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Biopharmaceuticals HIV/AIDS

 News Release - November 13, 2006

Interim Analysis of New Study Suggests Boosted INVIRASE(R) May Achieve Similar Levels of HIV Suppression to Boosted Lopinavir with a Favorable Lipid Profile

NUTLEY, N.J., Nov. 13 (HSMN NewsFeed) -- Encouraging results from an interim analysis of a new study suggest that the boosted protease inhibitor (PI/r) INVIRASEŽ 500 mg/r (saquinavir mesylate) has the potential to achieve comparable levels of viral suppression to the most commonly used PI, lopinavir/r (KaletraŽ), with less lipid elevation. The results are from a planned 24-week interim analysis of 150 patients from the Gemini study, presented today at the Eighth International Congress on Drug Therapy in HIV Infection (HIV-8) in Glasgow, Scotland. These interim findings have potential beneficial implications for many HIV patients, who experience elevated cholesterol and triglycerides as common side effects of some antiretroviral (ARV) treatments.

"These preliminary results suggest that boosted INVIRASE has the power to control the virus in treatment-naīve patients, while also managing their lipid profile," said Jihad Slim, M.D., Infectious Disease Specialist at St. Michael's Medical Center in Newark, New Jersey and lead investigator of the Gemini study. "If the final results show that boosted INVIRASE maintains its ability to suppress the virus with a good lipid profile, it could become a preferred choice for some patients, especially those troubled by treatment side effects."

Now that patients are remaining on effective HIV treatment for longer periods of time, managing the disease includes more than just treating the virus. It is essential that other factors that affect patient quality of life, such as high cholesterol and adverse gastrointestinal (GI) events, are considered.

About the Gemini Study

The Gemini study is a Phase IIIb multi-center, randomized, open-label, 48- week study, designed to evaluate the efficacy and safety of INVIRASE 500/r vs. lopinavir/r. These treatments are given at their approved twice-daily dosages in combination with two nucleoside reverse transcriptase inhibitors (emtricitabine/tenofovir [TruvadaŽ], once daily) in treatment-naīve adults. The Gemini study enrolled 337 patients from Canada, France, Puerto Rico, Thailand and the United States. The primary efficacy endpoint of the trial is the number of patients with an HIV-1 RNA viral load of less than 50 copies/mL at week 48. There are two planned interim analyses.

The interim data suggest that treatment-naīve patients on either boosted INVIRASE or boosted lopinavir achieved a comparable level of viral suppression (69.4 percent vs. 75.3 percent, respectively, with less than 50 copies/mL at week 24). The data also suggest favorable lipid profile as measured by increase in incidence of high cholesterol (greater than 200 mg/dl) or high triglycerides (greater than 400 mg/dl):

* Only four percent of INVIRASE 500/r patients developed high cholesterol compared with 25 percent of lopinavir/r patients

* Only one percent of INVIRASE 500/r patients developed high triglycerides compared with nine percent of lopinavir/r patients

Importantly, fewer GI adverse events were seen in the INVIRASE 500/r arm (14 percent vs. 23 percent) with lower incidence of nausea and diarrhea.

About INVIRASE

INVIRASE in combination with ritonavir and other antiretroviral agents is indicated for the treatment of HIV infection. The twice-daily administration of INVIRASE in combination with ritonavir is supported by safety data from the MaxCMin1 study and pharmacokinetic data. The efficacy of INVIRASE with ritonavir has not been compared against the efficacy of antiretroviral regimens currently considered standard of care.

INVIRASE is contraindicated in patients with clinically significant hypersensitivity to saquinavir or to any of the components contained in the capsule. INVIRASE/ritonavir should not be administered concurrently with terfenadine, cisapride, astemizole, pimozide, triazolam, midazolam or ergot derivatives. Inhibition of CYP3A4 by saquinavir could result in elevated plasma concentrations of these drugs, potentially causing serious or life- threatening reactions, such as cardiac arrhythmias or prolonged sedation.

INVIRASE when administered with ritonavir is contraindicated in patients with severe hepatic impairment. Patients with hepatic impairment have not been studied and caution should be exercised when prescribing saquinavir in this population. Concomitant use of INVIRASE with lovastatin or simvastatin is not recommended. Caution should be exercised if HIV protease inhibitors, including INVIRASE, are used concurrently with other HMG-CoA reductase inhibitors that are also metabolized by the CYP3A4 pathway (eg, atorvastatin).

Concomitant use of INVIRASE and St. John's wort (hypericum perforatum) or products containing St. John's wort is not recommended. Garlic capsules should not be used while taking saquinavir as the sole protease inhibitor, due to the risk of decreased saquinavir plasma concentrations. For a complete list of drugs that should not be taken with saquinavir, please see TABLE 5 in the summary of complete product information.

New-onset diabetes mellitus, exacerbation of preexisting diabetes mellitus and hyperglycemia have been reported during postmarketing surveillance in HIV- infected patients receiving protease-inhibitor therapy. No initial dose adjustment is necessary for patients with renal impairment. However, patients with severe renal impairment have not been studied, and caution should be exercised when prescribing saquinavir in this population. There have been reports of spontaneous bleeding in patients with hemophilia A and B treated with protease inhibitors.

Elevated cholesterol and/or triglyceride levels have been observed in some patients taking saquinavir in combination with ritonavir. Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy. A causal relationship between protease- inhibitor therapy and these events has not been established, and the long-term consequences are currently unknown.

Varying degrees of cross-resistance among protease inhibitors have been observed. In clinical trials with saquinavir (1000 mg) in combination with ritonavir (100 mg) and other antiretrovirals, the grade 2, 3 and 4 adverse events occurring in greater than or equal to 2% of 148 patients (considered at least possibly related to study drug or of unknown relationship): abdominal pain (6.1%), back pain (2%), bronchitis (2.7%), constipation (2%), diarrhea (8.1%), diabetes mellitus/hyperglycemia (2.7%), dry lips/skin (2%), eczema (2%), fatigue (6.1%), fever (3.4%), influenza (2.7%), lipodystrophy (5.4%), nausea (10.8%), pneumonia (5.4%), pruritus (3.4%), rash (3.4%), sinusitis

(2.7%) and vomiting (7.4%).

INVIRASE is not a cure for HIV infection or AIDS. INVIRASE does not prevent the transmission of HIV.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or www.roche.us.

KaletraŽ is a registered trademark of Abbott Laboratories

TruvadaŽ is a registered trademark of Gilead Sciences, Inc.


Source: Roche

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