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Treatment News

June/July 2002


Protease Inhibitors Compared: Studies Examine Dosing, Cholesterol Levels Among Patients Using Fortovase, Invirase

Article: T-20, Protease Inhibitors in the News

New information regarding the widely used protease inhibitors Fortovase and Invirase was announced in April by Roche Pharmaceuticals.

Clinical trial patients who increased their daily dose of Fortovase and decreased their dose of Norvir were able to maintain viral suppression (under 400 copies of virus) as well as reduce cholesterol and triglyceride levels. Currently, many individuals who take these medications experience an enormous rise in cholesterol and triglycerides, which may lead to cardiac arrest.

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Only 21 participants were studied in this trial, which randomized individuals to receive 400 mg of Fortovase along with 400 mg of Norvir or receive 1000 mg of Fortovase along with 100 mg of Norvir. Both arms of this study involved twice-daily regimens.

Results demonstrate that those individuals who took an increased amount of Fortovase and a reduced amount of Norvir had reduced their cholesterol levels from 259 to 227. Their triglyceride levels decreased from 488 to 329. Only 11 participants had been switched over from their original dosing levels.

Of the individuals who took their original regimen (400/400), they had increases in both cholesterol (206 to 231) and triglycerides (210 to 237). All individuals who switched to the new regimen had suppressed viral loads, while all but four individuals had sustained viral suppression.

Another study showed that individuals might benefit from taking Invirase as opposed to taking Fortovase. Both medications are taken with a small dose of Norvir to boost the bioavailability.

In a substudy conducted in Thailand, participants who had been using Fortovase/r (1,600 mg/100 mg) as part of their regimen were switched to Invirase/r and showed higher levels of drug in their system. Both medications are different formulations of saquinavir. The difference is that Invirase may be better tolerated, has smaller pills, and does not need any refrigeration.


T-20 Study Data Promising

Results from a 24-week Phase III trial of T-20, an experimental HIV fusion inhibitor, have been announced by Roche Pharmaceuticals and Trimeris.

When patients in the study used T-20 along with their current antiretroviral medications, a significant reduction in the amount of virus in the blood was seen. This study was conducted with treatment-experienced individuals who had previously become resistant to each of the approved classes of medications used to treat HIV infection.

Two groups of patients were studied. One group took their personal HIV regimen with T-20 and the other group took their medications but without T-20. Results indicate those who took their daily regimens along with T-20 had a higher reduction in viral load (1.7 logs) as compared to those who did not use T-20 (0.76 log reduction).

Since T-20 can only be injected and is not available in pill or tablet formulations, side effects included site injection reactions. Three percent of the study participants discontinued therapy with T-20 because of this side effect.

T-20 is not currently available for use outside of a clinical trial setting, but may be available soon through compassionate use or open-label safety programs. Since these results are only based on 24-week data, more information is needed in order to determine the efficacy and safety of T-20.

Ernie RodriguezErnie Rodriguez manages AIDS Project Los Angeles' Treatment Education Program. He can be reached by calling (213) 201-1486 or by e-mail at erodriguez@apla.org.


Back to the June/July 2002 issue of Positive Living.


This article has been reprinted at The Body with the permission of AIDS Project Los Angeles (APLA).




  
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This article was provided by AIDS Project Los Angeles. It is a part of the publication Positive Living.
 

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