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<!-- Definition and medical uses -->
<!-- Definition and medical uses -->
'''Pegylated interferon alpha-2a''', sold under the brand name '''Pegasys''' among others, is medication used to treat [[hepatitis C]] and [[hepatitis B]].<ref name=Pro2017/> For hepatitis C it is typically used together with [[ribavirin]] and cure rates are between 24 to 92%.<ref name=Pro2017/><ref>{{cite web|title=Pegasys 135 mcg and 180 mcg solution for injection in pre-filled pen - Summary of Product Characteristics (SPC) - (eMC)|url=https://www.medicines.org.uk/emc/medicine/32432|website=www.medicines.org.uk|accessdate=12 January 2017|deadurl=no|archiveurl=https://web.archive.org/web/20170113131243/https://www.medicines.org.uk/emc/medicine/32432|archivedate=13 January 2017|df=}}</ref> For hepatitis B it may be used alone.<ref name=BNF69/> It is given by [[injection under the skin]].<ref name=Pro2017>{{cite web|title=Peginterferon Alfa-2a (Professional Patient Advice) - Drugs.com|url=https://www.drugs.com/ppa/peginterferon-alfa-2a.html|website=www.drugs.com|accessdate=12 January 2017|deadurl=no|archiveurl=https://web.archive.org/web/20170116181400/https://www.drugs.com/ppa/peginterferon-alfa-2a.html|archivedate=16 January 2017|df=}}</ref>
'''Pegylated interferon alfa-2a''', sold under the brand name '''Pegasys''' among others, is medication used to treat [[hepatitis C]] and [[hepatitis B]].<ref name=Pro2017/> For hepatitis C it is typically used together with [[ribavirin]] and cure rates are between 24 to 92%.<ref name=Pro2017/><ref>{{cite web|title=Pegasys 135 mcg and 180 mcg solution for injection in pre-filled pen - Summary of Product Characteristics (SPC) - (eMC)|url=https://www.medicines.org.uk/emc/medicine/32432|website=www.medicines.org.uk|accessdate=12 January 2017|deadurl=no|archiveurl=https://web.archive.org/web/20170113131243/https://www.medicines.org.uk/emc/medicine/32432|archivedate=13 January 2017|df=}}</ref> For hepatitis B it may be used alone.<ref name=BNF69/> It is given by [[injection under the skin]].<ref name=Pro2017>{{cite web|title=Peginterferon Alfa-2a (Professional Patient Advice) - Drugs.com|url=https://www.drugs.com/ppa/peginterferon-alfa-2a.html|website=www.drugs.com|accessdate=12 January 2017|deadurl=no|archiveurl=https://web.archive.org/web/20170116181400/https://www.drugs.com/ppa/peginterferon-alfa-2a.html|archivedate=16 January 2017|df=}}</ref>


<!-- Side effects and mechanism -->
<!-- Side effects and mechanism -->
Side effects are common.<ref name=UW2017/> They may include headache, feeling tired, depression, trouble sleeping, hair loss, nausea, pain at the site of injection, and fever.<ref name=Pro2017/> Severe side effects may include [[psychosis]], [[autoimmune disorders]], [[blood clots]], or [[infections]].<ref name=Pro2017/> Use with ribavirin is not recommended during [[pregnancy]].<ref name=Pro2017/> Pegylated interferon alpha-2a is in the [[alpha interferon]] family of medications.<ref name=Pro2017/> It is [[pegylated]] to protect the molecule from breakdown.<ref name=UW2017/>
Side effects are common.<ref name=UW2017/> They may include headache, feeling tired, depression, trouble sleeping, hair loss, nausea, pain at the site of injection, and fever.<ref name=Pro2017/> Severe side effects may include [[psychosis]], [[autoimmune disorders]], [[blood clots]], or [[infections]].<ref name=Pro2017/> Use with ribavirin is not recommended during [[pregnancy]].<ref name=Pro2017/> Pegylated interferon alfa-2a is in the [[alpha interferon]] family of medications.<ref name=Pro2017/> It is [[pegylated]] to protect the molecule from breakdown.<ref name=UW2017/>


