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{{short description|Chemical compound}}
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{{Drugbox
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<!-- Side effects and mechanism -->
Common side effects include fatigue, headache, nausea, and trouble sleeping.<ref name=AHFS2016/> Side effects are generally more common in interferon-containing regimens.<ref name="Sovaldi FDA label">{{cite web | title=Sovaldi- sofosbuvir tablet, film coated Sovaldi- sofosbuvir pellet | website=DailyMed | date=27 September 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=80beab2c-396e-4a37-a4dc-40fdb62859cf | access-date=4 February 2020}}</ref>{{rp|7}} Sofosbuvir may reactivate [[hepatitis B]] in those who have been previously infected.<ref name=FDAwarning2016>{{cite web|title=Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating|url=https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523690.htm|website=FDA|access-date=6 October 2016|date=4 October 2016|url-status=dead|archive-url=https://web.archive.org/web/20161006160327/https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm523690.htm|archive-date=6 October 2016 }}</ref> In combination with [[ledipasvir]], [[daclatasvir]] or [[simeprevir]], it is not recommended with [[amiodarone]] due to the risk of an [[bradycardia|abnormally slow heartbeat]].<ref name="Sovaldi FDA label"/> Sofosbuvir is in the [[nucleotide analog]] family of medications and works by blocking the hepatitis C [[NS5B]] protein.<ref name=UKlabel>{{cite web|title=Sovaldi 400 mg film coated tablets - Summary of Product Characteristics|url=https://www.medicines.org.uk/emc/medicine/28539|publisher=UK Electronic Medicines Compendium|access-date=10 November 2016|date=September 2016|url-status=live|archive-url=https://web.archive.org/web/20161110235042/https://www.medicines.org.uk/emc/medicine/28539|archive-date=10 November 2016 }}</ref>
<!-- History and culture -->
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== Pharmacology ==
===Mechanism of action===
Sofosbuvir inhibits the hepatitis C [[NS5B]] protein.<ref name=UKlabel/> Sofosbuvir appears to have a high barrier to the development of resistance.<ref>{{cite journal | vauthors = Pol S, Corouge M, Vallet-Pichard A | title = Daclatasvir-sofosbuvir combination therapy with or without ribavirin for hepatitis C virus infection: from the clinical trials to real life | journal = Hepatic Medicine: Evidence and Research| volume = 8 | pages = 21–26 | date = March 2016 | pmid = 27019602 | pmc = 4786064 | doi = 10.2147/HMER.S62014 | doi-access = free }}</ref>
Sofosbuvir is a [[prodrug]] of the [[Protide]] type, whereby the active phosphorylated nucleotide is granted cell permeability and oral bioavailability. It is metabolized to the active antiviral agent GS-461203 (2'-deoxy-2'-α-fluoro-β-''C''-methyluridine-5'-triphosphate). GS-461203 serves as a defective substrate for the NS5B protein, which is the viral RNA polymerase, thus acts as an inhibitor of viral RNA synthesis.<ref>{{cite journal | vauthors = Fung A, Jin Z, Dyatkina N, Wang G, Beigelman L, Deval J | title = Efficiency of incorporation and chain termination determines the inhibition potency of 2'-modified nucleotide analogs against hepatitis C virus polymerase | journal = Antimicrobial Agents and Chemotherapy | volume = 58 | issue = 7 | pages = 3636–3645 | date = July 2014 | pmid = 24733478 | pmc = 4068585 | doi = 10.1128/AAC.02666-14 }}</ref> Although sofosbuvir has a 3' hydroxyl group to act as a nucleophile for an incoming NTP, a similar nucleotide analogue, 2'-deoxy-2'-α-fluoro-β-C-methylcytidine, is proposed to act as a chain terminator because the 2' methyl group of the nucleotide analogue causes a [[steric clash]] with an incoming NTP.<ref>{{cite journal | vauthors = Ma H, Jiang WR, Robledo N, Leveque V, Ali S, Lara-Jaime T, Masjedizadeh M, Smith DB, Cammack N, Klumpp K, Symons J | display-authors = 6 | title = Characterization of the metabolic activation of hepatitis C virus nucleoside inhibitor beta-D-2'-Deoxy-2'-fluoro-2'-C-methylcytidine (PSI-6130) and identification of a novel active 5'-triphosphate species | journal = The Journal of Biological Chemistry | volume = 282 | issue = 41 | pages = 29812–29820 | date = October 2007 | pmid = 17698842 | doi = 10.1074/jbc.M705274200 | doi-access = free }}</ref> Sofosbuvir
