Observational, Cross-Sectional Post-Authorisation Safety Study to Assess Healthcare Provider Awareness of Risks Related to Sofosbuvir and Ledipasvir/Sofosbuvir (EU HVN SOF Survey Study)

Study type

• Study topic:
  Disease /health condition

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

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  HARVONI

  SOVALDI
• Medical condition to be studied:
  Chronic hepatitis C

Population studied

• Short description of the study population:
  All healthcare providers (including gastroenterologists, hepatologists, infectious disease physicians, cardiologists, general practitioners/internists, and specialty and hospital pharmacists) responsible for the treatment of Chronic hepatitis C patients in Europe.
• 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:
  200

Study design details

• Main study objective:
  The primary objective of this study is as follows: Determine the proportion of healthcare providers aware of the risk of clinically significant arrhythmias when SOF (in combination with DCV or SMV) or LDV/SOF is prescribed concurrently with amiodarone.
• Outcomes:
  The risk evaluation and mitigation strategy will be considered effective if the majority of respondents demonstrate they are aware of the key risks communicated.
• Data analysis plan:
  Data from the survey questionnaire will be summarized descriptively (counts, ranges, proportions) overall, as well as by country and provider specialty where sample size allows. For the primary objective, frequency point-estimates with two-sided 95% confidence intervals(CIs) using the binomial distribution (Wald or Clopper-Pearson method, as appropriate) will be constructed to describe the proportion of physicians aware of the specified risk. The secondary objectives will produce categorical data which will be summarized by frequencydistributions.

Documents

Study results

GS-EU-337-2030+ABSTRACT+Clinical+Study+Report