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Use of nucleoside analogue therapy for hepatitis B virus (HBV) infection may need to be discontinued because of toxicity and because poor adherence may lead to resistance.
To determine outcomes after discontinuation of therapy with entecavir versus tenofovir and to identify predictors of relapse, researchers in Taiwan conducted a prospective cohort study of 100 noncirrhotic participants with chronic HBV infection who discontinued therapy between 2012 and 2017. Of these patients, 66 were receiving entecavir and 34 were receiving tenofovir. All patients were HBV e antigen (HBeAg)-negative and had an HBV DNA level of <20 IU/mL for more than 12 months before treatment was stopped.
Key findings were as follows:
Patients who discontinued tenofovir had viral relapse — defined as HBV DNA level of >2000 IU/mL — sooner and to a higher degree than those who discontinued entecavir (P=0.038).
Patients who discontinued tenofovir also had a higher 3-month cumulative clinical relapse rate — defined as a viral relapse combined with a twofold elevation of the alanine aminotransferase level from the upper limit of normal — than those who discontinued entecavir (15.2% vs. 1.5%; P=0.007).
After adjusting for age, sex, and HBV surface antigen (HBsAg) status, HBV DNA levels 1 month after stopping therapy predicted viral relapse (hazard ratio, 2.82; P<0.001) and clinical relapse (HR, 1.51; P<0.007).
Su TH et al. Distinct relapse rates and risk predictors after discontinuing tenofovir and entecavir therapy. J Infect Dis 2018 Mar 28; 217:1193. (http://dx.doi.org/10.1093/infdis/jix690)
Comment
This paper demonstrates that in patients with HBV infection, early viral and clinical relapse rates were higher among those who discontinued tenofovir than those who discontinued entecavir. Viral and clinical relapses were predicted by rising HBV DNA levels within 1 month of discontinuing either therapy. These findings suggest that close monitoring should be maintained during this period if nucleoside analogue therapy is discontinued. This issue may be particularly important for patients with HBV infection on tenofovir for other reasons, such as HIV infection or preexposure prophylaxis for HIV.