The new anti-AIDS drug dotelavirlamivudine will enter the domestic market

On February 18, the listing application of dotiravir / lamivudine, an anti AIDS drug of GlaxoSmithKline, was proposed to be included in the list of priority review varieties The drug is the first complete, once-a-day single tablet two drug program approved by FDA If it is successfully included in the priority review process, it is expected to be approved and listed in China as soon as possible Dotilavir / lamivudine is a single tablet composed of a fixed dose of dolutegravir (DTG) and lamivudine (3TC), which was jointly developed by GlaxoSmithKline and vivhealthcare It was approved by FDA in April 2019 for the treatment of HIV-1 infection that has not received antiretroviral treatment before and has no resistance to dotilavir or lamivudine Adult patient, trade name dovato, was approved by EMA in December 2019 for HIV-1 infected persons over 12 years old According to the CDE website, the application for phase III clinical trial of dotiravir / lamivudine for "adults with HIV infection who have achieved virologic inhibition" has been approved, but the data of the combination therapy in Chinese patients are not known However, according to the Gemini project data when dovato was approved by FDA, dovato is safe and effective Compared with triple therapy, dual therapy has similar effect of reducing HIV content in blood In addition, at the 10th International AIDS Association AIDS science conference (ias2019), the company vivhealthcare, a subsidiary of GSK, released the latest data of Gemini: after 96 weeks of treatment, 86% of patients in the dual antiviral therapy group were under control of viral activity, while 90% of patients in the triple antiviral therapy group were under control of viral activity This means that compared with the combination therapy of dotiravir / tenofovir / enteltabine, the dual therapy of dotiravir / lamivudine tablets has reached the standard of non inferiority In China, CDE has accepted the listing application of dotiravir / lamivudine submitted by GlaxoSmithKline in November 2019 Now, CDE plans to include the application in the priority review, which will undoubtedly accelerate the review progress of dotiravir / lamivudine in China, and sincerely hope that the drug can be approved in China as soon as possible AIDS and its treatment drug AIDS, acquired immune deficiency syndrome, is a disease caused by human immunodeficiency virus (HIV) infection, once known as "century killer" due to its high mortality According to the data released by who in 2017, there were 36.7 million HIV infected people in the world in 2016, with a total of 1 million deaths Although the incidence rate of AIDS in China is relatively low, data from the National Health Service Commission show that by the end of 2018, China's estimated HIV survival rate was about 1 million 250 thousand Since the first anti AIDS drug, zidovudine, came into the market in 1987, dozens of anti AIDS drugs have been approved, and these drugs can be roughly divided into six categories: NRTIs, NNRTIs, PIs, FIS, CCR5 receptor inhibitors and ini Data source of anti AIDS drug classification list: drug intelligence data In addition, with the approval of a number of AIDS drugs, he Dayi, a Chinese American scientist, put forward cocktail therapy, which uses three or more antiviral drugs in combination to reduce the drug resistance produced by a single drug, to maximize the inhibition of virus replication, so that the damaged immune function of the body can be partially or completely restored, thus delaying the progress of the course of disease and prolonging the life of patients, Improve the quality of life Since the first combination therapy Combivir (lamivudine + zidovudine) was approved in 1997, a number of anti AIDS combination therapies have been approved, such as trizivir (lamivudine + zidovudine + abacavir), kaletra (litonavir + lopinavir), Atripla (tenofovir + eferen + ntrutabine) At present, according to the drug intelligence database, many kinds of anti AIDS drugs have been approved by nmpa in China, among which ibovetam (trade name: iconine) is the world's first long-acting HIV fusion inhibitor independently developed in China, which only needs to be taken once a week, and is suitable for the combination of other anti retroviral drugs to treat HIV-1 infected people who have received anti-virus drugs Data source of anti AIDS drug list: drug intelligence data reference: [1] CDE, nmpa official website [2] Kaine technology official website [3] drug intelligence data 37 statement: this point of view only represents the author, does not represent the position of drug intelligence network, welcome to exchange and supplement in the message area; if you need to reprint, please be sure to indicate the author and source of the article.