Roche advocates development of HIV drug potency guidelines to help physicians make optimal treatment decisions

Glasgow, UK, 23 October, 2000 - F. Hoffmann-La Roche, makers of the anti-HIV agents Fortovase® (saquinavir) and Viracept® (nelfinavir*), has called on developers of other protease inhibitors to agree to a world-wide standardisation of measures of drug potency in vitro so helping physicians to make optimal treatment decisions.

Roche's call to action has been prompted by the current level of confusion amongst physicians about the relative potencies of boosted protease inhibitors (PIs) that has resulted from varying laboratory methodologies and analyses. In light of this confusing situation, Roche is inviting other PI manufacturers to participate in an initial 'Standardisation Forum' before the end of March 2001 to take the first steps towards the development of guidelines that will attempt to resolve this issue.

Professor Julio Montaner, British Columbia Centre for Excellence in HIV and AIDS, Vancouver, Canada, supports this action by Roche. “I am very keen to see companies acting responsibly to help physicians and their patients to make clear comparisons between different drugs through better understanding of the in vitro potency data and its limitations. At present, there is no doubt that potency data, particularly for PIs, is very confusing and this is not in the interests of those living with HIV. I hope that other pharmaceutical companies join Roche’s initiative to standardise potency measurements so we can help physicians achieve the task of therapeutic management more efficiently.”

*Excluding North America
Roche's commitment to provide clarity on this issue is illustrated by the fact that it has already begun its own in vitro studies in an attempt to compare the potencies of Fortovase® (saquinavir) and lopinavir (Abbott, ABT-378). These studies looked at the potency of both drugs side by side across a variety of laboratory conditions and against a variety of different PI-resistant viral strains.1

In addition to these in vitro studies, Roche has also been quick to provide support for the Copenhagen HIV Investigator Program (CHIP) that is currently undertaking a head-to-head clinical study of Fortovase® boosted with ritonavir versus indinavir boosted with ritonavir. The results of this study are expected mid-2001.

Dr Andrew Hill, International Medical Manager for Fortovase® at Roche, comments: “The issue of drug potency data, which at best is difficult to interpret and at worst is very misleading, must be addressed with urgency. At present it is a mistake to believe that comparisons of PI potency can easily be made as there is simply too much variation in methodology and analyses. Clearly this variation can lead to false assumptions about which PI is best, which is neither in the best interests of patients nor the physicians who are facing complex treatment decisions. Therefore, Roche will be approaching other companies with our proposal and we look forward to a positive response from them in the name of improved service to our shared customers - patients and their physicians.”

1. Craig C et al. Antiviral efficacy and effects of protein binding on HIV proteinase (PR) inhibitors (PI). Abstract 290. 5th International Congress on Drug Therapy in HIV Infection, Glasgow, UK, 22-26 October 2000.

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Editor's Notes
Protease inhibitors (PIs) are the class of drugs which brought about a revolution in the management of HIV. Over the past year PIs have been undergoing a revolution of their own with the new approach of ‘boosting’ them with ritonavir to achieve even more robust drug levels and more convenient dosing regimens. This revolution has led to the different pharmaceutical companies re-evaluating the predicted potency of their compounds. However, the differing laboratory conditions used in this evaluation process has led to a confusion as to the relative potency of these drugs.