Truvada receives scientific approval in Europe

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A fixed dose combination tablet of tenofovir and FTC called Truvada has received scientific approval by the European Medicines Agency’s scientific committee and will be available for prescription in some European Union countries, including the United Kingdom, within three to four months, manufacturer Gilead announced today.

Truvada has been approved for use in combination with other antiretrovirals and should not be used in combination with 3TC, tenofovir, FTC or any fixed dose combination which includes 3TC.

Truvada is the fourth fixed dose nucleoside analogue combination to be approved in Europe, and is likely to be strongly marketed for use in first line treatment following the results of studies that compare its components to popular nucleoside analogue combinations.

Glossary

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. 

fixed-dose combination (FDC)

Two or more drugs contained in a single dosage form, such as a capsule or tablet. By reducing the number of pills a person must take each day, fixed-dose combination drugs may help improve adherence.

equivalence trial

A clinical trial which aims to demonstrate that a new treatment is no better or worse than an existing treatment. While the two drugs may have similar results in terms of virological response, the new drug may have fewer side-effects, be cheaper or have other advantages. 

clinical trial

A research study involving participants, usually to find out how well a new drug or treatment works in people and how safe it is.

European Medicines Agency (EMA)

Regulatory agency that evaluates medicines for safety and efficacy in Europe, performing a similar role to the Food and Drug Administration (FDA) in the United States. The EMA recommends to the European Commission that a medicine can be marketed in the European Union and European Economic Area.

The Gilead 903 study compared a backbone of tenofovir and 3TC (considered to be equivalent to tenofovir and FTC for drug approval purposes) and found it to be comparable to a d4T/3TC backbone after 144 weeks of treatment when combined with efavirenz. Click here for further information

A 24 week interim analysis of the Gilead 934 study, which compared tenofovir/FTC with Combivir (AZT/3TC) found that patients who received Combivir were significantly more likely to have discontinued treatment by week 24 and significantly less likely to have viral load below 400 copies/ml by that point as a consequence. Click here for a full report

Truvada will face strong competition from Kivexa, a once daily combination of abacavir and 3TC recently approved in Europe. The two products have not been compared head to head in a clinical trial.