NMPA approves new HIV compound drug Descovy for treatment of HIV-1 infection in adults and adolescents

recently, gilead, thegiant ofPharmaceutical(http:// announced that China's NationalDrug(http://Regulatory Authority (NMPA) has approved theof the new drug(http:// of HIV
complex/Propofoltenofovir, 200/10mg and 200/25mg), combined with other antiretroviraldrug(http://for the treatment of HIV-1 infection in adults and adolescents (age 12 years old, weight of 35kg)Descovyin the United States and the European Union, Descovy was approved in 2016in the U.Smarket,FDA(http://approved only Descovy (200mg/25mg) tablets, and its drug label contains a black-box warning that the risk of acute exacerbation of hepatitis B after treatmentDescovy is a compound tablet consisting of a fixed dose of enquatabin (F) and fumaololprol tinofovwe (TAF)TAF is a new type of nucleoside reverse transcriptase inhibitor (NRTI), an upgraded version of Gilead's listed drug Viread (Fumaitofore dipolythane, TDF)taf has been shown to have very high antiviral efficacy at one-tenth of a dose of TDF in clinicaltrial(http://, while exhibiting better safety and improved renal function and bone safety parametersOn August 6 this year, Gilead's four-in-one NEW HIV drug Genvoya (Jeokang, E/C/F/TAF) was approved by the State Drug Administration of China as a complete treatment for HIV-1 infection in adults and adolescents (age 12 years old, weight of 35 kg)The approval makes Genvoya the first single tablet (STR) approved in China for HIV treatmentthe approval of theDescovy is based on 144 weeks of data from two key Phase III studies (Study 104, Study 111)These two studies were conducted in adult patients with HIV-1 initial treatment and will be based on the F/TAF-based four-in-one NEW HIV drug Genvoya (Je/C/F/TAF) and the F/TDF-based four-in-one HIV drug Stribild (E/C/F/TDF) was compared to the data showing that Genvoya (E/C/F/TAF) was not as effective as Stribild (E/C/F/TDF) and significantly improved kidney function and bone parameters, Descovy was approved for another Phase III clinical study (Study 109) and other studies based on the F/TAF program (given Genvoya) in adult and adolescent hiv infections with mild to moderate renal impairment 　　Study 109 is a phase III study of program conversion (F/TDF to F/TAF) that assesses the efficacy and safety of HIV-1 adult infections who have achieved virological inhibition from F/TDF to F/TAF (200/10mg, 200/25mg) The results show that compared with the F/TDF scheme, the F/TAF scheme achieves statistically significant non-disadvantage in addition, , the study demonstrated a statistically significant improvement in kidney function and bone laboratory parameters in patients in the F/TAF program group