Real world data show therapy discontinuation is feasible in chronic hepatitis B

It is feasible for patients with negative HBV e-antigen chronic hepatitis B to discontinue nucleos(t)ide analogues therapy with low quantitative hepatitis B surface antigen levels, per a presentation at The Liver Meeting Digital Experience.

“Severe ALT flare can occur even if you have low surface antigen levels at the time of stopping, which means we need to follow all those patients who stop treatment very closely and this recommended in our guidelines,” Hassan Azhari, MD, from the department of gastroenterology and hepatology at the University of Calgary, said during his presentation. “Most biochemical and virological flares occur with the first 6 months of treatment cessation once you are out of that window, the likelihood of a flare is lower.”

Azhari and colleagues performed an observation study of 1,337 patients with chronic hepatitis B on long-term nucleos(t)ide analogues (NA) therapy. Forty-seven patients stopped long-term NA therapy. As per standard of care, investigators collected data after therapy was stopped. They used chi-squared tests and Fisher’s exact tests to compare categorical variables. They also used Wilcoxon rank-sum tests to compare continuous variables.

Twenty-eight of the patients who stopped therapy were on tenofovir disoproxil fumarate, 16 patients were on Baraclude (entecavir, Bristol-Myers Squibb) and three patients were on lamivudine.

Investigators reported that at the time of NA discontinuation, all patients were HBeAg negative and 46 patients had undetectable HBV DNA.

Results showed the median liver stiffness was 5.2 kPa. Six patients restarted NA therapy because of a virologic flare up, according to Azhari.

“None of our patients had liver dysfunction and they all responded to the restart of the antiviral treatment,” Azhari said. “All patients were started on tenofovir.”

Factors that linked to the start of tenofovir included baseline positive HBeAg status pre-treatment (P = .004) and longer NA treatment duration (P = . 011). Factors not correlated with a relapse risk included age, sex, liver stiffness, NA, ethnicity and [quantitative HBsAg] level at stopping.

“Our data suggest that patients who experience a flare up do so within the first 6 months of discontinuing NAs and are less likely to have a flare up once this period has passed safely,” Azhari said.