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 identification

• PURI:
  https://redirect.ema.europa.eu/resource/20772
• EU PAS number:
  EUPAS15103
• Study ID:
  20772
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Bulgaria

  Denmark

  France

  Germany

  Hungary

  Spain

  United Kingdom
• Study description:
  Investigate healthcare provider awareness of the risk of clinically significant arrhythmias when sofosbuvir (in combination with daclatasvir or simeprevir) or ledipasvir/sofosbuvir is prescribed concurrently with amiodarone, and determine perceptions of co-medication frequency, reported changes in prescribing behaviour, and reported approaches to patient monitoring following dissemination of a direct healthcare professional communication.
• Study status:
  Finalised

Research institutions and networks

Institutions

Gilead Sciences

Multiple centres: 301 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 05/01/2016

Actual: 05/01/2016

Study start date

Planned: 01/12/2016

Actual: 25/11/2016

Data analysis start date

Planned: 15/03/2017

Actual: 10/03/2017

Date of final study report

Planned: 01/09/2017

Actual: 25/08/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Gilead Sciences Europe

Study protocol

Initial protocol

1.2-Prot GS-EU-337-2030 FINAL SIGNED

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)