Multicenter, Non-Interventional, Retrospective, Matched Cohort Study of Patients Monoinfected with Chronic Hepatitis B and with Moderate or Severe Renal Impairment Treated with Viread® or Baraclude® (ReCoRd)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective matched cohort study

Study drug and medical condition

• Medical condition to be studied:
  Hepatitis B

  Renal impairment

Population studied

• Short description of the study population:
  Adult chronic hepatitis B patients who had been treated with Viread® (monotherapy), administered either as oral granules once daily and/or as a tablet formulation once daily or in prolonged dosing intervals or patients who had been treated with Baraclude® (monotherapy) as a tablet formulation once daily and/or as oral solution at any time between 23rd April 2008 (Centralized European marketing authorization approval date for Viread® tablets in HBV indication) and 31st December 2015. Also included patients who had experienced at least one occurrence of moderate or severe renal impairment with CrCL between 20-60 mL/min inclusive (based on Cockcroft-Gault formula), while treated with Viread® or Baraclude®.
• 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

  Renal impaired
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To retrospectively evaluate the safety of Viread® among chronic hepatitis B patients with moderate or severe renal impairment, focusing on renal events of special interest.
• Outcomes:
  Renal events of special interest were defined as:- Presence of proximal tubulopathy (PRT)- Renal AEs leading to withdrawal of either Viread® or Baraclude® treatment- Renal AEs leading to dialysis- Renal SAEs including deaths- Decline in renal function if reported as an AE, To describe the effectiveness of Viread® in the treatment of chronic hepatitis B in patients with moderate or severe renal impairment.To compare safety and effectiveness between Viread® and Baraclude® among the matched study cohort arms.
• Data analysis plan:
  Data was summarized using univariate descriptive statistics. Continuous variables were summarized by mean, standard deviation, median, lower quartile, upper quartile, minimum and maximum. Categorical variables were summarized by number and percentage of patients in each categorical definition including according 95% confidence intervals.Multivariate analyses were used to estimate adjusted rates and proportions. In order to maximize homogeneity between the two cohorts and reduce the impact of treatment-selection bias a retrospective propensity score matching (PSM) approach was applied to enable usage of Inverse Probability Treatment Weighting analysis techniques. Conditional multivariate logistic regression models were used to assess differences between the two study cohorts.

Documents

Study results

GS-EU-174-1846 CSR Abstract_f-redact

Study publications

Poster THU-053 presented at EASL 2018: Moderate and Severe Renal Impairment in …