Sovaldi (sofosbuvir)

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

Sovaldi® (sofosbuvir) is a prescription drug that is combined with other drugs to treat people with chronic hepatitis C virus (HCV) infection. Sovaldi is a direct-acting antiviral (DAA).1-3

What are the ingredients in Sovaldi?

The active ingredient in Sovaldi is sofosbuvir.2

How does Sovaldi work?

The hepatitis C virus multiplies in the body, causing the liver to become inflamed and damaged. If left untreated, that liver damage can cause a serious problem called cirrhosis. As cirrhosis gets worse, it can cause liver failure, liver cancer, and other serious problems.1-3

Sovaldi is a DAA that targets NS5B. NS5B is a substance HCV needs to grow (replicate). By blocking the virus’ ability to grow, Sovaldi reduces the amount of virus in the body. When combined with other drugs, Sovaldi can cure HCV in 12 weeks. For people with HCV, “cured” means the HCV virus is no longer detectable in the body 3 months after treatment stops. This is known as “SVR”, Sustained Virologic Response.2,3

By providing your email address, you are agreeing to our Privacy Policy and Terms of Use.

What are the possible side effects of Sovaldi?

Side effects can vary depending on the specific drugs you are taking in combination with Sovaldi.

In people treated with Sovaldi + ribavirin + peginterferon alfa, the most common side effects include:3

  • Tiredness
  • Headache
  • Nausea
  • Trouble sleeping
  • Low red blood cell count (anemia)

In people treated with the combination of Sovaldi + ribavirin, the most common side effects include tiredness and headache.3

Sovaldi has a boxed warning, the strictest warning from the US Food and Drug Administration (FDA). It has this warning because, 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. Before starting treatment with Sovaldi, your doctor should check you for hepatitis B infection.2,3

Sovaldi may cause a slow heart rate (bradycardia) in people who are taking amiodarone (Cordarone®, Nexterone®, Pacerone®). This medicine is used to treat certain heart problems. In some cases, bradycardia may lead to needing a pacemaker or death.3

These are not all the possible side effects of Sovaldi. Talk to your doctor about what to expect when taking Sovaldi. You also should call your doctor if you have any changes that concern you when taking Sovaldi.

Things to know about Sovaldi

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 Sovaldi, tell your doctor if you have:3

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

Sovaldi 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 Sovaldi. You should also not breastfeed during treatment with Sovaldi and for some time after the last dose. Talk to your doctor about your options for birth control and breastfeeding while taking Sovaldi.3

Sovaldi may interact with other medicines. Before beginning treatment for HCV infection, 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 prescribing information of Sovaldi.