Serper M, et al. – This study was performed with the aim to determine the incidence of alanine aminotransferase (ALT) flares, clinically significant hepatic events, and hepatitis B virus reactivation (HBVr) among a national cohort of US veterans with prior exposure to HBV (anti–HBc+) treated with direct acting antiviral therapy (DAAs). Researchers realized rarity of clinically significant hepatic events and HBVr and these were much more frequent among HBsAg–positive individuals. They recommend monitoring anti–HBc + patients for ALT flares and HBVr during and possibly for up to 6 months post DAA therapy.

Methods

• A national administrative database was used to identify patients treated with DAAs from January 2014 through November 2016.
• Clinical and demographic as well as HBV and HCV treatment data were obtained.
• Researchers defined HBVr as an at least 1–log increase in HBV DNA titer.

Results

• 17,779 anti–HBc+ patients were identified; 17,400 were HIV– and 379 were HIV+. 17,266 (99%) were HBsAg– prior to DAA therapy among the HIV– patients and 134 were HbsAg+.
• Findings revealed that among HIV–, HBsAg– patients, alanine aminotransferase (ALT) elevations greater than 10 times the upper limit of normal (ULN) (≥300 IU/ml) were rare and occurred more frequently after treatment completion: 31 cases (<0.1%) during versus 85 (0.6%) following treatment.
• 39 cases (0.3%) indicated clinically significant hepatic events, defined as ALT increases > 100 IU/L with total bilirubin > 2.5 mg/dl, these were most often following DAA completion (n = 35 cases, 3/35 in setting of HCV relapse).
• Among 31 patients with post–DAA hepatic events without HCV relapse, 10 (32%) were confirmed unrelated to HBVr by HBsAg and/or HBV DNA testing, 1 (3%) confirmed due to HBVr, and 20 (65%) did not have documented HBV–related testing.
• They identified one additional case of HBsAg– to + seroreversion.
• Among HBsAg+ DAA recipients, ALT elevations ≥ 300 IU/ml was observed in 2/97 (2%), both with cirrhosis, in the setting of HBVr.