EDURANT / EVIPLERA Health Care Professional Survey (HCP survey on RPV)

Study identification

• EU PAS number:
  EUPAS5565
• Study ID:
  20230
• Official title and acronym:
  EDURANT / EVIPLERA Health Care Professional Survey (HCP survey on RPV)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Denmark

  France

  Germany

  Netherlands

  Norway

  Sweden

  United Kingdom
• Study description:
  The current summaries of product characteristics (SmPCs) state that EDURANT (rilpivirine) must be administered with a meal and EVIPLERA (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) must be administered with food. Adherence to these instructions is important to ensure that adequate rilpivirine levels are maintained in order to optimise a patient's response to rilpivirine treatment.There is a need to attest that patients are being properly instructed to take EDURANT and EVIPLERA with a meal / with food as part of the therapeutic advice they receive from a health care professional (HCP). To address this, a survey is to be undertaken to establish current prescribing practices and instructions given to patients when a HCP prescribes / dispenses / instructs on the use of EDURANT or EVIPLERA. This will enable an understanding of the effectiveness of the current prescribing conditions (SmPC instructions and HCP instructions) with regards to the intake of the products with food / with a meal. The survey is to be developed and conducted by Ipsos Healthcare (a division of Ipsos MORI), who are an independent research agency conducting the survey on behalf of Janssen-Cilag International NV and Gilead Sciences International Ltd.
• Study status:
  Finalised

Research institutions and networks

Institutions

IPSOS Healthcare

Study timelines

Date when funding contract was signed

Planned: 08/04/2013

Actual: 24/06/2013

Study start date

Planned: 06/01/2014

Actual: 10/01/2014

Date of final study report

Planned: 28/11/2014

Actual: 16/10/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen-Cilag International NV

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)