A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe DoRavirine Europe Real World/

Prior treatment

• Patients who have DOR as part of their fourth line or higher therapy
• Patients with prior virological failure with agents of the NNRTI class
  • Cohort 2 specific exclusion criteria
• Patients who have an INSTI and/or bPI in their DOR-containing therapy

Other

• Patients with no documented resistance testing.
• Patients with no genotype available at DOR initiation
• Patients enrolled in DOR trials
  • Cohort 1 specific exclusion criteria
• Patients who have NNRTI mutations that impact on DOR

• are HIV positive male or female
• are aged ≥18 years
• were prescribed and received at least one dose of DOR (without initial dose adjustment).
• have started/been switched to DOR for at least 12 months at time of data collection
• had a resistance genotype available before starting DOR
  • Cohort 1 Specific Inclusion Criteria
• had no evidence of DOR-associated resistance mutation
• were on DOR containing ART regimen that also contained 2 fully active nucleos(t)ides and patient had no documented NRTI resistance mutations to the two NRTIs in the combination.
• Patients who, at the time of initiation, were:
  • Category 1: HIV treatment naïve OR
  • Category 2: Virologically suppressed (HIV-1 RNA \<50 copies/mL) for at least 6 months with no evidence of prior virological failure with agents of the NNRTI class
  • Patients in category 1 and 2 above who have NNRTI mutations that do not impact on DOR (K103N, Y181C, and G190A) using the Stanford algorithm (https://hivdb.stanford.edu/hivdb/by-mutations) can be included in this study.
  • Cohort 2 Specific Inclusion Criteria
• must have evidence of NNRTI associated resistance mutations (other than DOR) according to Stanford algorithm
• their DOR-containing ART will contain 2 NRTIs but will not include an INSTI and/or a bPI.
• had no documented resistance to the other drugs in the combination.
• Patients who, at the time of initiation, were:
  • Category 1: HIV treatment naïve OR
  • Category 2: Virologically suppressed (HIV-1 RNA \<50 copies/mL) for at least 6 months
  • Cohort 3 Specific Inclusion Criteria
• ART naïve or virologically suppressed (HIV-1 RNA \<50 copies/mL) for at least 6 months at the time of DOR initiation