<!-- History and culture -->
<!-- History and culture -->
Pegylated interferon alpha-2a was approved for medical use in the United States in 2002.<ref name=Pro2017/> It is on the [[World Health Organization's List of Essential Medicines]], the most effective and safe medicines needed in a [[health system]].<ref name=WHO19th>{{cite web|title=WHO Model List of Essential Medicines (19th List)|url=http://www.who.int/medicines/publications/essentialmedicines/EML_2015_FINAL_amended_NOV2015.pdf?ua=1|work=World Health Organization|accessdate=8 December 2016|date=April 2015|deadurl=no|archiveurl=https://web.archive.org/web/20161213052708/http://www.who.int/medicines/publications/essentialmedicines/EML_2015_FINAL_amended_NOV2015.pdf?ua=1|archivedate=13 December 2016|df=}}</ref> The wholesale cost in the [[developing world]] is between 500.00 and 4,800.00 USD for 12 weeks.<ref>{{cite web|title=Inclusion of the injectable formulation of peginterferon alfa-2a and -2b is proposed for the treatment of hepatitis C among adults.|url=http://www.who.int/selection_medicines/committees/expert/19/applications/Pegyinterferon_6_4_3_A_Ad.pdf|website=who.int|accessdate=12 January 2017|page=11|deadurl=no|archiveurl=https://web.archive.org/web/20170113131153/http://www.who.int/selection_medicines/committees/expert/19/applications/Pegyinterferon_6_4_3_A_Ad.pdf|archivedate=13 January 2017|df=}}</ref> In the United States this costs about 9,250.00 USD,<ref name=UW2017>{{cite web|title=Peginterferon alfa-2a (Pegasys) - Treatment - Hepatitis C Online|url=http://www.hepatitisc.uw.edu/page/treatment/drugs/peginterferon-alfa-drug|website=www.hepatitisc.uw.edu|accessdate=12 January 2017|deadurl=no|archiveurl=https://web.archive.org/web/20161223133654/http://www.hepatitisc.uw.edu/page/treatment/drugs/peginterferon-alfa-drug|archivedate=23 December 2016|df=}}</ref> while in the United Kingdom 12 weeks costs the [[NHS]] about 1492.80 pounds.<ref name=BNF69>{{cite book|title=British national formulary : BNF 69|date=2015|publisher=British Medical Association|isbn=9780857111562|page=639|edition=69}}</ref>
Pegylated interferon alfa-2a was approved for medical use in the United States in 2002.<ref name=Pro2017/> It is on the [[World Health Organization's List of Essential Medicines]], the most effective and safe medicines needed in a [[health system]].<ref name=WHO19th>{{cite web|title=WHO Model List of Essential Medicines (19th List)|url=http://www.who.int/medicines/publications/essentialmedicines/EML_2015_FINAL_amended_NOV2015.pdf?ua=1|work=World Health Organization|accessdate=8 December 2016|date=April 2015|deadurl=no|archiveurl=https://web.archive.org/web/20161213052708/http://www.who.int/medicines/publications/essentialmedicines/EML_2015_FINAL_amended_NOV2015.pdf?ua=1|archivedate=13 December 2016|df=}}</ref> The wholesale cost in the [[developing world]] is between 500.00 and 4,800.00 USD for 12 weeks.<ref>{{cite web|title=Inclusion of the injectable formulation of peginterferon alfa-2a and -2b is proposed for the treatment of hepatitis C among adults.|url=http://www.who.int/selection_medicines/committees/expert/19/applications/Pegyinterferon_6_4_3_A_Ad.pdf|website=who.int|accessdate=12 January 2017|page=11|deadurl=no|archiveurl=https://web.archive.org/web/20170113131153/http://www.who.int/selection_medicines/committees/expert/19/applications/Pegyinterferon_6_4_3_A_Ad.pdf|archivedate=13 January 2017|df=}}</ref> In the United States this costs about 9,250.00 USD,<ref name=UW2017>{{cite web|title=Peginterferon alfa-2a (Pegasys) - Treatment - Hepatitis C Online|url=http://www.hepatitisc.uw.edu/page/treatment/drugs/peginterferon-alfa-drug|website=www.hepatitisc.uw.edu|accessdate=12 January 2017|deadurl=no|archiveurl=https://web.archive.org/web/20161223133654/http://www.hepatitisc.uw.edu/page/treatment/drugs/peginterferon-alfa-drug|archivedate=23 December 2016|df=}}</ref> while in the United Kingdom 12 weeks costs the [[NHS]] about 1492.80 pounds.<ref name=BNF69>{{cite book|title=British national formulary : BNF 69|date=2015|publisher=British Medical Association|isbn=9780857111562|page=639|edition=69}}</ref>


==Medical uses==
==Medical uses==
This drug is approved around the world for the treatment of chronic [[hepatitis C]] (including people with [[HIV]] co-infection, [[cirrhosis]], 'normal' levels of [[Alanine transaminase|ALT]]) and has recently been approved (in the [[European Union|EU]], [[United States|U.S.]], [[China]] and many other countries) for the treatment of chronic [[hepatitis B]]. It is also used in the treatment of certain T-cell lymphomas, particularly [[mycosis fungoides]].
This drug is approved around the world for the treatment of chronic [[hepatitis C]] (including people with [[HIV]] co-infection, [[cirrhosis]], 'normal' levels of [[Alanine transaminase|ALT]]) and has recently been approved (in the [[European Union|EU]], [[United States|U.S.]], [[China]] and many other countries) for the treatment of chronic [[hepatitis B]]. It is also used in the treatment of certain T-cell lymphomas, particularly [[mycosis fungoides]].


