Ledipasvir/sofosbuvir

Ledipasvir/sofosbuvir
Combination of
LedipasvirNS5A inhibitor
SofosbuvirNS5B (RNA polymerase) inhibitor
Clinical data
Trade namesHarvoni, Hepcinat-LP, others
AHFS/Drugs.comMonograph
MedlinePlusa614051
License data
Pregnancy
category
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
PubChem CID
KEGG
ChEBI
Chemical and physical data
FormulaC71H83F3N11O15P
Molar mass1418.476 g·mol−1
3D model (JSmol)
  • CC(C)C(C(=O)N1CC2(CC2)CC1C3=NC=C(N3)C4=CC5=C(C=C4)C6=C(C5(F)F)C=C(C=C6)C7=CC8=C(C=C7)N=C(N8)C9C1CCC(C1)N9C(=O)C(C(C)C)NC(=O)OC)NC(=O)OC.CC(C)OC(=O)C(C)NP(=O)(OCC1C(C(C(O1)N2C=CC(=O)NC2=O)(C)F)O)OC3=CC=CC=C3
  • InChI=1S/C49H54F2N8O6.C22H29FN3O9P/c1-24(2)39(56-46(62)64-5)44(60)58-23-48(15-16-48)21-38(58)42-52-22-37(55-42)28-9-13-32-31-12-8-26(18-33(31)49(50,51)34(32)19-28)27-10-14-35-36(20-27)54-43(53-35)41-29-7-11-30(17-29)59(41)45(61)40(25(3)4)57-47(63)65-6;1-13(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/h8-10,12-14,18-20,22,24-25,29-30,38-41H,7,11,15-17,21,23H2,1-6H3,(H,52,55)(H,53,54)(H,56,62)(H,57,63);5-11,13-14,16,18,20,28H,12H2,1-4H3,(H,25,31)(H,24,27,30)/t29-,30+,38-,39-,40-,41-;14-,16+,18+,20+,22+,36+/m00/s1
  • Key:YWRYBUCQWKGONV-CABNZSRHSA-N

Ledipasvir/sofosbuvir, sold under the trade name Harvoni among others, is a medication used to treat hepatitis C.[8] It is a fixed-dose combination of ledipasvir and sofosbuvir.[8] Cure rates are 94% to 99% in people infected with hepatitis C virus (HCV) genotype 1.[9] Some evidence also supports use in HCV genotype 3 and 4.[9] It is taken daily by mouth for 8–24 weeks.[8]

It is generally well tolerated.[10] Common side effects include muscle pains, headache, nausea, rash, and cough.[8] It is unclear if use in pregnancy is safe for the baby.[8] Ledipasvir works by decreasing the activity of NS5A and sofosbuvir works by decreasing the activity of NS5B polymerase.[8]

Ledipasvir/sofosbuvir was approved for medical use in the United States, in the European Union, and in Canada in 2014.[8][11][7][12][13] It is on the World Health Organization's List of Essential Medicines.[14]

  1. ^ a b "Ledipasvir / sofosbuvir (Harvoni) Use During Pregnancy". Drugs.com. 28 October 2019. Retrieved 17 March 2020.
  2. ^ "AusPAR: Ledipasvir / Sofosbuvir". Therapeutic Goods Administration (TGA). 29 October 2015. Retrieved 29 August 2020.
  3. ^ "AusPAR: Sofosbuvir / Ledipasvir". Therapeutic Goods Administration (TGA). 16 November 2017. Retrieved 29 August 2020.
  4. ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
  5. ^ Cite error: The named reference Harvoni UK label was invoked but never defined (see the help page).
  6. ^ Cite error: The named reference Harvoni FDA label was invoked but never defined (see the help page).
  7. ^ a b "Harvoni EPAR". European Medicines Agency (EMA). 17 September 2018. Retrieved 29 August 2020.
  8. ^ a b c d e f g "Ledipasvir and Sofosbuvir". The American Society of Health-System Pharmacists. Archived from the original on 25 December 2016. Retrieved 8 December 2016.
  9. ^ a b Keating GM (April 2015). "Ledipasvir/Sofosbuvir: a review of its use in chronic hepatitis C". Drugs. 75 (6): 675–685. doi:10.1007/s40265-015-0381-2. PMID 25837989. S2CID 31943736.
  10. ^ World Health Organization (2015). The selection and use of essential medicines. Twentieth report of the WHO Expert Committee 2015 (including 19th WHO Model List of Essential Medicines and 5th WHO Model List of Essential Medicines for Children). Geneva: World Health Organization. pp. 69–70. hdl:10665/189763. ISBN 9789241209946. ISSN 0512-3054. WHO technical report series;994.
  11. ^ "Drug Approval Package:Harvoni (ledipasvir and sofosbuvir) Tablets NDA 205834". U.S. Food and Drug Administration (FDA). 3 November 2014. Retrieved 29 August 2020.
    "APPLICATION NUMBER: 205834Orig1s000" (PDF) (Summary Review). Center for Drug Evaluation and Research.
  12. ^ "Notice of Compliance (NOC) online query". 25 August 2010.
  13. ^ "Health Canada Issues Notice of Compliance for Gilead's Harvoni (Ledipasvir/Sofosbuvir), the First Once-Daily Single Tablet Regimen for the Treatment of Genotype 1 Chronic Hepatitis C" (Press release). Gilead Sciences, Inc. 16 October 2014. Retrieved 29 August 2020 – via Business Wire.
  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.