TDF alone may be sufficient maintenance in chronic HBV patients

Jun 1 2015

By Shreeya Nanda, Senior medwireNews Reporter

Tenofovir disoproxil fumarate (TDF) monotherapy may be sufficient to maintain complete virological suppression in patients with chronic hepatitis B virus (HBV) infection previously treated with TDF plus entecavir (ETV), suggests a review of patients.

However, treatment with ETV alone resulted in an “unacceptably high” rate of virological breakthrough, say Mindie Nguyen (Stanford University Medical Center, Palo Alto, California, USA) and team.

“In this patient population, especially for those who cannot continue combination therapy because of nonadherence and financial problems, switching to TDF monotherapy is a better option than reverting to ETV monotherapy after successful ETV + TDF combination therapy”, they write in the European Journal of Gastroenterology & Hepatology.

Of the 57 chronic HBV patients with a partial response to ETV who achieved complete virological suppression after subsequent treatment with TDF plus ETV, 18 switched to TDF monotherapy, 16 reverted to ETV monotherapy and the remaining 23 patients continued with dual therapy.

After 6 months of monotherapy, patients in the TDF alone group had a significantly lower cumulative viral breakthrough rate than those in the ETV alone group, at 39% versus 88% (p=0.004). This difference was maintained at 1 year, with rates of 44% and 88% (p=0.01) for patients given TDF and ETV monotherapy, respectively.

Interestingly, virological breakthrough occurred in 26% of patients in the combination therapy group by month 12, which the researchers attribute to nonadherence.

Multivariate analysis showed that ETV monotherapy and complete virological suppression of less than a year were significantly associated with virological breakthrough, with adjusted odds ratios of 112.7 (p=0.03) and 60.2 (p=0.03), respectively.

“Additional studies including larger patient cohorts are also needed to further define patient selection criteria for ETV partial responders who can achieve [complete virological suppression] with TDF monotherapy with and without a period of ‘bridging’ ETV + TDF combination therapy first”, conclude Nguyen et al.  

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