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Discontinuation of TDF for HBV safe under strict observation

Results of a randomized control study showed the potential for hepatitis surface antigen loss and sustained virologic response in patients without cirrhosis and negative for HBV e-antigen after stopping long-term tenofovir disoproxil fumarate, according to recently published data.

“Although there is currently no cure for chronic hepatitis B virus (HBV) infection, the virus can be effectively controlled with current antiviral treatment strategies using either interferon (IFN) or nucleos(t)ide analogues (NA),” Thomas Berg, MD, from the University Clinic Leipzig in Germany, and colleagues wrote. “The results of this study support the concept of stopping antiviral therapy in long-term HBV DNA-suppressed patients without cirrhosis, under strict observation.”

The researchers randomly assigned 21 patients to stop TDF therapy and 21 patients to continue therapy. Of those who stopped therapy, 13 remained off-therapy up to 144 weeks of follow-up.

During the study, eight patients qualified to restart TDF due to persistently high levels of viremia or early flares of HBV DNA and alanine aminotransferase levels.

By week 144, four patients who discontinued TDF achieved HBsAg loss and three patients achieved HBsAg seroconversion. No patients who continued therapy achieved HBsAg loss or seroconversion.

HBV DNA and ALT levels fluctuated among patients who discontinued therapy, whereas those who remained on therapy demonstrated constant HBV DNA levels.

At study end, 76% of those who discontinued TDF therapy had HBV DNA of 2,000 IU/mL or less and ALT levels at the upper limit of normal or lower.

“Although there were clear fluctuations in HBV DNA levels and ALT levels in the patients who discontinued TDF therapy, there were no unexpected safety issues in this patient group,” the researchers wrote. “Overall, the results from this study are encouraging. However, this study was experimental in nature and was conducted with a highly controlled cohort that was under strict observation. The study did not aim to make any recommendations regarding stopping TDF therapy in patients with HBV during routine clinical practice.” – by Talitha Bennett

Disclosure: The study was funded by Gilead Sciences. Berg reports grants and personal fees from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, Bayer, Vertex, Tibotec, Intercept, Merck Sharp & Dohme, and Roche. Please see the full study for all other authors’ relevant financial disclosures.