# The efficacy and safety of doravirine/lamivudine/tenofovir disoproxil fumarate in treatment-naïve and treatment-experienced patients with HIV

## TL;DR

This study examines the effectiveness and safety of a HIV treatment regimen containing doravirine, lamivudine, and tenofovir in both treatment-naïve and experienced patients.

## Contribution

The study provides real-world evidence of DOR/3TC/TDF efficacy and safety in developing countries, where prior data is limited.

## Key findings

- Treatment-naïve patients showed significant increases in CD4+ T-cell counts and high virological suppression rates at 24 and 48 weeks.
- Treatment-experienced patients experienced significant reductions in plasma lipids and BMI, along with improved mental health outcomes.
- The regimen was generally safe with no significant adverse effects on kidney or liver function.

## Abstract

Doravirine (DOR) has demonstrated good efficacy for the treatment of people with HIV (PWH); however, there is limited real-world research in developing countries.

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.

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.

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.