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Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing approved hepatitis C drugs in the country for links to a possible reactivation of the hepatitis B virus, which could result in label changes.
In a notice last week, PMDA said that the review covers Gilead Sciences’ ($GILD) Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) as well as AbbVie’s ($ABBV) Viekirax (ombitasvir and paritaprevir and ritonavir), Bristol-Myers Squibb’s ($BMY) Daklinza (daclatasvir) and Sunvepra (asunaprevir), Mitsubishi Tanabe’s Telavic (telaprevir), Janssen Pharmaceutical K.K.’s Sovriad (simeprevir), and Merck’s ($MRK) Vanihep (vaniprevir).
Related to the review, PMDA posted a notice from BMS warning that a suspected reactivation of hepatitis B virus following the use of Daklinza and Sunvepra caused hepatic dysfunction, including one death.
On the PMDA notice, BMS called on doctors to send patients for hepatitis B virus marker tests prior to treatment.
A similar review is being conducted by the EMA, which began back in March. The agency has recently extended its review to also look at the risk of liver cancer (hepatocellular carcinoma) coming back in patients who were treated with direct-acting antivirals for hepatitis C, after a study published in April suggested this may be the case.
– here’s the PMDA release
Read more…http://www.fiercepharma.com/pharma-asia/japan-s-pmda-reviews-hep-b-risk-link-to-hep-c-therapies