Abstract / Summary
Ainuovirine (ANV), a novel Chinese non-nucleoside reverse transcriptase inhibitor (NNRTI), requires post-marketing data on blood biochemical markers. This study enrolled 76 adult people living with HIV (PLWH) on an ANV-based regimen (May 2022–February 2023) with 96-week follow-up. Virologic suppression, CD4 + count, liver function (ALT, AST, GGT, TBil), renal function (Cr, urea), and lipid markers (TG, TC, LDL-C, HDL-C) were assessed. Paired-sample nonparametric tests were used. At week 96, all achieved virologic suppression (HIV RNA = 0 copies/mL). Median CD4 + increased from 358 to 492 cells/µL ( P ≤ 0.05), and CD4/CD8 ratio improved. Regarding safety, ANV showed a favorable metabolic profile: TG, TC, and LDL-C decreased (all P < 0.05), while HDL-C increased ( P < 0.05). Liver function improved: total bilirubin and GGT decreased early and remained low through week 96 ( P ≤ 0.05); ALT and AST improved later. Renal markers remained stable. In this study, the ANV-containing ART regimen provided potent virologic suppression, excellent immune reconstitution, and a favorable safety profile. It significantly improved lipid profiles, reduced cardiovascular risk, and showed good hepatic tolerability. ANV is an effective, metabolically friendly core agent, offering an optimized first-line option for PLWH requiring long-term management, especially those with dyslipidemia or hepatic abnormalities. Trial registration This study was registered with the Chinese Clinical Trial Registry on March 31, 2025 ChiCTR2500099875.