From Wikipedia, the free encyclopedia
Mr. Ibrahem/Sofosbuvir
Clinical data
Trade namesSovaldi, Soforal, others [1]
Other namesPSI-7977; GS-7977
AHFS/ Drugs.com Monograph
MedlinePlus a614014
License data
Pregnancy
category
Routes of
administration
by mouth [3]
Drug class HCV polymerase inhibitor
Legal status
Legal status
Pharmacokinetic data
Bioavailability92%
Protein binding61–65%
MetabolismQuickly activated to triphosphate ( CatA/ CES1, HIST1, phosphorylation)
Elimination half-life0.4 hrs (sofosbuvir)
27 hrs (inactive metabolite GS-331007)
Excretion80% urine, 14% feces (mostly as GS-331007)
Identifiers
  • Isopropyl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate
Chemical and physical data
FormulaC22H29FN3O9P
Molar mass529.458 g·mol−1
3D model ( JSmol)
  • C[C@@H](C(=O)OC(C)C)N[P@](=O)(OC[C@@H]1[C@H]([C@@]([C@@H](O1)N2C=CC(=O)NC2=O)(C)F)O)OC3=CC=CC=C3
  • InChI=1S/C22H29FN3O9P/c1-13(2)33-19(29)14(3)25-36(31,35-15-8-6-5-7-9-15)32-12-16-18(28)22(4,23)20(34-16)26-11-10-17(27)24-21(26)30/h5-11,13-14,16,18,20,28H,12H2,1-4H3,(H,25,31)(H,24,27,30)/t14-,16+,18+,20+,22+,36-/m0/s1
  • Key:TTZHDVOVKQGIBA-IQWMDFIBSA-N

Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. [3] It is only recommended with some combination of ribavirin, peginterferon-alfa, simeprevir, ledipasvir, daclatasvir, or velpatasvir. [7] [8] Cure rates are 30 to 97% depending on the type of hepatitis C virus involved. [9] Safety during pregnancy is unclear; some of the medications used in combination may result in harm to the baby. [9] It is taken by mouth. [3]

Common side effects include feeling tired, headache, nausea, and trouble sleeping. [3] Side effects are generally more common in interferon-containing regimens. [10]: 7  Sofosbuvir may reactivate hepatitis B in those who have been previously infected. [11] In combination with ledipasvir, daclatasvir or simeprevir it is not recommended with amiodarone due to the risk of an abnormally slow heartbeat. [10] Sofosbuvir is in the nucleotide analog family of medication and works by blocking the hepatitis C NS5B protein. [12]

Sofosbuvir was discovered in 2007, and approved for medical use in the United States in 2013. [10] [7] [13] It is on the World Health Organization's List of Essential Medicines. [14] As of 2016, a 12-week course of treatment costs about US$84,000 in the United States, US$53,000 in the United Kingdom, US$45,000 in Canada, and about US$500 in India. [15] Over 60,000 people were treated with sofosbuvir in its first 30 weeks being sold in the United States. [16] The patent is not recognized by Egypt, were generic versions are made. [17]


