Peginterferon alfa-2a

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Peginterferon alfa-2a
Clinical data
Trade names Pegasys, others
AHFS/Drugs.com Professional Drug Facts
MedlinePlus a605029
License data
Pregnancy
category
  • AU:B3
Routes of
administration 		Subcutaneous injection
ATC code
Legal status
Legal status
  • AU: S4 (Prescription only)
  • UK: POM (Prescription only)
  • US: WARNING [1] Rx-only
  • EU:Rx-only [2]
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
DrugBank
ChemSpider
  • none
UNII
KEGG
ChEMBL
Chemical and physical data
Formula C860H1353N227O255S9
Molar mass 19241.16 g·mol−1
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Pegylated interferon alfa-2a, sold under the brand name Pegasys among others, is medication used to treat hepatitis C and hepatitis B. [3] For hepatitis C it is typically used together with ribavirin and cure rates are between 24 and 92%. [3] [4] For hepatitis B it may be used alone. [5] It is given by injection under the skin. [3]

Contents

Side effects are common. [6] 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. [6]

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. [7]

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.[ citation needed ]

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. [8]

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 , [9] 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. [10]

Manufacturing

It is pegylated with a branched 40 kg/mol PEG chain. [11]

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&). [12] [13] [14] [15] [16] In May 2022, Roche Australia transferred the sales and marketing of Pegasys to Echo Therapeutics Pty Ltd. [17]

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. [18]

Related Research Articles

<span class="mw-page-title-main">Interferon</span> Signaling proteins released by host cells in response to the presence of pathogens

Interferons are a group of signaling proteins made and released by host cells in response to the presence of several viruses. In a typical scenario, a virus-infected cell will release interferons causing nearby cells to heighten their anti-viral defenses.

<span class="mw-page-title-main">Ribavirin</span> Antiviral medication

Ribavirin, also known as tribavirin, is an antiviral medication used to treat RSV infection, hepatitis C and some viral hemorrhagic fevers. For hepatitis C, it is used in combination with other medications such as simeprevir, sofosbuvir, peginterferon alfa-2b or peginterferon alfa-2a. Among the viral hemorrhagic fevers it is sometimes used for Lassa fever, Crimean–Congo hemorrhagic fever, and Hantavirus infection but should not be used for Ebola or Marburg infections. Ribavirin is taken orally or inhaled. Despite widespread usage, since the 2010s it has faced scrutiny for a lack of efficacy in treating viral infections it has historically been prescribed for.

<span class="mw-page-title-main">Hepatitis C virus</span> Species of virus

The hepatitis C virus (HCV) is a small, enveloped, positive-sense single-stranded RNA virus of the family Flaviviridae. The hepatitis C virus is the cause of hepatitis C and some cancers such as liver cancer and lymphomas in humans.

Pegylated interferon alfa-2b is a drug used to treat melanoma, as an adjuvant therapy to surgery. Also used to treat hepatitis C, it is no longer recommended due to poor efficacy and adverse side-effects. Subcutaneous injection is the preferred delivery method.

<span class="mw-page-title-main">PEGylation</span> Chemical reaction

PEGylation is the process of both covalent and non-covalent attachment or amalgamation of polyethylene glycol polymer chains to molecules and macrostructures, such as a drug, therapeutic protein or vesicle, which is then described as PEGylated. PEGylation affects the resulting derivatives or aggregates interactions, which typically slows down their coalescence and degradation as well as elimination in vivo.

<span class="mw-page-title-main">Boceprevir</span> Chemical compound

Boceprevir is a protease inhibitor used to treat hepatitis caused by hepatitis C virus (HCV) genotype 1. It binds to the HCV nonstructural protein 3 active site.

<span class="mw-page-title-main">Telaprevir</span> Chemical compound

Telaprevir (VX-950), marketed under the brand names Incivek and Incivo, is a pharmaceutical drug for the treatment of hepatitis C co-developed by Vertex Pharmaceuticals and Johnson & Johnson. It is a member of a class of antiviral drugs known as protease inhibitors. Specifically, telaprevir inhibits the hepatitis C viral enzyme NS3/4A serine protease. Telaprevir is only indicated for use against hepatitis C genotype 1 viral infections and has not been proven to be safe or effective when used for other genotypes of the virus. The standard therapy of pegylated interferon and ribavirin is less effective than telaprevir in those with genotype 1.

