Tenofovir vs lamivudine plus adefovir in chronic hepatitis B: TENOSIMP-B study

Abstract

AIMTo 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.METHODSThis 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.RESULTSForty-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 < 0.001).CONCLUSIONTDF 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.

Guidelines for Prevention and Treatment of Chronic Hepatitis B

“…In addition, virological response rates increased during treatment. [129][130][131][132][133][134][135][136][137][138][139] Tenofovir alafenamide fumarate tablets (TAF): In a global phase III clinical trial, 581 HBeAg-positive CHB patients (which excluded patients with decompensated cirrhosis) received TAF treatment for 48 weeks. HBV DNA levels were <29 IU/mL in 64% of patients and ALT levels returned to normal in 72% of patients.…”

Comparing the efficacy and safety of tenofovir and adefovir or combined drug treatment for the treatment of chronic hepatitis B infection: a systematic review and meta-analysis

“…There have also been reports by Sun et al of severe hypophosphatemia associated with ADV treatment (39). TDF is like ADV in structure, and there was no statistical difference in adverse reactions to TDF compared to ADV in Rodríguez et al study (40). A total of 10 studies were included in this study.…”

“Elimination of Hepatitis by 2030”: Present Realities and Future Projections

“…But is it possible?Several commercially available antiviral drugs can now be used to treat CHB patients. However, there are some limitations to these drugs in addition to their limited efficacy and notable adverse effects [14–23] All the antiviral drugs can reduce HBV DNA in the sera.…”

“…However, there are some limitations to these drugs in addition to their limited efficacy and notable adverse effects. [14][15][16][17][18][19][20][21][22][23] 2. All the antiviral drugs can reduce HBV DNA in the sera.…”