Introduction

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 children over the age of 12.

Hepatitis B viruses (HBVs) are usually spread through body fluids like blood or sperm. They attack the liver, where they can cause the acute inflammation known as hepatitis. In many cases, the condition doesn't cause any symptoms and remains undetected. If it does cause symptoms, they are usually non-specific in the early stages, including things like loss of appetite, exhaustion, muscle and joint pain, and mild fever. As the condition progresses, the skin, the mucous membranes and the whites of the eyes can take on a yellowish color (jaundice). In most people, hepatitis B goes away on its own.

But in about 10 out of 100 people, the immune system is unable to successfully fight the virus, and the condition becomes chronic. This is most common in children or people with a weakened immune system. Hepatitis B is considered to be chronic if the viruses are detectable in the blood for more than six months. Chronic hepatitis doesn't necessarily cause symptoms either. In rare cases it can lead to liver cirrhosis, though. In cirrhosis, the liver function gets worse over time and the risk of liver cancer increases.

Tenofovir alafenamide aims to keep the viruses from multiplying. It is thought that patients who permanently have no detectable viruses in their blood following treatment are at lower risk of complications like these.

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 medications PEG interferon alfa, tenofovir disoproxil fumarate or entecavir.

Adults who have already taken medication for hepatitis B are generally given an individually tailored subsequent treatment. This type of treatment takes into consideration which treatments were tried before and why they were stopped. For instance, the previous treatment may not have been effective enough against the viruses or may have caused side effects that were too severe.

The first-line treatment options for children over the age of 12 are tenofovir disoproxil fumarate and entecavir. Tenofovir disoproxil fumarate can also be used in subsequent treatment.

Assessment

In 2018, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) looked into whether tenofovir alafenamide has any advantages or disadvantages for teenagers and adults with chronic hepatitis B when compared with the current standard treatments.

The manufacturer provided a total of four studies. Only the data concerning adults receiving tenofovir alafenamide as first-line treatment was suitable for use in the assessment. The researchers at IQWiG were able to use the data of 1,090 patients in their analysis: 727 people were given tenofovir alafenamide and 363 people received tenofovir disoproxil fumarate (standard treatment).

After almost two years, the study showed the following in adults receiving tenofovir alafenamide as first-line treatment:

What are the advantages or disadvantages of tenofovir alafenamide?

Tenofovir alafenamide wasn’t found to have any advantages or disadvantages compared to tenofovir disoproxil fumarate.

No differences

There was no difference between tenofovir alafenamide and the standard treatment in terms of:

  • Life expectancy: None of the patients passed away over the course of the studies
  • Number of cases of liver cancer
  • Serious side effects
  • Treatments stopped due to side effects
  • Kidney or urinary problems
  • Bone fractures

What remains unanswered?

  • Health-related quality of life: It is not possible to determine how tenofovir alafenamide compares with tenofovir disoproxil fumarate in terms of quality of life. Quality of life wasn't considered in these studies.
  • Liver cirrhosis: There was also no relevant data on how the treatment influenced the development of liver cirrhosis.

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 tenofovir alafenamide (Vemlidy).