Harvoni (ledipasvir and sofosbuvir)

Harvoni® is a treatment option for chronic hepatitis C (HCV) infection. FDA recommendations and national guidelines for hepatitis C treatment change often. Ask your doctor what treatment options might work for you, or consider reviewing the guidelines provided by the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA).

It combines two drugs for HCV – ledipasvir and sofosbuvir – into a single once-daily oral tablet. It is manufactured by Gilead Sciences, Inc. Whether or not Harvoni is recommended for you depends on what type of HCV drugs you have taken in the past.1

Harvoni can be used for adults and pediatric patients age 3 years and older with:2

  • Genotype 1,4,5, or 6 without cirrhosis or with compensated cirrhosis
  • Genotype 1 with decompensated cirrhosis, in combination with ribavirin
  • Genotype 1 or 4 who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin

What are the ingredients in Harvoni?

The two active ingredients in Harvoni are ledipasvir and sofosbuvir.2

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.2

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, also known as SVR.2,3

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:1,2

  • Tiredness or weakness
  • Headache
  • Nausea
  • Diarrhea
  • Difficulty sleeping (insomnia)

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 amiodarone (a medicine used to treat certain heart problems); 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:2

  • 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. Prescribers may test for baseline NS5A resistance-associated substitutions in HCV genotype 1a-infected, treatment-experienced patients to make sure treatment is appropriate.

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Written by: Emily Downward | Last reviewed: August 2020