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On August 27, 2014, the FDA approved Triumeq (abacavir 600 mg, dolutegravir 50 mg, and lamivudine 300 mg) tablets for the treatment of adults and adolescents 12 years and older (with a body weight of at least 40 kg) infected with human immunodeficiency virus (HIV).

Dolutegravir tablets (Triumeq) are ViiV Healthcare's first fixed combination formulation based on dolutegravir. It combines the integrase strand transfer inhibitor (INSTI) dolutegravir with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine into one, providing a single-pill drug treatment solution.

The approval was based on data from the SINGLE study and an independent bioequivalence 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 identifiers 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%). Patients with current or past resistance to any component of Triumeq are advised not to use Triumeq alone. For patients in these populations who have developed resistance-associated integrase substitution due to insufficient dolutegravir dose in Triumeq or for whom INSTI resistance is clinically suspected, it is recommended not to use Triumeq alone.

Screening for the HLA-B5701 allele should be performed before initiating treatment with abacavir-containing products, as patients carrying the HLA-B5701 allele should not be treated with abacavir-containing products. For adults and adolescents, the recommended dose of Triumeq 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.