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Off-therapy serum qHBsAg level can predict durability of Baraclude-treated HBV patients

Recent findings published in The American Journal of Gastroenterology showed that off-therapy serum quantitative hepatitis B surface antigen level can predict the durability of patients with chronic hepatitis B virus infection who were treated with Baraclude and are stopping therapy.

In addition, the researchers found that sustained viral response can be attained in a minority of patients after discontinuation of Baraclude and that serum hepatitis B virus DNA level at 6 months off-therapy can predict clinical relapse over time.

“Our results confirm that [quantitative hepatitis B surface antigen level (qHBsAg)] off-therapy can predict durability of [chronic hepatitis B (CHB)] patients stopping entecavir treatment,” Chia-Chi Wang, MD, of the department of gastroenterology at the School of Medicine of Tzu Chi University in Taiwan, and colleagues wrote.

New clinical markers to better predict off-therapy of Baraclude (entecavir, Bristol-Myers Squibb) treatment are necessary, the researchers wrote. Because it shares a complementary relationship with HBV DNA in clinical practice, serum qHBsAg levels were hypothesized by the researchers as a potential clinical marker.

The researchers conducted a multicenter study of 93 patients with chronic HBV without cirrhosis who discontinued entecavir treatment in Taiwan. The primary endpoints were clinical relapse and SVR, which they defined as undetectable serum HBV DNA levels at 12 months off-therapy.

All 12 patients who did not achieve therapeutic end points experienced clinical relapse. In the 81 patients who achieved the end points, 54.3% experienced clinical relapse and 13.6% experienced SVR. The researchers found that serum HBV DNA at 3 months and 6 months off-therapy were associated with clinical relapse over time, whereas qHBsAg level at 6 months off-therapy had a marginal effect. In addition, they found that end-of-treatment qHBsAg levels were associated with SVR (P = .009).

Serum qHBsAg level less than 100 IU/mL is recognized as a new therapeutic end point, the researchers wrote.

“[This] can serve as a surrogate end point of existing treatment guidelines,” they wrote. – by Will Offit

Disclosure: Kao reports being a consultant for Abbott, Bristol-Myers Squibb, Gilead Sciences, GlaxoSmithKline, Merck Sharp & Dohme, Novartis and Roche and reports being on the speakers bureau for Abbott, Roche, Bayer, Bristol-Myers Squibb, GlaxoSmith Kline and Novartis. All other researchers declare no conflict of interest.