=== Pharmacokinetics ===
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== History ==
Sofosbuvir was discovered in 2007 by [[Michael J. Sofia]], a scientist at [[Pharmasset]], and the drug was first tested in people in 2010. In 2011, [[Gilead Sciences]] bought Pharmasset for about $11 billion.<ref name=NewYorker/> Gilead submitted the [[New Drug Application]] for sofosbuvir in combination with [[ribavirin]] in April 2013, and in October 2013 it received the FDA's [[Breakthrough therapy|Breakthrough Therapy Designation]].<ref name=FDAreview>{{cite web|title=Application Number: 204671Orig1s000: Medical Reviews|url=https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000MedR.pdf|publisher=FDA|date=November 20, 2013|url-status=live|archive-url=https://web.archive.org/web/20161110175252/https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204671Orig1s000MedR.pdf|archive-date=November 10, 2016 }}</ref> In December 2013, the [[FDA]] approved sofosbuvir in combination with ribavirin for oral dual therapy of [[Hepatitis C virus#Genotypes|HCV genotypes]] 2 and 3, and for triple therapy with injected [[pegylated interferon]] (pegIFN) and RBV for treatment-naive people with HCV genotypes 1 and 4.<ref name=FDA2013>{{cite web | url = https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm377888.htm | title = FDA approves Sovaldi for chronic hepatitis C | date = 2013-12-06 | work = FDA New Release | publisher = U.S. Food and Drug Administration | url-status = live | archive-url = https://web.archive.org/web/20131209000157/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm | archive-date = 2013-12-09 }}</ref><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| website = Medscape| url-status = live| archive-url = https://web.archive.org/web/20150517012529/http://www.medscape.com/viewarticle/817371| archive-date = May 17, 2015}}</ref> Two months before, the FDA had approved another drug, [[simeprevir]], as a hepatitis C treatment.<ref name=FDA2013/>
In 2014, the fixed dose [[combination drug]] sofosbuvir/[[ledipasvir]], the latter a viral [[NS5A]] inhibitor, was approved; it had also been granted breakthrough status.<ref name=FDA2014>{{cite web |url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm |title=FDA approves first combination pill to treat hepatitis C |website=[[Food and Drug Administration]] |url-status=live |archive-url=https://web.archive.org/web/20150504075208/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418365.htm |archive-date=2015-05-04 }}</ref>
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=== Economics ===
Following its approval by the FDA in 2013,<ref name="FDA2013" /> the price of sofosbuvir as quoted in various media sources in 2014 ranged from $84,000 to $168,000 depending on course of treatment in the U.S.<ref name=NYTprice2014>{{cite news | vauthors = Harris G |title=Maker of Costly Hepatitis C Drug Sovaldi Strikes Deal on Generics for Poor Countries |url=https://www.nytimes.com/2014/09/16/business/international/maker-of-hepatitis-c-drug-strikes-deal-on-generics-for-poor-countries.html |work=[[The New York Times]] |date=15 September 2014 |url-status=live |archive-url=https://web.archive.org/web/20170131153408/https://www.nytimes.com/2014/09/16/business/international/maker-of-hepatitis-c-drug-strikes-deal-on-generics-for-poor-countries.html?_r=0 |archive-date=31 January 2017 }}</ref> and £35,000 in the United Kingdom for a 12-week regimine,<ref name=Guardian2015>{{cite news | vauthors = Boseley S |title=Hepatitis C drug delayed by NHS due to high cost |url=https://www.theguardian.com/society/2015/jan/16/sofosbuvir-hepatitis-c-drug-nhs |work=[[The Guardian]] |date=15 January 2015 |url-status=live |archive-url=https://web.archive.org/web/20161110174558/https://www.theguardian.com/society/2015/jan/16/sofosbuvir-hepatitis-c-drug-nhs |archive-date=10 November 2016 }}</ref> causing considerable controversy.<ref name="Stanton"/><ref name="Waldman"/> Sofosbuvir was more affordable in Japan and South Korea at approximately $300 and $5900 respectively for a 12-week treatment, with each government covering 99% and 70% of the cost respectively.