52-Week Efficacy and Safety of Telbivudine with Conditional Tenofovir Intensification at Week 24 in HBeAg-Positive Chronic Hepatitis BReport as inadecuate




52-Week Efficacy and Safety of Telbivudine with Conditional Tenofovir Intensification at Week 24 in HBeAg-Positive Chronic Hepatitis B - Download this document for free, or read online. Document in PDF available to download.

Background and Aims

The Roadmap concept is a therapeutic framework in chronic hepatitis B for the intensification of nucleoside analogue monotherapy based on early virologic response. The efficacy and safety of this approach applied to telbivudine treatment has not been investigated.

Methods

A multinational, phase IV, single-arm open-label study ClinicalTrials.gov ID NCT00651209 was undertaken in HBeAg-positive, nucleoside-naive adult patients with chronic hepatitis B. Patients received telbivudine 600 mg once-daily for 24 weeks, after which those with undetectable serum HBV DNA <300 copies-mL continued to receive telbivudine alone while those with detectable DNA received telbivudine plus tenofovir 300 mg once-daily. Outcomes were assessed at Week 52.

Results

105 patients commenced telbivudine monotherapy, of whom 100 were included in the efficacy analysis. Fifty-five 55% had undetectable HBV DNA at Week 24 and continued telbivudine monotherapy; 45 45% received tenofovir intensification. At Week 52, the overall proportion of undetectable HBV DNA was 93% 93-100 by last-observation-carried-forward analysis 100% monotherapy group, 84% intensification group and no virologic breakthroughs had occurred. ALT normalization occurred in 77% 87% monotherapy, 64% intensification, HBeAg clearance in 43% 65% monotherapy, 16% intensification, and HBeAg seroconversion in 39% 62% monotherapy, 11% intensification. Six patients had HBsAg clearance. Myalgia was more common in the monotherapy group 19% versus 7%. No decrease in the mean glomerular filtration rate occurred in either treatment group at Week 52.

Conclusions

Telbivudine therapy with tenofovir intensification at Week 24, where indicated by the Roadmap strategy, appears effective and well tolerated for the treatment of chronic hepatitis B.

Trial Registration

ClinicalTrials.gov NCT00651209



Author: Teerha Piratvisuth , Piyawat Komolmit, Tawesak Tanwandee, Wattana Sukeepaisarnjaroen, Henry L. Y. Chan, Mário G. Pessôa, Eduard

Source: http://plos.srce.hr/



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