On February 14, 2017, the FDA released a Black Box warning for these drugs with the following text:
Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death.
Recently, the safety of the newer hepatitis C treatment drugs — such as Solvadi and Harvoni — is being called into question. These drugs are known as direct-acting antiviral (DAA) drugs, and come with a steep cost of approximately $1,000 per pill.
Here is a list of DAAs currently available in the US:
- Sovaldi (sofosbuvir) — Gilead Sciences
- Harvoni (ledipasvir and sofosbuvir) — Gilead Sciences
- Viekira Pak (dasabuvir and ombitasvir and paritaprevir and ritonavir) — Abbvie
- Viekira Pak XR (dasabuvir and ombitasvir and paritaprevir and ritonavir) — Abbvie
- Epclusa (sofosbuvir and velpatasvir) — Gilead Sciences
- Daklinza (daclatasvir) — Bristol-Myers Squibb
- Olysio (simeprevir) — Janssen
- Technivie (ombitasvir and paritaprevir and ritonavir) — Abbvie
- Zepatier (elbasvir and grazoprevir) — Merck Sharp Dohme
A report issued by the Institute for Safe Medication Practices (ISMP) provided information on the possibility of liver injury, liver failure, and reactivation of hepatitis B in patients who were treated with DAAs such as Solvadi and Harvoni. This report is based on the adverse drug event reports submitted to the FDA, also known as MedWatch reports.
Here is an excerpt from the ISMP QuarterWatch report, which provides details on the number of adverse drug effects that have been reported to the FDA:
The FDA report described 24 cases of hepatitis B reactivation, including 3 cases of acute liver failure, a catastrophic drug adverse event involving damage to the liver so severe that continued survival is threatened. Searching beyond the FDA’s cited cases to review the most recent 12 months’ FAERS data, we identified 524 reported cases of liver failure associated with the drugs, and another 1,058 reports of severe liver injury. In a further 761 cases the adverse event was antiviral failure against the targeted virus. Our data show the need for further investigation into the negative consequences of these expensive and important new drugs.
This WebMD article provides some additional statistics:
The study said about 250,000 people worldwide took the newer drugs in 2015. Among patients treated with the drugs during the year ending June 30, 2016, 524 suffered liver failure, and 165 of those patients died…The study also said the drugs appeared ineffective in 761 patients.
Of note, approximately 90% of the 524 reports linking liver failure to DAAs were submitted to the FDA by health professionals. While these hepatitis C drugs are still being prescribed at the same rate they have previously been, the FDA findings are staggering, and should be cause for alarm.
Thomas J. Moore, senior scientist for drug safety and policy at ISMP is quoted as saying the following in a recent Healio article:
This is an example of the price we pay for faster drug approval with reduced clinical testing…Don’t we really want to know more than this about a new drug treatment on which we spent more than $10-20 billion in 2015 alone? We spent more than twice as much on these direct-acting antivirals for about 250,000 patients as the NIH did on all research into all infectious diseases.
The FDA identified the first new major safety problem linked to these nine new DAAs in their Drug Safety Communication from October of 2016. They found that these drugs were linked to the reactivation of hepatitis B, with severe health consequences such as liver transplant and death. As a result, they expressed their intention to include a “black-box warning,” the most prominent warning, in the near future.
However, as of today, January 27, 2016, the current drug label for Harvoni still does not include this warning.
We will continue to monitor the medical literature for additional information on the link between these hepatitis C drugs and their harmful side effects. We will also be on the lookout for the new drug labels with the “black-box” warning of possible hepatitis B recurrence.
In the meantime, please feel free to complete our Free Case Evaluation if you have experienced liver injury, liver failure, or hepatitis B recurrence after using one of the nine newer hepatitis C drugs.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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