<span class="mw-page-title-main">Alisporivir</span> Chemical compound

Alisporivir (INN), or Debio 025, DEB025, is a cyclophilin inhibitor. Its structure is reminiscent of, and synthesized from ciclosporin.

WGAViewer is a bioinformatics software tool which is designed to visualize, annotate, and help interpret the results generated from a genome wide association study (GWAS). Alongside the P values of association, WGAViewer allows a researcher to visualize and consider other supporting evidence, such as the genomic context of the SNP, linkage disequilibrium (LD) with ungenotyped SNPs, gene expression database, and the evidence from other GWAS projects, when determining the potential importance of an individual SNP.

<span class="mw-page-title-main">Sofosbuvir</span> Chemical compound

Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. It is taken by mouth.

<span class="mw-page-title-main">Interferon Lambda 3</span> Protein-coding gene in the species Homo sapiens

Interferon lambda 3 encodes the IFNL3 protein. IFNL3 was formerly named IL28B, but the Human Genome Organization Gene Nomenclature Committee renamed this gene in 2013 while assigning a name to the then newly discovered IFNL4 gene. Together with IFNL1 and IFNL2, these genes lie in a cluster on chromosomal region 19q13. IFNL3 shares ~96% amino-acid identity with IFNL2, ~80% identity with IFNL1 and ~30% identity with IFNL4.

<span class="mw-page-title-main">Simeprevir</span> Chemical compound

Simeprevir, sold under the brand name Olysio among others, is a medication used in combination with other medications for the treatment of hepatitis C. It is specifically used for hepatitis C genotype 1 and 4. Medications it is used with include sofosbuvir or ribavirin and peginterferon-alfa. Cure rates are in 80s to 90s percent. It may be used in those who also have HIV/AIDS. It is taken by mouth once daily for typically 12 weeks.

<span class="mw-page-title-main">Faldaprevir</span> Chemical compound

Faldaprevir was an experimental drug for the treatment of hepatitis C (HCV). It was being developed by Boehringer-Ingelheim and reached Phase III clinical trials in 2011. Boehringer announced in 2014 that it would not pursue approval of the drug any more because of better HCV treatments having become available.

<span class="mw-page-title-main">Deleobuvir</span> Chemical compound

Deleobuvir was an experimental drug for the treatment of hepatitis C. It was being developed by Boehringer Ingelheim. It is a non-nucleoside hepatitis C virus NS5B polymerase inhibitor. Deleobuvir was tested in combination regimens with pegylated interferon and ribavirin, and in interferon-free regimens with other direct-acting antiviral agents including faldaprevir.

<span class="mw-page-title-main">Beclabuvir</span> Chemical compound

Beclabuvir is an antiviral drug for the treatment of hepatitis C virus (HCV) infection that has been studied in clinical trials. In February 2017, Bristol-Myers Squibb began sponsoring a post-marketing trial of beclabuvir, in combination with asunaprevir and daclatasvir, to study the combination's safety profile with regard to liver function. From February 2014 to November 2016, a phase II clinical trial was conducted on the combination of asunaprevir/daclatasvir/beclabuvir on patients infected with both HIV and HCV. Furthermore, a recent meta-analysis of six published six clinical trials showed high response rates in HCV genotype 1-infected patients treated with daclatasvir, asunaprevir, and beclabuvir irrespective of ribavirin use, prior interferon-based therapy, or restriction on noncirrhotic patients, IL28B genotype, or baseline resistance-associated variants

Elbasvir/grazoprevir, sold under the brand name Zepatier, is a fixed-dose combination for the treatment of hepatitis C, containing elbasvir and grazoprevir. It is used to treat chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in both treatment-naïve and treatment-experienced patients.

<span class="mw-page-title-main">Mericitabine</span> Chemical compound

Mericitabine (RG-7128) is an antiviral drug, a deoxycytidine analog. It was developed as a treatment for hepatitis C, acting as a NS5B RNA polymerase inhibitor, but while it showed a good safety profile in clinical trials, it was not sufficiently effective to be used as a stand-alone agent. However mericitabine has been shown to boost the efficacy of other antiviral drugs when used alongside them, and as most modern treatment regimens for hepatitis C use a combination therapy of several antiviral drugs, clinical trials have continued to see if it can form a part of a clinically useful drug treatment program.

