绥美凯的疗效好吗？

Is it effective? The efficacy and safety of Trimax in treatment-naïve HIV-infected subjects was based on an analysis of data from two randomized, international, double-blind, active-controlled trials, SINGLE (ING114467) and SPRING-2 (ING13086), and an international, open-label, active-controlled trial, FLAMINGO (ING114915). In SINGLE, 833 patients received dolutegravir 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 dolutegravir XxXABC/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). Median time to virological suppression was shorter in the ABC/3TCXxXDTG group (28 days vs. 84 days, p<0.0001).

Relative to baseline, the adjusted mean changes in CD4 cell counts were 267 cells versus 208 cells/mm (p<0.001). Analyzes of time to attainment of virological suppression and change from baseline were prespecified and adjusted for multiplicity. At week 96, responses were 80% and -72%, respectively. The end point difference is still statistically significant (p=0.006). The statistically higher response in the DTGXxXABC/3TC group was primarily due to a higher proportion of withdrawals due to adverse events in the FTC/TDF/FTC group, independent of viral load stratification. Overall treatment differences at week 96 applied to patients with higher and lower baseline viral loads. Patients could maintain virological suppression during the 1440 weeks of the SINGLE open period, and the DTGXxXABC/3TC group (71%) was better than the EFV/TDF/FTC group (63%), with a treatment difference of 8.3% (2.0, 14.6).

In a phase I/II 48-week multicenter, open-label study (P1093/ING112578), the pharmacokinetic parameters, efficacy, tolerability, and safety of dolutegravir were evaluated in HIV-I-infected infants, children, and adolescents receiving the combination regimen. At week 24, 16 of 23 adolescents (aged 12 to 17 years) who received once-daily dolutegravir (35mgn=4; 50mgn=19) plus OBR achieved viral loads <50 copies/mL. In 20 of 23 children and adolescents (87%), the reduction in HIV-1 RNA from baseline at week 24 was greater than 1 log10 copies/mL or HIV-1 RNA <400 copies/mL. Four subjects experienced virological failure, but none had INI resistance at the time of virological failure.

It is a once-daily three-in-one drug developed by ViiV Healthcare, a joint venture between GlaxoSmithKline and Pfizer. The drug is based on the treatment plan of the integrase inhibitor Tivicay (Dolutegravir) and also contains two nucleoside reverse transcriptase inhibitors, Abacavir and Lamivudine. It was approved by the FDA on August 27, 2014.