Promising Study On Kaletra Monotherapy

[MitchMiller]

I'm posting this study here because it is probably of most interest to those suffering from lipoatrophy.  Although, from what I've heard, Kaletra is not always a walk in the park, the is an opportunity to get away from NRTI's that are thought to cause lipoatrophy.  It was mentioned at the end of the article that this study is still considered too small and too short to recommend Kaletra monotherapy yet.

Here's the most important point... the results.  You can see the full story at www.natap.org.

At week 48, 94 of the 100 patients (94%) in the monotherapy group did not develop therapeutic failure compared to 88 of the 98 patients (90%) in the triple therapy group. The 95% CI for the difference between the two groups was -11.8 to 3.4% (P = 0.28), which fulfilled the pre-established criteria for non-inferiority of the monotherapy group. There were six therapeutic failures in the monotherapy group. Three were lost to follow-up. One changed randomized therapy without loss of virologic suppression. One lost virologic suppression and developed protease inhibitor resistance. One patient had loss of virologic suppression and then failed to maintain suppression after reinduction with baseline nucleosides. There were 10 therapeutic failures in the triple therapy group. Four were lost to follow up. Three had confirmed loss of virological suppression. Three discontinued randomized treatment due to adverse events. There were no significant statistical differences in the time to treatment failure between both groups by log-rank test (P = 0.29) (Fig. 2).
 
At week 48, six out of the 100 patients (6%) in the monotherapy group had developed confirmed loss of virological suppression compared to three out of 98 (3%) in the triple therapy group (P = 0.31). Of the six patients with loss of virological suppression in the monotherapy group, four resumed baseline nucleosides and regained virological suppression which was subsequently maintained for a median of 56 weeks (36-64). In one patient reinduction was not attempted per protocol, as genotypic testing showed lopinavir-ritonavir resistance and one patient did not maintain virological suppression after resuming baseline nucleosides.

[minismom]

Do you know if further studies going to happen?  What I'm wondering, and the article doesn't say, is: how long the people in the study were undetectable before going to monotherapy, how old they were, how long they were infected before starting, and what measures were taken to guaruntee compliance.  This is a very interesting article indeed.  Hubby and I were just talking about "maintainance" dosages yesterday and wondering why no one had done a study.  Thank you for posting this.

Mum

[MitchMiller]

I'm sure there will be more studies because this one was successful.  I have no doubt Abbott will be funding additional studies because this looks like it could prove to be a lucrative market for them.  The downside might be that PI monotherapy is also found to work for other PIs.  Good for us, bad for Abbott.