PARIS, Feb 5 (APM) - The European Commission has approved a new formulation of Abbott's Norvir (ritonavir) in the form of heat-stable tablets at the end of January.

Ritonavir was the first protease inhibitor to be marketed in 1996. However, ritonavir is currently only used as a booster with other protease inhibitors to improve their bioavailability and reduce the number of tablets HIV-positive patients need to take.

Apart from paediatric syrup, the product is only available in soft capsule form. The soft capsules need to be stored in a fridge, resulting in storage difficulties in some southern countries.

The European commission authorised the film-coated tablet formulation (dosed at 100 mg, same as for the soft capsule) on Jan 25. The film-coated tablets will be packaged in bottles of 30 or 60 tablets, APM has learnt from Abbott France.

The soft capsules are marketed in bottles of 84 capsules,

Abbott said the reimbursement file is currently being reviewed and that it has requested a price identical to that of the soft capsules. A bottle of 84 soft capsules costs 95.51 euros.

Abbott also said the soft capsules will remain available for several months, until the film-coated tablets are available and patients have adapted to the new tablets.

Before Norvir, Abbot's protease inhibitor Kaletra (lopinavir + ritonavir) also underwent a similar change in 2006, when a heat-stable tablet was marketed and replaced the soft capsule formulation.

Norvir could soon lose its booster monopoly. Gilead is currently developing GS-9350 (a competitor product) and Phase II data will be available shortly.

rl/aki/ra


[18017] 05/02/2010 16:45 GMT - AIDS