A tablet combining tenofovir and FTC (emtricitabine) is likely to be available for prescription in Europe and the United States by the beginning of 2005, following today’s announcement by Gilead Sciences that it has applied for marketing approval in the European Union and the United States.
The tablet will provide a once daily combination of tenofovir (Viread) (300mg) and FTC (Emtriva) (200mg). Both drugs inhibit HIV’s reverse transcriptase enzyme. Tenofovir is a nucleotide analogue and FTC is a nucleoside analogue.
Once an application is submitted, it usually takes drug regulators six to nine months to reach a decision and grant marketing approval.
The fixed dose tablet, which still does not have a brand name, will compete with another fixed dose combination tablet about to come to market that combines 3TC and abacavir in a once daily tablet. This new fixed dose tablet, manufactured by GlaxoSmithKline, is also awaiting a brand name.
Both fixed dose tablets are likely to provide an attractive alternative to Combivir, the fixed dose combination of AZT and 3TC which must be taken twice a day. No head to head comparison of the new fixed dose tablets for respective tolerability, potency and resistance profiles after treatment failure can take place before they come to market and competition between the two companies in the large market for first-line nucleoside analogue backbone is likely to be fierce.
However, 24 week data from a North American study comparing tenofovir/FTC with Combivir in combination with efavirenz are likely to be available by the time of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy in November.