In all, 70 (63%) patients developed HBV reactivation, including 84% of the 37 patients with undetectable HBV DNA at baseline. During treatment, none of these patients had ALT rise more than twice the upper limit of normal. By 48 weeks post treatment, however, 77% still had quantifiable HBV DNA, and two had marked ALT rises. Furthermore, by posttreatment week 53, one of these patients developed bilirubinemia and symptomatic HBV infection (malaise, anorexia, sclera jaundice, and nausea), which resolved after treatment with entecavir.
A total of 74 patients had quantifiable baseline HBV DNA (at least 20 IU/mL). Three received entecavir or tenofovir disoproxil fumarate based on confirmed HBV reactivation with a concomitant ALT rise of at least twice the upper limit of normal. All were asymptomatic. There were no cases of liver failure or death.
“Regardless of HBV DNA and/or ALT elevations, no patient had signs of liver failure,” the researchers wrote. “Our results support the recommendations put forth in clinical treatment guidelines: HCV-infected patients should be evaluated for HBV infection prior to HCV treatment with direct-acting antivirals. Those who are HBsAg positive should be monitored during and after treatment for HBV reactivation, and treatment should be initiated in accordance with existing guidelines.”
Gilead funded the study. Dr. Liu and 12 coinvestigators reported having no conflicts of interest. Nine coinvestigators reported being employees and shareholders of Gilead, and one coinvestigator reporting consulting for Gilead. The senior author disclosed ties to Roche, Bristol-Myers Squibb, Johnson & Johnson, Bayer, MSD, and Taiha.
SOURCE: Lui C-J et al. Gastroenterology. 2017 Nov 21. doi: 10.1053/j.gastro.2017.11.011.