Biotech Values

[willyw]

I probably should keep my answer short,
but first, I guess I felt that not being prohibited is not the same as being approved for.

No trials were run by Abbvie to test the cure rate on Harvoni failures, nor did Gilead did not run trials to test 3D failures cure rate when given Harvoni. There is zero data here. I am not seeing express labeling to cover those treatments; merely lack of restrictions on it.
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To treat a Harvoni failure?
...with the toolbox today:
Viekira pak. I see no reason it shouldn't be good for Harvoni failures. I just don't see it in it's labeling.
THIS WOULD BE MY FIRST CHOICE. (due to cost, ease, simplicity)
---- You also know it would have been my first choice also for treating the G-1b.(instead of Harvoni)

Harvoni and a PI (either Olysio or 450/r) and optional w/ riba

Sovaldi and Daclatasvir and a PI (either Olysio or 450/r). (RBV optional) Daclatasvir is not approved...yet...but there is a lot of data on safety efficacy w/ sovaldi. By the time there are IFN free treatment failures, I believe Daclatasvir should be approved.
Hard to know how effective this could be since it is a nuke and a NS5A being used to treat a failure treated with the same.
Since they have has some success with retreating Harvoni w/ Harvoni and RBV, it could be that adding the better NS5a (Daclatasvir) and a PI would/could be more successful.

Harvoni with riba. There is plenty of data on safety and efficacy but very little on retreating past Sovaldi exposures. This does not sound like a compelling choice, but the riba and a longer duration might take it over the top and provide a decent solution

Just as drugs can be switched in combinations, dosage durations may also be tweaked we may see increased durations for DAA failures, or the addition of ribavirin to what may have been past RBV free regimens.

In general, past treatment is not recommended with a drug class that there has been a prior exposure to. Sovaldi has a high barrier to resistance. If a cocktail is used, in theory, most of the paths to mutating around the treatment are blocked. This is one reason Viekira pak works well; multiple mechanisms of operation.

These are all things that *could* be used.

The question is, will doctors be given the latitude to choose, or will they be given more direction? If there is direction in labeling, what will it be based upon?