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Revision as of 15:22, 9 January 2012 editBeetstra (talk | contribs)Edit filter managers, Administrators172,031 edits Saving copy of the {{drugbox}} taken from revid 468987118 of page Peginterferon_alfa-2b for the Chem/Drugbox validation project (updated: 'DrugBank', 'UNII', 'ChEMBL').  Latest revision as of 08:07, 8 October 2024 edit Orenburg1 (talk | contribs)Extended confirmed users166,119 editsm sp 
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{{Short description|Pharmaceutical drug}}
{{ambox | text = This page contains a copy of the infobox ({{tl|drugbox}}) taken from revid of page ] with values updated to verified values.}}
{{Use dmy dates|date=March 2024}}
{{Drugbox {{Drugbox
| Verifiedfields = changed | Verifiedfields = changed
| verifiedrevid = 458269117 | verifiedrevid = 470447710
| image =
⚫ | IUPAC_name = PEGylated human interferon alpha 2b
| image = | alt =


<!--Clinical data--> <!-- Clinical data -->
| tradename = | tradename = PegIntron, Sylatron, ViraferonPeg, others
| Drugs.com = {{drugs.com|CDI|peginterferon_alfa-2b}} | Drugs.com = {{drugs.com|ppa|peginterferon-alfa-2b}}
| MedlinePlus = a605030 | MedlinePlus = a605030
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X --> | pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_category =
| pregnancy_US = <!-- A / B / C / D / X -->
⚫ | routes_of_administration = ]
| pregnancy_category = contraindicated<ref>http://www.fda.gov/downloads/Drugs/DrugSafety/UCM133677.pdf See line 27</ref>
⚫ | ATC_prefix = L03
⚫ | ATC_suffix = AB10
| ATC_supplemental = {{ATC|L03|AB60}}

| legal_AU = <!-- Unscheduled / S2 / S4 / S8 --> | legal_AU = <!-- Unscheduled / S2 / S4 / S8 -->
| legal_UK = <!-- GSL / P / POM / CD --> | legal_UK = <!-- GSL / P / POM / CD -->
| legal_US = <!-- OTC / Rx-only --> | legal_US = Rx-only
| legal_US_comment = <ref>{{cite web | title=PegIntron- peginterferon alfa-2b injection, powder, lyophilized, for solution PegIntron- peginterferon alfa-2b kit | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b70816bb-913a-467f-acb8-67ef62cf8dac | access-date=28 September 2020}}</ref><ref>{{cite web | title=Sylatron- peginterferon alfa-2b kit | website=DailyMed | date=28 August 2019 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3874c95c-092e-4cd5-b104-6ed2bc391b0e | access-date=28 September 2020}}</ref>
⚫ | legal_status =
| legal_EU = Rx-only
⚫ | routes_of_administration =
| legal_EU_comment =
⚫ | legal_status =


<!--Pharmacokinetic data--> <!-- Pharmacokinetic data -->
| bioavailability = | bioavailability =
| protein_bound = | protein_bound =
| metabolism = | metabolism =
| elimination_half-life = 22-60 hrs | elimination_half-life = 22–60 hrs
| excretion = | excretion =


<!--Identifiers--> <!-- Identifiers -->
| CAS_number_Ref = {{cascite|correct|??}} | CAS_number_Ref = {{cascite|correct|CAS}}
| CAS_number = 99210-65-8 | CAS_number = 215647-85-1
⚫ | ATC_prefix = L03
⚫ | ATC_suffix = AB10
| PubChem = | PubChem =
| DrugBank_Ref = {{drugbankcite|changed|drugbank}} | DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB00022 | DrugBank = DB00022
| IUPHAR_ligand = 7462
| UNII_Ref = {{fdacite|changed|FDA}} | UNII_Ref = {{fdacite|changed|FDA}}
| UNII = <!-- blanked - oldvalue: G8RGG88B68 --> | UNII = G8RGG88B68
| KEGG_Ref = {{keggcite|correct|kegg}} | KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D02745 | KEGG = D02745
| ChEMBL_Ref = {{ebicite|changed|EBI}} | ChEMBL_Ref = {{ebicite|changed|EBI}}
| ChEMBL = <!-- blanked - oldvalue: 1201561 --> | ChEMBL = 1201561
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} | ChemSpiderID_Ref = {{chemspidercite|changed|chemspider}}
| ChemSpiderID = NA | ChemSpiderID = none


