52-week efficacy and safety of telbivudine with conditional tenofovir intensification at week 24 in HBeAg-positive chronic Hepatitis B
- Piratvisuth, Teerha
- Komolmit, Piyawat
- Tanwandee, Tawesak
- Sukeepaisarnjaroen, Wattana
- Chan, Henry L. Y.
- Pessôa, Mário G.
- Fassio, Eduardo
- Ono, Suzane K.
- Bessone, Fernando
- Daruich, Jorge
- Zeuzem, Stefan
- Cheinquer, Hugo
- Pathan, Rashidkhan
- Dong, Yuhong
- Trylesinski, Aldo
DOIAbstract
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 wer...
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