RE:RE:RE:RE:RE:Philip Dubuc answered my Q'sThanks....lots of data to look back on.
The JAMA 2014 shows a nice drop in triglycerides over 6 months. I wonder if they have this measure for the current trial (they should but it is not listed as an outcome) as I suspect it may be significant over 1 year.
Anyway, I would think the bar should be lower to get a NASH drug approved only in HIV vs the general market. The FDA will want to be careful about opening up the general market floodgates for NASH unless they have cardio benefit data in hand. In HIV, the prevalence is much higher so patients and docs should be more motivated to find a drug (and the population size is limited).
In any case, smart analysts clearly should be raising their target for TH. Dropping the target on announcement that they are pursuing a huge opportunity is beyond ludicrous.
Bfw
Wino115 wrote: Qwerty/BF/Spceo - thanks for very helpful discussions. As for additional data, don't forget that there was the original test listed in JAMA 2014. It showed modest cardiovascular positives but not strong statistically. Nothing went the wrong way, it just wasn't statistically sig. It was short and small test. It did show it lowered vascular inflammation (measuring carotid artery).
But therre was also the 2017 study that Grinspoons colleague Takara Stanley did on tesamorelin's effects on liver enzymes. It was bigger test and had 26 and 52 week readings. AST and ALT were measured --ALT being the most important for liver since it's only associated with liver and one where cells are degrading already. Both showed significant reductions at 26 and 52 weeks. Interestingly, the levels did not go back to baseline after switching some to placebo (their visceral fat did go back toward baseline, but not the liver enzymes) which is also a very powerful statement. And has you can see from the statement below, this was associated with just a >8% reduction in VAT.
So we do have this additional very positive liver damage readings for AST and ALT..
Here's the 2017 paper link if you want all the details and here's the conclusion:
VAT Reduction assoc with improved Liver Enzymes "In conclusion, we show for the first time that a selective, clinically significant reduction in VAT of ≥ 8% is associated with improved ALT and AST among tesamorelin-treated individuals with elevations in these markers at baseline. This decrease in ALT and AST occurred irrespective of viral hepatitis status, and outlasted the reduction in VAT among initial tesamorelin responders who were reassigned to placebo. Through its longitudinal interventional design, this study suggests potential clinical benefits of VAT reduction on the liver among HIV-infected patients."