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Invirase and PPIs

Updated Resistance Profile

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Updated Resistance Profile

HIV Doesn’t Stop Them. Their Meds Shouldn’t.

New clinical cut-offs more accurately predict clinical response to boosted INVIRASE

Many resistance laboratories use clinical cut-offs which are based on unboosted saquinavir data
INVIRASE/r may be labeled ‘resistant’ when it in fact it may offer a viable treatment
A number of laboratories have recently updated their cut-offs to better predict the clinical response to treatment with ritonavir-boosted INVIRASE
The updatedresistance profile supports boosted INVIRASE as a powerful option for an initial boosted-PI based regimen

New clinical cut-off for PhenoSense™

The PhenoSense (Monogram Biosciences) defines a 12.0-fold change in IC 50 as the upper clinical cut-off for boosted INVIRASE. Loss of virologic response (>80%) to ritonavir-boosted saquinavir is expected only in virus samples exceeding this 12.0-fold change ¹

New virtual phenotype cut-offs for virco ® TYPE HIV-1 ^2,3

The virco TYPE HIV-1 Resistance Analysis defines a 26.5-fold change in IC 50 as the upper clinical cut-off for boosted saquinavir. Loss of virologic response (>80%) to saquinavir is expected only in virus samples exceeding this 26.5-fold change ²
Virtual phenotype compares viral genotype with a reference database of paired genotypes and phenotypes; it has been shown to have similar clinical utility to actual phenotype ³

High genetic barrier to boosted saquinavir

The introduction of ritonavir boosting has improved the potency of PI-based HAART, limiting the emergence of PI resistance and lessening the clinical impact of PI resistance mutations ⁴
Resistance to unboosted saquinavir associated with two major protease mutations: L90M + G48V
However, multiple mutations are required for a significant loss in susceptibility to boosted saquinavir

INVIRASE 500

More Than 10 Years of Study and Clinical Experience With Saquinavir

PhenoSense is a registered trademark of Monogram Biosciences Inc.

Virco is a registered trademark of Virco BVBA.

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	Click here for Complete Product Information. Indication 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 MaxCMin 1 study and pharmacokinetic data. The efficacy of INVIRASE with ritonavir or FORTOVASE (with or without ritonavir coadministration) has not been compared against the efficacy of antiretroviral regimens currently considered standard of care. Important Safety Information
	WARNING: INVIRASE® (saquinavir mesylate) capsules and tablets and FORTOVASE® (saquinavir) soft gelatin capsules are not bioequivalent and cannot be used interchangeably. INVIRASE may be used only if it is combined with ritonavir, which significantly inhibits saquinavir's metabolism to provide plasma saquinavir levels at least equal to those achieved with FORTOVASE. When using saquinavir as the sole protease inhibitor in an antiviral regimen, FORTOVASE is the recommended formulation.
	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 unboosted saquinavir, 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 FORTOVASE (1000 mg) in combination with ritonavir (100 mg) and other antiretrovirals, the grade 2, 3 and 4 adverse events occurring in ≥ 5% of patients included: lipodystrophy (5.4%), nausea (10.8%), vomiting (7.4%), diarrhea (8.1%), abdominal pain (6.1%), fatigue (6.1%) and pneumonia (5.4%) INVIRASE is not a cure for HIV infection or AIDS. INVIRASE does not prevent the transmission of HIV.
	THIS SITE IS INTENDED FOR U.S. AUDIENCES ONLY. Copyright © 2004-2009 Roche Laboratories Inc. All rights reserved. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Statement.


	Click here for Complete Product Information.

	THIS SITE IS INTENDED FOR U.S. AUDIENCES ONLY. Copyright © 2004-2009 Roche Laboratories Inc. All rights reserved. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Statement.
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