- |||||||||| Daklinza (daclatasvir) / BMS
Journal: Effects of Age on Treatment of Chronic Hepatitis C with Direct Acting Antivirals. (Pubmed Central) - Apr 14, 2020 Real world studies are needed to assess clinical relevance of this interaction and describe actual spectrum of possible DDI between DAAs and other DOACs. The high efficacy and tolerance of interferon-free regimens is confirmed in elderly patients in real-life conditions.
- |||||||||| Olysio (simeprevir) / J&J, Medivir, Daklinza (daclatasvir) / BMS
Clinical, P2 data, Journal: Simeprevir, daclatasvir, and sofosbuvir for hepatitis C virus-infected patients: Long-term follow-up results from the open-label, Phase II IMPACT study. (Pubmed Central) - Apr 11, 2020 P2 No new safety signals were identified. In the IMPACT study, virologic response to simeprevir, sofosbuvir, and daclatasvir was durable over 3 years (http://ClinicalTrials.gov number: NCT02262728).
- |||||||||| Copegus (ribavirin) / Bausch Health, Sovaldi (sofosbuvir) / Gilead
Journal: Tolerability of erythrocyte ribavirin triphosphate concentrations depends on the ITPA genotype. (Pubmed Central) - Mar 12, 2020 Different SOF-based regimens were effective with high SVR12 rates in a difficult-to-treat population, recurrent HCV post LDLT. The increased tolerability to RTP concentrations in erythrocytes in the ITPA variant rs1127354 plays a role in preventing RBV-induced severe anemia in this ITPA variant.
- |||||||||| [VIRTUAL] RESISTANCE ANALYSIS IN HCV-3–INFECTED PATIENTS WITHIN THE ITALIAN NETWORK VIRONET-C ([VIRTUAL]) - Mar 2, 2020 - Abstract #CROI2020CROI_897;
Moreover, 14.8% of pts were treated with suboptimal regimens for GT3: 3DRBV (Paritaprevir/r+Ombitasvir+Dasabuvir, N=15), SOF+Simeprevir (N=1) or SOF/ Ledipasvir (LDV)+RBV (N=4)...The presence of natural NS5A RAS before treatment was associated with failure. Further analyses are needed to confirm this observation, particularly for the new current regimens.
- |||||||||| Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Journal: A proof-of-concept study in HCV-infected Huh7.5 cells for shortening the duration of DAA-based triple treatment regimens. (Pubmed Central) - Jan 15, 2020 Although a virologic breakthrough occurred after an intermittent treatment regimen at the low fixed dose, the high fixed dose cured HCV-positive Huh7.5 cells with intermittent treatment. In conclusion, HCV is persistently present below detectable levels in HCV-infected Huh7.5 cells for a long time after treatment, and a shortened therapy duration is associated with an increased risk of virologic relapse, but virologic relapse or breakthrough might be avoided by treatment with a combination of more highly effective DAAs.
- |||||||||| Daklinza (daclatasvir) / BMS
Clinical, Retrospective data, Journal, Heterogeneity: Efficacy, Safety, and Predictors of Direct-acting antivirals in Hepatitis C Virus Patients with Heterogeneous Liver Diseases. (Pubmed Central) - Dec 19, 2019 Model-for-End-Liver-Disease score <10 and alanine aminotransferase ≤20 U/L at week 8 of therapy proved positive predictors of sustained virological response. Direct-acting antiviral therapy is efficacious and safe even in patients with advanced liver disease and/or previous virological failure; Model-for-End-Liver-Disease <10 and alanine aminotransferase reduction during therapy were found to be reliable predicting markers of sustained-virologicalresponse.
- |||||||||| pibrentasvir (ABT-530) / AbbVie, Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie, glecaprevir (ABT-493) / AbbVie
Clinical, Journal, Real-World Evidence: Direct-Acting Antivirals for Hepatitis C: Predictors of Early Discontinuation in the Real World. (Pubmed Central) - Dec 6, 2019 These real-world data confirm low rates of early discontinuation in users of second-generation DAAs. Future research focusing on socio-economic and sex/gender issues may help further optimize care for patients with HCV.
- |||||||||| Copegus (ribavirin) / Bausch Health, Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie
Clinical, Journal, Real-World Evidence: Ombitasvir/paritaprevir/ritonavir + dasabuvir +/- ribavirin in real world hepatitis C patients. (Pubmed Central) - Dec 6, 2019 Future research focusing on socio-economic and sex/gender issues may help further optimize care for patients with HCV. In an all-comers HCV GT1 population, 12 or 24-wk of OBV/PTV/r + DSV +/- RBV is highly effective and tolerable and results in better mental and physical health following treatment.
- |||||||||| Mekinist (trametinib) / Novartis, Trintellix (vortioxetine) / Lundbeck, Takeda, Olysio (simeprevir) / J&J, Medivir
Clinical, Journal: Automatic extraction of quantitative data from ClinicalTrials.gov to conduct meta-analyses. (Pubmed Central) - Nov 23, 2019 EXACT (http://bio-nlp.org/EXACT) automatically and accurately extracted data elements from ClinicalTrials.gov and thus reduced time in data extraction. The ClinicalTrials.gov data reproduced most meta-analysis results in our study, but this conclusion needs further validation.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Journal: Improvement in Waldenström's Macroglobulinemia after Successful Treatment of HCV with Direct-acting Antivirals. (Pubmed Central) - Nov 19, 2019 The recent advent of direct acting antivirals (DAAs) in the therapeutic armamentarium of HCV infection made possible treatment of patients with advanced liver disease. Here we report on a rare association of a cirrhotic patient with HCV and Waldenström's Macroglobulinemia with severe cryoglobulinemia, who had already failed an interferon-based antiviral regimen, whose haematologic disease was ameliorated by HCV eradication following treatment with sofosbuvir and simeprevir with ribavirin, and where successful treatment was accompanied also by consistent improvement in liver function and parameters of portal hypertension.
