People with HIV failing on existing protease inhibitor treatment will have the chance to obtain the new protease inhibitor ABT-378 (also known as lopinavir or by the trade name Aluviran) within weeks, the French drug regulatory agency announced yesterday.
Under a scheme called Autorisation temporaire d'utilisation (ATU), the French government can compel companies to make an anti-retroviral drug available before it has completed clinical trials or received a European license.
Under the ATU negotiated with Abbott Laboratories, individuals with viral load greater than 10,000 copies and a CD4 below 200 who are failing on, or intolerant to currently licensed protease inhibitors, will be able to obtain ABT-378.
In October Abbott Laboratories was attacked by the European AIDS Treatment Group for failing to make progress in establishing a meaningful expanded access programme in Europe, despite six months of lobbying by European activists. Expanded access plans for other European countries remain uncertain despite the French announcement.
One clinical study has shown that approximately two thirds of individuals with rising viral load after their first PI failure achieved undetectable viral load within six months of switching to ABT-378. Data on the efficacy of the drug in individuals with multi-PI experience is still lacking.