RT Journal Article
T1 Tenofovir vs lamivudine plus adefovir in chronic hepatitis B: TENOSIMP-B study.
A1 Rodríguez, Manuel
A1 Pascasio, Juan Manuel
A1 Fraga, Enrique
A1 Fuentes, Javier
A1 Prieto, Martín
A1 Sánchez-Antolín, Gloria
A1 Calleja, José Luis
A1 Molina, Esther
A1 García-Buey, María Luisa
A1 Blanco, María Ángeles
A1 Salmerón, Javier
A1 Bonet, María Lucía
A1 Pons, José Antonio
A1 González, José Manuel
A1 Casado, Miguel Ángel
A1 Jorquera, Francisco
A1 TENOSIMP-B Research Group, 
K1 Adherence
K1 Costs
K1 Efficacy
K1 Hepatitis B
K1 Lamivudine+Adefovir
K1 Safety
K1 Tenofovir
AB To demonstrate the non-inferiority (15% non-inferiority limit) of monotherapy with tenofovir disoproxil fumarate (TDF) vs the combination of lamivudine (LAM) plus adefovir dipivoxil (ADV) in the maintenance of virologic response in patients with chronic hepatitis B (CHB) and prior failure with LAM. This study was a Phase IV prospective, randomized, open, controlled study with 2 parallel groups (TDF and LAM+ADV) of adult patients with hepatitis B e antigen (HBeAg)-negative CHB, prior failure with LAM, on treatment with LAM+ADV for at least 6 mo, without prior resistance to ADV and with an undetectable viral load at the start of the study, in 14 Spanish hospitals. The follow-up time for each patient was 48 wk after randomization, with quarterly visits in which the viral load, biochemical and serological parameters, adverse effects, adherence to treatment and consumption of hospital resources were analysed. Forty-six patients were evaluated [median age: 55.4 years (30.2-75.2); 84.8% male], including 22 patients with TDF and 24 with LAM+ADV. During study development, hepatitis B virus DNA (HBV-DNA) remained undetectable, all patients remained HBeAg negative, and hepatitis B surface antigen (HBsAg) positive. Alanine aminotransferase (ALT) values at the end of the study were similar in the 2 groups (25.1 ± 7.65, TDF vs 24.22 ± 8.38, LAM+ADV, P = 0.646). No significant changes were observed in creatinine or serum phosphorus values in either group. No significant differences between the 2 groups were noted in the identification of adverse effects (AEs) (53.8%, TDF vs 37.5%, LAM+ADV, P = 0.170), and none of the AEs which occurred were serious. Treatment adherence was 95.5% and 83.3% in the TDF and the LAM+ADV groups, respectively (P = 0.488). The costs associated with hospital resource consumption were significantly lower with the TDF treatment than the LAM+ADV treatment (€4943 ± 1059 vs €5811 ± 1538, respectively, P  TDF monotherapy proved to be safe and not inferior to the LAM+ADV combination therapy in maintaining virologic response in patients with CHB and previous LAM failure. In addition, the use of TDF generated a significant savings in hospital costs.
YR 2017
FD 2017
LK http://hdl.handle.net/10668/11814
UL http://hdl.handle.net/10668/11814
LA en
DS RISalud
RD Apr 19, 2025