‘COMBINE-2’: Real-world evidence for effectiveness of Two Drug Regimen, Antiretroviral therapy with integrase inhibitors plus a reverse transcriptase inhibitor (207859)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Multi-site observational study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DOLUTEGRAVIR

  RILPIVIRINE

  LAMIVUDINE
• Medical condition to be studied:
  Human immunodeficiency virus transmission

Population studied

• Short description of the study population:
  The study population included HIV positive patients aged 18 years or older initiated two drug regimen, antiretroviral therapy with integrase inhibitors plus a reverse transcriptase inhibitor in 2014 in Europe.; Inclusion Criteria: ; a) a first-line treatment among naïve patients, or; b) a switching option for those with HIV RNA suppression on current treatment (stable switches), or ; c) a second-line treatment for those with virological failure (VF) on prior treatment
• 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

  Other
• Special population of interest, other:
  Patients with HIV transmission
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  To assess the effectiveness of 2DR (integrase inhibitor plus a reverse transcriptase inhibitor) and to collect information on the safety of 2DR in terms of drug related adverse events (AEs) and serious adverse events (SAEs) and development of resistance.
• Data analysis plan:
  The primary effectiveness endpoint will be analysed separately for each population (naïve, stable switch, and treatment-experienced with VF) with an intent-to-treat (ITT) approach. 95% CIs of the observed proportion of patients reaching the effectiveness endpoint will be calculated. Changes from baseline in continuous endpoints in each population between baseline and week 48 will be compared by using Wilcoxon’s paired test with the ITT population. Descriptive statistics will be generated for the following:– Grade 3 and 4 adverse events– Serious adverse events (SAE)– ART related adverse events (all grades)– Treatment-modifying adverse events (all grades)– AIDS defining event– Death– Study treatments discontinuation