FTC (Emtriva) recommended for European approval

Michael Carter
Estimated reading time 2 minutes
This article is more than 21 years old.

The investigational nucleoside analogue FTC (emtricitabine, EmitrivaTM) has been recommended for approval by the scientific committee of the European Union's drug licensing agency.

FTC, manufactured by Gilead, received marketing approval in the US earlier this month. The recommendation for marketing authorisation by the European Union’s Committee for Proprietary Medicinal Products (CPMP) means that the European Commission is set to issue a license for the drug in the last quarter of 2003.

CPMP has endorsed the use of FTC for the treatment of HIV in adults and children in combination with other HIV drugs. The recommendation is based on studies in treatment-naïve patients.

Glossary

treatment-naive

A person who has never taken treatment for a condition.

hepatitis B virus (HBV)

The hepatitis B virus can be spread through sexual contact, sharing of contaminated needles and syringes, needlestick injuries and during childbirth. Hepatitis B infection may be either short-lived and rapidly cleared in less than six months by the immune system (acute infection) or lifelong (chronic). The infection can lead to serious illnesses such as cirrhosis and liver cancer. A vaccine is available to prevent the infection.

nucleoside

A precursor to a building block of DNA or RNA. Nucleosides must be chemically changed into nucleotides before they can be used to make DNA or RNA. 

naive

In HIV, an individual who is ‘treatment naive’ has never taken anti-HIV treatment before.

half-life

The amount of time it takes for a concentration in blood to be reduced by 50%. After one half-life, the concentration of a drug in the body amounts to half the starting dose of any drug to be eliminated from the body.

When final European licensing is approved, FTC will join the growing number of antiretroviral drugs available for one daily dosing. The drug has a similar structure and resistance profile to 3TC (lamivudine). However, resistance to FTC is less likely to emerge when compared to 3TC, even though the two drugs share the same resistance pathway. This is because FTC remains in the blood for much longer than 3TC - its intracellular half-life is 39 hours.

Evidence was presented to the International AIDS Conference in Paris last week that FTC is also a safe and effective treatment for hepatitis B in HIV-positive individuals who are coinfected with the liver disease.

Further information on this website

FTC - overview

FTC approved in USA - news story July 2003

FTC safe and effective as a hepatitis B treatment in HIV/HBV coinfected patients - news story July 2003

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