Introduction

The fixed-dose combination of glecaprevir / pibrentasvir (trade name: Maviret) has been approved in Germany since July 2017 for the treatment of chronic hepatitis C in adults. Since April 2019, it has also been approved for teenagers from the age of 12.

Hepatitis C viruses (HCV) 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 starts working less effectively. 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 such complications if patients consistently have no detectable virus in their blood following that treatment. The combination of glecaprevir / pibrentasvir is used to try to keep the viruses from multiplying.

Application

Three tablets of glecaprevir / pibrentasvir are taken once a day with a meal. The daily dose is 300 mg of glecaprevir and 120 mg of pibrentasvir.

The treatment lasts 8 to 16 weeks, depending on the genes of the virus (genotype), previous treatments, and the extent of damage to the liver.

Other treatments

People with chronic hepatitis C can receive different combinations of antiviral drugs. The combination is determined by the genotype and extent of liver damage.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into the advantages and disadvantages of the combination glecaprevir / pibrentasvir compared with the standard treatments for adults with chronic hepatitis C. In 2019 they looked into the same question for teenagers aged 12 and over.

But the manufacturer didn't provide any suitable data on either of the two groups. It's therefore not possible to determine whether the fixed-dose combination glecaprevir / pibrentasvir has any advantages or disadvantages compared to the standard treatments for adults or teenagers from the age of 12 who have chronic hepatitis C.

More information

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of glecaprevir / pibrentasvir (Maviret) for adults and teenagers.