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FDA Warns Against Hepatitis B Reactivation In Some Patients Taking Direct-Acting Hepatitis C Antivirals

5 October 2016, 10:40 am EDT By Saranya Palanisamy Tech Times
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The U.S. Food and Drug Administration has issued a warning against the potential risk of Hepatitis B virus reactivation in patients treated with direct-acting antiviral drugs for Hepatitis C virus.

Patients who have already been infected by the HB virus and those who have ongoing infection are likely to develop serious liver conditions or even death when treated with HC direct-acting antiviral drugs for HC infection. The FDA has mandated the inclusion of "Boxed Warning," a prominent warning concerning the risks of HB virus reactivation on the HC direct-acting antiviral drug labels.

The drugs are used to treat chronic HC infection that can last even for a life time. The drugs help in reducing the HC virus load, containing the virus from multiplying as well as to cure the infection in most cases. Without the HC drugs infected individuals could end up in severe liver conditions, including liver cirrhosis, liver cancer and death.

Daklinza (daclatasvir), Sovaldi (sofosbuvir), Harvoni (a combination of ledipasvir and sofosbuvir) and Olysio (simeprevir) are some of the well-known direct-acting antiviral drugs in the market.

It is noted in the FDA's statement that HB virus reactivation is reported in 24 cases treated with direct-acting antiviral drugs between Nov. 22, 2013 and July. 18, 2016 in patients who suffered HB and HC co-infection. The agency also noted that the number includes only those obtained from published literature and there could also be more unknown cases.

The recommendations have it that the patients should notify doctors about their history of HB infection and associated liver problems beforehand to avoid co-infection treatment risks. Meanwhile, patients on HC drugs are not advised to discontinue medication in any case without consulting the concerned doctor.

However, many people may not be aware of their past HB infection. The worst part is the infection cannot be cured completely and the virus can remain dormant for life.

To overcome such issues, FDA has recommended all the physicians to screen the patients for past or current HB virus infection before putting them on HC medication. Patients on direct-acting antiviral drug should be subjected to a blood test to detect HB virus reactivation along the treatment process as well as post-treatment follow-ups.

"Doctors should be screening everybody," said Dr. John Farley, deputy director of FDA's Office of Antimicrobial Products. "The mechanism of action is not clearly understood ... I think it is important to recognize that these hepatitis C drugs are lifesaving medications. What we don't want to do is discourage patients with hepatitis C from getting treatment."

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