MHLW approves Gilead's three-in-one new drug Biktarvy for treatment of HIV-1 infection

recently, the U.SPharmaceutical(http://giant Gilead announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved the three-in-onenew drug(http://biktarvy for the treatment of HIV-1 infectionBiktarvy combines the efficacy and safety of the new integrated enzyme chain transfer inhibitor (INSTI) bictegravir (BIC) with the marketeddrug(http://Descovy (emtricitabine 200 mg/tenofovir alafenamide 25 mg, FTC/TAF), which is the recommended dual-effect nucleoside reverse enzyme inhibitor (N)In Phase III clinical studies, the Biktarvy program achieved very high virological inhibition rates and did not develop resistance to treatment when used to treat previously untreated (first treatment) adult patients and to achieve virological inhibition and switch treatment optionsIn the United States, Biktarvy was approved in February 2018, becoming the third FTC/TAF-based STR approved in the market in the past three yearsBiktarvy is suitable for HIV-1 adult infections as a complete program for the integrated enzyme drug enquatororortaorortaors, which has no existing or prior evidence of drug resistanceIn patients with an estimated creatinine removal rate (CrCL) of 30 ml/min, there is no need to adjust the dose of Biktarvy, which has a convenient dose and does not requiredetection(http://HLA-B 5701, without the need for food intake or baseline viral load or CD4 count limitsIt should be noted that biktarvy's drug label contains a black-box warning, indicating the risk of exacerbation of acute hepatitis B after treatmentBiktarvy's approval is based on data from four ongoing Phase III clinical studies: study 1489 and 1490 in adult patients with initial treatment of HIV-1, study 1844 and study 1878 in adult patients with hiv-1 who achieve dissotological inhibitionThe study enrolled 2,414 patients, and the data showed that all four studies reached the end of the 48-week primary therapeutic endDuring 48 weeks of treatment, the BIC/FTC/TAF program was well tolerated, and no patients treated developed treatment for drug resistance, none of the patients had interrupted BIC/FTC/TAF treatment due to kidney events, and no near-end glomerular or Van Conney syndrome type occurredThe most common adverse reactions in BIC/FTC/TAF patients are diarrhea, nausea and headache, Gilead is currently conducting other studies to assess the efficacy and safety of Biktarvy in adolescents, children, and female HIV groupsData released at the(http://of the 2019 2019 Retrovirus and Opportunistic Infection (CROI)Conference in Seattle, USA, in early March, showed that Biktarvy showed high efficacy in older groups, women's groups, children and adolescents, and NRTI drug-resistant groups