Introduction

The drug dasabuvir (trade name: Exviera) was approved in January 2015 for the treatment of hepatitis C infections. It is used in combination with other drugs. The aim of the treatment is to stop the virus from multiplying and prevent complications.

Hepatitis C viruses (HCVs) attack the liver, where they can cause acute inflammation. Six different forms of hepatitis C viruses are now known, referred to as genotypes 1 to 6. In up to 80 out of 100 people with hepatitis C, the immune system is unable to fight the virus on its own. They develop a permanent (chronic) inflammation of the liver which can cause cirrhosis. The liver cannot work properly as a result, and this gets worse and worse. The risk of liver cancer increases too. It is thought that patients who permanently have no detectable viruses in their blood following treatment are at lower risk of complications like these.

Hepatitis C viruses are made up of DNA inside a membrane made out of various proteins. When the viruses infect a cell, some of these proteins cause the cell to make a lot of copies of the DNA, producing a large amount of new virus proteins, out of which new viruses are made.

There are a number of drugs that aim to prevent hepatitis C viruses from multiplying. Different drugs target different sites. Some influence the structure of the membrane surrounding the virus, while others interfere with DNA replication.

Dasabuvir blocks a specific protein needed to make copies of the viral DNA. The treatment is only meant for people who have chronic hepatitis C genotype 1.

Application

Dasabuvir is taken twice a day (in the morning and in the evening) in tablet form. One tablet contains 250 mg of dasabuvir. If you forget to take a tablet at a certain time, you can still take it within six hours.

Depending on the type of virus, the symptoms and how the disease progresses, dasabuvir can be taken together with the following drugs:

  • In dual therapy together with the combination drug ombitasvir / paritaprevir / ritonavir
  • In triple therapy together with ribavirin and the combination drug ombitasvir / paritaprevir / ritonavir

The treatment usually lasts between 12 and 24 weeks, depending on the symptoms and progression of the disease.

Other treatments

Depending on the symptoms and progression of the disease, the standard therapy options are dual therapy with peginterferon and ribavirin, or triple therapy with peginterferon, ribavirin and either boceprevir or telaprevir.

Assessment

In the spring of 2015, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of dasabuvir when used together with the combination drug ombitasvir / paritaprevir / ritonavir and/or ribavirin in people with hepatitis C, compared with the standard therapies so far.

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 therapies. IQWiG assessed dasabuvir for several groups of patients.

The manufacturer did not provide any relevant data for the following groups:

  • People with chronic hepatitis C (HCV) genotype 1b and no liver cirrhosis who have had unsuccessful treatment
  • People with HCV genotypes 1a or 1b and liver cirrhosis who have not had previous treatment
  • People with HCV genotypes 1a or 1b and liver cirrhosis who have had unsuccessful treatment
  • People with HCV genotype 1 who are also HIV positive
  • People with HCV genotype 1 who have had a liver transplant

It was not possible to determine the advantages or disadvantages of dasabuvir compared with standard therapy for these groups.

Data was available for the following three groups: 

  • People with HCV genotype 1a and no liver cirrhosis who have not had previous treatment
  • People with HCV genotype 1b and no liver cirrhosis who have not had previous treatment
  • People with HCV genotype 1a and no liver cirrhosis who have had previous unsuccessful treatment

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 IQWiG review was commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of these reviews and the hearings received, the G-BA passed a resolution on the added benefit of dasabuvir (Exviera).

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