绥美凯好吗？

The effectiveness of the treatment 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 one 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 vs. 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 SPRING-2, 822 patients received dolutegravir 50 mg once daily or raltegravir 400 mg twice daily (blinded), both administered in an open-label manner in combination with fixed-dose ABC/3TC (approximately 40%) or TDF/FTC (approximately 60%). Dolutegravir was non-inferior to raltegravir, including in the subset of patients treated with a nibicavir/lamivudine-based regimen. In FLANINGO, 485 patients received dolutegravir 50 mg once daily or darunavir/ritonavir (DRX/rD 800 mg/100 mg once daily), all in combination with ABC/3TC (approximately 33%) or TDF/FTC (approximately 67%). All treatments were administered in an open-label manner. At week 96, dolutegravir virologic suppression in the DRY/r group (80%) versus the DRY/r group (68%) Adjusted treatment difference [DTG-(DRVXxXRTV)]: 12.4%; 95% CI: [4.7, 20.2]) 2 Response rates at Week 96 were 82% (DTGXxXABC/3TC) and 75% (DRV/rXxXABC/3TC). New drug resistance in patients who failed treatment in the SINGLE, SPRING-2, and PLAMINGO studies: No new drug resistance to integrases or NRTIs was detected in patients treated with dolutegravir, abacavir, or lamivudine in any of the three studies. Regarding the control drugs, typical resistance was detected in the TDF/FTC/EFV group (SINGLE; 6 cases with NNRTI-related resistance and one case with severe NRTI resistance) and 2NRTIXxX raltegravir (SPRING-2; 4 cases with severe NRTI resistance and 1 case with raltegravir resistance), whereas no de novo resistance was detected in patients treated with 2NRTIXxXDRV/RTV (FLAMINGO).

In a Phase I/II 48-week multicenter, open-label study (P1093/ING112578), the pharmacokinetic parameters, safety, tolerability, and safety of dolutegravir were evaluated in HIV-I-infected infants, children, and adolescents receiving the combination dosing 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. Taken together, the safety and effectiveness are good, and it is worth choosing for patients.