|
|
| Line 1: |
Line 1: |
| __NOTOC__ | | __NOTOC__ |
| {{Sofosbuvir}}
| | {{CMG}}; {{AE}} {{Alonso}} |
| {{CMG}}; {{AE}} {{SS}} | |
|
| |
|
| {{SK}} Sovaldi and Virunon
| | Infobox goes here |
|
| |
|
| ==Overview==
| | <nowiki>{{SI}}</nowiki> |
| '''Simeprevir''' (formerly '''TMC435'''; trade name '''Olysio''') is a drug for the treatment and cure of [[hepatitis C]].<ref>[http://www.nature.com/news/united-states-to-approve-potent-oral-drugs-for-hepatitis-c-1.14059 News: United States to approve potent oral drugs for hepatitis C,] Sara Reardon, Nature, 30 October 2013</ref> It was [[drug development|developed]] by '''Sofosbuvir''' (brand names '''Sovaldi''' and '''Virunon''') is a drug used for [[hepatitis C]] virus (HCV) infection, with a high cure rate.<ref>[http://www.nature.com/news/united-states-to-approve-potent-oral-drugs-for-hepatitis-c-1.14059 News: United States to approve potent oral drugs for hepatitis C,] Sara Reardon, Nature, 30 October 2013</ref><ref name="pmid20845908">{{cite journal | author = Sofia MJ, Bao D, Chang W, Du J, Nagarathnam D, Rachakonda S, Reddy PG, Ross BS, Wang P, Zhang HR, Bansal S, Espiritu C, Keilman M, Lam AM, Steuer HM, Niu C, Otto MJ, Furman PA | title = Discovery of a β-d-2'-deoxy-2'-α-fluoro-2'-β-C-methyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus | journal = J. Med. Chem. |volume = 53 | issue = 19 | pages = 7202–18 | year = 2010 | month = October | pmid = 20845908 | doi = 10.1021/jm100863x }}</ref> It inhibits the [[RNA polymerase]] that the hepatitis C virus uses to replicate its RNA. It was discovered at [[Pharmasset]] and [[drug development|developed]] by [[Gilead Sciences]].<ref>{{cite web | url = http://www.gilead.com/pipeline | title = PSI-7977 | publisher = Gilead Sciences}}</ref>
| |
|
| |
|
| Sofosbuvir is the first all-oral, [[Interferon]]-free regimen approved for treating chronic Hepatitis C.<ref name="medscape">{{cite web | url =http://www.medscape.com/viewarticle/817371 | title = FDA Approves 'Game Changer' Hepatitis C Drug Sofosbuvir| author = Tucker M | date = December 6, 2013| publisher = Medscape}}</ref>
| | '''For patient information, click [[Insert page name here (patient information)|Insert page name here]]''' |
|
| |
|
| In 2013, the [[FDA]] approved sofosbuvir in combination with [[ribavirin]] (RBV) for oral dual therapy of HCV genotypes 2 and 3, and for triple therapy with injected pegylated interferon (pegIFN) and RBV for treatment-naive patients with HCV genotypes 1 and 4.<ref name="medscape"/> Sofosbuvir treatment regimens last 12 weeks for genotypes 1, 2 and 4, compared to 24 weeks for treatment of genotype 3.<ref>{{cite web | url =http://www.gilead.com/news/press-releases/2013/12/us-food-and-drug-administration-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c | title = U.S. Food and Drug Administration Approves Gilead’s Sovaldi™ (Sofosbuvir) for the Treatment of Chronic Hepatitis C - See more at:http://www.gilead.com/news/press-releases/2013/12/us-food-and-drug-administration-approves-gileads-sovaldi-sofosbuvir-for-the-treatment-of-chronic-hepatitis-c#sthash.T9uTbSWK.dpuf | date = December 6, 2013| publisher = Gilead}}</ref> Sofosbuvir will cost $84,000 for 12 weeks of treatment and $168,000 for the 24 weeks, which some patient advocates have criticized as unaffordable.
