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European flu samples show Tamiflu resistance

Certain strains of influenza that have been circulating in Europe this winter are resistant to Roche's drug Tamiflu  according to the European Centre for Disease Prevention and Control.

Certain strains of influenza that have been circulating in Europe this winter are resistant to Roche's drug Tamiflu  according to the European Centre for Disease Prevention and Control (ECDC).

So far, 148 samples of influenza A(H1N1) viruses isolated during November and December from ten European countries have been tested by the EU funded VIRGIL network.  Of the 148 samples, 19 showed evidence of resistance to Tamiflu.

Influenza viruses in the UK, Denmark, France and Norway have shown resistance to Tamiflu (oseltamivir).

Norway appears the most effected, with 12 samples out of 16 testing positive coming from the Nordic country.

Overall in Europe, the proportion of viruses showing resistance is around 13 per cent. If the 16 Norwegian viruses are excluded the proportion
with resistance would fall to around 5 per cent.

According to the ECDC, "these resistant viruses are a new phenomenon this winter".

However, the ECDC is quick to point out that "it is impossible to say what the level of resistance is in influenza across Europe. However from the limited data, the proportion of influenza viruses exhibiting resistance to Tamiflu must be significant, but not as high as in Norway".

It is unlikely that the antiviral-resistant viruses are anything to do with antiviral use in Europe, since they are rarely used. This is demonstrated by the fact that Norwegian patients did not take any antivirals.

"These data come from only some 150 viral isolates from very early in this winter epidemics in ten of the thirty European countries therefore the results are preliminary and it would be unwise to make any statement for Europe as a whole. However Norway is still seeing them in specimens collected this month. There are some indications that A/H1N1 viruses with the same resistance mutation are being seen in some other countries, notably North America. However, the data from Europe is showing the highest resistance levels at present," said the ECDC.

Rival drug

The European Medicines Agency (EMEA) has stated that resistance has been observed more frequently, in particular amongst children, with increasing use of Tamiflu.

The updated EMEA guidance highlights that, viral resistance to GlaxoSmithKline's (GSK) Relenza (zanamivir) is extremely rare, and that some viral strains that are resistant to Tamiflu remain sensitive to Relenza.

"The new EMEA guidance is a timely reminder that we need to constantly review our pandemic preparedness plans," said Professor Albert Osterhaus, Professor of Virology, University of Rotterdam, Netherlands, and Chairman of the European Scientific Working Group on Influenza (ESWI), "The issue of viral resistance is of concern to influenza experts and I welcome the EMEA guidance that the availability of more than one antiviral would be useful. On reviewing pandemic strategies, Governments should seriously consider including more than one antiviral."

Declining sales

As threats of a  global avian flu pandemic fail to materialise, sales of Tamilfu are falling. In Q3 2007, sales dropped by 2 per cent compared to the Q3 2006. Sales were more than CHF400m less than the previous year, primarily because stockpiling orders from governments and corporations as part of pandemic readiness plans have largely been completed, and no significant new orders have been received recently.

29th January 2008

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