Discontinuing adefovir did not lead to any adverse events during 5.5 years of follow-up.

Although oral antiviral agents are effective in suppressing hepatitis B virus (HBV) in hepatitis B e antigen (HBeAg)-negative patients, it is unclear if therapy can ever be stopped. Previous studies observed that viral relapse occurred universally after a short course of treatment (J Gastroenterol Hepatol 2011; 26:456). Long-term suppressive therapy may afford an opportunity to eventually stop treatment.

In this observational study, a group of 33 well-characterized HBeAg-negative patients with HBV infection who had been receiving suppressive therapy with adefovir (10 mg daily) for 4 to 5 years discontinued treatment. Patients were then followed for 5.5 years, with measurement of serum alanine aminotransferase (ALT), hepatitis B surface antigen (HBsAg), and HBV DNA every 3 to 6 months to assess for relapse of HBV infection.

During a median follow-up of 69 months, 18 of 33 patients (55%) maintained persistently normal ALT and undetectable viral load (HBV DNA <29 IU/mL). Of these 18 responders, 13 (72%) cleared HBsAg, and 9 of the 13 (69%) seroconverted to hepatitis B surface antibody (HBsAb). No adverse events occurred, and in the 45% of patients who relapsed, an oral antiviral agent was safely restarted.

Comment: This long-term, prospective cohort study of a small group of HBeAg-negative patients with hepatitis B infection suggests that patients whose viral loads are suppressed with an oral agent for 4 to 5 years can safely discontinue antiviral therapy. Moreover, about half will not experience viral relapse, and the majority of these patients will develop HBsAb. However, stopping therapy should be considered only in highly compliant patients without cirrhosis. In patients with cirrhosis, close monitoring is necessary, and viral relapse can lead to hepatic decompensation.

Souurce: Journal Watch Gastroenterology