Peginterferon alpha-2a is a long acting interferon. Interferons are [[proteins]] released in the body in response to [[viral infections]]. Interferons are important for fighting [[viruses]] in the body, for regulating reproduction of [[Cell (biology)|cells]], and for regulating the immune system.{{Citation needed|date=October 2009}}
Peginterferon alfa-2a is a long acting interferon. Interferons are [[proteins]] released in the body in response to [[viral infections]]. Interferons are important for fighting [[viruses]] in the body, for regulating reproduction of [[Cell (biology)|cells]], and for regulating the immune system.{{Citation needed|date=October 2009}}


=== Host genetic factors===
=== Host genetic factors===


For genotype 1 hepatitis C treated with [[pegylated interferon-alpha-2a]] or [[pegylated interferon-alpha-2b]] combined with [[ribavirin]], 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|title=Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance |vauthors=Ge D, Fellay J, Thompson AJ, etal |journal=Nature |year=2009 |volume=461|pages=399–401 |pmid=19684573 |doi=10.1038/nature08309|issue=7262}}</ref> showed 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. Another report in Nature <ref>{{cite journal|title=Genetic variation in IL28B and spontaneous clearance of hepatitis C virus |vauthors=Thomas DL, Thio CL, Martin MP, etal |journal=Nature |year=2009 |pmid=19759533 |doi=10.1038/nature08463|volume=461|issue=7265|pages=798–801|pmc=3172006}}</ref> demonstrated the same genetic variants are also associated with the natural clearance of the genotype 1 hepatitis C virus.
For genotype 1 hepatitis C treated with [[pegylated interferon-alfa-2a]] or [[pegylated interferon-alfa-2b]] combined with [[ribavirin]], 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|title=Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance |vauthors=Ge D, Fellay J, Thompson AJ, etal |journal=Nature |year=2009 |volume=461|pages=399–401 |pmid=19684573 |doi=10.1038/nature08309|issue=7262}}</ref> showed 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. Another report in Nature <ref>{{cite journal|title=Genetic variation in IL28B and spontaneous clearance of hepatitis C virus |vauthors=Thomas DL, Thio CL, Martin MP, etal |journal=Nature |year=2009 |pmid=19759533 |doi=10.1038/nature08463|volume=461|issue=7265|pages=798–801|pmc=3172006}}</ref> demonstrated the same genetic variants are also associated with the natural clearance of the genotype 1 hepatitis C virus.


===Other infections===
===Other infections===
Line 61: Line 61:


==Research==
==Research==
A [[Cochrane (organisation)|Cochrane Review]] sought to determine whether interferon alpha-2a could be used as a treatment for individuals with [[macular degeneration|neovascular age-related macular degeneration]]. They found no evidence of improved visual acuity with potential harm.<ref name="Reddy">{{cite journal |vauthors= Reddy U, Krzystolik M |title= Antiangiogenic therapy with interferon alfa for neovascular age-related macular degeneration |journal=Cochrane Database Syst Rev |volume=1 |pages= CD005138 |date=2006 |pmid= 16437522|doi= 10.1002/14651858.CD005138.pub2}}</ref>
A [[Cochrane (organisation)|Cochrane Review]] sought to determine whether interferon alfa-2a could be used as a treatment for individuals with [[macular degeneration|neovascular age-related macular degeneration]]. They found no evidence of improved visual acuity with potential harm.<ref name="Reddy">{{cite journal |vauthors= Reddy U, Krzystolik M |title= Antiangiogenic therapy with interferon alfa for neovascular age-related macular degeneration |journal=Cochrane Database Syst Rev |volume=1 |pages= CD005138 |date=2006 |pmid= 16437522|doi= 10.1002/14651858.CD005138.pub2}}</ref>


==References==
==References==

Revision as of 13:35, 2 November 2017

Peginterferon alfa-2a
Clinical data
Trade namesPegasys, others
AHFS/Drugs.comProfessional Drug Facts
MedlinePlusa605029
License data
Pregnancy
category
Routes of
administration
subcutaneous
ATC code
Legal status
Legal status
  • US: WARNING[1]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC860H1353N227O255S9
Molar mass19241 g/mol (unpegylated)
40000 g/mol (pegylated) g·mol−1
 ☒NcheckY (what is this?)  (verify)

