Roche has obtained the European marketing approval for new 500 mg formulation of Invirase ( Saquinavir ), an protease inhibitor used in the treatment of HIV infection.
The new 500 mg tablet will simplify the dosing regimen for patients by reducing the daily tablet count by more than half, from five tablets twice-daily to two tablets twice-daily.
Antiretroviral therapies have transformed HIV infection into more of a chronic disease with patients living much longer than before.
Patients can easily switch from the current 200 mg capsule to the new 500 mg tablets, continuing to benefit from Invirases high antiviral efficacy but with far more convenience.
Invirase is recommended as a first line boosted PI ( protease inhibitor ) in the International AIDS Society ( IAS ) guidelines which gave it the highest possible clinical evidence based rating.
Invirase 500 mg received FDA approval in the USA after priority review on December 18, 2004.
Invirase, originally approved by the FDA in 1995, was the first HIV protease inhibitor on the market.
Its introduction represented a major milestone in the treatment of HIV/AIDS.
In December 2003, the FDA approved Invirase for use in boosted dosing regimens with Ritonavir ( 1000 mg Invirase/100 mg Ritonavir bid ).
Co-administering Invirase with Ritonavir enhances therapeutic blood levels of the drug and enables simplified dosing.
Data from the STACCATO clinical study show reductions in patients HIV RNA recorded in the first 24 weeks on therapy that are the best ever seen in a large cohort of patients given HAART. Some 96% of patients achieved viral load reductions to < 400 HIV RNA copies/ml and 89% were shown to have undetectable levels (