The 32nd Conference on Retroviruses and Opportunistic Infections (CROI 2025) will be held from March 9 to 12 in San Francisco, USA. As a globally recognized bellwether in HIV research, the annual CROI convenes leading scientists, clinical pioneers, and public health experts to unveil the latest advances in the fight against HIV. We are proud to announce that the 96-week results from the SPRINT study of Ainuomiti Tablets (ANV/3TC/TDF) have been officially accepted for presentation at CROI 2025—marking another milestone for Chinese scientific innovation on the global stage in the ongoing battle against HIV.

Ainuomiti Tablets (ANV/3TC/TDF) represents China’s first domestically developed Class 1 single-tablet regimen (STR) with independent intellectual property rights. The SPRINT study is the world’s first randomized controlled trial to conduct a head-to-head comparison between a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based regimen and an integrase strand transfer inhibitor (INSTI)-based regimen. Led by Prof. Fujie Zhang from Beijing Ditan Hospital, Capital Medical University, the Phase III, randomized, double-blind, active-controlled, multi-center trial assessed the efficacy and safety of ANV/3TC/TDF (NNRTI-based regimen) versus EVG/Cobi/FTC/TAF (INSTI-based regimen) in virologically suppressed adult people living with HIV (PLWH).

The study was conducted in two phases. In the first phase, participants were randomized to receive either double-blind ANV/3TC/TDF or EVG/Cobi/FTC/TAF treatment for 48 weeks. In the second phase, all participants continued with open-label ANV/3TC/TDF treatment, continuing up to week 96. The abstract selected for this presentation primarily evaluates the 96-week antiviral efficacy, immune reconstitution and safety profile benefits of the SPRINT study (P703).

Sustained Virological Suppression: At Week 96, both the ANV/3TC/TDF group (N=381) and the switch group (from EVG/Cobi/FTC/TAF to ANV/3TC/TDF, N=377) achieved virological suppression rate of 97%. The efficacy outcomes of these two groups exceed those reported in comparable clinical trials of marketed imported antiretroviral drugs and represent the only regimen to surpass the 95% virologic suppression target set by UNAIDS.

Improved Immune Reconstitution: At week 96, both groups exhibited increases in CD4⁺ cell counts compared to week 48, with a greater increase observed in the group switched from EVG/Cobi/FTC/TAF to ANV/3TC/TDF (22 vs. 32 cells/μL).

Weight and Lipid Profile Benefits: At Week 96, body weight in the ANV/3TC/TDF group remained stable compared to Week 48, whereas participants in the switch group (from EVG/Cobi/FTC/TAF to ANV/3TC/TDF) experienced a significant reduction in body weight. Low-density lipoprotein cholesterol (LDL-C) levels in the ANV/3TC/TDF group remained stable compared to Week 48, and the LDL-C elevation observed during the initial 48 weeks of EVG/Cobi/FTC/TAF treatment was notably reversed (-0.37 mmol/L). Furthermore, levels of non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), and triglycerides (TG) remained stable in the ANV/3TC/TDF group compared to Week 48, while participants in the switch group ((from EVG/Cobi/FTC/TAF to ANV/3TC/TDF) exhibited marked improvements in these lipid profile.

This study demonstrated that Ainuomiti Tablets (ANV/3TC/TDF) exhibits virological efficacy comparable to INSTI-based regimens, and further supports its role as a stable switch option for virologically suppressed PLWH previously treated with INSTI-based regimens. Switching to Ainuomiti Tablets (ANV/3TC/TDF) was also associated with additional cardiometabolic benefits, potentially reducing the risk of INSTI-associated weight gain and dyslipidemia, thereby lowering the overall cardiovascular disease risk.

The inclusion of the 96-week SPRINT study results of Ainuomiti Tablets (ANV/3TC/TDF) at CROI 2025 underscores the international academic recognition of domestically developed antiretroviral new drugs. Moreover, it provides robust support for the global outreach of Chinese pharmaceutical innovation, as the HIV field transitions into an era increasingly defined by the management of comorbidities.