Estudio primario
No clasificado
Este artículo está incluido en 3 Revisiones sistemáticas Revisiones sistemáticas (3 referencias) 1 Síntesis amplia Síntesis amplias (1 referencia)
Background & Aims: Adefovir dipivoxil possesses potent in vitro and in vivo antiviral activity in wild-type hepatitis B. This study assessed the safety and efficacy of adefovir dipivoxil alone and in combination with lamivudine compared with ongoing lamivudine therapy in patients with chronic hepatitis B with compensated liver disease and lamivudine-resistant hepatitis B virus (HBV). Methods: Fifty-nine hepatitis B e antigen (HBeAg)-positive patients with genotypic evidence of lamivudine-resistant HBV, serum alanine aminotransferase (ALT) level ≥1.2 times the upper limit of normal, and serum HBV DNA level ≥6 log10 copies/mL despite ongoing treatment with lamivudine were randomized to adefovir dipivoxil 10 mg, lamivudine 100 mg, or addition of adefovir dipivoxil to ongoing lamivudine daily. The primary end point was the time-weighted average change from baseline in serum HBV DNA level (DAVG) up to week 16. Results: Rapid reductions in serum HBV DNA level were seen by 4 weeks in all recipients of adefovir dipivoxil; DAVG16 was -0.07 in the lamivudine group compared with -2.45 and -2.46 log10 copies/mL in the adefovir dipivoxil/lamivudine and adefovir dipivoxil monotherapy groups, respectively (P < 0.001). Median change from baseline in serum HBV DNA level at week 48 was 0.0, -3.59, and -4.04 log10 copies/mL in the lamivudine, adefovir dipivoxil/lamivudine, and adefovir dipivoxil groups, respectively. ALT level normalized in 10 of 19 (53%) and 9 of 18 (47%) recipients of adefovir dipivoxil/lamivudine and adefovir dipivoxil, respectively, compared with 1 of 19 (5%) recipients of lamivudine. Three patients receiving adefovir dipivoxil or adefovir dipivoxil/lamivudine and none receiving lamivudine monotherapy were HBeAg negative at week 48 and one became hepatitis B surface antigen negative. Conclusions: These data, limited to patients with compensated liver disease, indicate that adefovir dipivoxil alone or in combination with ongoing lamivudine therapy provides effective antiviral therapy in patients with lamivudine-resistant HBV.
Resumen estructurado de revisiones sistemáticas
No clasificado
Este artículo incluye 1 Revisión sistemática Revisiones sistemáticas (1 referencia)
Este artículo no tiene resumen
Estudio primario
No clasificado
Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)
Este artículo no tiene resumen
Estudio primario
No clasificado
Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)
Estudio primario
No clasificado
Este artículo no está incluido en ninguna revisión sistemática
Estudio primario
No clasificado
Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)
Revisión sistemática
No clasificado
Aim: The therapeutic effect of interferon (IFN)-α plus adefovir (ADV) combination therapy versus IFN-α monotherapy in chronic hepatitis B (CHB) treatment remains under debate. The objective of the present study was to compare the efficacy between these two regimens in CHB treatment. Methods: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Database, National Knowledge Infrastructure, WANFANG and VIP databases were searched until 15 April 2012. All randomized controlled trials (RCT) comparing IFN-α plus ADV combination therapy versus IFN-α monotherapy for treating CHB patients were included. Review Manager ver.5.1.0 was used for meta-analysis. Results: Our results showed that the rate of undetectable serum hepatitis B virus (HBV) DNA was significantly higher in the IFN-α plus ADV combination group than in the IFN-α monotherapy group, both at 24 weeks (relative risk [RR]=1.74, 95% confidence interval [CI]=1.47-2.05, P<0.00001) and 48 weeks (RR=1.56, 95% CI=1.35-1.80, P<0.00001) of treatment and after treatment (RR=1.35, 95% CI=1.10-1.66, P=0.004). The serum hepatitis B e-antigen (HBeAg) negativation and HBeAg seroconversion rates were also higher in the combination group. However, a greater hepatitis B surface antigen loss rate was not found in the combination group. Forty-eight weeks of combination therapy improved the alanine aminotransferase normalization rate, but did not improve the rate of undetectable HBV DNA or that of HBeAg seroconversion as compared with 24 weeks of combination therapy. Conclusion: Based on the current studies, the efficacy of IFN-α plus ADV combination therapy is superior to IFN-α monotherapy. © 2013 The Japan Society of Hepatology.
Estudio primario
No clasificado
Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)
Estudio primario
No clasificado
Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)
To compare the efficacy and safety of Lamivudine (LAM) plus Adefovir dipivoxil (ADV) combination therapy and Entecavir (ETV) monotherapy for chronic hepatitis B patients. 120 patients with chronic hepatitis B managed in a single-centre clinical practice (median 96 weeks) were split into 2 cohorts, one was treated with de-novo combination Lamivudine (100 mg/day) plus Adefovir (10 mg/day) (LAM+ADV), the other with Entecavir (0.5 mg/day) monotherapy. Serum levels of ALT, creatinine, HBsAg, HBeAg and HBV viral load, together with genotypic resistence were analyzed at 0, 12, 24, 48, 96 weeks, respectively. HBV DNA was determined by real-time PCR. HBsAg and HBeAg were assessed by chemiluminescence. Serum levels of ALT and creatinine were detected by automatic biochemical analyzer. HBV genotypic resistence was tested by direct sequencing. (1) At the time point of 96 weeks, a total of 99 patients (51 cases in combination therapy cohort and 48 case in monotherapy cohort) were compared. The baseline characteristics as for HBV viral load, median age, serum levels of ALT and creatinine were compatible between combination therapy cohort and monotherapy cohort. (2) The rates of HBV DNA values is less than 300 copies/ml and HBV DNA values is less than 1000 copies/ml had no significant difference between LAM + ADV and ETV cohorts by the 12 and 24 weeks (P more than 0.05). (3) At the time point of 48 weeks, the rates of HBV DNA is less than 1000 copies/ml, HBeAg seroconversion, and ALT normalization were similar in both cohorts, though the rate of HBV DNA values is less than 300 copies/ml was obviously higher in combination therapy cohort than that of monotherapy cohort (90.7% vs 76%, P values is less than 0.05). (4) At the time point of 96 weeks, the rates of HBV DNA values is less than 300 copies/ml (96.1% vs 79.2%), HBV DNA values is less than 1000 copies/ml (98% vs 87.5%) and the HBeAg seroconversion (41.7% vs 16.7%) were markedly higher in combination therapy cohort than those of monotherapy cohort statistically (P values is less than 0.05 for all). The mean values of decreases for HBV viral loads and HBsAg levels were smilar in both cohorts at 48 and 96 weeks. (5) Elevated serum creatinine not be found in both cohorts at the end of treatment. (6) No virological breakthrough occurred in combination therapy cohort at the end of treatment. Four patients in monotherapy cohort were found with virological breakthrough at 96 weeks and three cases among were confirmed to be of variants associated with ETV resistance (rtL180M + T184L + M204V). Present study suggests that Lamivudine plus Adefovir dipivoxil de-novo combination therapy was more efficacious than Entecavir monotherapy for CHB patients and the tolerance is compatible.
Resumen estructurado de revisiones sistemáticas
No clasificado
Este artículo incluye 1 Revisión sistemática Revisiones sistemáticas (1 referencia)