Observational Cohort Study to Assess Rilpivirine (RPV) Utilization According to the European SmPC

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33836
• EU PAS number:
  EUPAS5766
• Study ID:
  33836
• Official title and acronym:
  Observational Cohort Study to Assess Rilpivirine (RPV) Utilization According to the European SmPC
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Croatia

  Denmark

  Estonia

  Finland

  France

  Germany

  Greece

  Hungary

  Ireland

  Italy

  Latvia

  Lithuania

  Luxembourg

  Netherlands

  Norway

  Poland

  Portugal

  Romania

  Slovakia

  Spain

  Sweden

  Switzerland

  United Kingdom
• Study description:
  Rilpivirine (RPV) is an NNRTI for the treatment of HIV-1 infection in antiretroviral treatment-naïve adult patients with a baseline viral load ≤ 100,000 HIV-1 RNA copies/mL. RPV will be available as two formulations on the European market: a single agent, marketed by Janssen-Cilag International NV, and a fixed-dose combination containing FTC/RPV/TDF, marketed by Gilead Sciences International Ltd. The CHMP has requested further assessment of the development of resistance and whether the product is used in accordance with the Summary of Product Characteristics (SmPC). The development of resistance and the utilization of RPV according to the SmPC will be assessed through a drug utilization study (DUS) conducted in HIV observational cohorts within Europe. Additionally, the DUS will provide context to the observed rates of virologic failure and development of resistance by describing the treatment outcomes of patients treated with efavirenz (EFV).
• Study status:
  Finalised

Research institutions and networks

Institutions

Eurosida

Networks

EuroSIDA

Study timelines

Date when funding contract was signed

Planned: 11/07/2012

Actual: 11/07/2012

Study start date

Planned: 28/11/2011

Actual: 28/11/2011

Date of final study report

Planned: 31/07/2019

Actual: 18/06/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen Sciences Ireland UC + Gilead Sciences Ireland UC

Study protocol

Initial protocol

TMC278-DUS-CTP sep2011

Updated protocol

TMC278-DUS-CTP-Amend1 aug2013

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)