Introduction

The drug tenofovir alafenamide (trade name: Vemlidy) has been approved in Germany since January 2017 for the treatment of chronic hepatitis B. It is an option for adults and teenagers over the age of 12.

Hepatitis B viruses are usually spread through bodily fluids such as blood or semen. They attack the liver, where they can cause an inflammation (hepatitis). In many cases, the condition causes no symptoms and remains undetected. If there are symptoms, they are non-specific at first and include things like loss of appetite, exhaustion, muscle and joint pain, and mild fever. Later, the skin, mucous membranes and the whites of the eyes may take on a yellowish color. Hepatitis B goes away on its own in most people.

In about 10 out of 100 people, though, the immune system is unable to successfully fight the virus, resulting in chronic hepatitis B. This is particularly likely in children and people with weakened immune systems. Hepatitis B is considered to be chronic if there are detectable viruses in the blood for more than six months. Even chronic hepatitis doesn't necessarily cause symptoms. But in a small number of cases it can cause liver cirrhosis. In cirrhosis, the performance of the liver gradually gets worse and the risk of liver cancer increases.

Tenofovir alafenamide aims to stop the viruses from multiplying. It is currently believed that treatment can reduce the risk of such complications if patients consistently have no detectable viruses in their blood due to the treatment.

Application

Tenofovir alafenamide is taken once a day in the form of a tablet (25 mg) with a meal.

Other treatments

The first-line treatment options for adults with chronic hepatitis B are the drugs peginterferon alfa-2a, tenofovir disoproxil or entecavir.

Adults who have taken hepatitis B drugs before are usually given an individualized second-line treatment, taking into account the treatments that were tried before and why they were discontinued. For instance, the previous treatment may not have been effective enough against the viruses or may have caused side effects that were too strong.

The first-line treatment options for teenagers over the age of 12 are the drugs tenofovir disoproxil or entecavir. In second-line treatment, tenofovir disoproxil is also an option.

Assessment

In 2017, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) wanted to find out whether tenofovir alafenamide has any advantages or disadvantages for people with chronic hepatitis B when compared with the current standard treatments. But the manufacturer didn't provide any suitable data with which to do the assessment.

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 this review and the hearings received, the G-BA passed a resolution on the added benefit of tenofovir alafenamide (Vemlidy).

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