Comparing Weight Gain on F/TAF and Placebo Using DISCOVER and iPrEx Study Data

Study type

• Study topic:
  Disease /health condition

  Human medicinal product

  Other
• Study topic, other:
  Research method
• Study type:
  Non-interventional study
• Data collection methods:
  Secondary use of data

Study drug and medical condition

• Medicinal product name:
  DESCOVY
• Medicinal product name, other:
  emtricitabine/tenofovir alafenamide
• Study drug International non-proprietary name (INN) or common name:
  EMTRICITABINE

  TENOFOVIR ALAFENAMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (J05AR17) emtricitabine and tenofovir alafenamide

  emtricitabine and tenofovir alafenamide
• Medical condition to be studied:
  HIV infection
• Additional medical condition(s):
  Pre-Exposure Prophylaxis of HIV-1 Infection

Population studied

• Short description of the study population:
  individuals not living with HIV, all of whom were adults aged at least 18 years, and with 1 or more ; behavioral risk factors for contracting HIV-1. All iPrEx study participants were born male, and were recruited from North and South America, South Africa, and Thailand. All DISCOVER study ; participants were born male or were TGW, and were recruited from North America, 8 European Union (EU) countries, and the UK. Study start and randomized-primary completion dates were as ; follows, iPrEx: June 2007 to February 2011; DISCOVER: September 2016 to January 2019.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  This study will utilize existing data collected during 2 large Phase 3 clinical studies of FTC/TDF and F/TAF to conduct an indirect comparison of F/TAF (DISCOVER) and placebo treatment groups (iPrEX), using the common FTC/TDF treatment groups as negative controls.
• Main study objective:
  To compare weight change/trajectory distributions between F/TAF and placebo cohorts from the DISCOVER and iPrEx studies
• Setting:
  Both studies that will be used for this study recruited individuals not living with HIV, all of whom were adults aged at least 18 years, and with 1 or more behavioral risk factors for contracting HIV-1. ; All iPrEx study participants were born male, and were recruited from North and South America, South Africa, and Thailand. ; All DISCOVER study participants were born male or were TGW, and were recruited from North America, 8 European Union (EU) countries, and the UK. ; ;
• Outcomes:
  - weight change trajectories/distributions ; - weight gain; - incidence of weight-related comorbidities