References

  1. ^ Divya Rajagopal for the Economic Times. Sept 12, 2015. Can Indian generic makers find gold with a blockbuster Hepatitis C drug? Archived 20 March 2016 at the Wayback Machine
  2. ^ a b "Sofosbuvir (Sovaldi) Use During Pregnancy". Drugs.com. 16 December 2019. Archived from the original on 5 February 2020. Retrieved 5 February 2020.
  3. ^ a b c d e "Sofosbuvir". The American Society of Health-System Pharmacists. Archived from the original on 2016-12-01. Retrieved November 30, 2016.
  4. ^ "Sovaldi 400 mg film coated tablets - Summary of Product Characteristics (SmPC)". (emc). 6 November 2019. Archived from the original on 22 October 2020. Retrieved 18 April 2020.
  5. ^ a b "SOFOSBUVIR = SOF oral - Essential drugs". medicalguidelines.msf.org. Archived from the original on 26 November 2020. Retrieved 25 August 2020.
  6. ^ "WHOCC - ATC/DDD Index". www.whocc.no. Archived from the original on 29 July 2020. Retrieved 15 September 2020.
  7. ^ a b "Sofosbuvir (Sovaldi) - Treatment - Hepatitis C Online". www.hepatitisc.uw.edu. Archived from the original on 23 December 2016. Retrieved 8 January 2017.
  8. ^ FDA, News Release (June 28, 2016). "FDA approves Epclusa for treatment of chronic Hepatitis C virus infection". Archived from the original on June 3, 2017. {{ cite journal}}: Cite journal requires |journal= ( help)
  9. ^ a b "Sovaldi 400 mg film coated tablets - Summary of Product Characteristics (SPC) - (eMC)". www.medicines.org.uk. Archived from the original on 31 January 2017. Retrieved 8 January 2017.
  10. ^ a b c "Sovaldi- sofosbuvir tablet, film coated Sovaldi- sofosbuvir pellet". DailyMed. 27 September 2019. Archived from the original on 21 September 2020. Retrieved 4 February 2020.
  11. ^ "Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating". FDA. 4 October 2016. Archived from the original on 6 October 2016. Retrieved 6 October 2016.
  12. ^ "Sovaldi 400 mg film coated tablets - Summary of Product Characteristics". UK Electronic Medicines Compendium. September 2016. Archived from the original on 10 November 2016. Retrieved 10 November 2016.
  13. ^ Gounder, Celine (9 December 2013). "A Better Treatment for Hepatitis C". The New Yorker. Archived from the original on 20 September 2016.
  14. ^ 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.
  15. ^ Hill A, Simmons B, Gotham D, Fortunak J (January 2016). "Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C". Journal of Virus Eradication. 2 (1): 28–31. PMC  4946692. PMID  27482432.
  16. ^ Alonso-Zaldivar, Ricardo (July 29, 2014). "Gilead's Sovaldi prescribed more than all other hepatitis C drugs combined". Mercury News. Archived from the original on May 23, 2015.
  17. ^ Radu, Alexandra (28 Jul 2021). "Affordable hepatitis drug offers new hope to millions". www.aljazeera.com. Archived from the original on 1 June 2023. Retrieved 10 September 2023.
From Wikipedia, the free encyclopedia
Mr. Ibrahem/Sofosbuvir
Clinical data
Trade namesSovaldi, Soforal, others [1]
Other namesPSI-7977; GS-7977
AHFS/ Drugs.com Monograph
MedlinePlus a614014
License data
Pregnancy
category
Routes of
administration
by mouth [3]
Drug class HCV polymerase inhibitor
Legal status
Legal status
Pharmacokinetic data
Bioavailability92%
Protein binding61–65%
MetabolismQuickly activated to triphosphate ( CatA/ CES1, HIST1, phosphorylation)
Elimination half-life0.4 hrs (sofosbuvir)
27 hrs (inactive metabolite GS-331007)
Excretion80% urine, 14% feces (mostly as GS-331007)
Identifiers
  • Isopropyl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate
Chemical and physical data
FormulaC22H29FN3O9P
Molar mass529.458 g·mol−1
3D model ( JSmol)
  • C[C@@H](C(=O)OC(C)C)N[P@](=O)(OC[C@@H]1[C@H]([C@@]([C@@H](O1)N2C=CC(=O)NC2=O)(C)F)O)OC3=CC=CC=C3
  • InChI=1S/C22H29FN3O9P/c1-13(2)33-19(29)14(3)25-36(31,35-15-8-6-5-7-9-15)32-12-16-18(28)22(4,23)20(34-16)26-11-10-17(27)24-21(26)30/h5-11,13-14,16,18,20,28H,12H2,1-4H3,(H,25,31)(H,24,27,30)/t14-,16+,18+,20+,22+,36-/m0/s1
  • Key:TTZHDVOVKQGIBA-IQWMDFIBSA-N

Sofosbuvir, sold under the brand name Sovaldi among others, is a medication used to treat hepatitis C. [3] It is only recommended with some combination of ribavirin, peginterferon-alfa, simeprevir, ledipasvir, daclatasvir, or velpatasvir. [7] [8] Cure rates are 30 to 97% depending on the type of hepatitis C virus involved. [9] Safety during pregnancy is unclear; some of the medications used in combination may result in harm to the baby. [9] It is taken by mouth. [3]

