Zepatier Part Ugh

I have spent the better part of this past month re-writing this post, and on March 11, i will find out much more.

Because I legitimately don't know how to properly convey my despair and disappointment and fear at what will soon unfold.

I had been eagerly awaiting the release of Zepatier,  the announcement last month was terribly exciting.

Zepatier is a Hep C drug that deals with NS5A resistance,has a very high success rate, and is almost half the price of the leading treatments Harvoni and Sovaldi.

It's amazing, and it has shown to work very well in other harder to treat cases.


The drug has one small hitch.

Well, i think it kinda sucks like... a lot.

The FDA/Merck released a contraindication for the drug for use with patients who with child pugh score B or C

"ZEPATIER is contraindicated in patients with moderate or severe hepaticimpairment (ChildPugh·B or C) due to the expected significantly increased grazoprevir plasmaconcentration and the increased risk of alanine aminotransferase (ALT)elevations" - 

The contraindication does have a rationale beneath it.

In 1% of cases ALT levels raised 5X within in the first 8 weeks, Clearly, an indicative factor of a problem.

Unless it isn't.

Which it isn't.

Most instances self corrected soon after:

" During clinical trials with ZEPATIER with or without ribavirin, regardless of treatment duration, 1% (12/1599) of subjects experienced elevations of ALT from normal levels to greater than 5 times the ULN, generally at or after treatment week 8 (mean onset time 10 weeks, range 6-12 weeks). These late ALT elevations were typically asymptomatic. Most late ALT elevations resolved with ongoing therapy with ZEPATIER or after completion of therapy [see Warnings and Precautions (5.1)]. The frequency of late ALT elevations was higher in subjects with higher grazoprevir plasma concentrations [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)]. The incidence of late ALT elevations was not affected by treatment duration. Cirrhosis was not a risk factor for late ALT elevations."

In fact the contraindication seems odd considering the big new DAAs carried no such contraindication:
 Sovaldi 
Harvoni 
Daklinza 

Olysio 

"Initial analysis of Zepatier’s label showed comparatively fewer AE(Adverse Effects)s (29 vs 41 for Sovaldi). Liver cirrhosis, the only ImportantMedical Event (IME) listed on the label, is largely associated with HCV and notwith the drug. "

So... Now it's time to figure out how the hell I get this drug, because I suspect this will be my last treatment. success or failure.
Further research should show it's true efficacy, which i feel will reflect poorly on Zepatier if the drug is prioritized because of its price-point rather than it's efficacy.