title: Treatment Outcomes With First-line Therapies With Entecavir and Tenofovir in Treatment-Naive Chronic Hepatitis B Patients in a Routine Clinical Practice.
abstract: BACKGROUND
  Given their high efficacy, entecavir (ETV) and tenofovir (TDF), are the recommended first-line therapies for chronic hepatitis B, but it is not clear whether the efficacy reported from pivotal trials is similar to the outcomes seen in routine practice.
  
  
  OBJECTIVE
  Our goal was to examine the treatment outcomes of antiviral therapy in such setting.
  
  
  METHODS
  We conducted a retrospective study of 557 consecutive treatment-naive patients who started either ETV (n=443) or TDF (n=114) at 3 US liver clinics between January 2005 and 2012. Primary study endpoint was complete viral suppression (CVS) rate (hepatitis B virus DNA<40 IU/mL).
  
  
  RESULTS
  The majority of patients in both ETV and TDF groups were Asians, hepatitis B e antigen (HBeAg) negative, male, and with similar pretreatment alanine aminotransferase and hepatitis B virus DNA levels. Similar proportions of patients in the ETV and TDF groups achieved CVS at 24 months: 87.7% versus 87.0%, respectively. Cumulative rates of virological breakthrough in the ETV and TDF groups were 1.0% versus 4.8% (P=0.26) and 3.7% versus 9.8% (P=0.04) at month 12 and 24, respectively; and all were associated with medication nonadherence. Cumulative rate of medication nonadherence was lower in the ETV than TDF group: 4.6% versus 7.8% at month 12 and 8.9% versus 16.9% at month 24, respectively.
  
  
  CONCLUSIONS
  Patients treated with either ETV or TDF achieve a similar rate of CVS at 24 months. The primary contributor to suboptimal response was medication nonadherence. Attention to medication adherence is needed in a routine clinical setting.
authors.affiliation: *School of Medicine, University of California Davis, Sacramento †Division of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto ‡San Jose Gastroenterology, San Jose, CA §Bristol-Myers Squibb, Plainsboro, NJ.
authors.forename: Nghiem B
authors.initials: NB
authors.lastname: Ha
authors.forename: Huy N
authors.initials: HN
authors.lastname: Trinh
authors.forename: Lisa
authors.initials: L
authors.lastname: Rosenblatt
authors.forename: Dat
authors.initials: D
authors.lastname: Nghiem
authors.forename: Mindie H
authors.initials: MH
authors.lastname: Nguyen
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D024882:Drug Resistance, Viral; D005260:Female; D006147:Guanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000187:drug effects / Q000235:genetics / Q000276:immunology; D019694:Hepatitis B, Chronic / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D012074:Remission Induction; D012189:Retrospective Studies; D000068698:Tenofovir / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States; D019562:Viral Load
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D004279:DNA, Viral; D006513:Hepatitis B e Antigens; C413685:entecavir; D006147:Guanine; D000068698:Tenofovir