Algorithms Evaluated by IAPAC Norvir Advisory Committee
Comments from Joel Gallant, MD, Infectious Diseases, John Hopkins HospitalHere are my comments on the Fortovase algorithm: Left branch of algorithm:
NFV should NOT be recommended as a PI for patients failing RTV/SQV. It doesn't work. For that matter, neither should IDV. No one knows what to do about RTV/SQV failures, but it's certainly going to involve something other than simply changing protease inhibitors and using new RTIs. (By the way, the inconsistent use of generics, brand names, abbreviations, and full names in this algorithm should be fixed--e.g. "CRIX," "NLF" (should be NFV), "RIT" (should be RTV), and "INVIRASE.") Also, why would we recommend that people stay on RTV/Invirase, when Fortovase is available?
This algorithm is inconsistent with the Stadtlanders algorithm*. Why would you switch from RTV/SQV to Fortovase? Why not to NFV or IDV, or NFV/FTV? Also, SPICE does not support intensification with NFV, it supports intensification of NFV/SQV with nucleosides--very different.
Right branch of algorithm:
No matter what happens here, Fortovase ends up as the choice, even in patients who are doing well on RTV/SQV as a salvage regimen and who've never been on indinavir. For the most part, people on RTV/SQV as a salvage regimen will have failed either IDV or NFV, in which case they should make EVERY attempt to remain on the drug regimen that's working. There's probably more evidence supporting IDV as a salvage regimen for NFV failure than there is for FTV alone.
*Stadtlanders algorithm to be posted 9/18/98.
IAPAC's Request to Bob Posch at Hoffmann-LaRoche for Information Regarding the Fortovase Algorithm (August 20, 1998)We are launching an International Norvir Advisory next week on our Web site that is under the direction of the IAPAC Norvir Advisory Committee, the members of which are listed in the enclosed attachment. One of the items scheduled to be featured on the site will be recommendations for changes in therapeutic regimens of patients on Norvir therapy when such changes are appropriate. The attached algorithm recommending Fortovase was sent tome by a physician for comment. We are sending it to the committee this afternoon for their review and comments. The algorithm and the committee's comments will be posted on the new Norvir Advisory site. Dr. Farthing prefers to have the source of the algorithm identified.
It is necessary to document whether this is an official Roche document, a document prepared by your public relations firm, or a document prepared by the local representative with or without official company approval. Unfortunately, there is no formal identification on the document. Could you provide me with this information?
Response to IAPAC's Inquiry Regarding the Fortovase Algorithm from Amy Sunshine, Hoffmann-LaRoche Inc. (September 3, 1998)
On July 27, Abbott Laboratories announced manufacturing difficulties with their HIV protease inhibitor, Norvir (ritonavir) capsules, which will result in a shortage. In the interim, Abbott is supplying a liquid formulation of Norvir until production of capsules can resume. Hoffmann-La Roche would like to express its support for those people who are living with HIV/AIDS and are affected by this situation and Roche products.
Since the Abbott announcement, health care providers and treatment educators have raised questions about how to advise the many people living with HIV/AIDS who currently take Norvir in combination with Roche antiviral therapeutics, including Fortovase (saquinavir) and Invirase (saquinavir mesylate). To this end, Roche created educational materials to assist Roche employees who interact regularly with health care providers and the AIDS treatment community and who now must field inquiries and concerns regarding the Norvir situation.
These educational materials emphasize the continuity of care and the importance of individualized treatment. Patients using Norvir should contact their health care provider to discuss their treatment regimen in light of the development with ritonavir capsule production. Since every patient has his or her own treatment history, Roche cannot advise any specific patient on a course of action or make any dosing recommendations. Additionally, these educational materials were only developed to provide information on treatment regimens involving Roche HIV/AIDS therapeutics because Roche is not at liberty to provide guidelines that encompass other pharmaceutical companies' therapeutics.
However, immediately after the Abbott announcement, Roche convened a panel of expert AIDS treating physicians to develop an independent set of guidelines relating to the Norvir situation. This panel will meet to discuss the most recent developments in relation to Norvir and begin work on these treatment guidelines.
Charles Farthing's Request to Bob Posch, Hoffmann-LaRoche, for Information Regarding the Fortovase Algorithm (September 9, 1998)
September 9, 1998
Thank you for sending IAPAC Amy Sunshines statement which will be included with all of the related documents on the Roche algorithm in the IAPAC Norvir Advisory. The statement may benefit from some clarification. Would you respond to the following questions?
As we all know, information developed for physicians also gets into the hands of patients in similar ways that materials developed for marketing employees may get into the hands of physicians. The IAPAC Norvir Advisory Committee would welcome the opportunity of publishing the treatment guidelines developed by the Roche committee. This Web site forum for the open review and comments on all treatment guidelines would be helpful to many affected by HIV disease and physicians who care for them.
We are addressing similar questions to Standtlanders on their algorithm. Your assistance in clarifying these issues will be deeply appreciated.
Comments from other Committee members will be added as they are received.