Gilead's Ekoun tablets used to treat HIV-1 infection are approved in China
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, Gilead Science s
(announced that the NationalDrug(the Supervisory Authority approved the use of Jetcon (Ecoon tablets, or E/C/F/TAF) to treat HIV-1 infectionin China, Jetkang is a complete program that can be used to treat adults and adolescents infected with HIV-1 (over 12 years of age, weighing more than 35 kg) without known mutations associated with the integration of enzyme inhibitorsdrug(enquatabin or tinoforvir resistance)Phase 3 HIV clinical study for Jethealth included more than 3,500 patients from 21 countries, including first treatment, viral suppression, renal impairment, and adolescent patientsthe approval was based on 144 weeks of data from two phase 3 double-blind studies (study 104 and 111), which included 1,733 first-term patients, and at 48 weeks, the treatment reached a non-disadvantageous effect on Gilead's StriThe main end point of bild (Averewe 150 mg/Corbyn 150mg/Nquitabin200mg/Fumarictinovir dipolythane 300mg or E/C/F/TDF)At 48 weeks, 92.4% (n s 800/866) patients taking Stepoand and 90.4% of patients taking Stribild achieved HIV-1 RNA levels below 50 copies/mLanother phase 3 study (Study 109), which also supported the approval of Gitcon, assessed the effectiveness of patients previously accepted with a TDF-based virus-suppressing treatment for use with JetComstudy included 1,436 subjects, 1,196 of whom werethetrial (of which 48 weeks were assessed at the time of evaluation)Based on the percentage of patients with HIV-1 RNA levels below 50 copy/mL at 48 weeks, the treatment of Stepgkang achieved statistically significant non-performance compared to the TDF programpatients who have been receiving TDF-based treatments significantly improved in terms of kidney function and bone laboratory parameters compared to patients who have been receiving TDF-based treatmentsFinally, the Phase 3 study data for evaluating the efficacy of Stepo-Con (for adolescents and adult patients with mild moderate renal impairment) also supported the approval
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