The fixed-dose combination of elbasvir / grazoprevir (trade name: Zepatier) has been approved in Germany since July 2016 for the treatment of chronic hepatitis C in adults (inflammation of the liver caused by hepatitis C viruses). It aims to keep the viruses from multiplying.
There are seven known forms of hepatitis C viruses, referred to as genotypes 1 to 7. The combination of elbasvir / grazoprevir has been approved for people with chronic hepatitis C caused by the virus genotypes 1 and 4.
In up to 80 out of 100 people with hepatitis C, the immune system is unable to successfully fight the virus on its own. This means that they constantly have the virus in their blood. The inflammation of the liver becomes permanent (chronic) over time, and may cause cirrhosis. The liver then performs increasingly worse. There is also a greater risk of liver cancer.
It is currently believed that treatment can reduce the risk of such complications if patients consistently have no detectable virus in their blood following the treatment.
Elbasvir / grazoprevir is taken once a day in tablet form independently of meals. One tablet contains 50 mg of elbasvir and 100 mg of grazoprevir. Depending on factors such as the amount of virus in the blood (viral load), the drug can be combined with ribavirin. Treatment usually lasts 12 to 16 weeks.
Depending on the genotype, viral load and other factors, various combinations of other drugs are available for the treatment of chronic hepatitis C.
In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to look into the advantages and disadvantages of elbasvir / grazoprevir compared with the standard treatments for people with hepatitis C.
But the manufacturer did not provide any suitable data with which to do the assessment.
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, the G-BA passed a resolution on the added benefit of elbasvir / grazoprevir (Zepatier).
Institute for Quality and Efficiency in Health Care (IQWiG, Germany). Elbasvir / grazoprevir (chronic hepatitis C) – Benefit assessment according to §35a Social Code Book V. Dossier assessment; commission A16-75. March 10, 2017. (IQWiG reports; volume 492).
IQWiG health information is written with the aim of helping
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