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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ALIROCUMAB
• Medical condition to be studied:
  HIV infection

Population studied

• Short description of the study population:
  Adult patients with HIV infection receiving alirocumab and other lipid-lowering treatments identified from the study period of 25 July 2015, utilizing data source from the Optum Clinformatics DataMart (Optum CDM) and the Truven Health Marketscan (Marketscan).; Inclusion criteria: ; • A new prescription of a statin or ezetimibe in the study period ; • HIV infection confirmed by the presence of relevant diagnosis codes (Appendix 1) prior to the index date; ; Exclusion criteria:; • Age < 18 years; • No continuous enrollment with prescription and medical coverage in the database for the 180-day period prior to the index date; • Use of the same index drug prior to the index date ; • Use of any PCSK-9 inhibitors prior to the index date
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  765

Study design details

• Main study objective:
  The objective of this post-authorization safety study is to monitor muscle events, and liver function and creatine kinase abnormalities in HIV patients treated with alirocumab by assessing the incidences of these safety outcomes using existing healthcare databases.
• Outcomes:
  Serious muscle events: rhabdomyolysis, myositis and myopathy Abnormal liver function: ALT and AST elevation > 5 times above the upper limit of normal value, total bilirubin and alkaline phosphatase elevation > 2 and > 1.5 times above the upper limits of normal value, respectively Abnormal creatine kinase: elevation > 10 times above the upper limit of normal value
• Data analysis plan:
  Patients in the alirocumab cohort and those in the other lipid-lowering drug cohort will be matched on the propensity of being treated with alirocumab at a 1:1 ratio using greedy matching. Proportion and means will be used to summarize the categorical and continuous variables (demographic and baseline characteristics), respectively, for the alirocumab and the other drug cohorts both prior to and after the propensity matching. For each outcome of interest, the overall incidence rate (cases per 1,000 person-years) and its 95% confidence interval (CI) in each database will be calculated using the data of the matched cohorts. Kaplan-Meier curves will be used to display the risk of each outcome over time.

Documents

Study results

rdct-aliroc07997-csr abstract-pdfa