<!--Chemical data--> <!-- Chemical data -->
⚫ | IUPAC_name = PEGylated human interferon alpha 2b
| C=860 | H=1353 | N=229 | O=255 | S=9 | C=860 | H=1353 | N=229 | O=255 | S=9
| molecular_weight = 19269.1 g/mol
}} }}

'''Pegylated interferon alfa-2b''' is a drug used to treat ], as an ] to surgery.<ref name="Pro2017">{{cite web|title=Peginterferon Alfa-2b (Professional Patient Advice) - Drugs.com|url=https://www.drugs.com/ppa/peginterferon-alfa-2b.html|url-status=live|archive-url=https://web.archive.org/web/20170116190131/https://www.drugs.com/ppa/peginterferon-alfa-2b.html|archive-date=16 January 2017|access-date=12 January 2017|website=www.drugs.com}}</ref> Also used to treat hepatitis C (typically, in combination with ]), it is no longer recommended due to poor efficacy and adverse side-effects.<ref name="UW2017">{{cite web|date=January 2021|title=Peginterferon alfa-2b (PegIntron)|url=http://www.hepatitisc.uw.edu/page/treatment/drugs/peginterferon-alfa-2b-drug|access-date=12 January 2017|website=Hepatitis C Online|publisher=Infectious Diseases Education & Assessment, University of Washington}}</ref> ] is the preferred delivery method.<ref name="Pro2017" />

Belonging to the ] family of medications, the molecule is ] to prevent breakdown.<ref name="Pro2017" /><ref name="UW2017" /> Approval for medical use in the United States was granted in 2001.<ref name="Pro2017" /> It is on the ] as a therapy for chronic hepatitis C.<ref name="WHO21st">{{cite book|title=World Health Organization model list of essential medicines: 21st list 2019|vauthors=((World Health Organization))|publisher=World Health Organization|year=2019|location=Geneva|hdl=10665/325771|id=WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO|author-link=World Health Organization|hdl-access=free}}</ref><ref name=":2">{{Cite web|title=eEML - Electronic Essential Medicines List|url=https://list.essentialmeds.org/medicines/522|access-date=21 May 2021|website=list.essentialmeds.org}}</ref>

==Medical uses==

=== Hepatitis ===
Till around 2010, PEGylated interferon alfa-2b in combination with ], was part of the standard regimen used in management of ].<ref name="UW2017" /><ref name=":0">{{cite journal |author4-link=Ding-Shinn Chen | vauthors = Hsu CS, Chao YC, Lin HH, Chen DS, Kao JH | title = Systematic Review: Impact of Interferon-based Therapy on HCV-related Hepatocellular Carcinoma | journal = Scientific Reports | volume = 5 | issue = 1 | pages = 9954 | date = May 2015 | pmid = 25963067 | doi = 10.1038/srep09954 | pmc = 4428066 }}</ref> Ribivarin helped in increasing the ] (SVR) even more.<ref name=":3">{{Cite book|url=https://list.essentialmeds.org/files/trs/PXjEBzgbrMCpEHRGYEuB56NGdqGSBShvFrSzvRTL.pdf|title=The Selection and Use of Essential Medicines: Report of the WHO Expert Committee|publisher=]|year=2013|series=WHO Technical Report Series: 985|location=Geneva|pages=42}}</ref> Developed by ], the drug was approved by ] (FDA) of the ] in 2001, and has been on the ] as a therapy for chronic hepatitis C since 2013.<ref name="UW2017" /><ref name="WHO21st" /><ref name=":2" />

