Abstract
Aim The efficacy of tenofovir disoproxil fumarate (TDF) monotherapy as maintenance therapy in multidrug-resistant (MDR) hepatitis B virus (HBV) patients after complete virologic suppression (CVS) has not been well evaluated. We evaluated the efficacy of maintenance TDF monotherapy compared with conventional TDF plus entecavir combination therapy after CVS of MDR HBV. Methods In this single-center retrospective study, patients with MDR HBV who were previously treated with entecavir plus TDF combination therapy and achieved CVS were included. Patients were either maintained on entecavir plus TDF combination therapy or switched to TDF monotherapy after CVS. The primary endpoint was the virologic breakthrough, and secondary outcomes were liver cirrhosis (LC) or hepatocellular carcinoma (HCC) development. To overcome immortal time bias, time-varying Cox proportional hazard regression analysis was performed. Results A total of 201 patients were included, and 153 patients were maintained on entecavir plus TDF combination therapy (combination group); 48 patients were converted from combination therapy to TDF monotherapy (single group) after CVS. Five patients experienced a virologic breakthrough, one patient in the single group owing to poor transient compliance and four patients in the combination group (P = 0.51). One new case of LC developed in the single group; five cases of LC developed in the combination group (P = 0.35). No new HCC development occurred in the single group, while seven cases of HCC developments were noted in the combination group. However, these results were not statistically significant (P = 0.54). Conclusions For patients with suppressed HBV DNA, the efficacy of TDF monotherapy as maintenance therapy is comparable to that of entecavir plus TDF combination therapy.
Highlights
Treatment outcomes of patients with chronic hepatitis B (CHB) have improved since the development of nucleos(t)ide analogs (NAs), including lamivudine (LAM), adefovir (ADV), telbivudine (LdT), entecavir (ETV), or tenofovir disoproxil fumarate (TDF) [1,2,3]
MDR hepatitis B virus (HBV) is of particular interest because MDR HBV has higher chances of increased viral loads, elevated serum alanine aminotransferase (ALT) levels, and development of liver cirrhosis (LC) or hepatocellular carcinoma (HCC) owing to viral control difficulties as MDR HBV has higher risks of resistance to other NAs [6,7,8,9]
All patients had an experience in other NAs before ETV-TDF combination therapy, and 182 patients were exposed to LAM and 25 patients were exposed to LdT
Summary
Treatment outcomes of patients with chronic hepatitis B (CHB) have improved since the development of nucleos(t)ide analogs (NAs), including lamivudine (LAM), adefovir (ADV), telbivudine (LdT), entecavir (ETV), or tenofovir disoproxil fumarate (TDF) [1,2,3]. As the duration of NA treatment prolongs, the incidence of antiviral drug resistance increases, especially in patients using low potent and low genetic barrier NAs, including LAM or ADV. Many patients with single drug resistances are treated with sequential monotherapies. As TDF has a very high barrier to resistance, the possibility of TDF monotherapy successfully treating MDR CHB has increased.
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