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

A Cohort Study of Use of Doravirine (DOR) Based Regimens in Clinical Practice in Europe

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 400 patients, 100 treatment naïve and 300 virally suppressed patients switching from a 1st or second line treatment, is planned to be collected from 6 - 10 European sites.

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

Study Overview

• Status: Completed
• Conditions: HIV I Infection

• Study Type: Observational
• Enrollment (Actual): 399

Contacts and Locations

• Study Contact: Name: DREW Project Manager; Phone Number: +44 203 859 7747; Email: drew@rokcservices.com

Study Locations

• France
  • Nantes, France
    • CHU de Nantes
  • Paris, France
    • St Louis Hospital
  • Paris, France
    • Hôpital Universitaire Pitié-Salpêtrière
• United Kingdom
  • London, United Kingdom
    • Guy's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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
• 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.

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
• Patients with no documented resistance testing.
• Patients with no genotype available at DOR initiation
• Patients enrolled in DOR trials

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Treatment naive
Treatment switched; Virologically suppressed (VL < 50 copies for more than 6 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients, virologically suppressed/undetectable (<50 copies/mL) at week 48 who have remained on DOR.		Week 48 after DOR initiation
Proportion of patients with virologic failure (Cohort 1 - treatment naive)	i. Two consecutive HIV RNA VL levels ≥50 copies/mL after reaching at HIV RNA < 50 copies/mL or ii. One HIV RNA VL level ≥50 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA < 50 copies/mL	on or after week 48 after DOR initiation
Proportion of patients with virologic failure (Cohort 2 - treatment suppressed)	i. Two consecutive HIV RNA VL levels ≥50 copies/mL after reaching at HIV RNA < 50 copies/mL or ii. One HIV RNA VL level ≥50 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA < 50 copies/mL	up to 12 months after initiation of DOR
Proportion of patients switched for reasons other than virological failure.		up to 12 months after initiation of DOR

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)	i. Two consecutive HIV RNA VL levels ≥200 copies/mL after reaching HIV RNA < 200 copies/mL or ii. One HIV RNA VL level ≥200 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA < 200 copies/mL.	on or after week 48 after DOR initiation
Proportion of patients with confirmed virologic failure, commonly used to make treatment related clinical decisions (Cohort 1 - treatment naive)	i. Two consecutive HIV RNA VL levels ≥200 copies/mL after reaching HIV RNA < 200 copies/mL or ii. One HIV RNA VL level ≥200 copies/mL and DOR regimen is discontinued immediately or at next hospital visit, after reaching HIV RNA < 200 copies/mL.	up to 12 months after initiation of DOR
Estimated proportion of patients with low level viremia (≥50-<200 copies/mL)		up to 12 months after initiation of DOR
HIV resistance mutations subtypes for all DOR treated patients with virologic failure		during the 12-month data collection period.

Collaborators and Investigators

• Sponsor: NEAT ID Foundation
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Director: Anton Pozniak, Chelsea and Westminster NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: June 10, 2022
• First Submitted That Met QC Criteria: June 14, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: HIV
• Other Study ID Numbers: NEAT1010; NEAT 1010 (Other Identifier: NEAT ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No