Harvoni (ledipasvir and sofosbuvir)

Harvoni® is a treatment option for chronic hepatitis C (HCV) infection. Harvoni may be used by:

  • Adults with genotype 1, 4, 5, or 6 who do not have cirrhosis or who have compensated cirrhosis
  • Adults with genotype 1 who have decompensated cirrhosis in combination with ribavirin
  • Adults with genotype 1 or 4 who have had a liver transplant and who do not have cirrhosis or who have compensated cirrhosis, in combination with ribavirin
  • Children 12 years of age or older with genotype 1, 4, 5, or 6 who do not have cirrhosis or who have compensated cirrhosis1

It combines two drugs for HCV – ledipasvir and sofosbuvir – into a single once-daily oral tablet. It is manufactured by Gilead Sciences, Inc.

What are the ingredients in Harvoni?

The two active ingredients in Harvoni are ledipasvir and sofosbuvir. 1

How does Harvoni work?

Harvoni contains two active mechanisms that fight HCV: ledipasvir and sofosbuvir. Each of these medications target specific proteins in HCV. Ledipasvir is part of a class of drugs called NS5A inhibitors. This type of drug works by affecting the life cycle of the HCV virus. Sofosbuvir is a type of drug called a nucleotide analog NS5B polymerase inhibitor, which works by keeping the HCV virus from multiplying in the liver. Sofosbuvir is marketed as a separate drug by Gilead Sciences under the brand name Sovaldi.1

In clinical trials, Harvoni was 96-99% effective in curing people with HCV who had genotype 1 and 93-96% effective in curing people with genotype 4, 5, or 6. For people with HCV, “cured” means that the HCV virus is no longer detectable in a person’s body 3 months after the treatment was over.1,2

What are the possible side effects of Harvoni?

During the clinical trials that tested the safety of Harvoni, the patients who took part in the studies reported several common side effects. Commonly reported side effects included:

Harvoni may cause serious side effects. In people who have previously had hepatitis B, Harvoni may reactivate this infection. Hepatitis B reactivation may result in liver damage, liver failure, and death. 1 Harvoni can cause serious bradycardia (low heart rate) when used in combination with amiordarone; this combination should be avoided.

Things to know about Harvoni

Before starting treatment with Harvoni, it is important for patients to let their healthcare providers know if:

  • They have any liver problems other than HCV
  • They have previously had hepatitis B
  • They have severe kidney problems, or are on dialysis
  • They have any other medical conditions
  • They are pregnant, planning to get pregnant, or breastfeeding

Before starting treatment with Harvoni, patients should talk to their doctor about all medications (prescription and over-the-counter), herbal supplements, and vitamins they are taking. Some medications may interact badly with Harvoni, and several different medicines can keep Harvoni from working in the way that it should.

Dosing information

Each tablet of Harvoni contains 90 mg of ledipasvir and 400 mg sofosbuvir. The tablets are taken by mouth and can be taken with or without food. The length of treatment will depend on the genotype of HCV, as well as other factors, and may vary from 12 to 24 weeks.1

Written by: Emily Downward | Last reviewed: March 2018.
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