Metabolic and Immunological Trajectories and Virological Outcomes of Ainuovirine-Based Antiretroviral Therapy: A 48-Week Longitudinal Cohort Study in Treatment-Naïve Adults.

Ainuovirine (ANV) is a novel non-nucleoside reverse transcriptase inhibitor used in China, but longitudinal real-world evidence on its virological outcomes and trajectories of immunological, metabolic, hepatic, and renal parameters in treatment-naïve adults remains limited. In this single-center longitudinal observational cohort study, 383 treatment-naïve adults with HIV-1 initiating ANV/lamivudine/tenofovir disoproxil fumarate (ANV/3TC/TDF) were followed for 48 weeks. Virological, immunological, anthropometric, metabolic, hepatic, and renal parameters were assessed repeatedly. Longitudinal changes in continuous outcomes were analyzed using linear mixed models, and repeated virological suppression outcomes were evaluated using generalized estimating equations. Virological suppression increased from 80.42% (308/383) at Week 24 to 89.56% (343/383) at Week 48, whereas 10.44% participants (40/383) were not suppressed at Week 48. Among the Week-48 nonsuppressed participants, resistance mutations were uncommon and 36/40 later achieved HIV-1 RNA < 50 copies/mL on at least two consecutive measurements. CD4+ T-cell counts and CD4/CD8 ratio improved significantly over time, with an estimated mean CD4+ increase of 246.43 cells/μL at Week 48. Body weight and body mass index showed modest early increases followed by lower values at Week 48 relative to baseline. Favorable longitudinal trends were also observed in fasting glucose, lipid parameters, alanine aminotransferase, aspartate aminotransferase, and total bilirubin. In contrast, estimated glomerular filtration rate declined and uric acid levels decreased during follow-up. In this 48-week real-world cohort, ANV/3TC/TDF was associated with sustained virological suppression, immune recovery, and generally favorable longitudinal trends in several metabolic and hepatic markers. However, because of the observational single-arm design and the inability to separate the contributions of ANV, the TDF-containing backbone, and recovery from baseline disease status, these findings should be interpreted cautiously and regarded as hypothesis-generating rather than confirmatory.