Barcelona, Spain, July 10 � Final results from the MaxCmin1 trial, the first large, randomised study to compare two "boosted" protease inhibitor regimens, showed that boosted saquinavir (saquinavir 1000mg with ritonavir 100mg twice daily) reduced HIV to undetectable levels in significantly more patients than boosted indinavir (indivavir 800mg with ritonavir 100mg twice daily) at 48 weeks. This was the result of a more favorable safety profile in the saquinavir arm. The results were presented here today during an oral session by Dr Pedro Cahn, Director of Fundaci�n HUESPED, Buenos Aires, Argentina.

The final 48-week results of the MaxCmin 1 study showed that the "boosted" saquinavir regimen (saquinavir/ritonavir 1000/100mg BID) reduced the levels of HIV in patients� blood to below detection (<400 copies/mL) in a significantly greater proportion of patients (68%) than the boosted indinavir arm (53%; p=0.014) according to the ITT analysis (non-completers = failures).

"Saquinavir/ritonavir 1000/100 mg twice daily is an excellent option for patients who require a boosted protease inhibitor, including those who have experienced toxicity or virological failure with a prior protease inhibitor-containing regimen" said Dr. Bill O Brien.

"Using saquinavir 1000mg twice daily in combination with ritonavir 100mg twice daily appears to produce saquinavir levels at which efficacy is well established for treatment experienced patients. Unlike some of the other boosted protease inhibitors, there is evidence that this combination does not cause significant elevations of plasma lipid levels nor, based on available data, other metabolic adverse effects. Overall, saquinavir/r appears to be among the best tolerated boosted protease inhibitors." Said Dr Calvin Cohen.

The MaxCmin 1 study evaluated 317 patients in 14 countries across Europe, South America and the US and was managed by the Copenhagen HIV Programme (CHIP), an independent collaborative investigator group.

Saquinavir is a member of the class of anti-HIV drugs known as protease inhibitors (PIs). PIs block a part of the HIV reproduction process involving the HIV protease, thus preventing the formation of new infectious HIV particles. Saquinavir is almost always used in combination with at least two other anti-HIV drugs and has been shown to significantly improve survival and reduce the occurrence of AIDS-defining events for people infected with HIV. Saquinavir is not a cure for HIV.

Boosting saquinavir with low doses of ritonavir allows more saquinavir to be absorbed into the blood and keeps saquinavir in the body for longer. The benefit for patients is that using this approach it is possible to reduce the dosing frequency together with the required number of capsules while still maintaining therapeutic drug levels.

In June of 2002 the Committee for Proprietary Medicinal Products (CPMP) granted a positive opinion for both INVIRASE� (saquinavir hard gel capsules) and FORTOVASE� (saquinavir soft gel capsules) to include co-administration with a low dose of ritonavir for the treatment of human HIV. The corresponding Commission Decision for the dosage schedule (1000mg saquinavir BID in combination with ritonavir 100mg BID) is expected by the end of August 2002.

The new schedule allows for the use of both saquinavir formulations, INVIRASE� and FORTOVASE�. The new saquinavir/ritonavir schedule is also recommended in the new draft WHO guidelines, "Scaling up antiretroviral therapy in resource limited settings: Guidelines for a public health approach".

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