Invirase 500 mg provides a potent, well-tolerated and convenient treatment regimen
Basel, 18 November, 2005. New European Guidelines for the Clinical Management and Treatment of HIV Infected Adults published today recommend boosted Invirase� (saquinavir mesylate) as a first choice protease inhibitor for patients starting antiretroviral treatment.1 A twice daily dose of saquinavir/ritonavir 1000/100 mg in combination with other antiretrovirals offers physicians and patients proven effective control of the HIV virus.2,3 Furthermore, Invirase is now available in a more convenient dosing schedule as the recently approved 500 mg formulation reduces the daily Invirase pill count from ten to four tablets.
The new evidence-based guidelines published in November to coincide with the 10th European AIDS Conference in Dublin, result from the comparison of guidelines from several European countries as well as from panel discussions with representatives from more than ten countries. �The recognized efficacy and tolerability of boosted Invirase together with the convenience of the new 500 mg formulation position it as one of the preferred boosted protease inhibitors for patients starting their antiretroviral therapy� says Fran�ois Raffi, Professor of Infectious and Tropical Diseases, University Hospital Hotel-Dieu in Nantes, France, and member of the EACS guidelines panel.
Invirase is also recommended as a first line boosted protease inhibitor in the International AIDS Society (IAS) guidelines which gave it the highest possible clinical evidence based rating.4 The Invirase 500 mg formulation received approval from the US Food and Drug Administration (FDA) in December 2004 and from the European Commission in May 2005.
About Boosted Invirase
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 (�boosting�) and enables simplified dosing.
The Invirase 500 mg formulation received approval from the US Food and Drug Administration (FDA) in December 2004 and from the European Commission in May 2005. The new formulation significantly simplifies the Invirase dosing regimen by reducing the daily tablet count by more than half, from five tablets twice-daily to two tablets twice-daily.
Boosted Invirase provides exceptional and well proven control of HIV.5 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 (<50 HIV RNA copies/ml). Over the 24 week induction phase of the study, these reductions in patient viral load were accompanied by a median increase of CD4 cells of 109 cells/mm3.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world�s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people�s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. For further information: www.roche.com
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More information
-Roche in HIV: www.roche.com/pages/downloads/company/pdf/mbhiv05e.pdf
-Roche and HIV: www.roche-hiv.com
-Healthkiosk: HIV, AIDS: www.health-kiosk.ch/start_aids.htm
Media Relations Contacts
Dr Nina Hautzinger at Roche:
Telephone: +41 (0) 61 688 13 65
Mobile: +41 (0) 79 593 43 07
E-mail: nina.hautzinger@roche.com
Rosemary Hennings at Galliard Healthcare:
Telephone: + 44 (0) 207 663 2253
Mobile: + 44 (0) 779 941 1325
E-mail: rhennings@galliardhealth.com
References:
1. European Guidelines for the Clinical Management and Treatment of HIV Infected Adults in Europe 2005. Produced by the European AIDS Clinical Society (EACS).
2. Dragsted UB, Gerstoft J, Pedersen C et al. JID. 2003; 188:635-642.
3. Dragsted et al. Antivir Ther 2005; 10:735-743
4. Yeni PG, Hammer SM, Hirsch MS et al. JAMA 2004; 292/2:251-265.
5. Ananworanich J et al. Antiviral Therapy 2005; 10(6): 761-767
