New study results support use of boosted Invirase for patients starting HIV treatment
Basel, July 25, 2005. Starting treatment of HIV infection with Roche�s protease inhibitor Invirase� (saquinavir mesylate) boosted with a small dose of ritonavir is not associated with the development of resistance. This was the conclusion of a study presented today at the 3rd IAS Conference on HIV Pathogenesis and Treatment being held in Rio de Janeiro, Brazil.1
This is good news for physicians and HIV patients, as resistance to treatment is one of the major problems they face in trying to control the disease. HIV can become resistant to an anti-HIV drug, or combinations of drugs, because the virus reproduces at such a rapid rate that mutations occur, allowing the virus to partly, or fully, resist the effects of treatment.
Commenting on the new results, lead investigator of the study Dr. Jintanat Ananworanich of the HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand said, �We know that the antiviral efficacy of Invirase is excellent. The good news now is that we also know that we can start treatment with Invirase early and deliver an outstanding level of HIV suppression, without the development of problematic protein resistance.�
The new data come from the Staccato study which has already shown exceptional reduction in viral load. 2 The results strongly support the use of Invirase, a powerful and well-tolerated protease inhibitor, as part of combination therapy when patients begin treatment of their HIV infection.
Roche recently announced the European marketing approval for its new 500 mg formulation of Invirase. The new convenient 500 mg tablet simplifies the dosing regimen for patients by reducing the daily tablet count by more than half, from five tablets twice-daily to two tablets twice-daily, plus ritonavir.
About the STACCATO study (Swiss-Thai-Australia Treatment Interruption Trial)
The 258 antiretroviral (ART)-na�ve patients with a baseline CD4 count of 200�350 cells/mm3 received Invirase/ritonavir 1600/100 mg once-daily plus 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 6 months. Viral load failure was defined as two consecutive viral loads >500 copies/ml after 12 weeks of therapy.
The results showed there was a low incidence of viral failure. Only 10/258 (3.9%) patients experienced viral failure after a median of 29.6 weeks. None of these patients developed significant mutations of the HIV protease gene.
For further information please contact:
Dr. Nina Hautzinger at Roche:
Telephone: +41 (0) 61 688 13 65
Mobile: +41 (0) 79 593 43 07
Diane Lorton at Galliard Healthcare:
Telephone: +44 (0) 207 663 2265
Mobile: +44 (0) 7811 358 698
Notes to editors
References
1. Ananworanich J, Ruxrungtham K, Sirivichayakul S et al, 3rd IAS Conference on HIV Pathogenesis and Treatment; Rio de Janeiro, Brazil 24-27 July 2005: Poster WePe4.4C12
2. Ananworanich J, Ruxrungtham K, Siangphoe U et al, XV IAC; Bangkok 11-16 July 2004: Poster TuPeB4469
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About Invirase
Invirase�/r (saquinavir 1000/ritonavir 100mg twice daily) has shown high efficacy, an excellent safety and tolerability profile and is recommended as first choice boosted protease inhibitor in the International AIDS Society (IAS) guidelines. With the new Invirase� 500, the daily Invirase� pill count is reduced by more than half from 5 capsules twice-daily to 2 tablets twice-daily (plus one 100 mg capsule of ritonavir per dose of Invirase). Reducing the number of Invirase� pills people with HIV take each day is good news because it further simplifies the use of this very potent and well tolerated protease inhibitor.
About Roche in HIV
Invirase� (saquinavir) was the first protease inhibitor (PI) and was introduced by Roche in 1995. Invirase� 500, the new 500 mg formulation of Invirase�, received U.S. Food and Drug Administration (FDA) marketing approval in December 2004 and was approved by the European Authorities in May 2005.
Viracept (nelfinavir), a widely used protease inhibitor (PI), was launched as a 250 mg tablet in Europe in 1998. Viracept is supplied by Roche outside the USA, Canada, Japan and Korea.
Fuzeon� (enfuvirtide) received approval from the US Food and Drug Administration (FDA) in March 2003, from the European Commission and Switzerland in May 2003 and Canada in July 2003.
In addition, Roche successfully markets the AMPLICOR HIV-1 MONITOR TEST, version 1.5. This test from Roche Diagnostics is considered to be a highly sensitive measurement of the amount of HIV circulating in a patient�s blood (�viral load�). With a limited number of treatment regimens available, the accurate monitoring of viral load levels is essential to establish and monitor the effectiveness of therapeutic regimens and assess the potential onset of drug resistance.
Roche is a committed partner of the Accelerating Access Initiative to increase access to HIV care in sub-Saharan Africa and the world's Least Developed Countries. For more information on Roche policy and pricing of HIV protease inhibitors for these regions and research in HIV, visit the website.
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 some 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
