Following the initiation of Doravirine (DOR) regimen among people living with HIV (PLWH), the study will aim to assess effectiveness, discontinuation, and resistance over the 12-month period.

Retrospective data from 500 patients is planned to be collected from 6 - 10 European sites. Cohort 1 : 400 patients, 100 treatment naïve and 300 virally suppressed patients switching from a 1st or second line treatment, Cohort 2: 50 patients with NNRTI mutations (other than DOR), Cohort 3: 50 patients with NNRTI mutations (including DOR).

The study will be conducted through collaboration with the NEAT ID Network, a well-established network of clinical sites across Europe.

Inclusion Criteria:

• 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:

  1. Category 1: HIV treatment naïve OR
  2. 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:

  1. Category 1: HIV treatment naïve OR

  2. 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

Exclusion Criteria:

• 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 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
• Patients who have NNRTI mutations that impact on DOR

HIV-1 infected patients ≥ 18 years who were ART-naïve or virologically suppressed (VL < 50 copies for more than 6 months) and have been started/switched to DOR for at least 12 months at time of data collection.