New Treatment Strategy May Reduce Cost of HIV Therapy

Basel, 9. April 2001 - New data from four studies have demonstrated a potentially new cost effective treatment strategy for HIV infection with the protease inhibitor Fortovase^® (saquinavir soft gel capsules).

Data from four ongoing studies have suggested that treatment with 1600mg Fortovase boosted with low dose ritonavir provides:

• effective and well tolerated control of HIV infection
• patient convenience from once- daily dosing
• the ability to reduce the cost of protease inhibitor (PI) treatment.

These data were presented at the International Workshop on HIV Clinical Pharmacology, Noordwijk, Netherlands.

The FOCUS trial is a preliminary analysis of a study evaluating 78 patients new to HIV treatment across Canada and USA. The results of using once- daily Fortovase/r (1600mg/100mg) appear sufficient to achieve and maintain reductions in plasma HIV RNA for the majority of patients in the study. In addition, the cohort of patients examined for safety did not have associated significant laboratory abnormalities further supporting the potentially favourable safety profile of this experimental regimen.

In the Thai HIV-NAT trial, patients switched from Fortovase as the sole PI onto Fortovase/r (1600mg/100mg) once-daily and data were presented on the 66 patients who have completed 24 weeks of therapy. The regimen was very well tolerated with 100% of the patients continuing to take their medications after 6 months. 100% of patients had RNA levels under 400 copies/ml and 93% of patients had HIV RNA levels under 50 copies/ml at week 24 of the trial.

‘Both the pharmacokinetic and clinical results from HIV-NAT 001.3 support once-daily administration of saquinavir soft gel capsules/r (1600/100 mg), in combination with two NRTIs, as a convenient regimen to maintain suppression of viral replication in patients with a plasma viral load below 50 copies/mL’ said Dr. Rolf Van Heeswijk, presenting author at the conference. ‘ There is more data on Fortovase/r than any other once-daily boosted PI.’

The third study presented was the French IMEA 015 trial. This trial recruited 35 patients; either naive to HIV therapy or those with undetectable levels of virus, to receive Fortovase/r (1600mg/100mg) once-daily. The data assessed the possible use of Fortovase/r in HIV-infected patients and demonstrated good tolerability and immune and virological outcome.

In the Spanish once- daily Fortovase trial, patients failing Invirase based HAART were switched to once daily Fortovase/r. The mean number of previous antiretroviral treatments was 3 (range 1 - 7) and mean viral load was 3869 copies/mL. 12 out of 14 patients showed reductions in HIV RNA to less than 200 copies/mL after 12 weeks of treatment; including 4 patients who had the L90 M mutation at baseline which is usually associated with decreased sensitivity to saquinavir.

‘The data presented in these three trials add further support to the experimental Fortovase/r once-daily regimen’ said Andrew Hill, International Medical Manager, Roche. ‘In order to achieve once daily dosing, we have used low doses of ritonavir to dramatically increase blood plasma levels of saquinavir. It is thrilling to see that even at such high exposures saquinavir maintains a good safety profile. The regimen appears to be very well tolerated and accepted by the patients in these studies.’

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