The FORTOGENE study, conducted independently by a Spanish team of investigators, adds to the wealth of data supporting the use of Fortovase/r therapy. The study, involving 20 research sites and 102 patients who completed six months of therapy were examined with the aim of assessing the efficacy and safety of Fortovase/r in salvage therapy, as well as evaluating the predictive value of genotyping and drug levels in virologic response. At the start of the trial patients had a mean plasma HIV-RNA of 100,000 copies/ml and CD4 count of 367 cells/uL. Results show a potent anti-viral response to Fortovase/r with an HIV drop of more than 1 log in 75% of patients and in fact 60% of patients reached <50 HIV-RNA copies/ml at 6 months.

"Comparative results of boosted protease inhibitors are particularly important and encouraging", commented Dr Vincent Soriano, Section Chief at the department of Infectious Diseases, Instituto de Salud Carlos III, Madrid, Spain. "Our FORTOGENE data clearly demonstrates the excellent potency of Fortovase/r 1000/100mg twice daily, providing a high barrier to resistance. Our independent six month analysis of the three available boosted PI regimens* shows similar efficacy and tolerability with Fortovase/r as lopinavir/r. These data will be very useful in helping to evaluate appropriate treatment options for individual patients".

First Comparative Results of Boosted Protease Inhibitors

The first interim results from the MaxCmin1 trial supporting the excellent profile of Fortovase/r were announced at ECCATH by Dr. Ulrik Bak Dragsted, Hvidovre University Hospital, Copenhagen, representing the Copenhagen HIV Investigator Programme (CHIP). The MaxCmin1 trial, an independent randomised study of 306 patients evaluating the safety and efficacy of indinavir/r versus Fortovase/r in HIV infection, has just released 24 week results. These Intent To Treat (non completer equals failure) data highlight that 75% of patients receiving Fortovase/r achieved <400 copies/ml, compared to 60% of those taking indinavir/r. In addition there were 75 grade 3 or 4 (serious or life-threatening) adverse events in the indinavir/r arm compared to 45 events in the Fortovase/r arm. Only two patients in each arm discontinued due to virological failure. Thirty-one patients in the indinavir/r arm withdrew from the trial due to toxicity compared to 12 patients in the Fortovase/r arm.

"We believe that this investigational combination will maximise the efficacy of Fortovase while minimising the toxicity of ritonavir," reports Andrew Hill, International Medical Manager, Roche. "The significant wealth of positive data coming from several recent trials consistently support the Fortovase/r regimen at this new dose. These results suggest that a good safety profile is extremely important in determining long term success of HIV treatment. We are fully committed to finding and delivering more effective healthcare solutions to people living with HIV, and we hope this new boosted protease regimen will provide a further treatment option to patients."

- ENDS -

* The three boosted protease inhibitors investigated were Fortovase/r, indinavir/r and lopinavir/r.

For more information on the MaxCmin1 trial, please see http://www.cphiv.dk/maxcmin/

Further supportive evidence recently published by Dr.Agnes Veldkamp confirms the effective new boosted dose of Fortovase/r - 1000/100mg twice-daily. When compared to historical control data with a 400/400mg regimen, the 1000/100mg dose twice-daily provided higher plasma levels of saquinavir. JAIDS 27: 344-349

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