Pegylated interferon alfa-2a, sold under the brand name Pegasys among others, is medication used to treat hepatitis C and hepatitis B.[2] For hepatitis C it is typically used together with ribavirin and cure rates are between 24 to 92%.[2][3] For hepatitis B it may be used alone.[4] It is given by injection under the skin.[2]

Side effects are common.[5] They may include headache, feeling tired, depression, trouble sleeping, hair loss, nausea, pain at the site of injection, and fever.[2] Severe side effects may include psychosis, autoimmune disorders, blood clots, or infections.[2] Use with ribavirin is not recommended during pregnancy.[2] Pegylated interferon alfa-2a is in the alpha interferon family of medications.[2] It is pegylated to protect the molecule from breakdown.[5]

Pegylated interferon alfa-2a was approved for medical use in the United States in 2002.[2] It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.[6] The wholesale cost in the developing world is between 500.00 and 4,800.00 USD for 12 weeks.[7] In the United States this costs about 9,250.00 USD,[5] while in the United Kingdom 12 weeks costs the NHS about 1492.80 pounds.[4]

Medical uses

This drug is approved around the world for the treatment of chronic hepatitis C (including people with HIV co-infection, cirrhosis, 'normal' levels of ALT) and has recently been approved (in the EU, U.S., China and many other countries) for the treatment of chronic hepatitis B. It is also used in the treatment of certain T-cell lymphomas, particularly mycosis fungoides.

Peginterferon alfa-2a is a long acting interferon. Interferons are proteins released in the body in response to viral infections. Interferons are important for fighting viruses in the body, for regulating reproduction of cells, and for regulating the immune system.[citation needed]

Host genetic factors

For genotype 1 hepatitis C treated with pegylated interferon-alfa-2a or pegylated interferon-alfa-2b combined with ribavirin, 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,[8] showed 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. Another report in Nature [9] demonstrated the same genetic variants are also associated with the natural clearance of the genotype 1 hepatitis C virus.

Other infections

Has also been used for Middle East respiratory syndrome and hepatitis E.[10]

Manufacture

It is pegylated with a branched 40 kg/mol PEG chain.

Research

A Cochrane Review sought to determine whether interferon alfa-2a could be used as a treatment for individuals with neovascular age-related macular degeneration. They found no evidence of improved visual acuity with potential harm.[11]

References

  1. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 Oct 2023.
  2. ^ a b c d e f g h "Peginterferon Alfa-2a (Professional Patient Advice) - Drugs.com". www.drugs.com. Archived from the original on 16 January 2017. Retrieved 12 January 2017. {{cite web}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  3. ^ "Pegasys 135 mcg and 180 mcg solution for injection in pre-filled pen - Summary of Product Characteristics (SPC) - (eMC)". www.medicines.org.uk. Archived from the original on 13 January 2017. Retrieved 12 January 2017. {{cite web}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  4. ^ a b British national formulary : BNF 69 (69 ed.). British Medical Association. 2015. p. 639. ISBN 9780857111562.
  5. ^ a b c "Peginterferon alfa-2a (Pegasys) - Treatment - Hepatitis C Online". www.hepatitisc.uw.edu. Archived from the original on 23 December 2016. Retrieved 12 January 2017. {{cite web}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  6. ^ "WHO Model List of Essential Medicines (19th List)" (PDF). World Health Organization. April 2015. Archived from the original (PDF) on 13 December 2016. Retrieved 8 December 2016. {{cite web}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  7. ^ "Inclusion of the injectable formulation of peginterferon alfa-2a and -2b is proposed for the treatment of hepatitis C among adults" (PDF). who.int. p. 11. Archived from the original (PDF) on 13 January 2017. Retrieved 12 January 2017. {{cite web}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  8. ^ Ge D, Fellay J, Thompson AJ, et al. (2009). "Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance". Nature. 461 (7262): 399–401. doi:10.1038/nature08309. PMID 19684573.
  9. ^ Thomas DL, Thio CL, Martin MP, et al. (2009). "Genetic variation in IL28B and spontaneous clearance of hepatitis C virus". Nature. 461 (7265): 798–801. doi:10.1038/nature08463. PMC 3172006. PMID 19759533.
  10. ^ "Peginterferon Alfa Monograph for Professionals - Drugs.com". www.drugs.com. Archived from the original on 16 January 2017. Retrieved 12 January 2017. {{cite web}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  11. ^ Reddy U, Krzystolik M (2006). "Antiangiogenic therapy with interferon alfa for neovascular age-related macular degeneration". Cochrane Database Syst Rev. 1: CD005138. doi:10.1002/14651858.CD005138.pub2. PMID 16437522.