Monitoring the safety of alirocumab in HIV patients: A Post-Authorization Safety Study Using Healthcare Databases

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/49411
• EU PAS number:
  EUPAS17314
• Study ID:
  49411
• Official title and acronym:
  Monitoring the safety of alirocumab in HIV patients: A Post-Authorization Safety Study Using Healthcare Databases
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This study is a retrospective cohort study using existing healthcare databases.The objective of this post-marketing study is to monitor muscle events, and liver function and creatine kinase abnormalities in HIV patients treated with alirocumab by quantifying the incidences of these safety outcomes using existing healthcare databases.Two databases, the Clinformatics DataMart and the MarketScan databases in the US, will be used in this study. The study period will be from July 25, 2015 to September 30, 2020. The main study cohort will consist of new users of alirocumab with HIV infection during the study period. The comparison cohort will consist of new users of a statin or ezetimibe with HIV infection. Patients will be followed till the occurrence of outcomes of interest, which are -Serious muscle events, abnormal liver function and abnormal creatine kinase values, end of index treatment episode, end of eligibility in the database, or end of the study period. For each outcome of interest, the incidence rate (cases per 1,000 person-years) and their 95% confidence intervals (CI) will be calculated for the matched cohorts.
• Study status:
  Finalised

Research institutions and networks

Institutions

Sanofi

Study timelines

Date when funding contract was signed

Planned: 21/12/2015

Actual: 21/12/2015

Study start date

Planned: 30/09/2017

Actual: 30/09/2017

Date of final study report

Planned: 30/09/2022

Actual: 29/09/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi and Regeneron

Study protocol

Initial protocol

rdct-aliroc07997-protocol-pdfa

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)

Other study registration identification numbers and links

ALIROC07997