Study of 1309 patients shows maintenance of viral suppression out to three years with 88% patients remaining on their Viracept regimen.

Buenos Aires, Argentina, July 9 2001 - Results reported today from a study of 1,309 patients on Viracept^â therapy demonstrated potent and effective viral suppression (69% achieving viral loads of less than 400 copies of viral RNA) at three years of treatment, regardless of initial baseline CD4 cell count. Equivalent and substantial replenishment of CD4 cells (an immune cell important in HIV infection) was seen regardless of the patient’s CD4 cell count at initiation of treatment or previous use of antiretroviral therapies.

‘Real and durable benefits of Viracept in such a large group of patients are very promising. Excellent compliance was seen with 88% of this sizeable group still remaining on Viracept based combination therapy after 3 years’ said Dr Frank Palella, Asst. Prof. of Medicine, Director, Sexually Transmitted Diseases Clinic, North Western University Medical School, Chicago. ‘This long term data adds to the current wealth of Viracept data reinforcing its established efficacy, safety and tolerability.’

The retrospective study was designed to profile long-term immunologic and virologic outcomes among patients receiving antiretroviral therapy with Viracept as a single Protease Inhibitor (PI) with dual NRTIs in first ever HAART. Of the 1,309 patients 718 were naive to antiretroviral therapy and 591 had experienced previous antiretroviral therapy.

For those people who at the initiation of the study had high viral loads (VL greater than 5 log 10 - over 100,000 copies of viral RNA) seven out of ten achieved substantial reductions (reduced to levels of less than 400 copies of viral RNA). From the starting point to the most recent measurement of mean CD4 cell count a substantial increase of 230 cells was observed.

Dr Hernando Knobel, Medical Doctor of the Infectious Diseases department, Hospital del Mar, Barcelona, Spain reported from the IAS meeting on the results of a Spanish multicentric hospital based study of 1063 patients naïve to protease inhibitors where 606 patients were placed on a twice daily regimen of Viracept and 457 on a three times daily dosing schedule. The study demonstrates that a twice-daily (BID) dosing schedule of the protease inhibitor (PI) Viracept produced an effective and durable antiviral response similar to a three-times daily (TID) dosing schedule as measured by HIV-RNA suppression (reductions in viral load) and CD4 cell count increase. Both regimens were well tolerated.

‘We are delighted to observe twelve months of durable, effective and well tolerated treatment provided by a twice daily dosing schedule of combination therapy containing Viracept in a hospital setting. Seeing 71 percent of the BID patients with viral loads suppressed below 500 copies of viral RNA at this stage and 71 percent still adhering to treatment is great news’ said study investigator Dr. Hernando Knobel. ‘A twice daily dosing regimen for Viracept will clearly help people living with HIV in their efforts to adhere with these complex treatment programmes and have more freedom in their daily lives.’

In addition to FDA approval Viracept has recently received marketing authorization from the European Commission (8 June 2001) for a twice daily dosage regimen in adult patients. Viracept is a leading HIV protease inhibitor (PI), a class of drug associated with a significant drop in mortality and opportunistic infections among people living with HIV.

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