Hepatitis C treatment factsheet: Vosevi (sofosbuvir + velpatasvir + voxilaprevir)

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.