绥美凯获批适应症是什么？

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.

On January 22, 2018, GlaxoSmithKline (GSK) announced that its single-pill compound preparation Triumeq, which is based on the new generation integrase inhibitor dolutegravir (DTG) and is used to treat HIV, was officially launched in mainland China. This is the first single-pill compound preparation with a complete treatment plan in the field of HIV treatment in mainland China.

This time it's based on a clinical study. The SINGLE study is a Phase III study of treatment-naïve patients receiving the combination of dolutegravir and abacavir/lamivudine; the bioequivalence study compared a fixed combination of abacavir, dolutegravir and lamivudine to dolutegravir and abacavir/lamivudine tablets (ClinicalTrials.gov identification numbers NCT01263015 and NCT01622790). SINGLE was a non-inferiority trial with a prespecified superiority analysis, with more patients in the dolutegravir and abacavir/lamivudine (stand-alone components of dolutegravir tablets (Triumeq)) undetectable (HIV-1 RNA <50 copies/mL) than Atripla(R)+ (efavirenz, emtricitabine and tenofovir) groups. The difference was statistically significant, reaching the preset test of superiority. The difference was due to a higher rate of discontinuation due to adverse events in the Atripla group. At week 96, 80% of subjects in the dolutegravir-based regimen were virologically suppressed, compared with 72% of subjects treated with Atripla.

Grade 2–4 treatment-emergent adverse reactions that occurred in 2% or more of subjects in the dolutegavir-based regimen were insomnia (3%), headache (2%), and fatigue (2%).

Take it under the guidance of a physician with experience in HIV infection. Dosage Adults and Adolescents (Weighing at least 40 kg) For adults and adolescents, the recommended dose is one tablet once daily. Adults or adolescents whose body weight is less than 40 kg should not be given this product because this product is a fixed-dose tablet and the dose cannot be reduced.