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HBV reactivation uncommon in rheumatologic patients, long-term therapy may not be needed

Hepatitis B virus reactivation was not prevalent among rheumatologic patients with previously resolved hepatitis B virus infection and rheumatologic indications for long-term biologic therapies, indicating that universal prophylaxis might not be cost-effective in this type of clinical setting, according to data published in Hepatology.

“European and Asian studies report conflicting data on the risk of HBV reactivation in rheumatologic patients with a [previously resolved HBV] infection undergoing long-term biologic therapies,” the researchers wrote. “The present study is the largest prospective trial aimed at evaluating the safety of biologic therapies, including 14 cases treated with rituximab, in rheumatologic patients with a [previously resolved HBV] infection.”

Researchers in Italy analyzed 1,218 Caucasian rheumatologic patients admitted for outpatient services and on biologic therapeutic regimens between 2001 and 2012. Each patient underwent evaluation for anti-HCV and HBV markers as well as liver aminotransferases every 3 months, according to the research. Researchers then began monitoring for HBV DNA in January 2009, among patients with a previously resolved HBV (prHBV) infection who began immunosuppressive biologic therapy before and after the start of 2009.

Overall, the researchers found prHBV infection prevalent in 179 patients. The other patients (n = 959) did not have a prHBV infection or other liver disease. Of the patients with previous infection, 14 were treated with Rituxan (rituximab, Genentech), 146 with anti-tumor necrosis factor-alpha and 19 with other therapies.

The researchers did not detect positive HBV DNA serum levels or antibody to hepatitis B surface antigen/hepatitis B surface antigen seroreversion in the patients with prHBV infection.

However, compared to the patients without any hint of liver disease, the prevalence of elevated aminotransferases in patients with prHBV infection was “significantly higher in the former group only for aminotransferase levels greater than 1 time the upper normal limit, but not when aminotransferase levels greater than two times the upper normal limit were considered,” according to the researchers.

“Considering that the prevalence of rheumatologic patients with a prHBV infection is high, while the incidence of seroreversion among our patient population was zero, universal prophylaxis is not justified and is not cost-effective in this clinical setting,” the researchers concluded. “Even if the number of patients receiving rituximab was limited, this concept may be extended to these patients.” – by Melinda Stevens

Disclosures: The researchers report no relevant financial disclosures.