Ledipasvir/sofosbuvir

Ledipasvir/sofosbuvir
Combination of
Ledipasvir NS5A inhibitor
Sofosbuvir NS5B (RNA polymerase) inhibitor
Clinical data
Trade names Harvoni, Hepcinat-LP, others
AHFS/Drugs.com Monograph
Pregnancy
category
  • US: B (No risk in non-human studies)
Routes of
administration		 by mouth
ATC code
Legal status
Legal status

Ledipasvir/sofosbuvir, sold under the trade name Harvoni among others, is a medication used to treat hepatitis C. It is a combination of ledipasvir and sofosbuvir.[1] Cure rates are 94% to 99% in people infected with hepatitis C virus (HCV) genotype 1. Some evidence also supports use in HCV genotype 3 and 4.[2] It is taken daily by mouth for 8–24 weeks.[1]

It is generally well tolerated.[3] Common side effects include muscle pains, headache, nausea, rash, and cough.[1] It is unclear if use in pregnancy is safe for the baby.[1] Ledipasvir works by decreasing the activity of NS5A and sofosbuvir works by decreasing the activity of NS5B polymerase.[1]

Ledipasvir/sofosbuvir was approved for medical use in the United States in 2014.[1] It is on the World Health Organization's List of Essential Medicines, the most effective and safe medicines needed in a health system.[4] The wholesale cost in the United States is about US$91,589.40 for 12 weeks as of 2016.[5] In Bangladesh this amount costs US$1,092.00.[6] Some people travel to India to get access to lower cost medication.[7]

Medical uses

Cure rates are 94% to 99% in people infected with genotype 1. It has also been evaluated for the treatment of infection with other hepatitis C genotypes, and has shown promising results in genotypes 3 and 4.[2][8][9][10]

It should not be used with amiodarone or other drugs that lower heart rate; there is a serious risk of the heart slowing or stopping when ledipasvir/sofosbuvir is used with such drugs.[8][11]

Side effects

More than 10% of people taking ledipasvir/sofosbuvir have headaches or fatigue; rashes, nausea, diarrhea, and insomnia occur in between 1% and 10% of people taking it.[8][11]

More severe reactions are connected with allergic reactions to the medications and cardiovascular problems.[12] Harvoni side effects are considered relatively mild compared to older interferon-based treatment.

References

  1. 1 2 3 4 5 6 "Ledipasvir and Sofosbuvir". The American Society of Health-System Pharmacists. Retrieved 8 December 2016.
  2. 1 2 Keating GM (2015). "Ledipasvir/Sofosbuvir: a review of its use in chronic hepatitis C". Drugs. 75 (6): 675–85. PMID 25837989. doi:10.1007/s40265-015-0381-2.
  3. ↑ 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). (PDF). WHO. 2015. p. 70. ISBN 9789240694941. Retrieved 8 December 2016.
  4. ↑ "WHO Model List of Essential Medicines (19th List)" (PDF). World Health Organization. April 2015. Retrieved 8 December 2016.
  5. ↑ "NADAC as of 2016-12-21 | Data.Medicaid.gov". Centers for Medicare and Medicaid Services. Retrieved 25 December 2016.
  6. ↑ Azam, Monirul. "1". Intellectual Property and Public Health in the Developing World. Open Book Publishers. ISBN 9781783742318.
  7. ↑ "Hep C drug tourism has begun as patients seek Harvoni, Sovaldi overseas". FiercePharma. 2015-06-02. Retrieved 2015-10-25.
  8. 1 2 3 "US Label" (PDF). FDA. June 2016.. See FDA index page for NDA 205834.
  9. ↑ "Sofosbuvir/ledipasvir effective for relapsed hep C patients". Family Practice News.
  10. ↑ Canadian Agency for Drugs and Technologies in Health (16 January 2015). "Holkira (Ombitasvir/Paritaprevir/ Ritonavir with Dasabuvir) and Harvoni (Ledipasvir/Sofosbuvir) for Chronic Hepatitis C: A Review of the Clinical Evidence". Rapid Response Service. Canadian Agency for Drugs and Technologies in Health. PMID 25674658.
  11. 1 2 "Harvoni 90 mg/400 mg film-coated tablets - Summary of Product Characteristics". UK Electronic Medicines Compendium. December 2016. Retrieved 4 February 2017.
  12. ↑ "Side effects of Harvoni - Hepatitis C Patients Help". Hepatitis C Society. Retrieved 2016-04-18.


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