TDF, entecavir efficacy confirmed in real-world HBV cohort
medwireNews: Treatment with a tenofovir disoproxil fumarate (TDF)-containing regimen or entecavir leads to high virologic and biochemical response rates in patients with chronic hepatitis B virus (HBV) infection, shows a registry analysis.
These findings confirm the efficacy of entecavir and TDF-based regimens in the real-world, with rates similar to those seen in the drug registration trials, say the study authors who analyzed data from the Spanish CIBERHEP registry comprising chronic HBV patients managed in routine practice. They also assessed the Page-B score for estimating hepatocellular carcinoma (HCC) risk.
Of 611 Caucasian patients (16.5% positive for hepatitis B e antigen [HBeAg]), included in the study, 424 received TDF, either alone or alongside emtricitabine, entecavir, or lamivudine, and the remaining 187 were treated with entecavir.
A virologic response – defined as HBV DNA below 69 IU/mL – was achieved by 92.0% of patients given a TDF-based regimen by 12 months after starting treatment and by 98.2% at the 60-month mark. The corresponding rates for entecavir-treated patients were 85.3% and 100%.
At the same timepoints, normalization of alanine aminotransferase levels occurred in 86.0% and 88.3% of TDF-treated patients, respectively, and in 85.1% and 92.2% of those given entecavir, according to the article published in Digestive Diseases and Sciences.
Of the 101 patients positive for HBeAg at baseline, 33.7% and 23.8% lost HBeAg and developed anti-HBeAg antibodies, respectively, during an average follow-up of 52 months, with no significant difference in the cumulative rates between the regimens.
Maria Buti (Hospital Universitari Vall d’Hebron and Universitat Autònoma de Barcelona, Spain) and co-investigators note that renal function, as indicated by serum creatinine levels and estimated glomerular filtration rate, “remained stable” for both nucleos(t)ide analogs during long-term follow-up, with even a tendency toward improvement at 60 months.
Fourteen (2.29%) individuals – three in the entecavir and 11 in the TDF group – developed HCC during the course of the study. The majority (71%) of these patients had cirrhosis at baseline.
The researchers also used the CIBERHEP cohort to validate the Page-B score, which estimates the HCC risk for Caucasian patients during the first 5 years after initiating antiviral therapy on the basis of age, gender, and baseline platelet count. In a previous report, a cutoff of 10 points or more identified patients who progressed to HCC with sensitivity and negative predictive values of 100%, they say.
According to the pre-treatment Page-B score, 27.8 cases of HCC were expected during the initial 5 years, but only nine were observed. Buti et al point out, however, that all nine patients had a baseline Page-B score of at least 10, giving a negative predictive value of 100%, “[i]n agreement with the results from the original cohort.”
Therefore, they comment that “[a] Page-B cut-off C10 may be useful for selecting patients who will benefit from HCC surveillance.”
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