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Author Topic: CROI: Management of Treatment-Experienced Patients  (Read 1651 times)

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Offline John2038

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CROI: Management of Treatment-Experienced Patients
« on: February 18, 2008, 02:09:58 PM »
A summary.

Vicriviroc (CCR5 Inhibitors)

VICTOR-E1 trial outcome:

If a patient had no active drugs in his or her background regimen, we can see, in terms of the percentage who achieved less than 50 copies/mL, that 29% on the 30-mg dose of vicriviroc got to less than 50 copies/mL. If we contrast that with those patients who had two or more active drugs in their background regimen, plus vicriviroc, then about 80% of patients achieved a viral load of less than 50 copies/mL in this study -- an impressive finding for a new drug and a new drug class. That this drug is active and certainly does suppress the virus in these patients is, I think, pretty optimistic and reassuring data for the field of HIV research and treatment.

There wasn't much of a safety signal in this study. It looked reasonably well tolerated. We saw some reassuring data in terms of liver function tests, as well as about blood levels, to suggest that this drug certainly does achieve virologic suppression as part of a well-tolerated overall regimen.


Maraviroc (CCR5 Inhibitors)

MOTIVATE trials outcome:

Patients who achieved virologic suppression at week 24 continued to do so to week 48.



BENCHMRK studies outcome:

The presentation on the BENCHMRK trials ended with a very memorable slide demonstrating how well raltegravir did when it was paired with two of the most active drugs available during the studies -- the combination of enfuvirtide and darunavir. In this study, at week 48, of the patients who received raltegravir, enfuvirtide and darunavir, 89% had less than 50 copies/mL. This is an astounding result, certainly a result as good as any seen when a treatment-naive patient starts to see on his or her first regimen. So the reassurance we had from these studies was certainly reinforced here with some great data, even one year later.



DUET trials outcome:

At this meeting, we saw the 48-week results of the DUET trials, which look at the activity of etravirine.11,12 These double-blind, placebo-controlled, randomized trials reinforce what we've seen earlier, which is that if patients get to a viral load of less than 50 copies/mL at week 24, they seem to stay there for an additional 24 weeks. The week 48 data are very reassuring, with continued CD4 improvements.
For patients who have additional active drugs, like enfuvirtide, they'll do even better than people who don't use enfuvirtide.

When darunavir is fully active, the fold change is less than 10. Certainly, when darunavir is fully active, with a good regimen, patients do the best. About 80% got to less than 50 copies/mL, with darunavir active, etravirine active, and at least one other drug.

But when darunavir was impaired in its activity, meaning that the phenotypic fold change was now less than 40-fold, the striking thing is that, 80% still got to a viral load of less than 50 copies/mL, even when the darunavir wasn't paired with the combination of etravirine and at least one other active drug, such as enfuvirtide.

The results are pretty reassuring that, while it's always great to have three fully active drugs, even when some of the drugs are compromised, we can still establish suppression in a remarkable majority of these patients.



There were very few mutations in those on darunavir, there was also very little cross-resistance, meaning that after darunavir didn't work and didn't result in suppression, most patients still had essentially every protease inhibitor appear to be phenotypically fully active.

about 90% of those who get three active drugs have a viral load of below 50 copies/mL a year later. So the rules of the game are to find three active drugs, though I think at this meeting we saw some information to suggest that three active drugs -- even if the drugs are not fully active -- can actually do pretty well. That doesn't, however, mean that we should choose less than fully active drugs when given the choice. But it does mean that if the best we can do is three drugs, where one of them is not at full activity, we still have reasons to be optimistic that that regimen can get the viral load back to less than 50 copies/mL and keep it there for at least the first year, and hopefully for years to come.


Full text: http://www.thebodypro.com/content/confs/retro2008/art45063.html


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