Sovaldi (sofosbuvir)

Sovaldi® (sofosbuvir) is a prescription medication used in combination with other medications to treat people with chronic hepatitis C virus (HCV) infection. Sovaldi is classified as a direct-acting antiviral and is produced by Gilead Sciences, Inc. Solvaldi may be used in patients with or without cirrhosis (scarring of the liver) as part of a combination regimen to treat adults with genotypes 1, 2, 3, or 4 HCV:

  • In genotypes 1 or 4, Solvadi is used in combination with peginterferon alfa and ribavirin
  • In genotypes 2 or 3, Solvadi is used in combination with ribavirin

Solvadi may also be used as part of a combination regimen to treat children 12 years of age and older with genotypes 2 or 3 HCV without cirrhosis or with compensated cirrhosis in combination with ribavirin.1

What are the ingredients in Sovaldi?

The active ingredient in Sovaldi is sofosbuvir, and each tablet contains 400 mg sofosbuvir.1

How does Sovaldi work?

The hepatitis C virus multiplies in the body, causing the liver to become inflamed and damaged. If left untreated, that damage from HCV over time can cause a serious liver problem called cirrhosis. People with cirrhosis have livers that do not function as well as they should. As cirrhosis advances, it can cause liver failure or liver cancer, among other serious problems.

Sovaldi is a direct-acting antiviral that is a nucleotide analog NS5B polymerase inhibitor. It works by targeting NS5B, a substance that is essential for the virus to replicate. By blocking the virus’ ability to replicate, Sovaldi reduces the amount of virus in the body. As part of a combination therapy, Sovaldi has been shown to be effective in curing HCV in 12 or 24 weeks, depending on the genotype of HCV. 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 Sovaldi?

During the studies to test Sovaldi’s safety, the type and frequency of the side effects that patients experienced depended on the combination of medicines that they received.

For patients were treated with Sovaldi + ribavirin + peginterferon alfa, side effects that were reported by 20% to 60% of patients were:

Side effects that were reported by between 15% and 20% of patients who received that type of treatment are:

  • Itchy skin
  • Weakness
  • Rash
  • Decreased appetite
  • Chills
  • Flu-like illness
  • Fever
  • Diarrhea
  • Low white blood cell count
  • Muscle pain
  • Irritability1

For patients who were treated with the combination of Sovaldi + ribavirin, side effects that were reported by between 20% and 40% of patients were:

  • Tiredness (fatigue)
  • Headache1

Between 10% and 20% of those patients reported the following side effects:

  • Nausea
  • Trouble sleeping
  • Itchy skin
  • Low red blood cell count
  • Weakness
  • Irritability1

Sovaldi may cause serious side effects. In people who have previously had hepatitis B, Sovaldi may reactivate this infection. Hepatitis B reactivation may result in liver damage, liver failure, and death.1

Sovaldi may cause a slow heart rate (bradycardia) in people who are taking amiodarone (Cordarone®, Nexterone®, Pacerone®), a medicine used to treat certain heart problems. In some cases, bradycardia may lead to needing a pacemaker or may lead to death.1

Things to know about Sovaldi

Before starting treatment with Sovaldi, patients should receive a blood test to check for hepatitis B infection.

Before treatment starts, patients should talk to their doctor about all their health conditions, including if they:

Some medications can interact badly with Sovaldi, or they can make Sovaldi work less effectively. Patients should talk to their doctor about all medications they are taking, including prescription and over-the-counter medications, herbal supplements, and vitamins.

It is very important for women who are taking Sovaldi not to get pregnant. This is because Sovaldi is taken in combination with a drug called ribavirin, which can cause serious birth defects, or even death, for an unborn baby. Ribavirin can also be dangerous for a pregnant woman whose male partner is taking ribavirin. During treatment with Sovaldi, women are required to use 2 forms of birth control. They will also need to take pregnancy tests before, during, and after treatment with Sovaldi.1

Dosing information

Sovaldi comes in a pill form that is taken once daily as part of a combination treatment. Sovaldi may be taken with or without food.1

For more information, read the prescribing information for Sovaldi.

Written by: Emily Downward | Last reviewed: March 2018.
View References
  1. Sovaldi prescribing information. Gilead Sciences, Inc. Available at http://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf. Accessed 2/26/18.
  2. Sovaldi product website. Gilead Sciences, Inc. Available at http://www.sovaldi.com/about-sovaldi/what-is-sovaldi. Accessed 2/26/18.