Efficacy of Tenofovir in Patients with Lamivudine Failure Is Not Different from That in Nucleoside/Nucleotide Analogue-Naïve Patients with Chronic Hepatitis B

Abstract

We evaluated the efficacy of tenofovir disoproxil fumarate (TDF) in patients with lamivudine failure (LAM-F) in comparison with that in nucleoside/nucleotide analogue (NA)-naïve patients with chronic hepatitis B (CHB). The criteria for inclusion were being NA naïve or having previous LAM-F and receiving TDF therapy for at least 6 months. Biochemical and virological tests were performed at the baseline, at 3-month intervals in the first year, and every 6 months thereafter. The primary outcome measure for efficacy was a complete virological response (CVR), defined as an HBV DNA level of <20 IU/ml. CVR rates were calculated by Kaplan-Meier analysis, and a multivariate Cox proportional-hazard model was generated in order to find predictive factors independently associated with the time to a CVR. We included 197 patients in the study (136 males; mean age, 43 ؎ 12 years; 105 patients were NA naïve). Sixty-five patients had hepatitis B e antigen (HBeAg)-positive CHB. The median duration of TDF treatment was 29 (range, 6 to 52) months. Seventy-one patients (77%) in the LAM-F group were treated with TDF add-on therapy. The CVR rates of the NA-naïve and LAM-F groups were comparable in HBeAg-negative (94% versus 96% at month 36, P ‫؍‬

Efficacy and Safety of Tenofovir Disoproxil Furmarate for Patients with Lamivudine-Resistant Hepatitis B Virus Infection

“…Virologic response was achieved 89.7% at 12 months after TDF treatment, and the rate increased up to 92% at 24 months. This result is comparable to the previous results in treatment-naïve patients [14,25] . The response rates are also comparable with previous clinical trial data by Fung et al, even though higher proportion of patients in our study was HBeAg positive and more cases were exposed to ADV compared with the previous study [18] .…”

“…Tenofovir (TDF) has a potent antiviral activity against both wildtype or LAM-resistant HBV [4] . TDF demonstrated superior antiviral efficacy compared to ADV at 48 weeks and long-term suppression of HBV DAN through 5 years with absence of long-term resistance [14,15] . TDF is currently recommended for the first-line agents for chronic hepatitis B patients [16,17] .…”

Real-life Outcomes of Tenofovir Disoproxil Fumarate Monotherapy in Nucleos(t)ide Analogue-naive and Nucleos(t)ide Analogue-experienced Chronic Hepatitis B Patients: A Single-center Experience

“…In our study, no statistically significant difference was found between CVR rates in NA-naive and NA-experienced patients at the 1 st , 2 nd , 3 rd , 4 th , and 5 th years of the treatment. TDF monotherapy was found to be efficient in NA-experienced patients as it was in NA-naive patients (8,9,10,11,14). However, data on long-term efficacy and safety in daily practice are still limited, especially in NA-experienced patients.…”

“…However, in the era when drugs with a high genetic barrier were not available, ADV and/or entecavir therapy was begun to manage LAM resistance (13). It has been determined that treatment response to TDF therapy was not affected in patients who were determined as having LAM resistance (8,10,14,16,17,18,19). So far, TDF resistance has not been described in NA-experienced patients (20).…”

“…However, there are a limited number of studies about the efficacy of TDF therapy in NA-experienced patients in our country (9,10,11). Since TDF therapy is a frequently preferred treatment for CHB in Turkey, long-term data-based outcomes are necessary to determine its efficacy in both NA-naive and NA-experienced patients.…”