Research has shown that oral direct-acting antivirals (DAAs) can be extremely dangerous for patients with compensated cirrhosis. Gilead Science's hepatitis C drug, Sovaldi, may cause serious liver injury, even death, mostly in patients with underlying advanced liver disease.
Sovaldi is the first non-injectable Hepatitis-C drug approved by the FDA. It is typically administered in conjunction with ribavirin.
Our New York dangerous drug attorneys currently investigating claims on behalf of injured users. Our firm has over 30 years of experience handling dangerous drugs cases. If you or someone you know has suffered liver damage from Sovaldi contact Rheingold Giuffra Ruffo & Plotkin LLP today.
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Sovaldi Linked to Liver Damage
A 2016 case study revealed a murky mechanism of action of drug-induced liver damage. The common factor in most cases of liver damage was treatment with Sovaldi and ribavirin. Given the timing of the events, it is highly probable that the liver injury was indeed related to Sovaldi. Researchers theorize that the body's ability to metabolize becomes severely inhibited after hepatic impairment, meaning that the way Sovaldi is metabolized in the body can lead to severe liver damage.
Researchers also suggest that the link between Sovaldi and liver damage could also be related to a patient's genetics. Further work is needed to establish a solid mechanism of action.
AbbVie's HCV Drugs Also Linked to Liver Injury
Gilead Science is not the first pharmaceutical company under fire for its hepatitis-C drugs causing severe damage to the liver. The FDA announced on October 22, 2015, that another manufacturer of Hepatitis-C drugs, AbbVie, would have to add a warning to its drug labels for the possibility of liver damage. Twenty six cases of liver complications had been reported since the drug's approval. Viekira Pak was approved in December 2014 and the combo drug Technivie in July 2015. The side effects were generally seen in the first four weeks.
The side effects in some cases led to liver transplantation or death. However, these serious effects were reported mostly in patients taking Viekira Pak who had evidence of advanced cirrhosis even before starting treatment with Sovaldi. You can find the full FDA warning here.
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At Rheingold Giuffra Ruffo & Plotkin LLP, our New York drug injury attorneys work closely with clients to determine the extent of their monetary damage and what legal remedies are at their disposal. Our goal is to help victims of injury obtain monetary compensation for their hardships.