When will Raltegravir be available for fist timers?

[Guest guest]

I can understand why Raltegravir is used by treatment experienced

patients (because they've run out of options) but why on earth can't

treatment naive people use this drug? It can't distinguish between

someone that has been on meds before and someone who hasn't so when

will first timers be able to use it or can we now? This isn't right.

In fact, the symptoms and side effects of this drug are listed as

minimal which is even better.

J.T.

[Guest guest]

Dear JT

Nothing prevents your doctor from prescribing it to you or any naive patient. We have a pretty good study in naives with the use of raltegravvir plus VIread plus Epivir. Just because it is not part of the current guidelines, it does not mean it is "forbidden" or illegal to prescribe this drug for an off label naive use. Some doctors, however, want to see more than 48 weeks of data.

Regards, Vergelpowerusa dot org

In a message dated 1/8/2008 8:19:25 A.M. Central Standard Time, malebeyo@... writes:

I can understand why Raltegravir is used by treatment experiencedpatients (because they've run out of options) but why on earth can'ttreatment naive people use this drug? It can't distinguish betweensomeone that has been on meds before and someone who hasn't so whenwill first timers be able to use it or can we now? This isn't right.In fact, the symptoms and side effects of this drug are listed asminimal which is even better.J.T.Start the year off right. Easy ways to stay in shape in the new year.

[Guest guest]

Dear JT

Nothing prevents your doctor from prescribing it to you or any naive patient. We have a pretty good study in naives with the use of raltegravvir plus VIread plus Epivir. Just because it is not part of the current guidelines, it does not mean it is "forbidden" or illegal to prescribe this drug for an off label naive use. Some doctors, however, want to see more than 48 weeks of data.

Regards, Vergelpowerusa dot org

In a message dated 1/8/2008 8:19:25 A.M. Central Standard Time, malebeyo@... writes:

I can understand why Raltegravir is used by treatment experiencedpatients (because they've run out of options) but why on earth can'ttreatment naive people use this drug? It can't distinguish betweensomeone that has been on meds before and someone who hasn't so whenwill first timers be able to use it or can we now? This isn't right.In fact, the symptoms and side effects of this drug are listed asminimal which is even better.J.T.Start the year off right. Easy ways to stay in shape in the new year.

[Guest guest]

"It can't distinguish betweensomeone that has been on meds before and someone who hasn't so whenwill first timers be able to use it or can we now? This isn't right.In fact, the symptoms and side effects of this drug are listed asminimal which is even better."Well, since there are good drugs out there, there is a reasonable bias against using an unproven agent at first. We all have seen what happened with early HAART, and the unexpected fat problems that only appeared when lots of people were on the drug for a period of time.New drugs do, from time to time, cause unexpected problems. Best to avoid them, if you have older drugs available. On the other hand, for experienced patients, Raltegravir looks very safe and effective, and an excellent option. The way things are currently looking, it will be part of first-line therapy, soon.JB

[Guest guest]

"It can't distinguish betweensomeone that has been on meds before and someone who hasn't so whenwill first timers be able to use it or can we now? This isn't right.In fact, the symptoms and side effects of this drug are listed asminimal which is even better."Well, since there are good drugs out there, there is a reasonable bias against using an unproven agent at first. We all have seen what happened with early HAART, and the unexpected fat problems that only appeared when lots of people were on the drug for a period of time.New drugs do, from time to time, cause unexpected problems. Best to avoid them, if you have older drugs available. On the other hand, for experienced patients, Raltegravir looks very safe and effective, and an excellent option. The way things are currently looking, it will be part of first-line therapy, soon.JB

[Guest guest]

It looks like there already is 48 week data on it in treatment naive.

Is anyone here currently taking Raltegravir and what have been your

experiences with side effects and effectiveness of this med?

The integrase inhibitor raltegravir has impressive activity in

treatment-experienced patients (ACC May 7 2007) and, according to a

24-week analysis, may have similarly potent effects in patients who

are treatment naive (ACC Sep 18 2006). Now, 48-week results are

available from this same industry-sponsored study.

The trial involved 201 treatment-naive patients, including 30 who

participated in an initial 10-day study of raltegravir monotherapy (J

Acquir Immune Defic Syndr 2006; 43:509). All were randomized to

receive tenofovir and 3TC, plus either efavirenz or one of four doses

of raltegravir (100 mg, 200 mg, 400 mg, or 600 mg twice daily). Entry

criteria included a viral load & #8805;5000 copies/mL and a CD4 count & #8805;100

cells/mm3. At baseline, the mean viral load ranged across treatment

arms from 4.6 to 4.8 log copies/mL, and the mean CD4 count ranged from

271 to 338 cells/mm3.

By week 48, approximately 85% of patients in each group had achieved

viral loads <50 copies/mL. Viral loads became undetectable more

rapidly in patients who received raltegravir at any dose than in those

who received efavirenz (P<0.05). CD4-cell responses were similar among

treatment arms. Central nervous system side effects and lipid

elevations occurred more commonly in those who received efavirenz.

Virologic failure occurred in 3% of patients in each group; of the

five raltegravir recipients who experienced virologic failure, two had

viruses with the N155H amino acid substitution, a mutation known from

in vitro experiments to be selected by raltegravir.

Comment

These 48-week results confirm that raltegravir is likely to be at

least as potent as efavirenz when used in an initial regimen with two

NRTIs. The clinical relevance of the faster decline in viral load is

unclear, but the observation is certainly remarkable given that

efavirenz-based regimens induce a faster HIV RNA decline than do

regimens using boosted PIs. Although the authors speculate that

patients with raltegravir resistance might have maintained viral loads

below baseline because of a reduction in viral fitness due to

raltegravir-selected mutations, this phenomenon has previously been

well described with NRTI resistance, which was also present in these

patients. Given these impressive results overall, we eagerly

anticipate the findings of a larger, phase III study of raltegravir

versus efavirenz that is already fully enrolled. If that study yields

similarly favorable results, the decision about when to consider

raltegravir a first-line therapy option will be up to individual

clinicians, patients, and various guidelines committees, with the

major concern being the absence of long-term safety data.

>

> Dear JT

>

> Nothing prevents your doctor from prescribing it to you or any naive

> patient. We have a pretty good study in naives with the use of

raltegravvir plus

> VIread plus Epivir. Just because it is not part of the current

guidelines, it

> does not mean it is " forbidden " or illegal to prescribe this drug

for an off

> label naive use. Some doctors, however, want to see more than 48

weeks of data.

>

>

> Regards,

>

> Vergel

> powerusa dot org

>

>

> In a message dated 1/8/2008 8:19:25 A.M. Central Standard Time,

> malebeyo@... writes:

>

>

>

>

> I can understand why Raltegravir is used by treatment experienced

> patients (because they've run out of options) but why on earth can't

> treatment naive people use this drug? It can't distinguish between

> someone that has been on meds before and someone who hasn't so when

> will first timers be able to use it or can we now? This isn't right.

> In fact, the symptoms and side effects of this drug are listed as

> minimal which is even better.

> J.T.

>

>

>

>

>

>

>

>

>

> **************Start the year off right. Easy ways to stay in shape.

> http://body.aol.com/fitness/winter-exercise?NCID=aolcmp00300000002489

>