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New Invirase® Data Demonstrate Undetectable Viral Load in 91% of Patients; Clinical trial demonstrates high potency combined with good tolerability

BANGKOK, Thailand, July 13 /PRNewswire/ -- Data from a new study with the HIV protease inhibitor Invirase® (saquinavir mesylate) has demonstrated the best HIV RNA response yet seen in a large group of HIV-infected patients given highly active antiretroviral therapy.(1-8)

The data announced today at the XV International AIDS Conference in Bangkok show that a convenient once daily regimen of boosted Invirase® plus 2 NRTIs delivers excellent antiviral potency:

* 96% of patients achieving HIV RNA levels of

Commenting on the results, Michael S. Saag, Professor of Medicine and Director, UAB AIDS Outpatient Clinic, Birmingham, Alabama, USA said, "The antiviral efficacy of Invirase shown in this study is the best we have seen across similar HAART studies. The good news for patients is that the outstanding level of HIV suppression achieved is also combined with good tolerability."

The data are reported from the induction phase of the STACCATO study in which once daily Invirase/r 1600/100 mg + 2 NRTIs was administered to 167 treatment-naive HIV-infected patients for 24 weeks.

The STACCATO study is being conducted in participation with the HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT). Dr. Jintanat Ananworanich, coordinator for STACCATO at HIV-NAT said, "These data demonstrate that Invirase, when combined with ritonavir, is a highly active regimen. The level of response we have seen could make a real difference both in terms of clinical outcome and adherence to therapy."

More about the study

The STACCATO study (Swiss-Thai-Australia Treatment Interruption Trial) is an international open label randomized study designed to evaluate the efficacy, safety and tolerability of continuous daily boosted Invirase + two NRTIs versus CD4 cell count guided treatment interruption. Prior to randomisation to the comparative phase of the study patients participate in a 24 week induction study.

The induction study population reported here was made of the first 74 men and 93 women to be enrolled into STACCATO. At the start of the induction study the median HIV RNA was 4.7 log10 copies/ml and median CD4 count 256 cells/mm3. The 2NRTIs used was d4T/ddI which was later changed to Tenofovir/3TC.

Using an intent-to-treat analysis, at 24 weeks the median reduction in HIV RNA was -2.9 log10 copies/ml, with a median CD4 count increase of 109 cells/mm3. Of the 167 patients entered into the study two were lost to follow up. Drug-related adverse events were mostly mild and self limiting; no severe or life-threatening events were recorded.

References: 1. Ananworanich J, Ruxrungtham K, Siangphoe U et al. XV IAC, 2004, poster TuPeB4469 2. Gulick RM, Ribaudo HJ, Shikuma CM et al. New Eng J Med 2004; 350: 1850-1861 3. Podzamczer D, Gathe J, Schwartz R et al. 9th EACS 2003; oral F1/3 4. Raffi F, Saag M, Cahn P et al. 2nd IAS 2002; abstract 38 5. Schurmann D, Gathe J, Sanne I et al. HIV 6, 2002; poster PL14.4 6. Staszewski S, Gallant JE, Pozniak A et al. 10th CROI 2003; poster 564b 7. Van Leth F, Phanuphak P, Ruxrungtham K, et al. Lancet 2004; 363: 1253-1263 8. Walmsley S, Bernstein B, King, M et al. N Engl J Med, 2002, 346: 2039-2046 All trademarks used or mentioned in this release are legally protected. Notes to editors: HIV-NAT

The primary goal of HIV-NAT is to conduct HIV clinical research in Thailand according to the ICH Harmonised Tripartite Guideline and the Declaration of Helsinki for Good Clinical Practice. Studies at HIV-NAT are of several kinds: investigator-initiated to answer locally relevant research questions; participation in pharmaceutical industry sponsored multi-centre trials; collaboration with bodies such as the US National Institutes of Health and operation research conducted as part of the Columbia University MTCT+ initiative and the Thai Red Cross "treat parents and save orphans" project.

HIV-NAT is grateful to patients for their participation in STACCATO and to the following Swiss organizations: Swiss National Science Foundation through the Swiss HIV Cohort Study, State of Geneva, Sidaide Foundation, Wilsdorf Foundation, for financial support. We thank Roche for financial support and supply of Invirase and to Abbott and Gilead for providing ritonavir and tenofovir respectively for use in the study.

For further information please contact: HIV-NAT contact: Dr. Jintanat Ananworanich, HIV-NAT Telephone: +66 2 255 7335 Roche contact: Dr. Nina Hautzinger at F. Hoffmann-La Roche Telephone: +41 (0) 61 688 13 65 Mobile: +41 (0) 79 593 43 07

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