Common side effects include feeling tired, headache, nausea, and trouble sleeping. [3] Side effects are generally more common in interferon-containing regimens. [10]: 7  Sofosbuvir may reactivate hepatitis B in those who have been previously infected. [11] In combination with ledipasvir, daclatasvir or simeprevir it is not recommended with amiodarone due to the risk of an abnormally slow heartbeat. [10] Sofosbuvir is in the nucleotide analog family of medication and works by blocking the hepatitis C NS5B protein. [12]

Sofosbuvir was discovered in 2007, and approved for medical use in the United States in 2013. [10] [7] [13] It is on the World Health Organization's List of Essential Medicines. [14] As of 2016, a 12-week course of treatment costs about US$84,000 in the United States, US$53,000 in the United Kingdom, US$45,000 in Canada, and about US$500 in India. [15] Over 60,000 people were treated with sofosbuvir in its first 30 weeks being sold in the United States. [16] The patent is not recognized by Egypt, were generic versions are made. [17]


References

  1. ^ Divya Rajagopal for the Economic Times. Sept 12, 2015. Can Indian generic makers find gold with a blockbuster Hepatitis C drug? Archived 20 March 2016 at the Wayback Machine
  2. ^ a b "Sofosbuvir (Sovaldi) Use During Pregnancy". Drugs.com. 16 December 2019. Archived from the original on 5 February 2020. Retrieved 5 February 2020.
  3. ^ a b c d e "Sofosbuvir". The American Society of Health-System Pharmacists. Archived from the original on 2016-12-01. Retrieved November 30, 2016.
  4. ^ "Sovaldi 400 mg film coated tablets - Summary of Product Characteristics (SmPC)". (emc). 6 November 2019. Archived from the original on 22 October 2020. Retrieved 18 April 2020.
  5. ^ a b "SOFOSBUVIR = SOF oral - Essential drugs". medicalguidelines.msf.org. Archived from the original on 26 November 2020. Retrieved 25 August 2020.
  6. ^ "WHOCC - ATC/DDD Index". www.whocc.no. Archived from the original on 29 July 2020. Retrieved 15 September 2020.
  7. ^ a b "Sofosbuvir (Sovaldi) - Treatment - Hepatitis C Online". www.hepatitisc.uw.edu. Archived from the original on 23 December 2016. Retrieved 8 January 2017.
  8. ^ FDA, News Release (June 28, 2016). "FDA approves Epclusa for treatment of chronic Hepatitis C virus infection". Archived from the original on June 3, 2017. {{ cite journal}}: Cite journal requires |journal= ( help)
  9. ^ a b "Sovaldi 400 mg film coated tablets - Summary of Product Characteristics (SPC) - (eMC)". www.medicines.org.uk. Archived from the original on 31 January 2017. Retrieved 8 January 2017.
  10. ^ a b c "Sovaldi- sofosbuvir tablet, film coated Sovaldi- sofosbuvir pellet". DailyMed. 27 September 2019. Archived from the original on 21 September 2020. Retrieved 4 February 2020.
  11. ^ "Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating". FDA. 4 October 2016. Archived from the original on 6 October 2016. Retrieved 6 October 2016.
  12. ^ "Sovaldi 400 mg film coated tablets - Summary of Product Characteristics". UK Electronic Medicines Compendium. September 2016. Archived from the original on 10 November 2016. Retrieved 10 November 2016.
  13. ^ Gounder, Celine (9 December 2013). "A Better Treatment for Hepatitis C". The New Yorker. Archived from the original on 20 September 2016.
  14. ^ 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.
  15. ^ Hill A, Simmons B, Gotham D, Fortunak J (January 2016). "Rapid reductions in prices for generic sofosbuvir and daclatasvir to treat hepatitis C". Journal of Virus Eradication. 2 (1): 28–31. PMC  4946692. PMID  27482432.
  16. ^ Alonso-Zaldivar, Ricardo (July 29, 2014). "Gilead's Sovaldi prescribed more than all other hepatitis C drugs combined". Mercury News. Archived from the original on May 23, 2015.
  17. ^ Radu, Alexandra (28 Jul 2021). "Affordable hepatitis drug offers new hope to millions". www.aljazeera.com. Archived from the original on 1 June 2023. Retrieved 10 September 2023.

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