艾滋病药物多替阿巴拉米片在国内上市了吗？

Are AIDS drugs on the market in China? The State Food and Drug Administration (CFDA) has approved Suimeikai, a new compound preparation for AIDS treatment (chemical name: doptabalamid tablets), to enter China. As an innovative single-pill compound preparation with obvious clinical therapeutic advantages, Suimeikai can provide great convenience for the treatment of AIDS patients and has received priority review and approval from the State Food and Drug Administration.

Analysis of data from an international, open-label, active-controlled trial FLAMINGO (ING114915). In SINGLE, 833 patients received 50 mg once daily plus fixed-dose abacavir-lamivudine (DTG-ABC/3TC) or fixed-dose efavirenz-tenofodoxine-emtricitabine (EFV/TDF/FTC). At baseline, the median age of patients was 35 years, 16% were female, 32% were nonwhite, 7% were co-infected with hepatitis C virus, and 4% were CDCC category. These characteristics were similar between the two treatment groups. In the 48-week primary analysis, the proportion of patients achieving virological suppression was better in the abacavir-lamivudine (DTG-ABC/3TC) group than in the FTC/TDF/ETC group, p=0.003. The same treatment difference was observed among subjects defined by baseline HIV RNA levels (or 100,000 copies/ml). The median time to virological suppression was shorter in the ABC/3TCXxXDTG group (28 days vs. 84 days, respectively). Relative to baseline, the mean changes in adjusted CD4 cell counts were 267 cells and 208 cells/mm, respectively. Analyzes of time to attainment of virological suppression and change from baseline were prespecified and adjusted for multiplicity.

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