Comparable efficacy of bictegravir/emtricitabine/tenofovir alafenamide and doravirine/lamivudine/tenofovir disoproxil fumarate in therapy-naive Human Immunodeficiency Virus adults with very high baseline viraemia

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Abstract
Introduction. Clinical trials and observational studies of co-formulated regimens bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF) and doravirine/lamivudine, tenofovir disoproxil fumarate (DOR/3TC/TDF) demonstrated potent efficacy in both antiretroviral therapy-naive and -experienced patients, but data on efficacy in naive people with high-level Human Immunodeficiency Virus (HIV) viraemia are still lacking. Hypothesis. BIC/F/TAF and DOR/3TC/TDF have comparable effectiveness in naive people with high-level viraemia. Aim. To compare the effectiveness of BIC/F/TAF and DOR/3TC/TDF in naive people with high-level viraemia. Methodology. We performed a retrospective cohort study of adult people living with HIV, who were naive to antiretroviral therapy, had baseline HIV-1 RNA > 500,000 copies ml −1 and initiated the co-formulated regimen BIC/F/TAF or DOR/3TC/TDF. Virological efficacy, changes in immunological parameters and safety profiles after 12 months of treatment were evaluated. Results. Inclusion criteria were met by 78 patients: 43 in the BIC/F/TAF group and 35 in the DOR/3TC/TDF group. Baseline characteristics were similar in both groups: median age was 45.2 years, median HIV RNA was 5.95 log 10 , median CD4 T lymphocyte count was 383 cells mm −3 and 22 patients (28%) had HIV RNA >10 6 copies ml −1 . After 12 months, virological efficacy was comparable: HIV RNA −1 was obtained in 40 patients (93%) in the BIC/F/TAF group and in 31 (89 %) in the DOR/3TC/TDF group. The median increase in CD4 T lymphocyte count was comparable between groups (+139 and +117 cells mm −3 , respectively), such as incidence of adverse events, while median increase in low-density lipoprotein cholesterol and weight gain was significantly greater in the BIC/F/TAF group (weight change, +1.64 kg vs. +0.85 kg; P =0.013). Conclusion. In this real-life cohort, BIC/F/TAF and DOR/3TC/TDF showed high and comparable virological efficacy in naive patients with baseline HIV RNA above 500,000 copies ml −1 .

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