Sovaldi (sofosbuvir)

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What is Sovaldi? 1,2

Sovaldi (sofosbuvir) is a treatment option for adults with chronic hepatitis C virus (HCV) infection. Gilead Sciences Inc. earned approval from the US Food and Drug Administration (FDA) in December 2013.

Sovaldi is approved for treating adult patients with HCV of different types. It is indicated for use as part of a combination therapy with other drugs for treating HCV. The combination therapy can include either:

  • Sovaldi + ribavirin + peginterferon alfa, or
  • Sovaldi + ribavirin

How does Sovaldi work? 1

HCV is a disease caused by the HCV virus. The virus multiplies in the body, causing the liver to become inflamed and damaged. If left untreated, that damage from the HCV virus 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.

The active mechanism in Sovaldi – sofosbuvir – is part of a class of drugs called “nucleotide analog inhibitors.” These kinds of drugs work to fight the HCV infection by keeping the HCV viruses from multiplying in the liver. Ribavirin and peginterferon alfa also help a patient’s body to attack the HCV virus and keep it from multiplying.

Patients being treated with Sovaldi take one pill once a day. Depending on their combination therapy, they will also take ribavirin and peginterferon alfa according to their healthcare providers’ instructions.

The effectiveness of Sovaldi was tested in six clinical studies, in which almost 2,000 adults with HCV took part. After being treated with a combination therapy including Sovaldi, between 84% and 96% of patients were considered to be cured 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.

For more information about the effectiveness of Sovaldi, click here.

Who can take Sovaldi? 1

There are different types of the HCV virus, which are called genotypes. Sovaldi is approved for treating patients with HCV genotypes 1, 2, 3, and 4. It is also approved for treating:

  • Patients who cannot have treatment for HCV that involves interferon
  • People with HCV who have liver cancer and are awaiting a transplant
  • Patients who have never been treated for HCV before
  • Patients who have been treated for HCV before, but the treatment did not work
  • Patients who have HCV as well as HIV infections

Sovaldi is approved by the FDA in combination therapy with ribavirin. Ribavirin can cause very serious birth defects, therefore:

  • Women who are being treated with it should not become pregnant
  • Women who have male partners being treated with ribavirin should also not become pregnant.

For more information about Sovaldi’s safety and side effects, click here.

What makes Sovaldi a “breakthrough” therapy? 1,2

The FDA approved Sovaldi with a special title of “breakthrough” therapy. This is only given to a very small number of drugs that the FDA believes may offer a significant improvement over any other available treatments for people with serious or life-threatening illnesses. Sovaldi is the first all-oral treatment for people with HCV genotypes 2 and 3.

A benefit of Sovaldi is that it can be taken in combination with ribavirin alone, not just with ribavirin + peginterferon alfa. This is important, because interferon can cause very serious side effects that many people cannot tolerate. People with liver cancer who are waiting for a transplant can also take Sovaldi – many treatment options are not available to this group of patients.