Biotech Values

[willyw]

I have thought about adding this a few days. I figure, why not?

Here is a fairly complete link to the study in question;


ENDURANCE-3: SAFETY AND EFFICACY OF GLECAPREVIR/PIBRENTASVIR COMPARED TO SOFOSBUVIR PLUS DACLATASVIR IN TREATMENT-NAÏVE HCV GENOTYPE 3-INFECTED PATIENTS WITHOUT CIRRHOSIS

http://www.natap.org/2017/EASL/EASL_13.htm
Also notice many other EASL papers, both under HCV or under EASL ~W

Some were underwhelmed with the response rates in G-3 by G/P. My answer is that we have gotten a little spoiled expecting 98%+ cure rates on everything. If you are focused ONLY on 95% you are missing part of the picture.

This isn't 1000's of patients; larger trials will bring slightly different results, but in the larger context, these are great results.

I may be nit picking a little, but the Sov/Daclatasvir cohort benefited a little where patients were randomized. I refer to the chart; Baseline Demographics and Clinical Characteristics Keep in mind, there is only 2 percentage points difference between the two cohorts (97% S/V 12 weeks compared to 95% G/P 8 weeks);
The Sovaldi/Daclatasvir cohort had the benefit of having the most easy to treat patients F0-F1 fibrosis (S/D 84% compared to G/P 78%)
It also had the benefit of having fewer hard to treat higher fibrosis patients F-3; (S/D 9% compared to G/P 17%- nearly double the cirrhotics).
To summarize, the Sovaldi/Dacalatasvir arms had more easier to cure and fewer harder to cure than the G/P 8 week cohorts.

In spite of this the G/P program had a statistically similar result, except it achieved it in 8 weeks compared to the 12 week Sov/Daclatasvir cohort.
If Joe Biden had been presenting he would have called it a big.... oh well, you get the idea.


A comment is that HCV stocks have been trailing downwards.
I think many people feel that as Gilead goes, so must other HCV stocks. My general feeling is that yes.... the price is coming down, and there are a few more competitors (and I think a few less too), and the urgency to treat some has diminished. So many may feel HCV is played out.
My response is that Gilead is still going to sell a lot of product this upcoming year and years to come.... but what is critical is that they will likely share more of the market with the Abbvie G/P program.

Abbvie/Enta has provided 8 weeks treatments across all genotypes in easier to treat patients compared to the largely 12 week treatments offered by Gilead.
The market in the USA, EU, Japan and China is still quite large, and studies are showing the benefit of curing people before they start developing serious (and more expensive) co-morbidities associated w/ long term HCV infection.

Keep in mind also.... that G/P may also be labeled for treatment failures in G-1 w/ past DAA exposure.
So G/P may share a bit of the salvage treatment business that Gilead hopes for with it's triple, and on a similar time frame as the Gilead approval.