Briefing note: sofosbuvir (Sovaldi)
What is sofosbuvir used for?
Sofosbuvir is a treatment for chronic hepatitis C (CHC), which is an infection caused by a virus that is transmitted by infected blood and causes inflammation and damage to the liver. There are six distinct genotypes of hepatitis C worldwide. A genotype is a classification of a virus based on the genetic material. At the onset of hepatitis C (acute phase), some people have no symptoms or only mild symptoms including muscle ache, tiredness, nausea, joint pain and loss of appetite, and they clear the infection naturally. However, some people cannot clear the virus and it remains active in the liver and bloodstream long term (this is known as a chronic hepatitis C infection). While some people with a chronic infection remain free of symptoms and well throughout life, some develop cirrhosis (scarring of the liver) after many years of infection, and a few develop liver cancer. Treatment of chronic hepatitis C infection aims at eliminating the virus and consequently preventing cirrhosis and its complications.
How does it work?
Sofosbuvir is the first medicine in a new class and stops the virus from multiplying. It can be used to treat all genotypes of hepatitis C. It must be given in combination with ribavirin or peginterferon plus ribavirin. Sofosbuvir is taken as a tablet, taken orally, once daily with food.
What has SMC advised?
SMC accepted sofosbuvir for restricted use in patients with genotypes 1 to 6. Use in treatment-naive patients with genotype 2 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa. Use of the 24-week interferon-free regimen of sofosbuvir in combination with ribavirin in patients with genotype 3 is restricted to those who are ineligible for, or are unable to tolerate, peginterferon alfa.
What is the evidence to support this?
• Studies showed that sofosbuvir in combination with ribavirin, or peginterferon plus ribavirin, produced sustained virological suppression (defined as virus levels below a certain threshold) in patients with all genotypes of hepatitis C.
• The submitting company presented economic analyses comparing various sofosbuvir regimens in different patient populations according to genotype, previous treatments and suitability for interferon treatment. For many of the patient populations, the medicine was considered to offer value for money. SMC can use a number of factors in their decision making; for the genotype 1 patients who were treatment naive and unsuitable for interferon-based treatments, the committee considered that in the absence of other treatment options, the relatively high cost was acceptable for this group given the expected benefits of the treatment.
SMC accepted sofosbuvir for restricted use because it is effective and is the first medicine licensed for use in interferon-free regimens, offering improved tolerability among patients who are unable to receive interferon thereby addressing an unmet treatment need.