A 2013 meta-analysis over ] noted the combination-treatment to be safe as well as effective for children and adolescents; other meta-analyses had noted the same for adult population.<ref>{{cite journal | vauthors = Druyts E, Thorlund K, Wu P, Kanters S, Yaya S, Cooper CL, Mills EJ | title = Efficacy and safety of pegylated interferon alfa-2a or alfa-2b plus ribavirin for the treatment of chronic hepatitis C in children and adolescents: a systematic review and meta-analysis | journal = Clinical Infectious Diseases | volume = 56 | issue = 7 | pages = 961–7 | date = April 2013 | pmid = 23243171 | doi = 10.1093/cid/cis1031 | doi-access = free }}</ref> A 2012 ] had found ] to be the more effective variant for treatment-naive patients.<ref>{{cite journal | vauthors = Singal AK, Jampana SC, Anand BS | title = Peginterferon alfa-2a is superior to peginterferon alfa-2b in the treatment of naïve patients with hepatitis C virus infection: meta-analysis of randomized controlled trials | journal = Digestive Diseases and Sciences | volume = 56 | issue = 8 | pages = 2221–6 | date = August 2011 | pmid = 21643737 | doi = 10.1007/s10620-011-1765-0 | s2cid = 34328390 }}</ref>

With the advent of Direct-Acting-Antivirals (DAAs — ), interferon-based treatment regimens gradually fell out of fashion due to relatively poor efficacy and high frequency of adverse side-effects.<ref name="UW2017" /><ref name=":0" /><ref>{{Cite web| vauthors = Pockros PJ |title=Direct-acting antivirals for the treatment of hepatitis C virus infection|url=https://www.uptodate.com/contents/direct-acting-antivirals-for-the-treatment-of-hepatitis-c-virus-infection|access-date=21 May 2021|website=]}}</ref> No longer recommended, the use of PEGylated interferon alfa-2b has essentially ceased in all countries, where DAA therapeutics are available.<ref>{{cite journal | vauthors = Spengler U | title = Direct antiviral agents (DAAs) - A new age in the treatment of hepatitis C virus infection | journal = Pharmacology & Therapeutics | volume = 183 | pages = 118–126 | date = March 2018 | pmid = 29024739 | doi = 10.1016/j.pharmthera.2017.10.009 | s2cid = 3337006 }}</ref><ref name="UW2017" />

=== Melanoma ===
For high-risk melanoma, it is used as an ] to surgery in some countries.<ref name="Pro2017" /><ref>{{cite journal | vauthors = Di Trolio R, Simeone E, Di Lorenzo G, Grimaldi AM, Romano A, Ayala F, Caracò C, Mozzillo N, Ascierto PA | display-authors = 6 | title = Update on PEG-interferon α-2b as adjuvant therapy in melanoma | journal = Anticancer Research | volume = 32 | issue = 9 | pages = 3901–9 | date = September 2012 | pmid = 22993335 | url = https://ar.iiarjournals.org/content/32/9/3901 }}</ref> It was first approved for the purpose by FDA on 29 March 2011, based on a single phase III trial.<ref>{{cite journal | vauthors = Herndon TM, Demko SG, Jiang X, He K, Gootenberg JE, Cohen MH, Keegan P, Pazdur R | display-authors = 6 | title = U.S. Food and Drug Administration Approval: peginterferon-alfa-2b for the adjuvant treatment of patients with melanoma | language = zh | journal = The Oncologist | volume = 17 | issue = 10 | pages = 1323–8 | date = 2012 | pmid = 23002124 | pmc = 3481898 | doi = 10.1634/theoncologist.2012-0123 }}</ref><ref>{{cite journal | vauthors = Eggermont AM, Suciu S, Santinami M, Testori A, Kruit WH, Marsden J, Punt CJ, Salès F, Gore M, Mackie R, Kusic Z, Dummer R, Hauschild A, Musat E, Spatz A, Keilholz U | display-authors = 6 | title = Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial | language = English | journal = Lancet | volume = 372 | issue = 9633 | pages = 117–26 | date = July 2008 | pmid = 18620949 | doi = 10.1016/S0140-6736(08)61033-8 | s2cid = 665063 | url = https://www.zora.uzh.ch/id/eprint/13909/1/EORTC18991_Lancet_FINAL_FINAL_Eggermont_et_al_2008_2_12.pdf }}</ref>

