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  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion, Enrollment change:  Study of Hepatitis C Treatment During Pregnancy (clinicaltrials.gov) -  Mar 4, 2020   
    P1,  N=9, Completed, 
    Large scale and exclusive studies in HCV genotype 6 prevalent areas are needed, while the current evidence suggests that DAAs are highly effective and safe. Active, not recruiting --> Completed | N=15 --> 9
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    [VIRTUAL] HCV REINFECTION AMONG HIV PATIENTS AFTER DAA THERAPY IN THE COUNTRY OF GEORGIA ([VIRTUAL]) -  Mar 2, 2020 - Abstract #CROI2020CROI_1248;    
    HIV positive IDUs are at high risk for HCV reinfection following successful DAA therapy. Greater engagement in OST programs are required to prevent reinfections and achieve elimination targets.
  • ||||||||||  Daklinza (daclatasvir) / BMS
    [VIRTUAL] HIV COINFECTION AND RISK OF MORBIDITY AND MORTALITY IN HCV PATIENTS TREATED BY DAA ([VIRTUAL]) -  Mar 2, 2020 - Abstract #CROI2020CROI_913;    
    After adjustment, HIV co-infection was not associated with a higher risk of liver-related events (HR=0.67 95%CI: 0.27 ; 1.67) or liver-related-mortality (HR=0.94 95%CI: 0.19 ; 4.67), but the risk of non-liver-related mortality (HR=2.67 95%CI: 0.97 ; 7.37) tended to be higher in HIV/HCV co-infected. After DAA treatment, SVR rates were not impacted by HIV co-infection, the risk of liver-related events and liver-related mortality were similar between HIV/HCV co-infected and HCV mono-infected but HIV co-infection tended to increase the risk of non-liver-related mortality.
  • ||||||||||  [VIRTUAL] EFFECTIVENESS OF DAA IN HIV-POSITIVE PATIENTS WITH HCV GENOTYPE 6 INFECTION ([VIRTUAL]) -  Mar 2, 2020 - Abstract #CROI2020CROI_909;    
    At the time of DAA initiation, all had estimated glomerular filtration rate 30 ml/min/1.73m2, and combination antiretroviral therapy included regimens containing TAF in 27.3% of the patients, TDF 32.2%, non-TDF/TAF 40.5%, NNRTI 29.9%, PI 3.4%, and InSTI 68.6% (dolutegravir 55.8%, elvitegravir 39.8%, and raltegravir 4.4%), with 95.5% of the patients having CD4 counts 200 cells/mm3 and 96.6% plasma HIV RNA load <50 copies/mL...Overall, 98.3% achieved undetectable plasma HCV RNA load (<15 IU/mL) at EOT and 96.6% achieved SVR12 (97.2% in patients receiving SOF/LED, 96.0% in GP, and 100% in SOF/VEL). Similar to the observation in HIV-negative patients, SVR12 with DAAs is high in HIV-positive patients with HCV-6.
  • ||||||||||  Tivicay (dolutegravir) / ViiV Healthcare, Vitekta (elvitegravir) / Japan Tobacco, Gilead
    [VIRTUAL] EFFECTIVENESS OF LDV/SOF FOR HIV-POSITIVE PATIENTS WITH HCV GENOTYPE 2 INFECTION ([VIRTUAL]) -  Mar 2, 2020 - Abstract #CROI2020CROI_908;    
    At the time of LDV/SOF initiation, all had estimated glomerular filtration rate (eGFR) 30 ml/min/1.73m2 and were receiving combination antiretroviral therapy (cART) with TAF-containing regimen in 38.6%, TDF 13.9%, non-TDF/TAF 47.5%, NNRTI 12.9%, PI 14.9%, and InSTI 72.3% (dolutegravir 46.6% and elvitegravir 53.4%%), with 98.0% having CD4 counts 200 cells/mm3 and 94.1% HIV RNA load <50 cp/mL...eGFR increased in 34.1% with a mean increase of 7.2 ml/min/1.73m2, while eGFR decreased in 65.9% with a mean decrease of 12.6 ml/min/1.73m2. Similar to the reported treatment response among HIV-negative patients, LDV/SOF is effective for HIV-positive patients infected with HCV-2.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    [VIRTUAL] RESISTANCE-ASSOCIATED SUBSTITUTIONS (RAS) IN “UNUSUAL” HCV SUBTYPES ([VIRTUAL]) -  Mar 2, 2020 - Abstract #CROI2020CROI_895;    
    Patients failed; SOF/DCV(n= 14), SOF/VEL +/- RBV(n=13), and EBR/GZR(n=10), SOF/LDV +/- RBV(n=10), G/P(n=5) or other regimens(n=2)...In-depth characterization of these subtypes is crucial, in Africa and Asia where these subtypes are common as well as in countries of immigration from these regions. Our results emphasize the need for identification of RAS in these subtypes and their in vitro drug susceptibilities.
