PRNewswire - November 22, 2002

Results from MaxCmin2

To preserve the integrity of the trial, which is designed to follow patients for 48 weeks, the trial's steering committee did not present efficacy results by treatment arm at 24 weeks. Therefore, efficacy results for the overall study population were presented. The "on treatment" analysis, which evaluates patients who completed the 24-week treatment period, showed that 90 percent of 326 patients in the study achieved HIV levels of less than 400 copies/mL. The "intent to treat" (ITT) analysis, which includes all patients who received at least one dose and considers patients who may have discontinued the assigned therapy as treatment failures, show that 77 percent of patients in the study had an HIV viral load of less than 400 copies/mL. Patients experienced a mean CD4 cell increase of 100 cells/ul.

Nineteen patients in the lopinavir/ritonavir arm experienced a severe (Grade 3 or 4) event at least possibly related to study drug, compared to 14 patients in the boosted saquinavir arm. The number and type of severe drug-related adverse events in the lopinavir/ritonavir and boosted saquinavir arms, respectively, included: gastrointestinal (6 and 3), pulmonary (2 and 0), cardiovascular (1 and 0), nervous system (2 and 1), fatigue and/or fever (2 and 1), laboratory (4 and 5), and other (2 and 4).

More About MaxCmin 2

The MaxCmin 2 trial is the largest clinical trial to date to directly compare two boosted protease inhibitor regimens. The trial was designed and is being coordinated by the Copenhagen HIV Programme. This trial included 339 protease inhibitor-experienced or naive patients from the U.S., Europe, Canada and Argentina, randomized 1:1 to receive either boosted saquinavir or lopinavir/ritonavir. (Patients randomized to the boosted saquinavir arm started on FORTOVASE(R) and had the option to switch to INVIRASE(R).) The primary objective of the study is to address whether there is a difference in the incidence of virological failure for the lopinavir/ritonvir arm relative to the boosted saquinavir arm at 48 weeks.

"Boosting" Protease Inhibitors

Co-administering saquinavir with a low dose of ritonavir ("boosting") is an approved treatment strategy in the European Union. By using low, "non-therapeutic" doses of ritonavir, the metabolism of saquinavir can be inhibited, resulting in higher and more consistent levels of the "therapeutic" protease inhibitor.

More About Saquinavir Soft Gel Capsules (FORTOVASE)

The most frequently reported adverse events at least possibly related to treatment with saquinavir soft gel capsules and of at least moderate intensity - observed in trials evaluating the approved 1200 mg three-times-daily dosing regimen - include nausea (17.8 percent), diarrhea (15.6 percent), abdominal discomfort (13.3 percent) and dyspepsia (8.9 percent). Saquinavir soft gel capsules should not be co-administered with astemizole, terfenadine, ergot derivatives, cisapride, midazolam or triazolam, due to the potential for serious and/or life-threatening events. Concomitant use with lovastatin or simvastatin is also not recommended; caution should be exercised with other HMG-CoA reductase inhibitors metabolized by the CYP3A4 pathway. Exacerbation of chronic liver dysfunction has been reported in patients treated with saquinavir soft gel capsules. Patients should be informed that redistribution or accumulation of body fat may occur in patients receiving protease inhibitors and that the cause and long-term health effects of these conditions are not known at this time. There have also been reports of hyperglycemia, new onset or exacerbation of diabetes and of spontaneous bleeding in patients with hemophilia. Please refer to the complete product information for detailed safety information for saquinavir soft gel capsules.

More About Saquinavir Hard Gel Capsules (INVIRASE)

Saquinavir hard gel capsules deliver the same active ingredient as saquinavir soft gel capsules, and the safety and drug interaction information provided above for saquinavir soft gel capsules also applies to saquinavir hard gel capsules. The saquinavir hard gel capsules product labeling warns that saquinavir hard gel capsules and saquinavir soft gel capsules are not bioequivalent and cannot be used interchangeably. When using saquinavir as part of an antiviral regimen saquinavir soft gel capsules is the recommended formulation. In rare circumstances, saquinavir hard gel capsules may be considered if it is to be combined with antiretrovirals, such as ritonavir, that significantly inhibit saquinavir's metabolism.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. prescription drug unit of the Roche Group, a leading research-based health care enterprise that ranks among the world's leaders in pharmaceuticals, diagnostics and vitamins. Roche discovers, develops, manufactures and markets numerous important prescription drugs that enhance people's health, well-being and quality of life. Among the company's areas of therapeutic interest are: dermatology; genitourinary disease; infectious diseases, including influenza; inflammation, including arthritis and osteoporosis; metabolic diseases, including obesity and diabetes; neurology; oncology; transplantation; vascular diseases; and virology, including HIV/AIDS and hepatitis C.

For more information on the Roche pharmaceuticals business in the United States, visit the company's website at: http://www.rocheusa.com.

Kaletra(TM) is a registered trademark of Abbott Laboratories

For further information about saquinavir:

Patients can call: (800) 910-4687

Healthcare Professionals: (800) 526-6367

Roche HIV Therapy Assistance Program: (800) 282-7780

Saquinavir soft gel capsules Web site: http://www.Fortovase.com

For a copy of the FORTOVASE or INVIRASE product package inserts with complete prescribing information please call: Heather Van Ness at (973) 562- 2203.

SOURCE Roche

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Always watch for outdated information. This article first appeared in 2002. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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