Ledipasvir/sofosbuvir

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

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 treatments amiodarone, Bristol-Myers Squibb's daclatasvir, or Johnson & Johnson's simeprevir developed abnormally slow heartbeats and one died of cardiac arrest. Three required a pacemaker to be inserted. Gilead said the combinations aren't recommended and product labels will be updated.[9]

References

  1. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  2. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  3. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  4. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  5. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  6. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  7. ↑ How I Got the $84,000 Hepatitis C Drug For $1500 By Buying It From India. How I got around one of the most obscene examples of Big Pharma overreach. By Phillip Smith, AlterNet, May 5, 2016
  8. ↑ Lua error in package.lua at line 80: module 'strict' not found.
  9. ↑ West, Stephen. "Gilead Warns After Hepatitis Patient on Heart Drug Dies". Published 21 March 2015.

External links

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