  • ||||||||||  Prezista (darunavir) / J&J
    [VIRTUAL] PLASMA & INTRACELLULAR PK AND RENAL SAFETY OF TAF 25MG WITH BOOSTED PI AND LDV/SOF ([VIRTUAL]) -  Mar 2, 2020 - Abstract #CROI2020CROI_496;    
    Ledipasvir/sofosbuvir (LDV/SOF) is a recommended therapy for Hepatitis C virus (HCV)...Ten participants (1 black female; 9 males [5 Hispanic, 4 white]) were enrolled; 9 were on darunavir (5 RTV, 4 COBI) and 1 on atazanavir/RTV...Unlike prior findings with TDF, adding LDV/SOF with TAF did not significantly increase plasma TFV or TFV-DP in PBMC. This is likely due to differences in hydrolysis pathways between TDF and TAF, and reassures on the safety of TAF + b/PI + LDV/SOF in HIV/HCV-coinfected patients.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Treatment with direct-acting antivirals improves peripheral insulin sensitivity in non-diabetic, lean chronic hepatitis C patients. (Pubmed Central) -  Feb 14, 2020   
    Hence, more specialized echocardiographic evaluations are recommended for whom with history of cardiac abnormalities, cardiac iron overload, and in case of any cardiac adverse event during DAA therapy in thalassemia patients. Pharmacological inhibition of HCV improves peripheral (but not hepatic) insulin sensitivity in non-diabetic, lean individuals with chronic hepatitis C without significant fibrosis.
  • ||||||||||  metformin / Generic mfg.
    Treatment of Hepatitis C Has Time-Dependent Relationship with Type 2 Diabetes Progress (ENDOExpo) -  Feb 7, 2020 - Abstract #ENDO2020ENDO_2670;    
    Prior to HCV treatment patient DM control was treated with oral medications (metformin and glipizide) with fast glucose level fluctuating 143±44 mg/dl; 2 hours postprandial level 205±57mg/dl; HbA1c 7.0%...Oral DM medications were doubled dosages and maximum dosage of pioglitazone was added on...Discussion Based on our observation there are four phases of DM development related to the HCV treatment: phase I silence stage (during 3 month HCV treatment) DM is stable; phase II deterioration stage (First 3 month after HCV treatment) DM is progressively getting worse; phase III recovery stage (4 to 6 month after HCV treatment) DM is gradually improving; phase IV stabilization stage (6 month after HCV treatment) DM is stabilized and improved. Conclusion Anti-viral treatment of HCV has possible intrinsic time-dependent relationship with DM development.
  • ||||||||||  Daklinza (daclatasvir) / BMS
    Journal:  Progress of antiviral therapy for hepatitis C virus-related decompensated cirrhosis (Pubmed Central) -  Feb 1, 2020   
    Furthermore, approximately 15.5% ~ 49% of patients waiting for liver transplantation after treatment with DAAs do not require liver transplantation for short-term and 10.3% ~19.2% of patients receiving SOF/LDV, and SOF combined with DCV not needed liver transplantation. Thus, the clinical application of DAAs provides a safe and reliable antiviral treatment plan for hepatitis C virus-related decompensated stage cirrhosis.
