What is Vemlidy - Tenofovir alafenamide used for?
Vemlidy is an antiviral medicine for the treatment of chronic (long-term) hepatitis B, an infectious disease that affects the liver.
It is used in patients over 12 years of age and with a body weight of at least 35 kg. It contains the active substance tenofovir alafenamide.
How is Vemlidy - Tenofovir alafenamide used?
Vemlidy is available as 25 mg tablets, taken orally (one tablet a day) during meals. The patient should generally take the medicine for at least 6-12 months and the treatment may last for several years.
Vemlidy can only be obtained with a prescription.
How does Vemlidy - Tenofovir alafenamide work?
The active ingredient in Vemlidy, tenofovir alafenamide, works by blocking the multiplication of hepatitis B virus in the liver. It is converted in the body into its active compound, tenofovir, which blocks the activity of reverse transcriptase, an enzyme produced by the hepatitis B virus that allows it to reproduce in the cells it has infected.
What benefit has Vemlidy - Tenofovir alafenamide shown during the studies?
Vemlidy reduces hepatitis B virus levels in most patients. In a study of 426 patients with "antigen-e" chronic hepatitis, 94% of patients treated with Vemlidy had very low levels of viral DNA after 48 weeks of treatment. This result was similar to that recorded in patients taking another form of tenofovir (tenofovir disoproxil fumarate), where 93% had very low levels of viral DNA.
In a second study of 875 patients with "positive antigen-e" chronic hepatitis, 64% of patients taking Vemlidy and 67% of those taking tenofovir disoproxil fumarate had very low levels of viral DNA after 48 weeks. These results suggest that the comparator may be more effective in "e-positive" cases, but the observed differences are mild.
The terms "antigen-e positive" and "antigen-e negative" refer to the presence or absence of antigen-e, a viral hepatitis B protein. The presence of this protein indicates that the virus is multiplying rapidly and the viral load may be higher.
What are the risks associated with Vemlidy - Tenofovir alafenamide?
The most common side effects of Vemlidy are headache (11% of patients), nausea (6% of patients) and fatigue (6% of patients). For the full list of side effects and limitations, see the package leaflet.
Why has Vemlidy - Tenofovir alafenamide been approved?
Vemlidy suppresses the levels of the hepatitis B virus in the body and its effectiveness is comparable to that of another tenofovir-based medicine (tenofovir disoproxil fumarate). Regarding the risks, the side effects of Vemlidy are manageable. Furthermore, Vemlidy is effective at a lower dose than tenofovir disoproxil fumarate and may result in a reduction in the undesirable effects on the kidneys and bones.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Vemlidy's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Vemlidy - Tenofovir alafenamide?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vemlidy have been included in the summary of product characteristics and the package leaflet.
Other information about Vemlidy - Tenofovir alafenamide
The full EPAR for Vemlidy can be found on the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Vemlidy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
