Bibliographic Details
| Title: |
DORA: 48‐week weight and metabolic changes in Black women with HIV, in a phase IIIb switch study from dolutegravir‐ or efavirenz‐ to doravirine‐based first‐line antiretroviral therapy. |
| Authors: |
Woods, Joana1 jwoods@ezintsha.org, Sokhela, Simiso1, Akpomiemie, Godspower1, Bosch, Bronwyn1, Möller, Karlien1, Bhaskar, Esther1, Kruger, Chelsea1, Manentsa, Ncomeka1, Tom, Noxolo1, Macholo, Philadelphia1, Chandiwana, Nomathemba1, Hill, Andrew2, Moorhouse, Michelle1, Venter, Willem D. F.1,3 |
| Source: |
HIV Medicine. Jan2025, Vol. 26 Issue 1, p81-96. 16p. |
| Abstract: |
Objectives: Treatment‐related weight gain and metabolic complications with antiretroviral integrase‐based regimens, especially among Black women, suggest the need for alternative options. Methods: We conducted a 48‐week, open‐label, single‐arm, single‐centre, phase IIIb switch study to evaluate the tolerability, safety and efficacy of switching from stable efavirenz‐ or dolutegravir‐based antiretroviral therapy to doravirine/lamivudine/tenofovir disoproxil fumarate in Black women. Results: The 101 participants enrolled (median age 35 years; interquartile range 31–40) were on efavirenz (n = 46; mean duration on therapy 1.7 years) or dolutegravir‐based (n = 55; mean duration 1.5 years) antiretrovirals at screening. Retention at 48 weeks was 92/101 participants, and viral suppression was >90% throughout the study, with a single case of doravirine resistance (106 M, V108I and H221Y mutations). The mean weight percentage change at week 48 was 4.7% (95% confidence interval [CI] 3.0–6.5; p < 0.001), and the adjusted mean change was 2.7 kg (95% CI 1.50–3.98; p < 0.001); for efavirenz, the percentage change was 5.0% (95% CI 2.9–7.1; p < 0.001), and the adjusted weight gain was 3.5 kg (95% CI 1.93–5.13); for dolutegravir, the percentage change was 4.5% (95% CI 1.8–7.3; p < 0.001), and the adjusted weight gain was 2.1 kg (95% CI 0.26–3.90). Statistically significant decreases in lipid panel percent mean to week 48 included: total cholesterol −8.4% (95% CI −11.3 to −5.5; p < 0.001), triglycerides −10.4% (95% CI −16.4 to −4.4; p < 0.001) and high‐density lipoprotein −14.8% (95% CI −18.5 to −11.2%; p < 0.001), with minor differences when disaggregating the mean percent change in lipids between previous efavirenz/dolutegravir regimens. Adverse events due to doravirine were few and mild. Conclusions: Our findings suggest that a switch to doravirine from efavirenz or dolutegravir is safe and effective in Black women, with significant improvement in lipid profiles, but does not arrest progressive weight gain. [ABSTRACT FROM AUTHOR] |
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