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Effectiveness of 12 week ledipasvir/sofosbuvir and predictors of treatment failure in patients with hepatitis C. (Pubmed Central) -  Jan 21, 2020   
    These results suggest DAA therapy is effective with high rates of SVR12 even in patients that do not achieve an EoTR. LDV/SOF combination has been very effective to treat GT1 and GT4 infected patients, however, has constituted a suboptimal therapeutic option for those patients infected with GT3, regardless of the rest of the variables analyzed.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion date, Trial primary completion date:  Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) (clinicaltrials.gov) -  Jan 15, 2020   
    P4,  N=15, Recruiting, 
    LDV/SOF combination has been very effective to treat GT1 and GT4 infected patients, however, has constituted a suboptimal therapeutic option for those patients infected with GT3, regardless of the rest of the variables analyzed. Trial completion date: Aug 2019 --> Sep 2020 | Trial primary completion date: Aug 2019 --> Aug 2020
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Trial completion date, Trial termination:  Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD) (clinicaltrials.gov) -  Jan 8, 2020   
    P=N/A,  N=14, Terminated, 
    The findings from this case suggest that LDV/SOF therapy can be a promising option for acute HCV monoinfection associated with a high risk of ALF. Trial completion date: Jun 2018 --> May 2019 | Completed --> Terminated; Unable to meet enrollment goal
  • ||||||||||  Sovaldi (sofosbuvir) / Gilead
    Trial completion date:  Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (clinicaltrials.gov) -  Dec 26, 2019   
    P4,  N=10000, Completed, 
    Early identification and prompt response to drug-drug interactions with the aid of pharmacists optimize the pharmacotherapeutic outcome and eliminate possible morbidities when using direct-acting antivirals in children and adolescents with hepatitis C virus. Trial completion date: Mar 2018 --> Dec 2019
  • ||||||||||  Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Direct-Acting Antiviral Therapy for Hepatitis C Infection in a Large Immigrant Community. (Pubmed Central) -  Dec 21, 2019   
    Ledipasvir/sofosbuvir was associated with favorable response among genotype 1 and 4 patients compared to other regimens (p < 0.001 and p = 0.05)...Patients with genotype 4 had lower SVR rates than other genotypes (58% vs. 89%, p < 0.001), particularly among East Africans (40% vs. 82% for other ethnicities). Our SVR rate for genotype 4 infection is lower than clinical trials and may be related to cultural, biologic and socioeconomic factors.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Clinical, Journal:  Direct-acting antivirals are effective and safe in HCV/HIV-coinfected liver transplant recipients who experience recurrence of hepatitis C: A prospective nationwide cohort study. (Pubmed Central) -  Dec 21, 2019   
    In this prospective, multicenter cohort study, the outcomes of 47 HCV/HIV-coinfected LT patients who received DAA therapy (with or without ribavirin [RBV]) were compared with those of a matched cohort of 148 HCV-monoinfected LT recipients who received similar treatment...Rates of SVR (negative serum HCV-RNA at 12 weeks after the end of treatment) were high and similar for coinfected and monoinfected patients (95% and 94%, respectively; p=0.239). Albeit not significant, a trend towards lower SVR rates among patients with advanced fibrosis (p=0.093) and genotype 4 (p=0.088) was observed.
  • ||||||||||  ledipasvir/sofosbuvir / Generic mfg.
    Clinical, Observational data, Journal:  Sofosbuvir-Based Therapy in Hepatitis C Virus-infected Cancer Patients: A Prospective Observational Study. (Pubmed Central) -  Dec 21, 2019   
    Albeit not significant, a trend towards lower SVR rates among patients with advanced fibrosis (p=0.093) and genotype 4 (p=0.088) was observed. SOFBT in HCV-infected cancer patients is effective and safe, may permit access to investigational cancer therapy expanding treatment options, may induce remission of NHL, and may be used for 8 weeks.
  • ||||||||||  Copegus (ribavirin) / Bausch Health, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
    Journal:  Experience of a Portuguese Center: Effectiveness of Direct-Acting Antiviral Therapy for Hepatitis C. (Pubmed Central) -  Dec 20, 2019   
    SOFBT in HCV-infected cancer patients is effective and safe, may permit access to investigational cancer therapy expanding treatment options, may induce remission of NHL, and may be used for 8 weeks. Our data showed that direct-acting antiviral-based regimens are safe and have a high success rate in the treatment of patients with hepatitis C virus infection in a real-world setting.
  • ||||||||||  pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie, daclatasvir/asunaprevir (BMS-60032/BMS-790052) / BMS
    Clinical, Journal:  Viral and host factors are associated with retreatment failure in hepatitis C patients receiving all-oral direct antiviral therapy. (Pubmed Central) -  Dec 18, 2019   
    Our data showed that direct-acting antiviral-based regimens are safe and have a high success rate in the treatment of patients with hepatitis C virus infection in a real-world setting. In addition to viral factors (e.g., Q24, L28, R30 and A92 or P32 deletion RASs), host factors (e.g., IL28B SNP) are associated with DAA retreatment failure.
  • ||||||||||  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) -  Dec 12, 2019   
    P4,  N=90, Recruiting, 
    In addition to viral factors (e.g., Q24, L28, R30 and A92 or P32 deletion RASs), host factors (e.g., IL28B SNP) are associated with DAA retreatment failure. Trial completion date: Dec 2020 --> Jul 2021 | Trial primary completion date: Dec 2019 --> Jul 2021