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Harvoni / Sovaldi / Viekira Pak / Technivie / Olysio / Daklinza / Epclusa / Zepatier

 

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Acute Liver Injury, Severe Liver Damage, Liver Failure, and Reactivation of Hepatitis B Linked to These Hepatitis C Treatment Drugs

 
The FDA is investigating a connection between Harvoni, Sovaldi, Viekira Pak, Technivie, Olysio, Daklinza, Epclusa, Zepatier, with these various medical complications as drug side effects:

Liver Failure

Acute Liver Injury 

Severe Liver Damage

Reactivation of Hepatitis B

We are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for diabetes patients who have developed any of the medical conditions listed above.


 

Hepatitis C Drugs Side Effects Case Evaluation

We encourage you to submit a Drug Injury Law Case Review – it is free, confidential, and there is no obligation. Or, if you prefer, call our toll-free number, (800) 426-9535, to speak directly to attorney Tom Lamb about a possible drug injury case. Either way, you will get Mr. Lamb’s impressions — not an intake person, a paralegal, nor some other lawyer — about your case based on his many years of experience.


 

Here is a list of direct-acting antivirals hepatitis C drugs currently available in the US:

Drug Name (active ingredient)ManufacturerFDA Approval
Sovaldi (sofosbuvir)Gilead Sciences2013
Olysio (simeprevir)Janssen2013
Harvoni (ledipasvir / sofosbuvir)Gilead Sciences2014
Viekira Pak
(dasabuvir / ombitasvir / paritaprevir / ritonavir)
Abbvie2014
Technivie
(ombitasvir / paritaprevir / ritonavir)
Abbvie2015
Daklinza (daclatasvir)Bristol-Myers Squibb2015
Viekira XR
(dasabuvir / ombitasvir / paritaprevir / ritonavir)
Abbvie2016
Zepatier (elbasvir / grazoprevir) Merck Sharp Dohme2016
Epclusa (sofosbuvir / velpatasvir)Gilead Sciences2016

 

No Link Seen Between Sovaldi Or Harvoni And Liver Cancer Recurrence

We continue to monitor the safety profile of Harvoni and Sovaldi, which have been associated with the possibility of liver cancer recurrence.

The May 2017 edition of Health Product InfoWatch included this report, “Summary Safety Review – Direct-Acting Antivirals – Assessing the Potential Risk of Liver Cancer Recurrence”, which was issued on April 27, 2017 by Health Canada.

From the Safety Review Findings part of same report we get this detailed information:

At the time of the review, Health Canada had received 3 unique Canadian reports of liver cancer recurrence related to DAAs use (2 with Sovaldi and 1 with Holkira Pak [(known as Viekira Pak in the US)]). All 3 reports were considered to be related to the use of DAAs. However, other factors present in the cases may have played a role in the liver cancer recurrence, such as serious scarring of the liver (cirrhosis), previous history of liver cancer and other treatments known to be associated with a higher risk of liver cancer recurrence, including surgery and a cancer treatment using radio waves (radiofrequency ablation).

This safety review also looked at information from 14 international reports of liver cancer recurrence related to DAAs use: 9 reports involved Sovaldi, 4 reports involved Harvoni and 1 report involved Holkira Pak [(known as Viekira Pak in the US)]. All 14 reports were considered to be related to DAAs use. However, factors known to be associated with a higher risk of liver cancer recurrence may have played a role.

A search of the scientific literature identified 7 relevant studies describing the recurrence of liver cancer related to DAA use. The safety review could not conclude whether the use of DAAs played a role because the lengths of time the patients were monitored were different between the studies. The patients also had a variety of risk factors for liver cancer, including HCV infection, cirrhosis, previous history of liver cancer and advanced age.

Some studies have found that liver cancer recurrence was more likely to happen in patients who underwent surgery or radiofrequency ablation compared to those patients that received a liver transplant.

Besides the possibility of liver cancer recurrence, Harvoni, Sovaldi, and Viekira Pak as well as the several other newer hepatitis C medicines which are part of the Direct-Acting Antivirals (DAAs) class of drugs have been associated with acute liver injury, liver failure, and reactivation of hepatitis B.

[Read this article in full at original source]
 
 
Earlier Harvoni / Sovaldi / Viekira Pak / Technivie articles by attorney Tom Lamb on the Side Effects Blog:

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All content by attorney Tom Lamb

Law Offices of Thomas J. Lamb, P.A.
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Wilmington, NC 28403
(800) 426-9535
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