Post-Licensure Safety Study of ISENTRESS™ in a US Managed Care Network

Study type

• Study topic:
  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

• Anatomical Therapeutic Chemical (ATC) code:
  (J05AR) Antivirals for treatment of HIV infections, combinations

  Antivirals for treatment of HIV infections, combinations

  (J05AX08) raltegravir

  raltegravir

Population studied

• Short description of the study population:
  HIV-infected patients treated with RAL.; Raltegravir Cohort Inclusion Criteria:; All HIV-infected patients treated with RAL in the course of ordinary clinical practice at the clinics and medical centers of KP during the study period will be included in the study. The date a patient first receives a dispensed prescription for RAL will serve as the index date for follow-up for that patient. Subjects must have at least one year of continuous membership with KP prior to index date to allow for the assessment of medical and treatment history. For a given HOI, follow-up for a patient treated with RAL will be censored on the date the patient experiences the HOI, death, ends membership with KP, or 90 days after the date patient ends use of RAL.; Raltegravir Cohort Exclusion Criteria:; Exclusion criteria are as follows: (1.) Patients less than 18 years of age; (2.) KP HIV-infected patients who do not receive their medications through the KP pharmacy system; (3.) KP HIV-infected patients who do not receive their laboratory examinations through the KP system; (4.) Patients participating in the phase III or expanded access program. Otherwise, all HIV-infected subjects who meet the continuous membership requirement and are treated with RAL at KP during the study period will be included in the study. ; Comparison Cohorts; Historical comparison cohort to assess background incidence of clinical events (primary comparator); An observational cohort of HIV-infected patients receiving treatment with antiretroviral therapy at KP between January 1, 2000 and the date RAL was licensed in the U.S. (October 12, 2007) will comprise the eligible study population. ; Concurrent comparison cohort to assess incidence of clinical events (secondary comparator); In addition to the historical cohort, the analysis will establish and report results from a post-licensure concurrent comparison cohort of HIV-infected patients receiving treatment with a new antiretroviral therapy at KP after licensure of RAL, and n
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  7124

Study design details

• Main study objective:
  The objective of this study is to monitor HOI in participants with human immunodeficiency virus-1 (HIV-1) infection following treatment with raltegravir.
• Outcomes:
  1. Incidence of AIDS-defining and non-AIDS-defining malignancy2. Incidence of clinically important hepatic events3. Incidence of clinically important skin events4. Incidence of clinically important muscle events5. Incidence of lipodystropy, 1. Incidence of clinically important cardiovascular events2. Incidence of all-cause mortality
• Data analysis plan:
  Multivariate Cox Proportional Hazard regression will be used to compare the hazard rates among the raltegravir-treated, historical comparison, and concurrent comparison cohorts. Hazard rate ratios (HR) of HOI will be calculated, and regression models that incorporate propensity scores will be used to adjust simultaneously for the potentially confounding effects of selected variables and comparison group characteristics using CoxProportional Hazard regression.