- |||||||||| 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.
- |||||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Clinical, Review, Journal: Drug-Drug Interactions of Newly Approved Direct-Acting Antiviral Agents in Patients with Hepatitis C. (Pubmed Central) - Feb 5, 2021 This review summarizes researches of DDIs focusing on newly approved DAAs (elbasvir, grazoprevir, velpatasvir, voxilaprevir, glecaprevir, pibrentasvir) for patients undergoing HCV treatment to provide clinical consideration for comedication. With respect to DDIs, newly approved DAA regimens, including elbasvir/grazoprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, and glecaprevir/pibrentasvir, are safely applicable.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Clinical, Retrospective data, Review, Journal: Sofosbuvir-velpatasvir in Mexican patients with hepatitis C: A retrospective review. (Pubmed Central) - Feb 4, 2021 With respect to DDIs, newly approved DAA regimens, including elbasvir/grazoprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir, and glecaprevir/pibrentasvir, are safely applicable. Treatments with SOF/VEL and SOF/VEL/RBV were highly safe and effective, results coinciding with those of other international real-world studies.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Trial primary completion date: Expanding the Pool in Lung Transplantation (clinicaltrials.gov) - Feb 2, 2021 P1, N=20, Recruiting, Treatments with SOF/VEL and SOF/VEL/RBV were highly safe and effective, results coinciding with those of other international real-world studies. Trial primary completion date: Feb 2021 --> Sep 2021
- |||||||||| [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.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Clinical, Journal: Is positivity for hepatitis C virus antibody predictive of lower risk of death in COVID-19 patients with cirrhosis? (Pubmed Central) - Dec 22, 2020 To this end, we have evaluated three cohorts of patients admitted at three Italian hospitals during the coronavirus pandemic; these included 332 patients with COVID-19 and 1527 patients with HCV who were from established real-world antiviral treatment study cohorts (sofosbuvir/velpatasvir), with either liver disease (various severities; n = 1319) or cirrhosis (n = 208)...Thus, the prevalence of HCV antibodies among COVID-19-infected patients was comparable to that currently reported for the general population in Italy. Amongst the COVID-19 patients, pre-existing metabolic cirrhosis appears to be associated with higher mortality, while HCV antibodies may be suggestive of "protection" against COVID-19.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Clinical, Journal, Real-World Evidence: Real-world effectiveness and safety of sofosbuvir and nonstructural protein 5A inhibitors for chronic hepatitis C genotype 1, 2, 3, 4, or 6: a multicentre cohort study. (Pubmed Central) - Dec 17, 2020 However, patients with liver cirrhosis infected by GT3 remain the most-difficult-to-treat group. 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.
- |||||||||| 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.
- |||||||||| pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie
Journal: Overview of hepatitis C infection, molecular biology, and new treatment. (Pubmed Central) - Nov 27, 2020 Recent developments include identification of the potential of low-cost anti-histamines for repurposing as inhibitors of hepatitis C viral entry. In this review we focus on molecular biology of hepatitis C virus, and the new developments in hepatitis C treatment.
- |||||||||| 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 HCV treatment with DMP was accepted by patients and clinicians and may support HCV treatment outcomes among patients at high risk for treatment non-adherence (Clinical trials.gov NCT03164902). 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.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Journal: Nucleotide analogues as inhibitors of SARS-CoV Polymerase. (Pubmed Central) - Nov 11, 2020 Based on our analysis of hepatitis C virus and coronavirus replication, and the molecular structures and activities of viral inhibitors, we previously reasoned that the FDA-approved hepatitis C drug EPCLUSA (Sofosbuvir/Velpatasvir) should inhibit coronaviruses, including SARS-CoV-2...Given the 98% amino acid similarity of the SARS-CoV and SARS-CoV-2 RdRps, we expect these nucleotide analogues would also inhibit the SARS-CoV-2 polymerase. These results offer guidance to further modify these nucleotide analogues to generate more potent broad-spectrum anti-coronavirus agents.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Trial completion date, Trial primary completion date: HCV Seek, Test and Rapid Treatment for Young PWID (clinicaltrials.gov) - Nov 10, 2020 P4, N=72, Recruiting, These results offer guidance to further modify these nucleotide analogues to generate more potent broad-spectrum anti-coronavirus agents. Trial completion date: Jul 2021 --> Jul 2022 | Trial primary completion date: Jul 2021 --> Jul 2022
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
[VIRTUAL] GATA2 Mutation in Twins with Transient Aplastic Anemia after Chloramphenicol Exposure; A Follow up to Nagao and Mauer 1969 (Poster Hall (Virtual Meeting)) - Nov 5, 2020 - Abstract #ASH2020ASH_1709; Later in life, he was diagnosed with transfusion acquired hepatitis C, treated with Sofosbuvir/Velpatasvir...It was proposed that these may be opposite ends of a spectrum with an underlying genetic predisposition leading to the more severe forms. The finding of a GATA2 mutation in these patients supports Nagao and Maurer’s speculation that an underlying genetic factor affecting stem cell regulation predisposed to the development of chloramphenicol induced aplastic anemia in these twins.
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Journal: Sofosbuvir terminated RNA is more resistant to SARS-CoV-2 proofreader than RNA terminated by Remdesivir. (Pubmed Central) - Oct 30, 2020 We report here that Sofosbuvir terminated RNA resists removal by the exonuclease to a substantially higher extent than RNA terminated by Remdesivir, another drug being used as a COVID-19 therapeutic. These results offer a molecular basis supporting the current use of Sofosbuvir in combination with other drugs in COVID-19 clinical trials.
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Enrollment open, Trial completion date, Trial primary completion date: Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir (clinicaltrials.gov) - Oct 25, 2020 P1, N=10, Recruiting, SOF/VEL combination ± ribavirin in the treatment of various common genotypes of chronic hepatitis C, compensated cirrhosis, decompensated cirrhosis and hepatocellular carcinoma has higher SVR12 in China, and the tolerance and safety are good. Not yet recruiting --> Recruiting | Trial completion date: Feb 2023 --> Jun 2023 | Trial primary completion date: Feb 2022 --> Jun 2022
- |||||||||| 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).
- |||||||||| sofosbuvir/velpatasvir / Generic mfg.
Clinical, Journal: Epclusa Approved For Children With Hepatitis C. (Pubmed Central) - Oct 21, 2020 Recruiting --> Active, not recruiting | Trial completion date: Oct 2021 --> Jun 2021 | Trial primary completion date: Jul 2021 --> Mar 2021 No abstract available
|