Sofosbuvir (brand name Sovaldi) is a new medication used to treat
hepatitis C. It was approved in Europe in January 2014 for treatment of adults
with all genotypes of chronic hepatitis C.
Sofosbuvir is a component of three fixed-dose combination tablets for
the treatment of hepatitis C:
Sofosbuvir can also be used in combination with daclatasvir (Daklinza).
See the factsheets for more information on these combinations.
Sofosbuvir is also licensed for
use in combination with simeprevir, with ribavirin alone or with pegylated
interferon and ribavirin, but these uses are no longer recommended in
international treatment guidelines.
How does sofosbuvir work?
Sofosbuvir is a nucleotide analogue HCV polymerase inhibitor, meaning it
blocks the polymerase enzyme which the virus must use to reproduce. Sofosbuvir
should be combined with other medications, which may include pegylated
interferon (which stimulates the body's own immune response), ribavirin or
other direct-acting antivirals that work differently.
Who can use sofosbuvir?
Sofosbuvir is indicated for use by adults with chronic hepatitis C,
meaning infection lasting more than six months. It is approved for people with
HCV genotype 1, 2, 3, 4, 5 or 6. Genotype 1 is the most common type in Europe.
Sofosbuvir is also approved for use in children and adolescents aged 3
years and over.
Sofosbuvir can be used by people being treated for hepatitis C for the
first time (known as 'treatment-naive') and for retreatment of people who were
not cured with previous interferon-based therapy (known as
'treatment-experienced').
Sofosbuvir has also been tested in people with HIV and HCV co-infection.
Response rates and side effects are similar to those of HIV-negative people,
and sofosbuvir does not interact with HIV drugs. People with co-infection who
want to take sofosbuvir should do so under the care of a doctor who has
experience treating both infections.
Sofosbuvir can be used by people with all stages of liver disease
including compensated and decompensated cirrhosis. However, it works better for
people with less advanced liver damage. Data on safety and efficacy in
decompensated cirrhosis have not yet been published. People with chronic
hepatitis C who are awaiting or have received a liver transplant tolerate
sofosbuvir better than older medications.
How is sofosbuvir taken?
Sofosbuvir is taken as a single pill once daily with food if combined
with daclatasvir. See Harvoni, Epclusa or Vosevi for instructions
on the use of combination pills containing sofosbuvir.
Sofosbuvir is not effective if
taken alone and this can lead to drug resistance.
Sofosbuvir is also available in a granule form that can be mixed with
food, for the treatment of children aged 3 years and over. Sofosbuvir and
daclatasvir should be taken for 12 weeks.
Recommended uses for people with HIV and HCV co-infection are the same
as for HIV-negative people.
How effective is sofosbuvir?
Sofosbuvir works better for some people than for others. Several factors
predict how well someone will respond, including HCV genotype, extent of liver
damage and previous treatment history. People with liver cirrhosis do not
respond as well as those with mild or moderate liver fibrosis. People who are
new to treatment have a better chance of being cured than those with little or
no response to prior treatment.
Sofosbuvir treatment response
Sofosbuvir was approved on the basis of clinical trials that tested the
drug’s efficacy in combination with pegylated interferon and/or ribavirin. Use
of sofosbuvir in combination with pegylated interferon and/or ribavirin is no
longer recommended in international guidelines. Subsequent studies have tested
sofosbuvir as part of a combination product (Harvoni, Epclusa or Vosevi)
or in combination with daclatasvir. See the factsheet
on daclatasvir for more information on the use of sofosbuvir in
combination with daclatasvir.
What are the side effects of sofosbuvir?
Sofosbuvir is generally well tolerated with no known specific
side effects of its own. The most common side effects seen in people taking
sofosbuvir with ribavirin or pegylated interferon/ribavirin are fatigue,
headache, nausea and insomnia.
Does sofosbuvir interact with other drugs?
Sofosbuvir can interact with certain drugs processed by a protein known
as 'P-gp', including some TB medications, psychiatric drugs and herbal products
containing St John's wort. Information about specific drug interactions is
available online at www.hep-druginteractions.org.
How can I get sofosbuvir?
Sofosbuvir is
available by prescription in European Union countries to treat all genotypes of
hepatitis C. Ask your GP or liver specialist if sofosbuvir
may be a good option.
Factsheet reviewed March 2022.