Vosevi is a medication used to treat hepatitis C. It is a combination pill
containing sofosbuvir (sold
separately as Sovaldi) plus velpatasvir and voxilaprevir. It was
approved in Europe in September 2017 for treatment of adults with all genotypes
of hepatitis C.
How does Vosevi
work?
Vosevi contains three direct-acting antiviral drugs that target different
steps of the hepatitis C virus (HCV) lifecycle. Sofosbuvir is a nucleotide
analogue HCV polymerase inhibitor, meaning it blocks the polymerase enzyme
which the virus must use to reproduce. Velpatasvir is a NS5A replication
complex inhibitor which blocks another protein HCV uses to reproduce. Voxilaprevir
blocks NS3A/4A protease, a third protein used by the virus to reproduce.
Blocking three steps in the lifecycle of the virus stops it from
reproducing and clears the virus from the body rapidly.
The aim of treatment is to achieve a sustained virologic response 12
weeks after completing treatment. If the hepatitis C virus remains undetectable
at this point, it means the virus has been cleared from the body and a person
is cured of hepatitis C.
Who can use Vosevi?
Vosevi can used to treat anyone aged 12 and over
with hepatitis C, including people whose previous treatment failed to clear the
virus.
Vosevi has not been tested in pregnant or
breastfeeding women.
How is Vosevi
taken?
Vosevi is taken as one tablet once a day, with or
without food. People without cirrhosis take Vosevi for 8 weeks. People
with cirrhosis or people who have taken a previous unsuccessful course of
direct-acting antiviral treatment take Vosevi for 12 weeks. People with
genotype 3 hepatitis C and compensated cirrhosis may receive 8 weeks of
treatment with Vosevi.
How effective is Vosevi?
People with sustained virological response, who
still have undetectable HCV viral load 12 weeks after finishing treatment
(known as ‘SVR12’), are considered cured.
The phase 3 POLARIS studies showed that the drugs in Vosevi,
sofosbuvir plus velpatasvir and voxilaprevir, cured 91 to 100% of
treatment-experienced people depending on genotype. Vosevi cured
hepatitis C in 95% of previously untreated people in the POLARIS-2 study.
What are the side
effects of Vosevi?
The most common side effects of Vosevi
(affecting more than one in ten people) are nausea, diarrhoea and headache.
Does Vosevi interact
with other drugs?
Vosevi can raise levels of
the HIV drug tenofovir disoproxil fumarate (in several antiretroviral co-formulations),
so people taking these drugs together should have their kidney function checked
regularly. Vosevi should be used with caution when taken with HIV
protease inhibitors. Information about other specific drug interactions is
available online at www.hep-druginteractions.org.
Vosevi should not be used
with the following medicines:
- rosuvastatin (medicine for lowering
cholesterol in the blood)
-
dabigatran etexilate (medicine for preventing
blood clots)
-
ethinyl oestradiol-containing products
(such as contraceptive medicines);
-
rifampicin, rifabutin (antibiotics
usually used to treat tuberculosis);
-
carbamazepine, phenobarbital,
phenytoin (medicines for epilepsy);
- St John’s wort (herbal
anti-depressant).
Factsheet published April 2022.