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Author Topic: Week 48 raltegravir results in treatment-naïve Phase II dose-finding study  (Read 2742 times)

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Offline newt

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Week 48 raltegravir results in treatment-naïve Phase II dose-finding study

Results generally rather good. The report notes that:

"[T]he US FDA advisory committee [has] recommended approval of raltegravir for treatment-experienced patients who have ongoing viral replication despite existing treatment.

"Several documents relating to this [...] suggest a good safety profile, and that raltegravir crosses the blood-brain barrier - something that until now had not been clearly addressed."

On effectiveness, the control drug for this study was Sustiva (efavirenz) and raltegravir seems as good as.

- matt


edited for sp.
« Last Edit: September 15, 2007, 07:44:19 AM by newt »
"The object is to be a well patient, not a good patient"

Offline Miss Philicia

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Re: Week 48 raltegravir results in treatment-naÔve Phase II dose-finding study
« Reply #1 on: September 15, 2007, 02:52:04 PM »
and that raltegravir crosses the blood-brain barrier - something that until now had not been clearly addressed."

Oh, that's fab as I'm about to go on this.
"Iíve slept with enough men to know that Iím not gay"

Offline J220

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Re: Week 48 raltegravir results in treatment-naÔve Phase II dose-finding study
« Reply #2 on: September 15, 2007, 08:26:32 PM »
I think Isentress is going to revolutionize treatement. I would not be surprised that this could also turn into a first line regime, once the last parts of the trials are completed. Cheers, J.
« Last Edit: September 16, 2007, 08:06:50 AM by J220 »
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline Miss Philicia

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Re: Week 48 raltegravir results in treatment-naÔve Phase II dose-finding study
« Reply #3 on: September 15, 2007, 08:49:18 PM »
I just read somewhere that they're already looking for it to be a first line treatment -- though assuredly that will be a year or so down the road.
"Iíve slept with enough men to know that Iím not gay"

Offline scud44

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Re: Week 48 raltegravir results in treatment-naÔve Phase II dose-finding study
« Reply #4 on: September 15, 2007, 08:51:44 PM »
I'm about to go on this as well - I hope this works as nothing else seems to be working!


I just read somewhere that they're already looking for it to be a first line treatment -- though assuredly that will be a year or so down the road.

I hope it is as good as they say it is - it could be a real help to a lot of people

Regards
Scuddles
CD4 = 110 - 30 July 2007 - 10%
VL = 139000 - 30 July 2007
CD4 = 252 - 6th August 2007
VL = 16400 - 23rd August 2007
CD4 = 240 - 23rd August 2007
VL = 400 4th Sept 2007
CD4 = 96 - 4th Sept 2007
CD4 = 120 18th Sept 2007
VL = 386000 19th Nov 2007
CD4 = 160 19th Nov 2007
CD4 = 110 10th Jan 2008
CD4 = 311 29th Jan 2008
VL = <50 29th Jan 2008
CD4 = 148 2nd April 2008
VL = 110,000 2nd April 2008
June 2010 and nothing has improved

Offline J220

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Re: Week 48 raltegravir results in treatment-naÔve Phase II dose-finding study
« Reply #5 on: September 15, 2007, 09:51:02 PM »
Hey Scuddles, do keep us posted, although I am sure that this new med will do wonders for you. When will you start on it?
"Hope is my philosophy
Just needs days in which to be
Love of Life means hope for me
Born on a New Day" - John David

Offline scud44

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Re: Week 48 raltegravir results in treatment-naÔve Phase II dose-finding study
« Reply #6 on: September 16, 2007, 03:05:50 AM »
Waiting for it to arrive down here - it isn't on subsidy at the moment so it could be expensive - should start in about 2 weeks time
CD4 = 110 - 30 July 2007 - 10%
VL = 139000 - 30 July 2007
CD4 = 252 - 6th August 2007
VL = 16400 - 23rd August 2007
CD4 = 240 - 23rd August 2007
VL = 400 4th Sept 2007
CD4 = 96 - 4th Sept 2007
CD4 = 120 18th Sept 2007
VL = 386000 19th Nov 2007
CD4 = 160 19th Nov 2007
CD4 = 110 10th Jan 2008
CD4 = 311 29th Jan 2008
VL = <50 29th Jan 2008
CD4 = 148 2nd April 2008
VL = 110,000 2nd April 2008
June 2010 and nothing has improved

Offline newt

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  • the one and original newt
Re: Week 48 raltegravir results in treatment-naÔve Phase II dose-finding study
« Reply #7 on: September 16, 2007, 06:56:29 AM »
No resistance? hmmm....

Integrase inhibitors and resistance

"One caution from the otherwise impressive results available on raltegravir, is that it appears to have a low genetic barrier to resistance. Michael Miller from Merck presented results from their Phase 2 dose-finding study ... [a]pproximately 70% of these three-class experienced patients achieved viral suppression to <400 copies/mL by week 16. 38 non-responders either failed to reduce viral load by > 1 log or reach and maintain levels <400 copies/mL. Mutations in integrase were found in 35/38 of these patients."

A drug immune to resistance, there's a nice idea... ::)

"The object is to be a well patient, not a good patient"

Offline newt

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  • the one and original newt
"The object is to be a well patient, not a good patient"

Offline scud44

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  • I am watching you
Re: Week 48 raltegravir results in treatment-naÔve Phase II dose-finding study
« Reply #9 on: September 16, 2007, 07:06:43 AM »
Thanks for that link - I'll pass it on to my Doctor

Regards
Scuddly
CD4 = 110 - 30 July 2007 - 10%
VL = 139000 - 30 July 2007
CD4 = 252 - 6th August 2007
VL = 16400 - 23rd August 2007
CD4 = 240 - 23rd August 2007
VL = 400 4th Sept 2007
CD4 = 96 - 4th Sept 2007
CD4 = 120 18th Sept 2007
VL = 386000 19th Nov 2007
CD4 = 160 19th Nov 2007
CD4 = 110 10th Jan 2008
CD4 = 311 29th Jan 2008
VL = <50 29th Jan 2008
CD4 = 148 2nd April 2008
VL = 110,000 2nd April 2008
June 2010 and nothing has improved

 


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