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.
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.