Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488) has announced the summary report of a Phase III clinical study for its fixed dose preparation ainuovirine, lamivudine, tenofovir disoproxil (ACC008) as a switch therapy for previously treated HIV-1 patients. The drug was previously approved to treat treatment-naïve HIV-1 patients in China in December 2022.
ACC008 vs. Genvoya in Phase III Study
In the head-to-head comparison with Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide), a single tablet compound preparation developed by Gilead Sciences and included in the National Reimbursement Drug List (NRDL) in China, the Phase III study results showed that at 48 weeks of treatment, 98.2% (374/381) and 98.4% (375/381) of subjects with HIV-1 RNA loads less than 50 copies/mL were in the ACC008 group and the Genvoya group, respectively, achieving non-inferiority. Both groups were well tolerated, with similar incidences of treatment emergent adverse events (TEAEs). However, the incidence of adverse drug reaction (ADR), Grade 3-5 TEAEs, and Grade 3-5 ADRs in the ACC008 group were lower than those in the Genvoya group (P<0.05). In terms of common TEAEs (≥ 5%), the incidence of weight gain, dyslipidemia, and elevated serum uric acid in the ACC008 group was relatively low.
Comparative Efficacy and Safety of ACC008
The study concluded that compared with Genvoya, ACC008 can sustainably maintain viral suppression in HIV-infected individuals who have been treated for viral suppression, with comparable efficacy and liver and kidney safety. Regarding cardiovascular metabolic safety indicators such as blood lipids, body weight, and uric acid, ACC008 demonstrated more favorable outcomes.-Fineline Info & Tech
