The high-profile direct-acting antiviral (DAA) hepatitis C drug at the center of the FDA’s mandate is sold under several brand names – most notably Sovaldi and Harvoni. According to U.S. News & World Report, the black box labeling is in response to three patients suffering from a hepatitis B flare-up after taking the medication.
Two of the patients who took the hepatitis C drug died while the third patient required a liver transplant, according to U.S. News & World Report.
These patients were previously treated for a hepatitis B infection in the past. Hepatitis B infections, for most people, can be cured easily. In some cases, hepatitis B can lead to more serious issues.
The FDA says at least 24 people who took the hepatitis C medication in question had a reoccurrence of hepatitis B between November 2013 and July of 2016. However, the FDA says the number of patients may actually be larger, since the 24 cases only included cases submitted to the FDA, reports U.S. News & World Report.
The hepatitis B resurgence side effect wasn’t previously reported because the DAA hepatitis C medications were not tested on people who previously had hepatitis B.
According to U.S. News & World Report, the direct-acting antiviral drug is very expensive, with state governments and prison systems struggling to afford it. More than 3 million people in the U.S. suffer from hepatitis C.
Patients are advised to tell their doctors if they have been infected with hepatitis B in the past before receiving treatment for hepatitis C.
|Brand name||Active ingredient(s)||Drug Manufacturer|
|Epclusa||sofosbuvir and velpatasvir||Gilead Sciences|
|Harvoni||ledipasvir and sofosbuvir||Gilead Sciences|
|Technivie||ombitasvir and paritaprevir and ritonavir||Abbvie|
|Viekira Pak||dasabuvir and ombitasvir and paritaprevir and ritonavir||Abbvie|
|Viekira Pak XR||dasabuvir and ombitasvir and paritaprevir and ritonavir||Abbvie|
|Zepatier||elbasvir and grazoprevir||Merck Sharp Dohme|