<ref name="view.asiae.co.kr"/><ref name="edaily.co.kr"/> In 2014, Gilead announced it would work with generic manufacturers in 91 developing countries to produce and sell sofosbuvir, and that it would sell a name brand version of the product in [[India]] for approximately $300 per course of treatment; it had signed agreements with generic manufacturers by September 2015.<ref name=Prices2014>{{cite journal | vauthors = van de Ven N, Fortunak J, Simmons B, Ford N, Cooke GS, Khoo S, Hill A | title = Minimum target prices for production of direct-acting antivirals and associated diagnostics to combat hepatitis C virus | journal = Hepatology | volume = 61 | issue = 4 | pages = 1174–1182 | date = April 2015 | pmid = 25482139 | pmc = 4403972 | doi = 10.1002/hep.27641 }}</ref><ref name=ReutersIndia2015>{{cite news | vauthors = Kalra A, Siddiqui Z |title=Gilead licenses hepatitis C drug to Cipla, Ranbaxy, five others|url=http://in.reuters.com/article/gilead-sciences-india-idINKBN0HA0TI20140915 |publisher=Reuters India |date=September 15, 2014 |url-status=
====United States====
Since its launch, the price of sofosbuvir declined as more competitors entered the [[Direct-acting antivirals|direct-acting antiviral]] (DAA) market.<ref>{{
{{blockquote|Sofosbuvir also is an excellent example of both the benefit and the challenge of specialty medications. On one hand, this agent offers up to a 95% response rate as part of an interferon-free treatment regimen for hepatitis C. Generally speaking, it is more effective and better tolerated than alternative treatments. Unfortunately, the current per pill cost—$1,000—results in an $84,000 treatment course, creating barriers to therapy for many. Patients, providers, and payors alike have expressed outrage, and the debate has even drawn the attention of the US Congress. Despite these concerns, sofosbuvir rapidly has become a top seller in the United States...<ref name="pppmag_2015" />}}
In February 2015, Gilead announced that due in part to negotiated discounts with pharmacy benefit managers and legally mandated discounts to government payers, the average discount-to-list price in 2014 was 22%. The company estimated that the average discount in 2015 would be 46%.<ref name="Martin_2014">{{cite web |url=http://seekingalpha.com/article/2880996-gilead-sciences-gild-ceo-john-martin-on-q4-2014-results-earnings-call-transcript?page=4 |title=Gilead Q4 2014 Earnings Call |date=3 February 2015 |url-status=live |archive-url=https://web.archive.org/web/20150222163149/http://seekingalpha.com/article/2880996-gilead-sciences-gild-ceo-john-martin-on-q4-2014-results-earnings-call-transcript?page=4 |archive-date=2015-02-22 }}</ref> According to the California Technology Assessment Forum, a panel of academic pharmacoeconomic experts, representatives of managed care organizations, and advocates for people with hepatitis, a 46% discount would bring the average price of treatment to about $40,000, at which price sofosbuvir-based treatment regimens represent a "high value" for people and healthcare systems.<ref>{{cite press release |url=http://www.ctaf.org/about-ctaf/news/2015/new-lower-prices-gilead-hepatitis-c-drugs-reach-ctaf-threshold-high-health |title=New Lower Prices for Gilead Hepatitis C Drugs Reach CTAF Threshold for High Health System Value |date=2015-02-17 |access-date=2015-02-22 |url-status=live |archive-url=https://web.archive.org/web/20150222163142/http://www.ctaf.org/about-ctaf/news/2015/new-lower-prices-gilead-hepatitis-c-drugs-reach-ctaf-threshold-high-health |archive-date=2015-02-22 }}</ref><ref>{{
