WASHINGTON — Novel direct-acting antiviral therapies carried a low hepatitis B virus reactivation risk, according to findings presented at The Liver Meeting 2017.
“With the widespread use of these regimens, we have started to see some unintended consequences that were not recorded or reported,” Adeel A. Butt, MD, MS, of the VA Pittsburgh Healthcare System and Weill Cornell Medical College in New York, said. “One outcome that has been reported is reactivation of HBV replication. Several of these reports have been published in the last several years.”
Butt noted, however, that many of those studies have not used a uniform definition of HBV reactivation, nor have they had a control group. He and his colleagues investigated rates of HBV reactivation in a cohort of 58,107 patients who initiated newer DAA regimens or a pegylated interferon plus ribavirin (PEG/RBV) regimen.
Outcomes included HBV reactivation (defined as new detectable HBV DNA or increase of more than 1 log10), ALT flare (defined as serum alanine aminotransferase flare greater than five times from baseline in presence of HBV reactivation), all-cause death, and hepatic decompensation.
Results showed an overall HBV viral reactivation rate of 30.04 per 1,000 person years follow-up (95% CI, 10.41-49.67) among patients on DAA regimens vs. 25.42 (95% CI, 17.23-33.62) among the PEG/RBV cohort. Regarding those who were HBsAg-positive at baseline, the rate was 24.53 per 1,000 person years follow-up in the DAA group vs. 37.43 (95% CI, 15.31-59.55) in the PEG/RBV group.
Data revealed an overall ALT flare of 0.11 per 1,000 person years follow-up (-0.01 to 0.24) in the DAA cohort vs. 1.31 (95% CI, 1.13-1.49) in the PEG/RBV cohort. For those who were HBsAg-positive at baseline, the rates were 0 per 1,000 person years follow-up in the DAA group vs. 1.43 in the PEG/RBV group.
“The number and rate of HBV reactivation in DAA-treated persons was relatively low,” Butt said.
Flare or reactivation risk was elevated in several subgroups, including men, black patients, those reporting alcohol use or dependence, and those with detectable HBV DNA at baseline. Conversely, flare or reactivation risk was reduced in patients treated with a DAA regimen.
The first hepatic decompensation curve was significantly faster in the HBV reactivation group than the non-reactivation group. Similarly, the mortality curve was also quicker in the reactivation group than in those who did not reactivate. – by Rob Volansky
For more information:
Butt AA, et al. Abstract 122. Presented at: The Liver Meeting; Oct. 20-24, 2017; Washington, D.C.
Disclosure: Butt reports receiving grant or research support from Gilead and Merck.
The data included has been updated to better reflect the results.