A recent trial of the hepatitis C virus (HCV) treatment Harvoni (ledipasvir/sofosbuvir) among those coinfected with HCV and hepatitis B virus (HBV) added nuance to the concerns about drugs for HCV negatively affecting HBV. Additionally, all the participants were cured of hep C.
In October 2016, FDA added a black box warning, the most serious kind, to the labels of hep C treatments alerting individuals that the meds may give rise to reactivation of hep B in those coinfected with both viruses.
Researchers conducted a Phase II open-label study of 12 weeks of Harvoni in 111 Taiwanese people with genotype 1 or 2 of HCV and active HBV coinfection (meaning they were hep B surface antigen positive) who were not receiving treatment for HBV. Seventeen of the participants had compensated cirrhosis, and 37 had previously failed a hep C treatment.
All the participants achieved a sustained virologic response 12 weeks after completing therapy (SVR12, considered a cure). Three of them experienced a serious adverse health event, although none were judged related to Harvoni treatment. The most common adverse events, reported by at least 5 percent of participants, were headache, upper respiratory infection and fatigue.
Twenty-three (21 percent) of the participants experienced a rise in their hep B viral load of at least 100-fold during or after treatment with Harvoni. However, none of them experienced a grade 3 or 4 increase in their ALT liver enzymes or any clinical manifestations that would suggest hep B reactivation. Two participants started treatment for hep B based on increases in their HBV viral load and mild ALT level elevations that did not come with any symptoms.
To read a press release about the study, click here.