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The forgotten patients
May 27, 2009

Dear Nelson

I am one of those "forgotten patients" who has Isentress resistance and my virus is dual mixed. I have no options besides the Taimed ibalizumab drug but they rejected me for their study because I do not have other drugs to combine it with. What am I going to do? I feel like a few of us are going to be forgotten and die without help. Any compassionate programs out there? What is the FDA and researchers doing for us, the forgotten few?

I am so glad I can ask you that question since you give a damn by being one of us. I bet you are doing some work on this..I truly hope. Let me know can I get involved!

Peter

Response from Mr. Vergel

Dear Peter

I am so glad you asked that question.

Patients with genotypic score of one or zero (GSS=1 or 0 , meaning their virus has developed resistance to all medications except one or zero) are not allowed in current studies (for a logical reasons.) I think now that the deep salvage population is decreasing in the US, we have to be cautious about not having these patients in need (I should include myself in that group) fall through the cracks.

I would like for the FDA to adopt (and mandate) a similar statement like the one to be published June 1 by the European equivalent of the FDA, the EMEA. I think the FDA may be planning to come up with a similar statement soon (at least I hope).

This is an excerpt from the new EMEA guidelines.

Excerpted from Section 4.2.3 'Studies in ART experienced patients' in the EMEA GUIDELINE ON THE CLINICAL DEVELOPMENT OF MEDICINAL PRODUCTS FOR THE TREATMENT OF HIV INFECTION:

'For add-on, active comparator-controlled studies on top of OBT (optimized background therapy), a sensitivity score (usually GSS) requirement of ≥2 for the OBT (together with treatment history) is considered appropriate.' (Meaning two or more active agents to be combines with a study drug)

'After screening for inclusion, there will be patients detected who are ineligible for randomisation because they have less than two likely active licensed drugs available for use in OBT. These patients could be included in a parallel arm of the study in which they receive the novel agent plus OBT (which in some circumstances might include another experimental compound). Such patients should be followed in the same manner as those in the randomised arms of the study with the primary aim to provide safety data. An assessment of the new agent in this manner is considered to be preferable to inclusion of these patients only in extended access programs.'

Full report: http://www.emea.europa.eu/pdfs/human/ewp/63302enfin.pdf

I think having an OLSS (open label safety study) for those patients and allowing other investigational agents that have passed phase II studies would be wise, or setting up compassionate access that allows multiple investigational agents. Unfortunately, we have very few agents that may help patients like me with MDR to current classes (I think this is TAG's latest revision on pipeline: http://www.atdn.org/TAG2008pipeline.pdf )

When it comes to the compassionate access ( Treatment IND- TIND) process, I would say that most doctors: a- don't know how to apply, b- do not want to do it since it requires at least 15 hours of non-reimbursed work, c- companies can say "no" and nothing happens. I summarized the process here since the FDA does not make it too clear. As it stands, the physican has to prove that the patient's life expectancy is under one year, so those healthier patients with no active HIV medications cannot be helped via the current TIND. This is another thing I want to the FDA to change. http://salvagetherapies.org/announcements.htm

However, companies can still refuse to provide the drug and no one is currently mandating that they collaborate.

I think companies should not be afraid of giving free access to compassionate TIND since there will not be too many requests in the US. But they may be concerned about potential bad publicity if a side effect happens outside a study setting.

Keep checking back with me on this issue since I think it will heat up and hopefully we can make compassionate access of multiple new agents a reality in HIV for the "forgotten patients"

Nelson



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