injection.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Heart Transplantation in a Fontan Patient Using a Hepatitis C-Positive Donor. (Pubmed Central) -  Sep 3, 2019   
    A 38-year-old female with tricuspid atresia and normally related great arteries, initially palliated with Björk modified Fontan, and ultimately converted to extracardiac conduit Fontan, with a history of ventricular tachycardia and hepatitis C virus (HCV) treated with sofosbuvir/ledipasvir, was referred to our center for consideration of combined heart and liver transplantation...Fifteen days later, an HCV-positive donor was identified, and she underwent heart transplantation with pulmonary artery reconstruction performed jointly by adult and pediatric transplant surgeons. To our knowledge, this the first time an HCV-positive donor heart has been to transplant an adult with congenital heart disease.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Ledipasvir/sofosbuvir combination for chronic hepatitis C infection in children and adolescents (Pubmed Central) -  Aug 30, 2019   
    To our knowledge, this the first time an HCV-positive donor heart has been to transplant an adult with congenital heart disease. Treatment with ledipasvir/sofosbuvir in paediatric patients with chronic HCV infection genotype 1 and 4 is safe and effective with SVR12 and similar to those reported in adults.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Journal:  CROI 2019: highlights of viral hepatitis. (Pubmed Central) -  Aug 27, 2019   
    Hepatitis B virus (HBV)-active antiretrovirals are generally effective in suppressing HBV but have low rates of surface antigen loss despite long term treatment. Initial results from novel laboratory assessments of intrahepatic HBV viral infection events were presented, hopefully paving the way for more effective HBV treatment strategies to control and potentially cure HBV.