Merck Provides Update on European Medicines Agency Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Elbasvir/Grazoprevir
Dateline City: KENILWORTH, N.J. KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has responded to the company’s marketing authorization application (MAA) for elbasvir/grazoprevir (50mg/100mg), which is under review for the treatment of adult patients with chronic hepatitis C (HCV) infection. Language: English Contact: MerckMedia:Doris Li, 908-246-5701Sarra Herzog, 201-669-6570orInvestors:Teri Loxam, 908-740-1986Justin Holko, 908-740-1879 Ticker Slug: Ticker: MRK Exchange: NYSE read more
Conclusions: In this community-based study, DAAs are safe, effective with high overall SVR12 in patients with active drug use (injectable and non-injectable) and OAT enrolled patients. These results support the removal of drug use as a barrier to DAA therapy. PMID: 31120776 [PubMed - as supplied by publisher]
There ’s been an odd-sounding word circulating in the English headlines recently.The word is Orkambi; a drug created by Vertex that treats approximately 40% of people born with the genetic condition, cystic fibrosis. It is the second drug to market in a promising pipeline that targets the CFTR mutation. True gene therapy it isn’t, but it represents a near-first for a biotech firm, by successfully altering the shape and function of a protein. And priced at £105,000 per patient per year, it is the latest in a long line of medicines the NHS can’t afford.Orkambi has been licensed by the EMAsin...
CONCLUSION: This case highlights the difficulties of diagnosing skin lesions caused by HCV infection in immunosuppressed patients. PMID: 31114644 [PubMed]
Authors: Hernández-Conde M, Fernández-Carrillo C, Llop E, Perelló C, López-Gómez M, Martínez-Porras JL, Fernández-Puga N, Calleja JL Abstract INTRODUCTION AND AIMS: To determine the prevalence of minimal hepatic encephalopathy (MHE) in patients with liver cirrhosis (LC) due to hepatitis C virus (HCV) infection and to evaluate the impact of sustained viral response (SVR) on MHE. MATERIAL AND METHODS: We performed a prospective study using MHE screening and follow-up on patients with HCV and LC. The patients were evaluated at the beginning of treatment and 24 weeks...
CONCLUSIONS: The high efficacy and tolerance of interferon-free regimens is confirmed in elderly patients in real-life conditions. PMID: 31113590 [PubMed - in process]
CONCLUSION: Latino and Caucasian patients with HCC present with a different profile of etiologies, but cancer features appear to be more severe in Latinos. PMID: 31113588 [PubMed - in process]
CONCLUSION: The Choosing Wisely recommendations will foster patient-physician discussions, reduce unnecessary treatment and testing, avert adverse effects from testing and treatment along with reducing medical expenditure in hepatology. PMID: 31113586 [PubMed - in process]
CONCLUSION: Tolerability should be monitored in older patients for whom concomitant medications are discontinued or changed because of drug interactions. PMID: 31113578 [PubMed - in process]
CONCLUSIONS: It was concluded that among the Egyptian families, HLA-DRB1*030101, and DRB1*130101 alleles associated with the risk of progression to CHC infection, while DRB1*040101, DRB1*040501, DRB1*7:01:01and DRB1*110101 act as protective alleles against HCV infection. PMID: 31113612 [PubMed - in process]
We present three case reports of retreatment with a new combination of Direct-acting antivirals (DAAs), Sofosbuvir, Elbasvir/Grazoprevir in patients with GT3 with a previous failure with Sofosbuvir/Ledipasvir. All the cases achieved sustained virologic response (SVR) at week +12 without adverse effects. In our experience, this combo may represent an effective and safe option for these patients. PMID: 31113598 [PubMed - in process]