| | {{CMG}} |
|
| |
|
| Interferon-free therapy for treatment of Hepatitis C eliminates the substantial side-effects associated with use of Interferon. Up to half of Hepatitis C patients cannot tolerate the use of Interferon.<ref name="news medical">{{cite web | url = http://www.news-medical.net/news/20130425/Sofosbuvir-is-safer-than-interferon-for-hepatitis-C-patients-say-scientists.aspx | title = Sofosbuvir is safer than interferon for hepatitis C patients, say scientists |date = April 25, 2013| publisher = News Medical}}</ref>
| | '''''Synonyms and keywords:''''' |
|
| |
|
| ==Category== | | == Overview == |
| Antiviral
| |
| ==US Brand Names==
| |
| SOVALDI<sup>®</sup>
| |
| ==FDA Package Insert==
| |
|
| |
|
| ''' [[Sofosbuvir description|Description]]'''
| | ==Historical Perspective== |
| '''| [[Sofosbuvir clinical pharmacology|Clinical Pharmacology]]'''
| |
| '''| [[Sofosbuvir microbiology|Microbiology]]'''
| |
| '''| [[Sofosbuvir indications and usage|Indications and Usage]]'''
| |
| '''| [[Sofosbuvir contraindications|Contraindications]]'''
| |
| '''| [[Sofosbuvir warnings and precautions|Warnings and Precautions]]'''
| |
| '''| [[Sofosbuvir adverse reactions|Adverse Reactions]]'''
| |
| '''| [[Sofosbuvir drug interactions|Drug Interactions]]'''
| |
| '''| [[Sofosbuvir overdosage|Overdosage]]'''
| |
| '''| [[Sofosbuvir clinical studies|Clinical Studies]]'''
| |
| '''| [[Sofosbuvir dosage and administration|Dosage and Administration]]'''
| |
| '''| [[Sofosbuvir how supplied|How Supplied]]'''
| |
| '''| [[Sofosbuvir labels and packages|Labels and Packages]]'''
| |
|
| |
|
| ==Mechanism of Action== | | ==Classification== |
| Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. Sofosbuvir is a nucleotide prodrug that undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator. In a biochemical assay, GS-461203 inhibited the polymerase activity of the recombinant NS5B from HCV genotype 1b, 2a, 3a and 4a with IC50 values ranging from 0.7 to 2.6 µM. GS-461203 is not an inhibitor of human DNA and RNA polymerases nor an inhibitor of mitochondrial RNA polymerase.
| | |
| | ==Pathophysiology== |
| | |
| | === Genetics === |
| | |
| | ===Associated Conditions=== |
| | |
| | ==Causes== |
| | |
| | ==Differentiating type page name here from other Diseases== |
| | |
| | == Epidemiology and Demographics == |
| | |
| | == Risk Factors == |
| | |
| | == Screening == |
| | |
| | == Natural History, Complications, and Prognosis== |
| | |
| | == Diagnosis == |
| | |
| | === Symptoms === |
| | |
| | ===Family History=== |
| | |
| | === Physical Examination === |
| | |
| | ==== Appearance of the Patient ==== |
| | |
| | ====Vital Signs==== |
| | |
| | ====Skin==== |
| | |
| | ====Head==== |
| | |
| | ==== Eyes ==== |
| | |
| | ==== Ear ==== |
| | |
| | ====Nose==== |
| | |
| | ====Throat ==== |
| | |
| | ==== Heart ==== |
| | |
| | ==== Lungs ==== |
| | |
| | ==== Abdomen ==== |
| | |
| | ==== Extremities ==== |
| | |
| | ==== Neurologic ==== |
| | |
| | ==== Other ==== |
| | |
| | === Laboratory Findings === |
| | |
| | ==== Biomarker Studies ==== |
| | |
| | ====CT ==== |
| | |
| | ==== MRI ==== |
| | |
| | ==== Ultrasound ==== |
| | |
| | == Treatment == |
| | === Pharmacotherapy === |
| | |
| | ==== Acute Pharmacotherapies ==== |
| | |
| | ==== Chronic Pharmacotherapies ==== |
| | |
| | === Surgery and Device Based Therapy === |
| | |
| | ==== Indications for Surgery ==== |
| | |
| | ==== Pre-Operative Assessment ==== |
| | |
| | ==== Post-Operative Management ==== |
| | |
| | ===Primary Prevention=== |
| | ====Genetic Counseling==== |
| | |
| | ==References== |
| | {{reflist|2}} |
| | |
| | {{WikiDoc Help Menu}} |
| | {{WikiDoc Sources}} |
| | |
| | [[Category:Disease]] |
| | [[Category:FLK]] |