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Stanton R Mehr
After the introductions of sofosbuvir (Sovaldi) and ledipasvir plus sofosbuvir (Harvoni) for the treatment of hepatitis C, employers have become very sensitive to new, and especially unforeseen, factors that significantly raise healthcare costs. With the recent launch of the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, self-insured and fully insured employers have been seeking information on this drug class and its potential for off-label use, which could amount to up to $23 billion in healthcare expenditures, according to a report from Prime Therapeutics...
May 2016: American Health & Drug Benefits
Sidra Rehman, Bushra Ijaz, Nighat Fatima, Syed Aun Muhammad, Sheikh Riazuddin
Discovery of alternative and complementary regimens for HCV infection treatment is a need of time from clinical as well as economical point of views. Low cost of bioactive natural compounds production, high biochemical diversity and inexistent/milder side effects contribute to new therapies. Aim of this study is to clarify anti-HCV role of Taraxacum officinale, a natural habitat plant rich of flavonoids. In this study, methanol extract of T. officinale leaves was initially analyzed for its cytotoxic activity in human hepatoma (Huh-7) and CHO cell lines...
August 8, 2016: Biomedicine & Pharmacotherapy, Biomédecine & Pharmacothérapie
Genevieve M Halpenny
Turing Pharmaceuticals raised the price of Daraprim 5,500%, illustrating how the absence of competition in the sale of low-volume, low-price drugs can lead to price gouging. For patented medicines, society allows supracompetitive pricing to incentivize innovation. However, Gilead's decision to sell Sovaldi for $84,000 per course of treatment raised the question whether society must accept any price set by the patent holder. Unfortunately, these incidents illustrate a broader trend in which pharmaceutical prices are greater in the United States than abroad, placing the United States at the top in per capita expenditures on pharmaceuticals...
June 9, 2016: ACS Medicinal Chemistry Letters
Brent M Tambourine, Arash Sadeghi, Jianing Yang, Karen M Stockl, Heidi C Lew, Brian K Solow, Josephine N Tran
BACKGROUND: In December 2013, the US Food and Drug Administration (FDA) approved sofosbuvir (Sovaldi) for the treatment of patients with chronic hepatitis C virus (HCV) infection. Given the potential "warehousing" of patients before the launch of sofosbuvir and the possibility that some patients and providers may have elected to continue deferring treatment in anticipation of more promising, interferon-free therapies in the pipeline, the early landscape for sofosbuvir treatment is difficult to ascertain...
April 2016: American Health & Drug Benefits
Xingquan Zhang
Unlike human immunodeficiency virus (HIV) and hepatitis B virus (HBV), hepatitis C virus (HCV) infection is a curable disease. Current direct antiviral agent (DAA) targets are focused on HCV NS3/4A protein (protease), NS5B protein (polymerase) and NS5A protein. The first generation of DAAs includes boceprevir and telaprevir, which are protease inhibitors and were approved for clinical use in 2011. The cure rate for genotype 1 patients increased from 45% to 70% when boceprevir or telaprevir was added to standard PEG-IFN/ribavirin...
January 2016: Acta Pharmaceutica Sinica. B
Thomas McQuaid, Carolyn Savini, Star Seyedkazemi
Nucleotide compounds like sofosbuvir, acyclovir, and tenofovir have proven to be amongst the most potent orally available antiviral treatments. These drugs exhibit high efficacy and a wide therapeutic index, with demonstrated utility in a number of chronic viral infections. The approval of Sovaldi™, brand name for sofosbuvir, by the U.S. Food and Drug Administration heralded improvements in chronic hepatitis C virus (HCV) treatment. Sofosbuvir was originally discovered by Pharmasset Corporation and named PSI-7977...
March 2015: Journal of Clinical and Translational Hepatology
Mary Lomberk, Olga M Klibanov
No abstract text is available yet for this article.
September 13, 2015: Nurse Practitioner
Sai Zhang, Nathaniel D Bastian, Paul M Griffin
BACKGROUND: The standard care of treatment of interferon plus ribavirin (plus protease inhibitor for genotype 1) are effective in 50 % to 70 % of patients with CHC. Several new treatments including Harvoni, Olysio + Sovaldi, Viekira Pak, Sofosbuvir-based regimens characterized with potent inhibitors have been approved by the Food and Drug Administration (FDA) providing more options for CHC patients. Trials have shown that the new treatments increased the rate to 80% to 95%, though with a substantial increase in cost...
2015: BMC Gastroenterology
Leora Schiff
PURPOSE: Public discourse regarding the hepatitis C virus (HCV) drug Sovaldi® (sofosbuvir) has become inflamed, generating much heat but little light concerning the clinical, health economic, and quality-of-life merits of Sovaldi®. The purpose of this article is to provide a factual basis for evaluating the claims regarding the benefits of Sovaldi® relative to its costs. METHODS: A comprehensive review was conducted of news stories highlighted in the daily updates of the electronic newsletters BIO SmartBrief, FiercePharma, FierceBiotech and BioCentury Extra published from November 1, 2013, through December 31, 2014, on the topics of the HCV market, Sovaldi®, and other HCV therapeutics...
