Tenofovir disoproxil fumarate monotherapy for nucleos(t)ide analogue-naïve and nucleos(t)ide analogue-experienced chronic hepatitis B patients

Abstract

Background/AimsThis study investigated the antiviral effects of tenofovir disoproxil fumarate (TDF) monotherapy in nucleos(t)ide analogue (NA)-naive and NA-experienced chronic hepatitis B (CHB) patients.MethodsCHB patients treated with TDF monotherapy (300 mg/day) for ≥12 weeks between December 2012 and July 2014 at a single center were retrospectively enrolled. Clinical, biochemical, and virological parameters were assessed every 12 weeks.ResultsIn total, 136 patients (median age 49 years, 96 males, 94 HBeAg positive, and 51 with liver cirrhosis) were included. Sixty-two patients were nucleos(t)ide (NA)-naïve, and 74 patients had prior NA therapy (NA-exp group), and 31 patients in the NA-exp group had lamivudine (LAM)-resistance (LAM-R group). The baseline serum hepatitis B virus (HBV) DNA level was 4.9±2.3 log IU/mL (mean±SD), and was higher in the NA-naïve group than in the NA-exp and LAM-R groups (5.9±2.0 log IU/mL vs 3.9±2.0 log IU/mL vs 4.2±1.7 log IU/mL, P<0.01). The complete virological response (CVR) rate at week 48 in the NA-naïve group (71.4%) did not differ significantly from those in the NA-exp (71.3%) and LAM-R (66.1%) groups. In multivariate analysis, baseline serum HBV DNA was the only predictive factor for a CVR at week 48 (hazard ratio, 0.809; 95% confidence interval, 0.729-0.898), while the CVR rate did not differ with the NA experience.ConclusionsTDF monotherapy was effective for CHB treatment irrespective of prior NA treatment or LAM resistance. Baseline serum HBV DNA was the independent predictive factor for a CVR.

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

“…These results show us that poor drug compliance is an important factor in the development of virologic breakthrough. In accordance with our study, Jung et al (14) reported that virologic breakthrough developed in a total of 5 patients due to poor medication compliance. The drug had not been switched, therapy was maintained regularly, and CVR was achieved in all of these patients.…”

“…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).…”

Treatment of Chronic Hepatitis B With Tenofovir At The University Teaching Hospital Campus of Lome (Togo)

“…This result can be explained by the fact that the contamination of HBV in Africa is most often occurred through mother to child transmission and during childhood. There was male predominance (68%) as in majority of studies in Africa [6,8], Europe and in Asia [10][11][12]. The circumstances of HBV discovery varied and were mainly dominated by blood donation and cirrhosis.…”

Recent Advances in the Management of Chronic Hepatitis B Including Suppression of Hepatocellular Carcinoma by Entecavir and Interferon

“…Sixty-two patients were NA-naïve and 74 patients received prior NA therapy (NA-exp group); 31 patients in the NA-exp group showed LAM resistance (LAM-R group; 5.9 ± 2.0 vs. 3.9 ± 2.0 vs. 4.2 ± 1.7 log IU/ml, p < 0.01). The complete virological response rate at week 48 in the NA-naïve group (71.4%) did not differ significantly from that in the NA-exp (71.3%) and LAM-R (66.1%) groups [31]. Following a 48-week randomized, double-blind evaluation of once-daily TDF versus once-daily ADV, open-label TDF for up to 240 weeks was evaluated.…”