MK-0518 aka raltegravir: study report and expanded access

[newt]

Raltegravir (MK-0518) Phase 3 trials show successful viral suppression in multi-drug resistant patients

Simon Collins, i-Base reports on this study from the recent Conference on Retroviruses Opportunistic Infections (CROI) in the latest HIV Treatment Bulletin.  He begins his comment on this report:

"Using RGV with T-20 and DRV [Prezista] reduced viral load to <400 copies/mL in 98% of these highly treatment experienced patients. These results are startlingly high – even given that this is only 16 week data – because we are accustomed to sub-optimal response to treatment in both first line and MDR therapy. But these are the results that we should be looking for from treatment, given that 3 sensitive drugs including two entirely new classes were being used, and that adherence is likely to be very high in such advanced patients in a clinical trial."

Goes on to add a cavet about rapid resistance in people failing to achieve viral suppression though...

Expanded access programme details at www.earmrk.com

- matt

[Miss Philicia]

Cool.  Thanks Matt.  I'm on t-20 and prezista now so I should keep this bookmarked.  My ID doctor is one of the top guys that does clinical trial in my area so I'll be sure to bring this up on my next visit, though I think he already may have mentioned it to me as an option if my numbers start going wonky, which fortunately they have not.

[Rusty]

Hi

I am currently taking Prezista ,TMC 125 & Truvada. My viral load is undectable and my CD4 is 105.( never been very high) I have been infected for 23 years and am treatment experianced. My consultants want me to add Raltegravir (MK 0518). Does anyone think I would benefit from doing this or should I leave it alone. I was on Fuzeon for 18 months previously but stopped it because of severe injection site reactions and replaced this with TMC 125.

Any comments would be helpful

Rusty

[newt]

Rusty

No, perhaps and yes...

1. NO. As your viral load is undetectable adding raltegravir will not improve the effectiveness of your combo. Prezista is a stunning drug resistance wise and prob. doing most of the work. Adding raltegravir ain;t gonna make this combo hugely (or indeed any) more effective.

2. PERHAPS. Your doc might be hoping for a CD4 increase.  The studies for raltegravir saw good CD4 increases in many people, but whether this is because of some magic immunological property of integrase inhibitors or because they got their viral load right down is not at all clear.

3. YES. If you have resistance that means the nukes and non-nuke (TMC 125) have a low barrier to resistance, your doc may think adding raltegravir will prevent further resistance emerging. This is a very good point, and worth exploring.  But maybe this is a "swap" rather than "add" discussion. Needs clarifying.

Hope this helps

- matt