May 1, 2015: Clinical Therapeutics
Brian J Kirby, William T Symonds, Brian P Kearney, Anita A Mathias
Sofosbuvir (SOVALDI(®)), a potent, once-daily, orally administered nucleotide analog prodrug inhibitor of the hepatitis C virus (HCV) NS5B polymerase is approved in the USA, EU, Canada, and other regions for the treatment of HCV infection as a component of an antiviral treatment regimen. Sofosbuvir undergoes intracellular activation to form GS-461203 (active triphosphate, not detected in plasma), and ultimately the inactive, renally eliminated metabolite GS-331007. GS-331007 was identified as the primary analyte of interest for clinical pharmacology studies as it accounted for >90 % of systemic drug-related material exposure, and provided comparable exposure-response relationships for viral kinetics as observed for sofosbuvir...
July 2015: Clinical Pharmacokinetics
(no author information available yet)
About 50% of patients with chronic hepatitis C virus (HCV) genotype 1 infection have a sustained virological response to a 48-week course of the peginterferon alfa + ribavirin combination. Adding a viral protease inhibitor to this combination for 12 to 32 weeks enhances antiviral effects but increases the risk of serious adverse effects. Between 70% and 80% of patients with HCV genotype 2 or 3 infection have a sustained virological response to a 24-week course of the peginterferon alfa + ribavirin combination...
January 2015: Prescrire International
Trang H Au, Christopher J Destache, Renuga Vivekanandan
OBJECTIVE: To describe chronic hepatitis C virus (HCV) infection, including its epidemiology and pathophysiology; review current treatment options for HCV infection; recognize investigational agents being studied as part of interferon-free therapy; and summarize clinical trials for the new agents. DATA SOURCES: PubMed for 2004 through August 2014 using search terms hepatitis C, American Association for the Study of Liver Diseases, sofosbuvir, simeprevir, and as needed specific names of other agents in development during this time; news articles and news releases about company actions with regard to clinical trials and filings for marketing approval in the United States...
March 2015: Journal of the American Pharmacists Association: JAPhA
Abhinav Dhingra, Saloni Kapoor, Saleh A Alqahtani
Hepatitis C virus (HCV) therapeutics is amidst a revolution. With the recent approval of sofosbuvir (Sovaldi) and simeprevir (Olysio), clinicians and patients started to recognize that for the first time in the history, hepatitis C can be cured in a majority of patients without interferon. These new regimens are safe, and have excellent efficacy and minimal adverse events. Sofosbuvir, a nucleotide analogue (NS5B polymerase inhibitor), is a potent drug with excellent tolerability and pan-genotypic activity with a high barrier to resistance...
October 2014: Discovery Medicine
John Carroll
No abstract text is available yet for this article.
September 2014: Managed Care
Eric F Donaldson, Patrick R Harrington, Julian J O'Rear, Lisa K Naeger
UNLABELLED: Sofosbuvir (Sovaldi, SOF) is a nucleotide analog prodrug that targets the hepatitis C virus (HCV) nonstructural protein 5B (NS5B) polymerase and inhibits viral replication. High sustained virological response rates are achieved when SOF is used in combination with ribavirin with or without pegylated interferon in subjects with chronic HCV infection. Potential mechanisms of HCV resistance to SOF and other nucleos(t)ide analog NS5B polymerase inhibitors are not well understood...
January 2015: Hepatology: Official Journal of the American Association for the Study of Liver Diseases
Merrill Goozner
No abstract text is available yet for this article.
May 5, 2014: Modern Healthcare
Paul Demko, Virgil Dickson
No abstract text is available yet for this article.
May 5, 2014: Modern Healthcare
Gillian M Keating
Sofosbuvir (Sovaldi(®)) is a nucleotide hepatitis C virus (HCV) NS5B polymerase inhibitor that has pangenotypic antiviral activity and a high genetic barrier to resistance. This article reviews the clinical efficacy and tolerability of sofosbuvir in patients with chronic hepatitis C and summarizes its pharmacological properties. Interferon-free treatment with sofosbuvir plus ribavirin achieved high sustained virological response (SVR) rates in treatment-naïve and treatment-experienced patients with HCV genotype 2 or 3 infection, and also had efficacy in patients with HCV genotype 1 infection...
July 2014: Drugs
Brian Lam, Linda Henry, Zobair Younossi
Hepatitis C (HCV) remains an important cause of chronic liver disease worldwide. Historically, treatment included pegylated-interferon and ribavirin with low efficacy and numerous side effects contributing to poor adherence and impairment of patients' well-being. The next step in developing better treatment regimens for HCV led to the development of the first-generation direct acting antivirals (DAAs). Although these DAAs improved efficacy, they also added substantial side effects. The next generation of DAAs include Simeprevir and Sofosbuvir (SOF) which not only further enhanced the efficacy of the regimens but also improve their safety profile...
September 2014: Expert Review of Clinical Pharmacology
Melanie Senior
No abstract text is available yet for this article.
June 2014: Nature Biotechnology
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