Because of sofosbuvir's high price in the United States, by 2017, some states—such as Louisiana—were withholding the medicine from [[Medicaid]] patients with hepatitis until their livers were severely damaged.<ref name="WaPo_2017_Johnson">{{cite news |url=https://www.washingtonpost.com/business/economy/louisiana-considers-radical-step-to-counter-high-drug-prices-federal-intervention/2017/07/03/456b99f6-4a59-11e7-a186-60c031eab644_story.html?tid=sm_tw |title=Louisiana considers radical step to counter high drug prices: Federal intervention | vauthors = Johnson CY |date=July 3, 2017 |access-date=July 4, 2017 |location=Baton Rouge, Louisiana |url-status=live |archive-url=https://web.archive.org/web/20170923235702/https://www.washingtonpost.com/business/economy/louisiana-considers-radical-step-to-counter-high-drug-prices-federal-intervention/2017/07/03/456b99f6-4a59-11e7-a186-60c031eab644_story.html?tid=sm_tw |archive-date=September 23, 2017 }}</ref> This puts "patients at increased risk of medical complications" and contributes to the "transmission of the hepatitis C virus".<ref name="Kapczynski_2016_patent">{{cite journal | vauthors = Kapczynski A, Kesselheim AS | title = 'Government Patent Use': A Legal Approach To Reducing Drug Spending | journal = Health Affairs | volume = 35 | issue = 5 | pages = 791–797 | date = May 2016 | pmid = 27140984 | doi = 10.1377/hlthaff.2015.1120 | url = https://law.yale.edu/system/files/documents/faculty/papers/kapcyznski_govpatentuse.pdf | access-date = June 4, 2017 | url-status = live | doi-access = free | archive-url = https://web.archive.org/web/20170901111149/https://law.yale.edu/system/files/documents/faculty/papers/kapcyznski_govpatentuse.pdf | archive-date = September 1, 2017 }}</ref> In an article published in May 2016 in ''Health Affairs'', the authors proposed the invocation of the federal "[[Government patent use (United States)|government patent use]]" law which would enable the government to procure "important patent-protected" drugs at lower prices while compensating "the patent-holding companies reasonable royalties ... for research and development."<ref name="Kapczynski_2016_patent"/> By July 2017, Louisiana's health secretary Rebekah Gee, who described Louisiana as America's "public-health-crisis cradle", was investigating the use of the "government patent use" as a strategy.<ref name="WaPo_2017_Johnson"/>
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====Croatia====
As of 2015, sofosbuvir is included on the list of essential medications in Croatia and its cost is fully covered by the [[Croatian Health Insurance Fund]]. As a result of negotiations with the manufacturer, only therapies with successful outcome would be paid by the Fund with the rest being covered by the manufacturer.<ref name=PoslovniDnevnik>{{
==== India ====
In July 2014, Gilead Sciences filed a patent for sofosbuvir in India. If the office of the controller general of patents had granted it, Gilead would have obtained exclusive rights to produce and sell sofosbuvir in the country. However, in January 2015, the [[Indian Patent Office]] rejected Gilead's application. Gilead's lawyers moved the [[Delhi High Court]] against this decision. That decision was overturned on appeal in February 2015.<ref>{{cite web|url=http://www.raps.org/Regulatory-Focus/News/2015/02/04/21240/India-Gilead-Patent/|title=Follow the Rules, Indian Court Tells Patent Office in Sovaldi Case| vauthors = Mezher M |date=February 4, 2015|publisher=Regulatory Affairs Professionals Society|archive-url=https://web.archive.org/web/20160501185954/http://www.raps.org/Regulatory-Focus/News/2015/02/04/21240/India-Gilead-Patent/|archive-date=2016-05-01|url-status=live}}</ref><ref>{{cite web|url=http://www.thehindubusinessline.com/companies/more-patentopposition-on-gileads-hepatitis-c-drug-sofosbuvir/article6847904.ece|title=More patent-opposition on Gilead's hepatitis C drug, sofosbuvir| vauthors = Datta J |date=2 February 2015|work=Hindu Business Line|archive-url=https://web.archive.org/web/20170923235702/http://www.thehindubusinessline.com/companies/more-patentopposition-on-gileads-hepatitis-c-drug-sofosbuvir/article6847904.ece|archive-date=23 September 2017|url-status=live
====Developing world====
In 2014, Gilead announced it would seek generic licensing agreements with manufacturers to produce sofosbuvir in 91 developing countries, which contained 54% of the world's HCV-infected population. Gilead also said it would sell a name brand version of the product in India for $300 per course of treatment, approximately double a third party estimate of the minimum achievable cost of manufacture.<ref name=Prices2014 /> It had signed licenses with generic manufacturers by September 2015.<ref name=ReutersIndia2015/> The leader of one Indian activist group called this move inadequate,<ref name=ReutersIndia2015/> but nine companies launched products, which "unleashed a fierce marketing war", according to India's ''[[The Economic Times]]''.<ref name=EcTimes2015>Divya Rajagopal for the Economic Times. Sept 12, 2015. [http://articles.economictimes.indiatimes.com/2015-09-12/news/66465866_1_sofosbuvir-sovaldi-drug-companies Can Indian generic makers find gold with a blockbuster Hepatitis C drug?]</ref>
