Introduction

The drug sofosbuvir (trade name: Sovaldi) has been approved since January 2014 for the treatment of hepatitis C infection in adults. Since September 2017, it has also been approved for teenagers over the age of 12. It offers antiviral treatment in combination with other medications.

Hepatitis C viruses (HCVs) attack the liver, where they can cause acute inflammation. There are seven known forms of hepatitis C viruses, referred to as genotypes 1 to 7. In up to 80 out of 100 people with hepatitis C, the immune system is unable to successfully fight the virus on its own. These people develop a permanent (chronic) inflammation of the liver which can cause cirrhosis. The liver then gradually loses its ability to work well. There is also a greater risk of liver cancer. It is currently believed that a treatment can reduce the risk of such complications if patients consistently have no detectable virus in their blood following that treatment.

Sofosbuvir is what is known as a direct-acting antiviral (DAA). In combination with other drugs, it aims to stop the virus from reproducing and to prevent hepatitis C complications.

Application

Sofosbuvir is taken once a day in tablet form (400 mg) with a meal. Sofosbuvir is combined with the drug ribavirin. Depending on the genotype, peginterferon alfa is given in addition.

Other treatments

People with chronic hepatitis C who have not had treatment with a direct-acting antiviral yet can receive different combinations of antiviral drugs. The combination is determined by the genotype and extent of liver damage.

For patients who have had treatment with a direct-acting antiviral, the treatment options depend on things like which drug had been used before. The treatment is individually adjusted by the doctor. For teenagers who have had treatment before, best supportive care (BSC) is an option. This should be tailored to the patient's individual needs with the aim of relieving symptoms and improving quality of life.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) has examined what advantages and disadvantages the combination of sofosbuvir with peginterferon and/or ribavirin offers in comparison with conventional standard treatments for hepatitis C.

The manufacturer provided data for the following groups:

  • First-line treatment for adults with chronic hepatitis C (genotype 2)
  • First-line or subsequent treatment for teenagers with chronic hepatitis C (genotype 2 or 3)

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More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of sofosbuvir (Sovaldi).