High Relapse Rate After Discontinuing Antiviral Therapy for HBV Patients With Cirrhosis

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The pooled proportions of virological relapse and clinical relapse after discontinuing treatment in cirrhotic patients was 55.23 and 43.56%, respectively.

Patients with chronic hepatitis B virus (HBV) infections and cirrhosis who discontinue nucleostide analogs (NA) are at an increased risk of relapse, even after achieving virologic suppression.

A team, led by Yuhao Yao, Department of Gastroenterology, Dongzhimen Hospital, Beijing University of Chinese Medicine, evaluated existing data on clinical outcomes of nucleostide analog withdrawal in patients with chronic HBV and cirrhosis.

The Medicine

The discontinuation of nucleostide analogs are controversial in the management of hepatitis B-related liver cirrhosis.

“The need for long-term NAs therapy raises safety issues for some patients (elderly patients with comorbidities like diabetes and renal insufficiency) and family planning issues in patients of reproductive age along with increases in treatment costs,” the authors wrote. “For these reasons, many physicians treating CHB patients with NAs for years have become interested in investigating the need for continuation as well as the safety of therapy withdrawal.”

However, investigators have not yet studies clinical outcomes following the discontinuation of nucleostide analogs.

“All NAs have an excellent tolerance and a good safety profile, but they cannot achieve HBV clearance or at least HBsAg loss in the vast majority of cases,” the authors wrote. “Therefore they should be given for very long periods, perhaps indefinitely, especially in cirrhotic patients.”

The Review

In the systematic review, the investigators searched for completed studies up until May 2022. The studies involved patients with hepatitis B-related cirrhosis who discontinued nucleostide analogs in virological remission with off-therapy follow-up for more than 12 months.

The team identified 19 studies involving 1287 patients with hepatitis B-related cirrhosis.

The majority of patients were compensated and achieved virological suppression when they concluded antiviral therapy.

The pooled proportions of virological relapse and clinical relapse after discontinuing treatment in cirrhotic patients was 55.23 (95% CI, 40.33–69.67) and 43.56% (95% CI, 26.13–61.85), respectively.

The investigators also observed HBsAg loss in 56 participants (pooled proportion = 13.68%; 95% CI, 5.82–24.18).

Finally, the pooled proportions of HCC development, hepatic decompensation, and overall mortality were 8.76 (95% CI, 2.25–18.95), 3.63 (95% CI, 1.31–7.03), and 0.85% (95% CI, 0.35–1.57), respectively.

“In hepatitis B-related compensated cirrhosis, who have achieved complete virological suppression, discontinuation of oral antivirals still carries a high relapse rate, but the incidence of adverse events is generally low and controlled during follow-up of at least 12 months,” the authors wrote. “Of attention is that discontinuation of NAs can achieve a high rate of HBsAg seroclearance. This study may be helpful in the management of NAs in cirrhotic patients.”

The study, “Systematic review: Clinical outcomes of discontinuation of oral antivirals in hepatitis B-related liver cirrhosis,” was published online in Frontiers in Public Health.