Peginterferon alfa-2a explained

Verifiedfields:changed
Verifiedrevid:458269040
Tradename:Pegasys, others
Dailymedid:Peginterferon_alfa-2a
Pregnancy Au:B3
Routes Of Administration:Subcutaneous injection
Atc Prefix:L03
Atc Suffix:AB11
Atc Supplemental:
(in combinations)
Legal Au:S4
Legal Uk:POM
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Status:Rx-only
Index2 Label:alfa-2b
Cas Number:198153-51-4
Cas Number2:215647-85-1
Drugbank:DB00008
Chemspiderid:none
Unii:Q46947ZFE7K
Unii2:G8RGG88B68
Kegg:D02748
Chembl:1201560
C:860
H:1353
N:227
O:255
S:9

Pegylated interferon alfa-2a, sold under the brand name Pegasys among others, is medication used to treat hepatitis C and hepatitis B. For hepatitis C it is typically used together with ribavirin and cure rates are between 24 and 92%.[1] For hepatitis B it may be used alone.[2] It is given by injection under the skin.[3]

Side effects are common. They may include headache, feeling tired, depression, trouble sleeping, hair loss, nausea, pain at the site of injection, and fever.[3] Severe side effects may include psychosis, autoimmune disorders, blood clots, or infections.[3] Use with ribavirin is not recommended during pregnancy.[3] Pegylated interferon alfa-2a is in the alpha interferon family of medications.[3] It is pegylated to protect the molecule from breakdown.[4]

Pegylated interferon alfa-2a was approved for medical use in the United States in 2002.[3] It is on the World Health Organization's List of Essential Medicines.[5]

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.[6]

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,[7] 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 demonstrated the same genetic variants are also associated with the natural clearance of the genotype 1 hepatitis C virus.[8]

Manufacturing

It is pegylated with a branched 40kg/mol PEG chain.[9]

Society and culture

Availability

Peginterferon alfa-2a is manufactured under the brand name Pegasys. In 2021, Roche Pharmaceuticals sold the worldwide rights of Pegasys (excluding China and Japan) to zr pharma& GmbH (pharma&).<ref>Web site: Pegasys (peginterferon alfa-2a) . Genentech . 8 January 2023 . 8 January 2023 . https://web.archive.org/web/20230108213950/https://www.gene.com/patients/medicines/pegasys . dead . [10] [11] [12] [13] In May 2022, Roche Australia transferred the sales and marketing of Pegasys to Echo Therapeutics Pty Ltd.[14]

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.[15]

Notes and References

  1. Web site: Pegasys 135 mcg and 180 mcg solution for injection in pre-filled pen - Summary of Product Characteristics (SPC) - (eMC). www.medicines.org.uk. 12 January 2017. live. https://web.archive.org/web/20170113131243/https://www.medicines.org.uk/emc/medicine/32432. 13 January 2017.
  2. Book: British national formulary : BNF 69. 2015. British Medical Association. 9780857111562. 639. 69.
  3. Web site: Peginterferon Alfa-2a (Professional Patient Advice) - Drugs.com. www.drugs.com. 12 January 2017. live. https://web.archive.org/web/20170116181400/https://www.drugs.com/ppa/peginterferon-alfa-2a.html. 16 January 2017.
  4. Web site: Peginterferon alfa-2a (Pegasys) - Treatment - Hepatitis C Online. www.hepatitisc.uw.edu. 12 January 2017. live. https://web.archive.org/web/20161223133654/http://www.hepatitisc.uw.edu/page/treatment/drugs/peginterferon-alfa-drug. 23 December 2016.
  5. Book: ((World Health Organization)) . World Health Organization model list of essential medicines: 21st list 2019 . 2019 . 10665/325771 . World Health Organization . World Health Organization . Geneva . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO . free .
  6. Web site: Interferon alfa-2a Uses, Side Effects & Warnings. Drugs.com. en. 10 January 2020.
  7. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance . Ge D, Fellay J, Thompson AJ, etal . Nature . 2009 . 461. 399–401 . 19684573 . 10.1038/nature08309. 7262. 2009Natur.461..399G . 1707096 .
  8. Genetic variation in IL28B and spontaneous clearance of hepatitis C virus . Thomas DL, Thio CL, Martin MP, etal . Nature . 2009 . 19759533 . 10.1038/nature08463. 461. 7265. 798–801. 3172006. 2009Natur.461..798T .
  9. Rajender Reddy K, Modi MW, Pedder S . Use of peginterferon alfa-2a (40 KD) (Pegasys) for the treatment of hepatitis C . Advanced Drug Delivery Reviews . 54 . 4 . 571–86 . June 2002 . 12052715 . 10.1016/s0169-409x(02)00028-5 .
  10. Web site: Verzichtserklärung der Zulassung - Mittelfristig läuft Pegasys aus. www.roche.de (German). 4 December 2021. 4 December 2021. https://web.archive.org/web/20211204170553/https://assets.cwp.roche.com/f/94122/x/2b0bc67a9f/mittelfristig-luft-pegasys-aus-original-1176.pdf. dead.
  11. Web site: Pegasys (Peginterferon alfa-2a) langfristig weiterhin erhältlich. Roche. de. 4 December 2021. 4 December 2021. https://web.archive.org/web/20211204170551/https://assets.cwp.roche.com/f/94122/x/8f2de3daec/kurzmeldung-pegasys-bleibt-verfugbar.pdf. dead.
  12. Web site: pharma& portfolio. zr pharma& GmbH . 4 December 2021.
  13. Web site: HALF-YEAR REPORT 2021, p.20. Roche. 4 December 2021. 24 November 2021. https://web.archive.org/web/20211124190028/https://www.roche.com/dam/jcr:7260c9fc-2310-4305-bc10-ca3cea0de87d/en/hy21e.pdf. dead.
  14. Web site: Pegasys . Roche Australia . 8 January 2023.
  15. Reddy U, Krzystolik M . Antiangiogenic therapy with interferon alfa for neovascular age-related macular degeneration . Cochrane Database Syst Rev . 1 . CD005138 . 2006 . 1 . 16437522. 10.1002/14651858.CD005138.pub2.