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

Contact details

Darren GRAINGER

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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)