People living with HIV-1 (PLWH) who discontinued traditional non-nucleoside reverse transcriptase inhibitor (NNRTI)- and boosted integrase strand transfer inhibitor (INSTI)-based regimens have maintained viral suppression following their switch to the next-generation NNRTI ainuovirine coformulated with lamivudine and tenofovir DF (ANV/3TC/TDF), as shown by the 144-week open-label results from the SPRINT* post-study presented at ESCMID Global 2026.
In addition, switching to ANV/3TC/TDF resulted in significant reductions in low-density lipoprotein cholesterol (LDL-C) levels, indicating cardiometabolic benefits, according to study author Dr Hong Qin, chief medical officer at Jiangsu Aidea Pharmaceutical Group Co., Ltd in Yangzhou, China.
The current study was an extension of the SPRINT trial, in which participants were divided into an immediate switch group (ANV/3TC/TDF from baseline to week 144) and a delayed switch group (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide [E/C/F/TAF] from baseline to week 144). [ESCMID Global 2026, abstract L0019]
The proportion of PLWH who achieved virologic suppression at week 144 was the primary efficacy endpoint. Qin and his team also assessed metabolic safety outcomes, including LDL-C levels and LDL-C stratification according to the atherosclerotic cardiovascular disease (ASCVD) risk, and renal safety via estimated glomerular filtration rate (eGFR).
A total of 731 participants met the eligibility criteria for the study. Of these, 370 were assigned to the immediate switch group and 361 to the delayed switch group.
Virologic suppression was maintained at week 144 in 95.3 percent of PLWH in the immediate switch group and 95.0 percent of those in the delayed switch group. Their CD4⁺ T-cell counts also increased steadily from week 48 to week 144 (mean increase: 70.9 vs 64.4 cells/μL).
LDL-C, renal outcomes
By week 48, participants in the ANV/3TC/TDF arm demonstrated a significant decrease in fasting LDL-C levels, as did those who switched from E/C/F/TAF. Moreover, this reduction persisted through week 144 (‒0.19 vs ‒0.44 mmol/L).
The proportion of participants with high-risk LDL-C also decreased from baseline to week 144, from 3.5 percent to 1.4 percent (‒60 percent) and from 3.2 percent to 0.7 percent (‒78 percent), respectively.
Notably, switching to ANV/3TC/TDF posed no danger to the liver, with eGFR remaining stable through week 144 (116.1 to 109.1 and 114.9 to 106.3 mL/min/1.73 m²), consistent with age-related change per the CKD-EPI equation.
“The accompanied safety benefits included persistent improvement in LDL-C level and ASCVD risk strata,” Qin said. Furthermore, “[r]enal function remained stable among this population and required general routine monitoring.”
These findings are consistent with previous 96-week results from the SPRINT extension study, which showed that switching to ANV/3TC/TDF maintained virologic suppression and even improved cardiometabolic parameters among PLWH who discontinued both classical NNRTI-based regimens and E/C/F/TAF, according to Qin and colleagues.
ANV is a new NNRTI that delivers high selectivity to neuroendocrine receptors and targets. [Bioorg Med Chem Lett 2010;20:1589-1592; Drug Des Devel Ther 2014;8:1613-1619; Curr HIV Res 2020;18:332-341; Antimicrob Agents Chemother 2023;67:e0121922; BMC Medicine 2025;23:524]
*Switching People with HIV to Receive Innovative NNRTI-Based Therapy