Introduction

The fixed combination of sofosbuvir / velpatasvir / voxilaprevir (trade name: Vosevi) has been approved in Germany since July 2017 for the treatment of chronic hepatitis C in adults.

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 the ability to work properly. As long as the effect on liver performance isn’t noticeable, it is known as “compensated cirrhosis." Signs of advanced (“decompensated”) cirrhosis include fluid retention in the abdominal cavity, blood clotting problems, and neurological and psychiatric problems, sometimes even as severe as a coma. The risk of liver cancer increases too.

It is currently believed that a treatment can reduce the risk of complications such as liver cancer if patients consistently have no detectable virus in their blood following that treatment. Sofosbuvir / velpatasvir / voxilaprevir is a fixed combination of substances referred to as direct-acting antivirals (DAAs). It is supposed to keep the number of viruses from growing.

Application

Sofosbuvir / velpatasvir / voxilaprevir is taken once a day in the form of a tablet. One tablet contains 400 mg sofosbuvir, 100 mg velpatasvir and 100 mg voxilaprevir. The length of treatment with the fixed combination is determined by the stage of the disease, and can last between 8 and 12 weeks.

Other treatments

Depending on the genotype and the amount of liver damage, various other combinations of DAAs are an option for adults with chronic hepatitis C who haven't yet had treatment with DAAs. For patients who have already had DAA treatment, the therapy options depend on things like which drug has been used before. The treatment is individually adjusted by the doctor.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether the fixed-dose combination of sofosbuvir / velpatasvir / voxilaprevir has any advantages or disadvantages compared with standard treatments for chronic hepatitis C.

People with chronic hepatitis C can be divided into different groups based on the genotype of their virus, the stage of the disease, and their previous treatments. IQWiG assessed the combination of sofosbuvir / velpatasvir / voxilaprevir in different groups of patients.

The manufacturer did not provide any usable data on the following:

  • People with and without compensated cirrhosis who have genotype 1, 4, 5, or 6 and who haven’t previously been treated with DAAs
  • People with compensated cirrhosis who have genotype 2 and who haven’t previously been treated with DAAs
  • People who have already been treated with DAAs

So it wasn't possible to find out whether sofosbuvir / velpatasvir / voxilaprevir has any advantages or disadvantages compared to the standard treatment for these groups of people.

Data was available for the following groups:

  • People who haven’t previously been treated with DAAs and have genotype 2 or 3 without compensated cirrhosis
  • People who haven’t previously been treated with DAAs and have genotype 3 and compensated cirrhosis

Learn more

More information

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