Monotherapy with Tenofovir Disoproxil Fumarate (TDF) in drug resistant hepatitis B


192 Korean patients with chronic hepatitis B with multiple drug resistance mutations against lamivudine (LAM), entecavir (ETV) and/or adefovir (ADF) were randomized to monotherapy with TDF or combination therapy with TDF and ETV. The primary endpoint was the proportion of patients with HBV-DNA < 15 IU/mL after 48 weeks. 66.3 and 68.0 % achieved HBV-DNA < 15 IU/mL with TDF monotherapy and TDF/ETV after 48 weeks. After 48 weeks all patients who wished to remain in the study (n=189) received monotherapy with TDF for another 96 weeks. After in total 144 weeks, the proportion of patients with viral load < 15 IU/mL had increased to 74.5 % according to intention to treat (on treatment 79.4 %). 19 patients with viral load >60 IU/mL had genotypic resistance analysis. No new resistance mutations were found.

Lim et al Hepatology 2017;00:1-12

Comment: Combination treatment with TDF/ETV has been recommended in hepatitis B with previous exposure and resistance development to LAM, ADF or ETV. In this study the addition of ETV did not have any impact on treatment results and it seems safe to use monotherapy with TDF in patients with resistant virus