Posted by Jeff Berk, BOLT International;
First some business: We had our 10,000th hit on the blog. YAY! Somebody in Princeton, NJ, at Biovid. So there. You be our 10,000th, and u get a free plug. New Jersey. What exit? (See – – I’ve been to NJ a couple of times). Okay, what else? This Lobivia leucomela was pretty stunning this morning, so there you go, a cactus flower. What else after that? Hat tip to the European guy who felt like he had to stick up for FDA after yesterday’s rant. Honorable. Misguided, but honorable. So you’re posted and I’m standing by what I said. But I’ve got a fuuuuuny feeling that I’m not going to be getting a job in Silver Spring anytime soon. Just as well, because I like to have my Maryland blue crabs airlifted to me here in the desert. And do those guys still drive 55 mph? Antiquated. They drive about as fast as they make good decisions.
And for the peep who asked where I get the stuff that I talk about, most of it is from old, non-proprietary BOLT reports. And if you want the more current stuff, go to www.medpredict.com. Who did you think pays for this blog, anyway?!
So I’m going to blog about Hep C today. Everybody and their brother (Is that mixing singular and plural? Can I have a Martini Mulligan if it is?) is talking about boceprevir and telaprevir, thanks to the anointing powers of FDA. I’m just throwing in a mention of them so that Google increases the number of hits to tomorrow’s blog. Sneaky. But as a consolation prize, I’m going to impart some thoughts on TMC-435 that BOLT’s Hepatitis C Virus Thought Leader Panel shared with me a couple of months back. They seemed to really like it, even if not quite ready for the big leagues today.
TMC-435 (Tibotec / Medivir)
- Our panel consensus was that the once-daily TMC-435 data in HCV patients with prior treatment failure (ASPIRE) was excellent. This compliments the previously reported results in PILLAR (treatment naive). In the interim analysis, patients treated with TMC435 and standard of care demonstrated high response rates and antiviral efficacy in all patient groups up to and including week 4, 12 and 24. In the relapser group, 81%, 92% and 94% of patients taking TMC435 and Peg-IFN and ribavirin achieved undetectable HCV RNA levels at week 4, week 12, and week 24, respectively. For the partial responder group 62%, 84%, and 86% achieved undetectable HCV RNA levels at week 4, week 12 and week 24, respectively. The null responder group also demonstrated significant response rates with 38%, 64%, and 78%, of patients taking TMC435 and Peg-IFN and ribavirin achieving undetectable HCV RNA levels at week 4, week 12 and week 24, respectively. All patients continue on active treatment up until week 48.
“There was a presentation by Mike Fried, the PILLAR study which was with the TMC435 compound. This is a follow up of the OPERA study, but CC genotype it got four weeks of TMC, peg interferon and ribavirin. Four weeks of those three drugs, CC genotype, SVRs. Just four weeks of ribavirin/ribavirin and TMC but they were all IL-28 CC. To me that is very impressive”.
“The other one is the Tibotec and I believe that is a protease inhibitor that TMC-435. That looked to have pretty good results and people are pretty excited about that. In what way does that stand out from the compounds that we initially talked about? It is just a little bit better. I guess the concern that I heard some people saying was that Tibotec has the rights to telaprevir in the world and telaprevir in the US is owned by Vertex. And so the concern was that if that Tibotec product is so good it would replace telaprevir before it had the run that they want from it. But here in the US I think Johnson and Johnson has the Tibotec compound if I am not mistaken. I think you may be correct. So I can’t see them waiting. I would agree with you. So if they push through a better product they are going to go to the head of the class”.
“It is a very difficult to make that determination because there is no direct head-to-head comparisons. But I think if you look at the later breaker abstracts at the ASLD Mike Fried did a presentation describing one of these agents called TMC. That appeared to be really amazing sustained virological response rates. I cannot remember the details too much but a small number of patients, etc, etc”.