Hepatitis C

How the Pharma War for Hep C could affect treatment outcomes.

Pharma drug wars these days make headlines for typically nefarious reasons.
More typically when Pharma companies are turned into pieces of an investment machine and no longer commit as much energy to research* and instead focus on paying their investors.

The Hep C drug market was blowing up from 2014 until 2016, 2017 saw some of the largest halts in manufacturing of treatments. But with an estimated five million Americans yet to be cured, it’s not a lack of demand that does it. Janssen, as of Sept. 2017 discontinued use of Olysio, a DAA which acted as part of a combination therapy, one I took back in 2014.

Merck having finally rejoined the game, made headlines with its price cutting Zepatier. As Gilead and AbbVie continued to push on with newer iterations of their Hep C treatment meds, Merck abandoned two drugs which were currently in the Hep C Pipeline. At an 8 week price point of $26,400, Mavyret is dragging Gilead’s Vosevi and Epclusa to push not for lower prices but shorter treatment durations to lower the price point to insurers.

The economic constraints which control these drug prices have little to do with consumer needs, they’re based on acceptable prices by insurers. Which means that the lowest price to them, is what will reign. Without going into the complex nature of these kickbacks and relationships, the bottom-line is that insurers aren’t picking the best meds for their patients.

Well at least they’re FDA approved

Each of these combinations has a different efficacy based on that person’s genotype and subtype, and while Epclusa and Mavyret are both touted as pan-genomic, they lack the core mechanisms to back up that claim. Having looked at Epclusa’s Mechanisms, both of my doctors and myself were leery to go on it having failed Harvoni. When someone fails treatments they develop a type of resistant polymorphism, or RAVs. These RAVs make the claim of Pan-Genomic treatment impossible from the get go. RAVs often develop during a treatment, which causes a person to fail the treatment. The issue at hand is that shorter treatments more typically work for newly diagnosed and patients who haven’t developed into F2 Fibrosis. But patients which more fibrosis run the risk of developing RAVs as they need longer treatment durations. This comes with a challenge when a doctor requests a 12 week round for a patient, and is approved for 8.

What this leads to is, exactly how I was approved: Off-Label approval. The doc can request the same meds as Off-label and have more control. The downside is that it requires a savvy doc and it is rarely extended. This means that people who need meds who don’t have a solid relationship with their doc, or don’t have a committed doc, they might not get the right treatment.

With insurance premiums on the rise, it’s hard to say how many insurers will carry more than one option in the future.


Research* is primarily paid for via government grants, smaller labs usually do most of the leg work and are acquired by larger manufacturers who have both the means of production and sales channels, but seldom devote time or money to research of their own beyond required government tests.


ABSTRACT

Chronic hepatitis C virus (HCV) infection is well-recognized as a common blood borne infection with global public health impact, affecting 3 to 5 million persons in the U.S. and over 170 million persons worldwide. Chronic HCV infection is associated with significant morbidity and mortality due to complications of liver cirrhosis and hepatocellular carcinoma (HCC). Current therapies with all-oral directly acting antiviral agents (DAAs) are associated with high rates of sustained virologic response (SVR), generally exceeding 90%. SVR is associated with a reduced risk of liver cirrhosis, hepatic decompensation, need for liver transplantation, and both liver-related and all-cause mortality. However, a subset of patients who achieve SVR will remain at long-term risk for progression to cirrhosis, liver failure, HCC, and liver-related mortality. Limited evidence is available to guide clinicians on which post-SVR patients should be monitored versus discharged, how to monitor and with which tests, how frequently should monitoring occur, and for how long. In this clinical practice update, available evidence and expert opinion are used to generate best practice recommendations on the care of patients with chronic HCV who have achieved SVR.

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