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Multicenter Study
. 2025 Aug;26(8):1289-1299.
doi: 10.1111/hiv.70061. Epub 2025 Jul 4.

Effectiveness of switching to doravirine-based antiretroviral therapy: A real-world study in Germany

Christoph Wyen  1   2 , Michael Sabranski  3 , Celia Jonsson-Oldenbüttel  4 , Johannes Bogner  5 , Heribert Knechten  6 , Stefan Esser  7 , Nazifa Qurishi  8 , Sven Schellberg  9 , Irina Kolobova  10 , Jann-Patrick Pelz  11 , Yohance O Whiteside  10 , Bekana K Tadese  10 , Jürgen K Rockstroh  12
Affiliations
Multicenter Study

Effectiveness of switching to doravirine-based antiretroviral therapy: A real-world study in Germany

Christoph Wyen et al. HIV Med. 2025 Aug.

Abstract

Objectives: Doravirine (DOR)-based antiretroviral therapy (ART) has been shown in clinical trials to be effective and well tolerated in treating HIV-1. The EffectiVeness of SwItChing to DORavirine-based Antiretroviral Therapy (VICDOR) study characterized the use, effectiveness and impact on body weight and lipids of DOR-based ART in a virologically suppressed switch population using real-world data from Germany.

Methods: VICDOR was a multicentre, retrospective chart review study of virologically suppressed adults with HIV in Germany who switched to DOR-based ART between January 2019 and February 2021. Demographic, clinical and laboratory data were collected up to 15 months after the switch.

Results: A total of 193 individuals were included, with a median age of 49 years (range = 21-78), 85.0% were male, 23.8% were obese (BMI ≥30 kg/m2) and 80.8% had at least one comorbidity. Overall, 84.5% switched to DOR/3TC/TDF. The most common reason for switching was to improve tolerability regarding weight gain (37.3%). Of the 161 individuals who remained on DOR and had HIV-1 RNA results, 99.4% remained virologically suppressed after 12 months (with one individual having ≥50 to <200 copies/mL at month 12 and following visit). No virological failures occurred. Median LDL-C change was -7.1 mg/dL (IQR = -23.0 to 8.0; n = 89). Individuals switched to DOR/3TC/TDF had a median weight change of -0.9 kg (IQR = -4.0 to 2.0; n = 50) at month 12; for those switched to DOR/3TC/TDF to improve tolerability regarding weight gain, median weight change was -2.0 kg (IQR = -5.0 to -1.0; n = 23) after 12 months.

Conclusions: DOR-based ART is effective in maintaining virological suppression without evidence of ART-related weight increase in a switch population of individuals with a high prevalence of comorbidities.

Keywords: ART; DOR; DOR/3TC/TDF; HIV; antiretroviral; doravirine; effectiveness.

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Conflict of interest statement

C. Wyen potential COIs: invited speaker and advisory board attendee for Gilead, GSK, Janssen, MSD, Pfizer and ViiV Healthcare. M. Sabranski potential COIs: payments or honoraria for presentations, lectures and educational events by MSD, GILEAD, ViiV; travel support and advisory board attendee for Gilead and ViiV; and board member dagnae e.V. C. Jonsson‐Oldebuttel potential COIs: consulting fees from GSK/Viiv Healthcare; payment or honoraria from Abbvie, Gilead, Janssen‐Cilag, GSK/ViiV healthcare; travel or meeting support from Abbvie, Gilead, GSK/ViiV healthcare; advisory or other board attendee for Abbvie, Gilead, GSK/ViiV healthcare, MSD. J. Bogner potential COIs: lecture honoraria‐ AbbVie, AstraZeneca, Pfizer, Boehringer‐Ingelheim, BMS, Gilead, GSK, Janssen, MSD, ViiV, NovoNordisk, Roche; Honoraria for advisory boards‐AbbVie, GSK, MSD, ViiV, Janssen, Pfizer, Gilead. H. Knechten potential COIs: grants, advisory board member and consulting fees from Gilead, MSD, ViiV, Janssen; expert testimony for Gilead, MSD, ViiV; travel/meeting support from Gilead. S. Esser potential COIs: grants, advisory board member, payments/honoraria, travel/meeting support and consulting fees from Gilead, MSD, ViiV, Janssen; leadership/fiduciary role German AIDS Society and Landeskommission AIDS NRW. N. Qurishi potential COIs: consulting fees from Gilead sciences, MSD, ViiV, Janssen‐Cilag; payments/honoraria, advisory board member, meeting/travel support from Gilead sciences, MSD, ViiV. S. Schellberg potential COIs: payments/honoraria from Gilead Sciences, ViiV Healthcare, MSD, AbbVie, Pfizer Inc.; meeting/travel support from Gilead Sciences; advisory board member, Gilead Sciences and ViiV Healthcare. I. Kolobova potential COIs: former employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, employed at the time of study, and holds stock for Merck & Co., Inc., Rahway, NJ, USA; current employee and holds stock for GSK/ViiV Healthcare. J.P. Pelz potential COIs: current employee of MSD Sharp & Dohme GmbH, Munich, Germany and holds stock of Merck & Co., Inc., Rahway, NJ, USA. Y.O. Whiteside potential COIs: current employee of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rayway, NJ,USA and holds stock for Merck & Co., Inc., Rahway, NJ, USA. B. Tadese potential COIs: current employee for Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. J.K. Rockstroh potential COIs: consulting fees from Abbvie, Boehringer, Gilead, MSD, ViiV; payments/honoraria from Gilead, Janssen, ViiV; board member for Berlin Cures; EACS Governing Board member; Editor‐in‐Chief of HIV Medicine.

Figures

FIGURE 1
FIGURE 1
Patient enrolment flow chart. Inclusion criteria: IC 1: age ≥18 years at the time of switch; IC 2: confirmed HIV‐1 infection; IC 3: virologically suppressed on prior non‐DOR‐based ART at the time of switch; IC 4: having switched to DOR‐based ART as part of a 2‐ or 3‐drug combination (decision to prescribe DOR had already been made before participant being considered for enrolment); IC 5: retrospective dataset with treatment history; IC 6: signed written informed consent. Exclusion criteria: EC 1: current enrolment in any interventional clinical trial; EC 2: pregnancy at the time of switching to DOR‐based ART and 12 months prior; EC 3: among participants switched to DOR/3TC/TDF, creatinine clearance <50 mL/min at the time of switch; EC 4: among participants switched to DOR/3TC/TDF, end‐stage renal disease or undergoing dialysis at the time of switch; EC 5: among participants with NNRTI mutations, DOR resistance‐associated mutations.
FIGURE 2
FIGURE 2
Virological suppression and virological failure. People with HIV who have continued DOR treatment and had a viral load measurement (HIV‐1 RNA copies/mL blood) at the respective timepoint. *Per protocol, these patients needed to have a follow‐up visit with a viral load of <50 copies/mL to be regarded as virologically suppressed. Of the three people with HIV with viral loads of ≥50 to <200 copies/mL at month 12, two had a viral load of <50 copies/mL at the following visit, while one had another viral load of ≥50 to <200 copies/mL at the following visit.
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