In Egypt, which had the world's highest incidence of hepatitis C, Gilead offered sofosbuvir at the discounted price of $900 to the Egyptian government. The government in turn made it free to patients. Later, Gilead licensed a generic version to be available in Egypt.<ref>{{
The [[Access to Medicine Index]] ranked Gilead first among the world's 20 largest pharmaceutical countries in the Pricing, Manufacturing and Distribution category in both 2013 and 2014, citing Gilead's "leading performance in equitable pricing."<ref>{{cite web|url=http://www.accesstomedicineindex.org/pricing-manufacturing-distribution-0|title=Pricing, Manufacturing & Distribution | Access to Medicine Index 2014|url-status=live|archive-url=https://web.archive.org/web/20150206113129/http://www.accesstomedicineindex.org/pricing-manufacturing-distribution-0|archive-date=2015-02-06 }}</ref> In contrast, Jennifer Cohn of [[Doctors Without Borders]] and the organization [[Doctors of the World]] criticized the price of sofosbuvir as reflecting "corporate greed" and ignoring the needs of people in developing countries.<ref name="Stanton"/><ref name="Waldman"/>
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== Research ==
Combinations of sofosbuvir with NS5A inhibitors, such as [[daclatasvir]], [[ledipasvir]] or [[Velpatasvir/sofosbuvir|velpatasvir]], have shown sustained virological response rates of up to 100% in people infected with HCV. Most studies indicate that the efficacy rate is between 94% and 97%; much higher than previous treatment options.<ref>{{cite journal | vauthors = Childs-Kean LM, Hand EO | title = Simeprevir and sofosbuvir for treatment of chronic hepatitis C infection | journal = Clinical Therapeutics | volume = 37 | issue = 2 | pages = 243–267 | date = February 2015 | pmid = 25601269 | doi = 10.1016/j.clinthera.2014.12.012 }}</ref><ref>{{cite journal | vauthors = Smith MA, Chan J, Mohammad RA | title = Ledipasvir-sofosbuvir: interferon-/ribavirin-free regimen for chronic hepatitis C virus infection | journal = The Annals of Pharmacotherapy | volume = 49 | issue = 3 | pages = 343–350 | date = March 2015 | pmid = 25515863 | doi = 10.1177/1060028014563952 | s2cid = 20944806 }}</ref><ref name=FDA2017Ep>{{
Sofosbuvir has also been tested against other viruses such as the [[Zika virus]]<ref>{{cite journal | vauthors = Sacramento CQ, de Melo GR, de Freitas CS, Rocha N, Hoelz LV, Miranda M, Fintelman-Rodrigues N, Marttorelli A, Ferreira AC, Barbosa-Lima G, Abrantes JL, Vieira YR, Bastos MM, de Mello Volotão E, Nunes EP, Tschoeke DA, Leomil L, Loiola EC, Trindade P, Rehen SK, Bozza FA, Bozza PT, Boechat N, Thompson FL, de Filippis AM, Brüning K, Souza TM | display-authors = 6 | title = The clinically approved antiviral drug sofosbuvir inhibits Zika virus replication | journal = Scientific Reports | volume = 7 | issue = 1 | pages = 40920 | date = January 2017 | pmid = 28098253 | pmc = 5241873 | doi = 10.1038/srep40920 | bibcode = 2017NatSR...740920S | doi-access = free }}</ref> and [[severe acute respiratory syndrome coronavirus 2]] (SARS-CoV-2).<ref>{{cite journal | vauthors = Mesci P, de Souza JS, Martin-Sancho L, Macia A, Saleh A, Yin X, Snethlage C, Adams JW, Avansini SH, Herai RH, Almenar-Queralt A, Pu Y, Szeto RA, Goldberg G, Bruck PT, Papes F, Chanda SK, Muotri AR | display-authors = 6 | title = SARS-CoV-2 infects human brain organoids causing cell death and loss of synapses that can be rescued by treatment with Sofosbuvir | journal = PLOS Biology | volume = 20 | issue = 11 | pages = e3001845 | date = November 2022 | pmid = 36327326 | pmc = 9632769 | doi = 10.1371/journal.pbio.3001845 | doi-access = free }}</ref>
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{{Portal bar | Medicine | Viruses }}
[[Category:Gilead Sciences]]
[[Category:Hepatitis C]]
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