Abstract
BACKGROUND: Doravirine (DOR) has demonstrated good efficacy for the treatment of people with HIV (PWH); however, there is limited real-world research in developing countries. METHODS: We retrospectively assessed the efficacy and safety of DOR/lamivudine (3TC)/tenofovir disoproxil fumarate (TDF) at 24 and 48 weeks in treatment-naïve and treatment-experienced PWH. RESULTS: A total of 83 PWH were included from January 1, 2022, to December 31, 2023. The median age was 40 years (32-54). Twenty-seven patients (32.5%) were treatment-naïve PWH, and 56 patients (67.5%) were treatment-experienced PWH, the most common switch was from integrase inhibitors (37/56) to DOR, followed by efavirenz (18/56) and nevirapine (1/56). In treatment-naïve PWH, the median CD4+ T-cell count was 222.9 ± 144.2 cells/mL at baseline, which increased to 337.8 ± 189.6 cells/μL at week 24 (p < 0.001) and to 431.6 ± 259.9 cells/μL at week 48 (p < 0.001). The overall VS rate was 76.9% (20/26) at week 24 and 93.3% (14/15) at week 48. Creatinine (Cr) significantly increased from baseline to week 48 (p = 0.013) but remained normal. There were no significant differences observed in BMI, glucose, estimated glomerular filtration rate (eGFR), liver enzymes, or plasma lipid levels between the baseline and follow-up data. In treatment-experienced PWH, there were no significant changes in the VS rate, CD4+ T-cell count, Cr, eGFR or liver enzymes between the baseline and follow-up data. However, compared to baseline, statistically significant reductions in plasma lipids were observed at week 24 and at week 48. There was also a significant decrease observed in BMI at week 48 compared with baseline. In addition, anxiety, depression and sleep disorders improved in those patients who switched regimens from efavirenz to DOR. CONCLUSIONS: We provide a short-term observational report of the efficacy and safety of DOR/3TC/TDF in routine clinical practice, further supporting its use in PWH.