VIR-Life: Prospective assessment of the real-life treatment outcomes of six years of Viread® in CHB following-up on the German Multicenter Non-Interventional Study GEMINIS

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Name of medicine:
  VIREAD
• Medical condition to be studied:
  Chronic hepatitis B

Population studied

• Short description of the study population:
  Adult, Hepatitis B Virus (HBV)-mono-infected Chronic hepatitis B (CHB) patients who started CHB treatment with Viread® in GEMINIS and completing 3 years in GEMINIS and still receiving a Viread®.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  150

Study design details

• Main study objective:
  Describe the virological response, defined as HBV-DNA concentration, during 6 years Viread® treatment for CHB in a real life setting.
• Outcomes:
  HBV-DNA concentration after 6 year TDF, ALT levels throughout 6 years TDFRenal function parameters throughout 6 years TDFLiver synthesis parameters throughout 6 years TDFLiver histology improvements throughout 6 years TDFAdverse Reactions to TDF throughout 6 years TDF
• Data analysis plan:
  Descriptive analysis:Categorical and ordinal variables will be described by sample size and the frequency of each modality (over the total number of responses).Quantitative variables will be described by the number of responses, mean, standard deviation, minimum, maximum, median of all available data.Inferential analysis: When deemed necessary, sub-group comparisons and/or between time point comparisons may be implemented.Patients who are lost to follow-up or discontinue therapy for any reason, including leaving the study for non-medical reasons will be censored at the discontinuation date. Person time will be computed from baseline to discontinuation and used as such for any time to event analysis.Multivariate analysis:The potential dependence of treatment outcome frequency with other variables or baseline characteristics will be investigated through multivariate analysis.

Documents

Study results

VIR_life_synopsis_16Dec2016