Tenofovir, the nucleotide analogue developed by Gilead, received scientific approval this week from the CPMP, the scientific advisory committee of the European Medicines Evaluation Agency, and is likely to be available for prescription in the European Union to anyone experiencing `early virological failure` by January 2002. The European Commission is required to decide whether to give marketing approval within 60 days, but this is usually a formality. The drug was reveiwed within six months, the first example of a speeded up exceptional approval process designed to expedite the availability of new drugs for highly treatment-experienced patients.
Tenofovir, brand named Viread, has already received scientific approval in the United States and could be available for prescription by mid-November.
The decision to give approval for treatment-experienced patients was made on the basis of evidence from a variety of studies in which tenofovir was added to failing therapy, or formed part of a salvage regimen. A Phase III study comparing tenofovir to d4T (stavudine) in treatment-naive patients is still underway, and Gilead will wait for results from this study before requesting a license to allow the use of tenofovir as a first-line treatment for HIV infection.
Tenofovir is likely to be widely used because it does not share the same resistance profile as nucleoside analogues such as AZT, d4T and 3TC, thus helping people who have experienced the failure of several different nucleoside analogues.
People currently having difficulty taking more complex regimens may also be attracted to tenofovir because the drug can be taken as one tablet, once daily, with any sort of food.
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