Sovaldi (sofosbuvir)

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) made by Gilead Sciences, Inc.

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).

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 or liver cancer, among other serious problems.

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Sovaldi is a DAA that targets NS5B. NS5B is a substance that 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 that the HCV virus is no longer detectable in the body 3 months after treatment stops, known as “SVR”.2,3

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 had depended on the combination of medicines they received.

For patients treated with Sovaldi + ribavirin + peginterferon alfa, side effects that were reported by 20 to 60 percent of patients were:3

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

Less common side effects of Sovaldi + ribavirin + peginterferon alfa are: Itchy skin, weakness, rash, decreased appetite, chills, flu-like illness, fever, diarrhea, low white blood cell count, muscle pain, and irritability.

For patients who were treated with the combination of Sovaldi + ribavirin, side effects that were reported by between 20 and 40 percent of patients were tiredness (fatigue) and headache.3 Less common side effects were nausea, trouble sleeping, itchy skin, low red blood cell count, weakness, and irritability.

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.2,3

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.3

These are not all the possible side effects of Sovaldi. Patients should talk to their doctor about what to expect with treatment with Sovaldi.

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:3

  • Have any liver problems other than HCV infection
  • Have had a liver transplant
  • Have severe kidney problems, or are on dialysis
  • Have HIV infection
  • Have any other medical conditions
  • Are pregnant, breastfeeding, or planning to become pregnant or breastfeed

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.3

For more information, read the prescribing information for Sovaldi.

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Written by: Emily Downward | Last reviewed: August 2020