Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study
Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study
The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.
Inclusion Criteria:
Exclusion Criteria:
Women who are pregnant or breastfeeding
Patients who, in the opinion of the investigator, are expected to have a liver transplant-free survival of less than one year
Patients who, in the opinion of the investigator, are virologically controlled on their current treatment regimen and clinically responding to treatment, unless the regimen needs to be modified for medication intolerance
Coinfection with HIV
History of malignant neoplasm(s), including hepatocellular carcinoma (HCC) and carcinoma in situ (CIS), but excluding non-melanoma skin cancers
Patients with chronic renal insufficiency, defined as a creatinine clearance < 50 ml/min who do not have either of the following means of dose reducing ETV:
i. an approved country-specific ETV label which includes the extended interval ETV dose modification method and/or ii. an approved country specific label for the ETV oral solution AND access to the oral solution
History of dysplastic liver nodules
Known history of allergy to nucleoside/tide analogues
Prior or current treatment with entecavir
An investigator proposed study regimen which will include only interferon-alfa
An investigator proposed study regimen of combination (two or more) HBV nucleoside/tide analogues
Ciudad de Buenos Aires, Buenos Aires 1155, Argentina
Rio de Janeiro / Rj, Rio de Janeiro 21041-030, Brazil
Porto Alegres/rs, Rio Grande do Sul 90020-090, Brazil
Santo Andre - Sp, São Paulo 09060-870, Brazil
Bogota, Cundinamarca, Colombia
Hyderabad, Andhra Pradesh 500012, India
Hyderabad, Andhra Pradesh 500034, India
Hyderabad, Andhra Pradesh 500068, India
Hyderabad, Andhra Pradesh 500082, India
Secunderabad, Andhra Pradesh 500003, India
Ahemedabad, Gujarat 380 006, India
Ermita Manila, 1000, Philippines
Metro Manila, 1500, Philippines
Nizhniy Novgord, 603076, Russia
Gangneung-si, 210-711, South Korea
Koyang City, 411-706, South Korea
Sungnam-si, 463-774, South Korea
Sungnam, 463-712, South Korea
San Sebastian Guipuzcuoa, 20014, Spain
Young Kang City, 710, Taiwan