Harvoni (ledipasvir and sofosbuvir)

Reviewed by: HU Medical Review Board | Last reviewed: May 2023

Harvoni® is a treatment option for chronic hepatitis C (HCV) infection. It combines 2 drugs for HCV – ledipasvir and sofosbuvir – into a single, once-daily oral tablet. 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 children 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 active ingredients in Harvoni are ledipasvir and sofosbuvir.2

How does Harvoni work?

The active ingredients in Harvoni work in different ways to target HCV:2

  • 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. It works by keeping the HCV virus from multiplying in the liver. Sofosbuvir is available as separate drug under the brand name Sovaldi.2

In clinical trials, Harvoni was 96 to 99 percent effective in curing people with HCV who had genotype 1. It was 93 to 96 percent effective in curing people with genotype 4, 5, or 6. For people with HCV, “cured” means the HCV virus is no longer detectable in their body 3 months after the treatment was over. This is also known as SVR.2,3

What are the possible side effects of Harvoni?

The most common side effects of Harvoni include:1,2

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

Harvoni has a boxed warning, the strictest warning from the U.S. Food and Drug Administration (FDA). This is because it may worsen or reactivate hepatitis B infection during or after treatment. This may cause serious liver damage, liver failure, or death. People with current or past hepatitis B infection should be monitored during treatment with Harvoni. Some may also need to be treated for hepatitis B. Before starting treatment with Harvoni, your doctor should check you for hepatitis B infection.1,2

Harvoni may cause slowed heart rate (bradycardia). People taking Harvoni with the heart medicine amiodarone (Cordarone®, Nexterone®, Pacerone®) may experience slowed heart rate. In some people, this has led to the need for a pacemaker or death. Tell your doctor right away if you have signs of slowed heart rate, such as fainting, dizziness, or chest pains.1

These are not all the possible side effects of Harvoni. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Harvoni.

Things to know about Harvoni

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).

Before starting Harvoni, tell your doctor if you have:2

  • Liver problems other than HCV
  • Previously had hepatitis B
  • HIV infection
  • Had a liver transplant
  • Severe kidney problems or are on dialysis

Harvoni taken in combination with ribavirin can harm an unborn baby. If you or your partner can become pregnant, you should use birth control during treatment and for some time after the last dose of Harvoni. You should also not breastfeed during treatment with Harvoni and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Harvoni.2

Harvoni may interact with other drugs. Before beginning treatment for HCV, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Harvoni.

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