HBcAg

Randomised study comparing 48 and 96 weeks peginterferon alpha-2a therapy in genotype D HBeAg-negative chronic hepatitis B. .

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Treatment with peginterferon alpha-2a (PegIFN) for 48 weeks is the standard of care for selected HBeAg-negative patients chronically infected with hepatitis B virus (HBV), but with limited treatment efficacy. A study was undertaken to investigate whether treatment extension to 96 weeks improves the outcome in this patient population.

METHODS: 128 HBeAg-negative patients (120 genotype D) were randomised to weekly 180 mug PegIFN for 48 weeks (group A, n=51), 180 mug PegIFN for 48 weeks followed by 135 mug weekly for an additional 48 weeks (group B, n=52) or 180 mug PegIFN plus lamivudine (100 mg/day) for 48 weeks then 135 mug PegIFN for 48 weeks (group C, n=25). Endpoints were alanine aminotransferase normalisation plus HBV DNA <3400 IU/ml (primary), HBV DNA <2000 IU/ml and HBsAg clearance at 48 weeks after treatment.
RESULTS: Forty-eight weeks after treatment, six patients in group A and 13 in group B achieved alanine aminotransferase normalisation plus HBV DNA <3400 IU/ml (11.8% vs 25.0%, p=0.08), 6 vs 15 patients had HBV DNA <2000 IU/ml (11.8% vs 28.8%, p=0.03), 0 vs 3 achieved HBsAg clearance (0% vs 5.8%, p=0.24) and 0 vs 5 had HBsAg <10 IU/ml (0% vs 9.6%, p=0.06). While extended PegIFN treatment was the strongest independent predictor of response, the combination with lamivudine did not improve responses. Discontinuation rates were similar among the groups (19.6%, 23.1%, 32.0%, p=0.81) and were mostly due to PegIFN-related adverse events.
CONCLUSIONS: In HBeAg-negative genotype D patients with chronic hepatitis B, PegIFN treatment for 96 weeks was well tolerated and the post-treatment virological response improved significantly compared with 48 weeks of treatment.

Source: gut

 

Antiviral Therapy Safely Stopped in HBeAg-Negative Patients with Hepatitis B Infection.

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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