The usage remains controversial — frequency of severe side-effects is high, ] benefits substantially vary across different trials, and there is no consensus on the dosage regimen.<ref name=":4">{{cite journal | vauthors = Trinh VA, Zobniw C, Hwu WJ | title = The efficacy and safety of adjuvant interferon-alfa therapy in the evolving treatment landscape for resected high-risk melanoma | journal = Expert Opinion on Drug Safety | volume = 16 | issue = 8 | pages = 933–940 | date = August 2017 | pmid = 28627943 | doi = 10.1080/14740338.2017.1343301 | s2cid = 22139797 }}</ref> Meta-analyses have suggested that the drug might be more helpful for patients with ulcerated primary lesion.<ref name=":4" />

=== COVID-19 ===
On 23 April 2021, the ] approved emergency use of the medication (upon a request by ]; trade name is Virafin) for treating moderate ] infections.<ref name=":1">{{Cite web| vauthors = Borana R |date=24 April 2021|title=DCGI Approves Virafin for Moderate COVID. Where's the Evidence It Works?|url=https://science.thewire.in/the-sciences/zydus-virafin-pegylated-interferon-alpha-2b-india-dcgi-approve-covid-trial-methods-flaw/|access-date=20 May 2021|website=The Wire Science|language=en-GB}}</ref> No publication (or ]) yet exists; the phase II trial was poorly designed and not robust.<ref name=":1" />

===Side effects===
Adverse side effects are common and often require dose reduction or outright discontinuation.<ref name="UW2017" /><ref name=":3" />

Common side effects include ], headache, ], ], ], ], ], ], ] and associated skeletal pain, ], fever etc.<ref name="Pro2017" /><ref name="UW2017" /> Relatively rare effects include ], ], ], ], ], ], ], ]es, ], ] etc.<ref name="Pro2017" /> Severe side effects may include a range of potentially fatal neuropsychiatric, autoimmune, ischemic, or infectious disorders.<ref name="Pro2017" /><ref name="UW2017" />

==Mechanism of action==
=== Host genetic factors===

For genotype 1 hepatitis C treated with ] or pegylated interferon-alfa-2b combined with ], it has been shown that genetic polymorphisms near the human IL28B gene, encoding interferon lambda 3, are associated with significant differences in response to the treatment. This finding, originally reported in Nature,<ref>{{cite journal | vauthors = Ge D, Fellay J, Thompson AJ, Simon JS, Shianna KV, Urban TJ, Heinzen EL, Qiu P, Bertelsen AH, Muir AJ, Sulkowski M, McHutchison JG, Goldstein DB | display-authors = 6 | title = Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance | journal = Nature | volume = 461 | issue = 7262 | pages = 399–401 | date = September 2009 | pmid = 19684573 | doi = 10.1038/nature08309 | bibcode = 2009Natur.461..399G | s2cid = 1707096 }}</ref> showed that genotype 1 hepatitis C patients carrying certain genetic variant alleles near the IL28B gene are more likely to achieve sustained virological response after the treatment than others. A later report from Nature<ref>{{cite journal | vauthors = Thomas DL, Thio CL, Martin MP, Qi Y, Ge D, O'Huigin C, Kidd J, Kidd K, Khakoo SI, Alexander G, Goedert JJ, Kirk GD, Donfield SM, Rosen HR, Tobler LH, Busch MP, McHutchison JG, Goldstein DB, Carrington M | display-authors = 6 | title = Genetic variation in IL28B and spontaneous clearance of hepatitis C virus | journal = Nature | volume = 461 | issue = 7265 | pages = 798–801 | date = October 2009 | pmid = 19759533 | pmc = 3172006 | doi = 10.1038/nature08463 | bibcode = 2009Natur.461..798T }}</ref> demonstrated that the same genetic variants are also associated with the natural clearance of the genotype 1 hepatitis C virus.

== References ==
{{reflist}}

== External links ==
* at the BBC, 2007
* from DrugLib.com

{{Interferons}}
{{Immunostimulants}}
{{Cytokine receptor modulators}}
{{Portal bar | Medicine | Viruses }}

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