Ledipasvir/sofosbuvir

Ledipasvir/sofosbuvir
Combination of
Ledipasvir NS5A inhibitor
Sofosbuvir NS5B (RNA polymerase) inhibitor
Clinical data
Trade names Harvoni, Hepcinat-LP,
AHFS/Drugs.com harvoni
Pregnancy
category
  • US: B (No risk in non-human studies)
Routes of
administration		 Oral
ATC code J05AX65 (WHO)
Legal status
Legal status
Identifiers

Ledipasvir/sofosbuvir (trade name Harvoni) is a two-drug combination for the treatment of hepatitis C. It is administered as a single daily pill containing 90 mg of the viral NS5A inhibitor ledipasvir and 400 mg of sofosbuvir, a nucleotide inhibitor of the viral RNA polymerase.

Ledipasvir/sofosbuvir was developed by the pharmaceutical company Gilead Sciences and first marketed in October 2014. Taken daily for 8–12 weeks, it provides cure rates of 94% to 99% in people infected with genotype 1, the most common form of hepatitis C in the U.S. and some European countries, irrespective of the presence or absence of liver cirrhosis or prior unsuccessful treatment. 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.[1][2][3][4]

In the United States, the average cost of treatment with Harvoni is over $90,000.[5] An increasing number of US patients are using drug tourism to countries like India to buy it for as little as 1% of the US cost.[6][7]

Side effects

Common side effects of Harvoni treatment as per Gilead Sciences clinical studies include but are not limited to:

More severe reactions are connected with allergic reactions to the medications and cardiovascular problems.[8] Harvoni side effects are considered relatively mild compared to older interferon-based treatment.

Interactions

In March 2015, Gilead Sciences e-mailed warnings to health care providers about nine patients that began taking its hepatitis C drugs Harvoni (ledipasvir/sofosbuvir) or Sovaldi (sofosbuvir) along with the heart treatment amiodarone. All these patients were taking amiodarone, with three also using Harvoni, five receiving Sovaldi (sofosbuvir) with Bristol-Myers Squibb Co.’s daclatasvir and one was on Sovaldi with Johnson & Johnson’s Olysio simeprevir. One of these patients died of cardiac arrest and three others required a pacemaker to be inserted. Gilead said the combinations aren't recommended and product labels will be updated.[9]

References

  1. ↑ Keating GM (2015). "Ledipasvir/Sofosbuvir: a review of its use in chronic hepatitis C". Drugs. 75 (6): 675–85. doi:10.1007/s40265-015-0381-2. PMID 25837989.
  2. ↑ "www.accessdata.fda.gov" (PDF).
  3. ↑ "Sofosbuvir/ledipasvir effective for relapsed hep C patients". Family Practice News.
  4. ↑ "Holkira (Ombitasvir/Paritaprevir/ Ritonavir with Dasabuvir) and Harvoni (Ledipasvir/Sofosbuvir) for Chronic Hepatitis C: A Review of the Clinical Evidence - National Library of Medicine - PubMed Health".
  5. ↑ "Specialty Drug Classes That Are Costing Consumers an Arm and a Leg". The Motley Fool. 2015-10-24. Retrieved 2015-10-25.
  6. ↑ "Hep C drug tourism has begun as patients seek Harvoni, Sovaldi overseas". FiercePharma. 2015-06-02. Retrieved 2015-10-25.
  7. ↑ New Hepatitis C Treatment Costs Only $1000. But Not For Everyone. By Hep C News, March 13, 2015
  8. ↑ "Side effects of Harvoni - Hepatitis C Patients Help". Hepatitis C Society. Retrieved 2016-04-18.
  9. ↑ West, Stephen. "Gilead Warns After Hepatitis Patient on Heart Drug Dies". Published 21 March 2015.
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