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

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.