Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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FDA Warning: Hepatitis C Treatments Viekira Pak & Technivie May Cause Serious Liver Injury

FDA is warning that hepatitis C treatments Viekira Pak and Technivie can cause serious liver injury mostly in patients with underlying advanced liver disease. As a result, FDA is requiring the manufacturer to include information about serious liver injury adverse events to the Contraindications, Warnings and Precautions, Postmarketing Experience, and Hepatic Impairment sections of the Viekira Pak and Technivie drug labels.


FDA review of adverse events reported to the FDA Adverse Event Reporting System (FAERS) database and to the manufacturer of these medicines, AbbVie, identified cases of hepatic decompensation and liver failure in patients with underlying liver cirrhosis who were taking these medicines. Some of these events resulted in liver transplantation or death. These serious outcomes were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with it.


Since the approvals of Viekira Pak in December 2014 and Technivie in July 2015, at least 26 worldwide cases submitted to FAERS were considered to be possibly or probably related to Viekira Pak or Technivie. In most of the cases, liver injury occurred within 1 to 4 weeks of starting treatment. Some of the cases occurred in patients for whom these medicines were contraindicated or not recommended (see the Drug Safety Communication Data Summary section). FAERS includes only reports submitted to FDA, so there are likely additional cases about which FDA is unaware.


BACKGROUND: Viekira Pak and Technivie are used to treat chronic hepatitis C. Viekira Pak is a fixed-dose combination of dasabuvir, ombitasvir, paritaprevir, and ritonavir used with or without ribavirin, another hepatitis C medicine. Technivie is a fixed-dose combination of ombitasvir, paritaprevir, and ritonavir, used in combination with ribavirin.


RECOMMENDATION: Health care professionals should closely monitor for signs and symptoms of worsening liver disease, such as ascites, hepatic encephalopathy, variceal hemorrhage, and/or increases in direct bilirubin in the blood.


Patients taking these medicines should contact their health care professional immediately if they develop fatigue, weakness, loss of appetite, nausea and vomiting, yellow eyes or skin, or light-colored stools, as these may be signs of liver injury. Patients should not stop taking these medicines without first talking to their health care professionals. Stopping treatment early could result in drug resistance to other hepatitis C medicines.

Pharma Guy's insight:

Oh my!

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According to @matthewherper "Me Too" Drugs Essential for Lower Drug Prices

According to @matthewherper "Me Too" Drugs Essential for Lower Drug Prices | Pharmaguy's Insights Into Drug Industry News | Scoop.it

 For biotech investors, the news that AbbVie has cut a deal with Express Scripts to sell its new hepatitis C treatment, the Viekira Pak, at a significant and undisclosed discount to its $83,319 seems nothing short of disaster. It means that Gilead Pharmaceuticals will have to compete on price, not just efficacy with its $84,000-per course Sovaldi and $95,000 Harvoni (they are inarguably better drugs). As Adam Feuerstein at The Street points out, that could put limits on the incredible pricing power that is fueling the biotech boom.


But there is another, longer view on this news: this is a reminder of the way the pharmaceutical market has always worked and of the importance of me-too drugs, which have been heavily criticized as proof that drug companies are not innovative, in controlling prices. In areas outside cancer and rare diseases, this is how the pharmaceutical market has always been. It’s not an out-and-out disaster for Gilead, which still has the first and best drug in what could be one of the modern era’s biggest pharmaceutical markets. But it shows that there is price competition pharma, and that is a good thing. Drug prices are too high, and they are rising too fast, and it would be best for everyone if we can find a free-market solution for fixing that problem. This is exactly that.


But today Express Scripts announced that it had made a deal with AbbVie to sell Viekira Pak exclusively [ESRX now says: "Harvoni will be available to those who fail Viekira"]. Twenty-five million patients on its plans will not be able to get Sovaldi at all, and will have to use Viekira. In return, AbbVie is going to pay a huge rebate. The move will probably cause negotiations with other plans, and Gilead may have to offer rebates too.


Patients may protest loudly enough that health plans will opt out of Express Scripts’ decision. For many, taking Viekira instead of Harvoni will mean taking many more pills, taking ribavirin, and being on medicine for another month. Those aren’t minor concerns.

Pharma Guy's insight:


I'm not sure Viekira qualifies as a "Me Too" drug in the classic sense - at least compared to Harvoni. It's difficult to say that one biologic has a nearly identical chemical composition as another, which is typical of me too drugs. Plus, as Herper points out, Viekira must be taken with ribavirin, whereas Harvoni includes that in a single dose. 


The real travesty of "me too" drugs is when a new Rx brand drug is introduced to compete with an older nearly identical cheaper generic version of the drug. A case in point is LOVAZA, which is an Rx drug that is a "me-too" of existing over-the-counter dietary supplements. I am talking about LOVAZA, aka omega-3-acid esters approved by the FDA for the treatment of high triglycerides. Is LOVAZA different than the OTC (over-the-counter) product I have in my kitchen cabinet? (Read more about that here).


At least LOVAZA is more convenient than the cheaper drug. It seems that Viekira does not compete on the convenience level with Harvoni. I expect to see this as a major message in future Harvoni DTC ads.


NOTE: Herper points out an interesting factoid: More relatively healthy patients are getting Sovaldi than very sick ones. "Insurers did very little to restrict Sovaldi to the patients who were most likely to lose liver function as a result of the virus. The severity of a patient’s liver disease is measured by a fibrosis score of between F1 (least severe) and F4 (most severe). As of June 2014, 60% of the patients getting Sovaldi had fibrosis scores of F1 or F2, according to investment bank Evercore ISI."

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