Returning to the “FDA Drug Safety Communication: FDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C”, which was issued on October 4, 2016:FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs during the 31 months from November 22, 2013 to July 18, 2016. This number includes only cases submitted to FDA, so there are likely additional cases about which FDA is unaware. Of the cases reported, two patients died and one required a liver transplant. HBV reactivation was not reported as an adverse event in the clinical trials submitted for the DAA approvals because patients with HBV co-infection were excluded from the trials.
A recent investigation into the Institute of Medicine (IOM) has revealed that several committee members tasked with setting official hepatitis C virus (HCV) treatment guidelines in 2015 had significant conflicts of interest involving the pharmaceutical and health care industries. The study, published in the Journal of the American Medical Association (JAMA), raises serious concerns about the ethics of the group’s official hepatitis C recommendations, ContagionLive reports. IOM is a division of the National Academy of Sciences, Engineering and Medicine, a conglomerate of private nonprofit institutions that provide expert advice to international policy makers on health care issues. The group’s 2015 HCV guidelines encompassed protocols on testing, management, treatment and additional aspects of the liver virus that were meant to be considered by doctors around the world as evidence-based and bias-free.
The US Food and Drug Administration (FDA) on Tuesday warned of serious risks for some patients who have been infected with the hepatitis B virus (HBV) and are being treated with certain direct-acting antiviral (DAA) medicines for hepatitis C virus (HCV).FDA identified 24 cases of HBV reactivation reported to FDA and from the published literature in HCV/HBV co-infected patients treated with DAAs between 22 November 2013 and 18 July 2016.Of the cases reported, two patients died and one required a liver transplant, though FDA cautions that this number includes only cases submitted to FDA, so there are likely additional cases.
It is estimated that 150 million people world-wide may have the Hepatitis C Virus. On October 10, 2014, the FDA approved the fixed-dose combination capsule of ledipasvir plus sofosbuvir (Harvoni; Gilead Sciences) for the treatment of patients with chronic HCV genotype 1 infection. Ledipasvir plus sofosbuvir is the first combination tablet approved for the treatment of patients with chronic HCV genotype 1 infection, as well as, the first approved regimen that does not require the use of interferon or ribavirin. The FDA approved the drug under breakthrough therapy designation, which is intended to expedite the development and review of drugs for serious conditions.