<span class="mw-page-title-main">Narlaprevir</span> Chemical compound

Narlaprevir, is an inhibitor of NS3/4A serine protease, intended for the treatment of chronic hepatitis C caused by genotype 1 virus in combination with other antiviral drugs.

<span class="mw-page-title-main">NS5B inhibitor</span> Class of pharmaceutical drugs

Non-structural protein 5B (NS5B) inhibitors are a class of direct-acting antivirals widely used in the treatment of chronic hepatitis C. Depending on site of action and chemical composition, NS5B inhibitors may be categorized into three classes—nucleoside active site inhibitors (NIs), non-nucleoside allosteric inhibitors, and pyrophosphate analogues. Subsequently, all three classes are then subclassified. All inhibit RNA synthesis by NS5B but at different stages/sites resulting in inability of viral RNA replication. Expression of direct-acting NS5B inhibitors does not take place in cells that are not infected by hepatitis C virus, which seems to be beneficial for this class of drugs.

<span class="mw-page-title-main">Interferon Lambda 4</span> Protein-coding gene in the species Homo sapiens

Interferon lambda 4 is one of the most recently discovered human genes and the newest addition to the interferon lambda protein family. This gene encodes the IFNL4 protein, which is involved in immune response to viral infection.

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 October 2023.
  2. ↑ "Pegasys EPAR". European Medicines Agency (EMA). 20 June 2002. Retrieved 5 September 2024.
  3. 1 2 3 4 5 6 7 8 "Peginterferon Alfa-2a (Professional Patient Advice) - Drugs.com". www.drugs.com. Archived from the original on 16 January 2017. Retrieved 12 January 2017.
  4. ↑ "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.
  5. ↑ British national formulary : BNF 69 (69 ed.). British Medical Association. 2015. p. 639. ISBN   9780857111562.
  6. 1 2 "Peginterferon alfa-2a (Pegasys) - Treatment - Hepatitis C Online". www.hepatitisc.uw.edu. Archived from the original on 23 December 2016. Retrieved 12 January 2017.
  7. ↑ World Health Organization (2019). World Health Organization model list of essential medicines: 21st list 2019. Geneva: World Health Organization. hdl: 10665/325771 . WHO/MVP/EMP/IAU/2019.06. License: CC BY-NC-SA 3.0 IGO.
  8. ↑ "Interferon alfa-2a Uses, Side Effects & Warnings". Drugs.com. Retrieved 10 January 2020.
  9. ↑ 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. Bibcode:2009Natur.461..399G. doi:10.1038/nature08309. PMID   19684573. S2CID   1707096.
  10. ↑ 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. Bibcode:2009Natur.461..798T. doi:10.1038/nature08463. PMC   3172006 . PMID   19759533.
  11. ↑ Rajender Reddy K, Modi MW, Pedder S (June 2002). "Use of peginterferon alfa-2a (40 KD) (Pegasys) for the treatment of hepatitis C". Advanced Drug Delivery Reviews. 54 (4): 571–86. doi:10.1016/s0169-409x(02)00028-5. PMID   12052715.
  12. ↑ "Pegasys (peginterferon alfa-2a)". Genentech. Archived from the original on 8 January 2023. Retrieved 8 January 2023.
  13. ↑ "Verzichtserklärung der Zulassung - Mittelfristig läuft Pegasys aus" (PDF). www.roche.de (German). Archived from the original (PDF) on 4 December 2021. Retrieved 4 December 2021.
  14. ↑ "Pegasys (Peginterferon alfa-2a) langfristig weiterhin erhältlich" (PDF). Roche (in German). Archived from the original (PDF) on 4 December 2021. Retrieved 4 December 2021.
  15. ↑ "pharma& portfolio". zr pharma& GmbH. Retrieved 4 December 2021.
  16. ↑ "HALF-YEAR REPORT 2021, p.20" (PDF). Roche. Archived from the original (PDF) on 24 November 2021. Retrieved 4 December 2021.
  17. ↑ "Pegasys". Roche Australia. Retrieved 8 January 2023.
  18. ↑ Reddy U, Krzystolik M (2006). "Antiangiogenic therapy with interferon alfa for neovascular age-related macular degeneration". Cochrane Database Syst Rev. 1 (1): CD005138. doi:10.1002/14651858.CD005138.pub2. PMID   16437522.
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