Randomized Clinical Trial
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Nov 18, 2016; 8(32): 1402-1413
Published online Nov 18, 2016. doi: 10.4254/wjh.v8.i32.1402
Telbivudine vs tenofovir in hepatitis B e antigen-negative chronic hepatitis B patients: OPTIMA roadmap study
Zahari Krastev, Diana Petrova, Iskren Kotzev, Mustafa Kemal Celen, Meryl Mendelson, Richa Chandra, Priti Pandey, Kamal Hamed
Zahari Krastev, Clinic of Gastroenterology, St. Ivan Rilsky University Hospital, Medical University, Sofia 1606, Bulgaria
Diana Petrova, Department of Gastroenterology, University Hospital Alexandrovska, Sofia 1431, Bulgaria
Iskren Kotzev, Clinic of Hepatogastroenterology, University Hospital St Marina, Varna 9010, Bulgaria
Mustafa Kemal Celen, Infectious Disease Clinic, Dicle University, 21280 Diyarbakir, Turkey
Meryl Mendelson, Richa Chandra, Kamal Hamed, Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, United States
Priti Pandey, Novartis Healthcare Pvt. Ltd., Hyderabad 500081, India
Author contributions: All authors were involved in study conduct, data interpretation and defining the content for the manuscript; all authors had full access to data in the study, discussed the results, critically reviewed the draft manuscript and agreed on the final version.
Supported by Novartis Pharma AG.
Institutional review board statement: The study received approval from the Ethik-Kommission der Medizinischen Universität Wien und des Allgemeinen Krankenhauses der Stadt in Austria; Ethics Committee for Multicentre Trials in Bulgaria; RF MoHSD, Department of State Regulation of Circulation of Medicines, Ethics Council in Russia; National Ethics Committee for Clinical Trials in Greece; Comitato Etico Azienda Ospedaliera Universitaria Policlinico P. Giaccone in Italy; Institut Municipal D’Investigació mèdica in Spain; Ethik-Kommission der Albert-Ludwigs-Universität Freiburg in Germany; and Ege University Medical Faculty Clinical Research Ethics Committee in Turkey.
Informed consent statement: This study was conducted in accordance with the Declaration of Helsinki and good clinical practice guidelines. Written informed consent was obtained from each patient before enrolment.
Conflict-of-interest statement: Krastev Z received fees for serving as a member of advisory board of Gilead, as well as research funding from Abbvie, Applied Clinical Pharmacology Services, Centocor, Comac Medical, Gilead, GSK, Idenix, Johnson and Johnson, Millennium Pharmaceuticals, MSD, Norgine, Novartis, Roche, Receptos and Schwabe; Petrova D received research funding from Aventis, Centocor, Gilead, GSK, Idenix, Johnson and Johnson, Norgine, Novartis and Roche; Kotzev I received lecture fees from Novartis; Celen MK has nothing to declare; Mendelson M, Chandra R and Hamed K are employees of Novartis Pharmaceuticals Corporation; Pandey P is an employee of Novartis Healthcare Pvt. Ltd.
Data sharing statement: No data were created, so no data are available.
Open-Access: This article is an open-access article, which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Kamal Hamed, MD, MPH, Sr Worldwide Medical Director, Novartis Pharmaceuticals Corporation, 1 Health Plaza, East Hanover, NJ 07936, United States. kamal.hamed@novartis.com
Telephone: +1-862-7781371 Fax: +1-973-7817153
Received: March 16, 2016
Peer-review started: March 18, 2016
First decision: April 19, 2016
Revised: May 6, 2016
Accepted: July 14, 2016
Article in press: July 18, 2016
Published online: November 18, 2016
Processing time: 245 Days and 7.7 Hours
Core Tip

Core tip: This was the first prospective, randomised, non-inferiority study in hepatitis B e antigen-negative chronic hepatitis B patients that compared telbivudine and tenofovir administered as per roadmap concept. Both treatments based on the roadmap approach were effective over a 156 wk treatment period. Non-inferiority of telbivudine arm to tenofovir arm was demonstrated at week 52, with over 91% of patients in each treatment arm achieving hepatitis B virus DNA level < 300 copies/mL. Both treaments showed acceptable safety profiles. Moreover, telbivudine showed an improvement in estimated glomerular filtration rate from baseline.