- |||||||||| velpatasvir (GS-5816) / Gilead, voxilaprevir (GS-9857) / Gilead, Daklinza (daclatasvir) / BMS
HAS REAL LIFE EFFICACY OF SOFOSBUVIR-BASED REGIMENS CHANGED OVER TIME? FINDINGS FROM THE ANRS CO22 HEPATHER COHORT (Hynes Convention Center, Hall B) - Sep 29, 2019 - Abstract #AASLD2019AASLD_2194; P=N/A In May 2018, 8278 patients with a least a 12 weeks post-treatmentfollow-uphad been treated with sofosbuvirin combination for 12 weeks with Ribavirin (RBV)(n =342, median date of prescription April 2014), Simeprevir (n=1033, October 2014, 14.5% with RBV and 8.8/4.7% for 24 weeks for cirrhotic/non cirrhotic patients), Daclatasvir (n=2755, January 2015, 30.4% with RBV and 64.5/27.4% for 24 weeks for cirrhotic/non cirrhotic patients), Ledipasvir (n=3526, November 2015, 50.3% with RBV and 16.0/2.8% for 24 weeks for cirrhotic/non cirrhotic patients), Velpatasvir (n=583, September 2017) and Velpatasvir+Voxilaprevir (n =39 for DAA failures, April 2018). In this large prospective cohort of French patients treated for HCV by a sofosbuvir- including regimen, SVR12 rates was greater than 95% in most of patients and did not significantly changed over time with the prioritization of the DAA combinations.
- |||||||||| Journal: Direct-Acting Antivirals to Prevent Vertical Transmission of Viral Hepatitis C: When Is the Optimal Time to Treat? (Pubmed Central) - Sep 26, 2019
Minor changes in tacrolimus dosing were needed. 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.
- |||||||||| Clinical, PK/PD data, Journal, Combination therapy, Monotherapy: Population Pharmacokinetics of AL-335 and Its Two Main Metabolites (ALS-022399, ALS-022227) in Monotherapy and in Combination with Odalasvir and/or Simeprevir. (Pubmed Central) - Sep 26, 2019
Internal evaluation confirmed that the population pharmacokinetic model developed was deemed appropriate to describe the time course of AL-335, ALS-022399, and ALS-022227 plasma concentrations and their associated variability in both healthy and HCV-infected subjects, as well as the interaction effect of simeprevir and/or odalasvir over AL-335 and its metabolites in healthy subjects. This model can be used as a starting point to evaluate drug-drug interaction processes in HCV-infected patients and support the development of a direct-acting antiviral (DAA) combination.
- |||||||||| tacrolimus / Generic Mfg., Daklinza (daclatasvir) / BMS
SAFETY AND EFFICACY OF SOFOSBUVIR BASED REGIMENS IN HEPATITIS C VIRUS RECURRENCE POST LIVER TRANSPLANTATION (Poster Exhibition - Hall 7) - Aug 18, 2019 - Abstract #UEGW2019UEGW_3046; All patients who received (SOF/SIM) were on Tacrolimus or rapamune based immunosuppression Mean age of the studied patients was 52.5±7.9 years (range 28-68), mostly males (99.7%)... Sofosbuvir based combinations are safe and effective in the treatment of recurrent HCV after LT, especially when combined with another directly acting antiviral.
- |||||||||| paritaprevir/ritonavir (ABT-450/r) / AbbVie, Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
STUDY OF THE RESPONSE AND SAFETY OF DIRECT ACTING ANTIVIRAL COMBINATION THERAPY IN HEPATITIS C VIRUS-RELATED CHILD-B LIVER CIRRHOSIS (Poster Exhibition - Hall 7) - Aug 18, 2019 - Abstract #UEGW2019UEGW_3041; In Child A patients, 260 had sofosbuvir (SOF)and daclatasvir (DAC) for 12 weeks,13 had SOF plus simeprevir (SIM) for 12 weeks and 2 had Ritonavir-Paritaprevir-Ombitasvir-Ribavirin for 12 weeks. Real-world results of generic DAAs combinations in Egyptian patients with chronic HCV-Child B were very safe and effective with SVR-12 (98.5%&86.7%) with very rare reported complications (0.01%,0.9%) in Child A&B, respectively.
- |||||||||| paritaprevir/ritonavir (ABT-450/r) / AbbVie, Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
COMPARATIVE STUDY FOR RETREATING PATIENTS WHO FAILED TO PRIOR SOFOSBUVIR/ DACLATASVIR REGIMEN: AN OPEN LABELED RANDOMIZED TRIAL (Poster Exhibition - Hall 7) - Aug 18, 2019 - Abstract #UEGW2019UEGW_1303; Eighty patients were randomly re-treated either by Sofosbuvir(400mg)/Daclatasvir(60mg)/ Simeprevir(150mg)/Ribavirin (SIM-group, n=40) versus Sofosbuvir(400mg) /Ombitasvir(25mg)/ Paritaprevir(150mg) /Ritonavir(100mg) /Ribavirin (OPr-group, n=40) for 12 weeks. Re-treating patients with previous NS5A failure is possible and safe with satisfactory results.
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