Merck's HIV drug latiravir (Isentress HD) receives FDA approval

Source: Sina medicine 2017-05-31 US pharmaceutical giant Merck & Co's AIDS pipeline recently received good news from US regulators The U.S Food and Drug Administration (FDA) has approved isentress HD (Chinese brand name: isentrate, generic name: latiravir, raltegravir) 600mg film coated tablets, combined with other antiretroviral (ARV) drugs, for the treatment of adult patients with HIV-1 infection and pediatric patients with a weight of at least 40 kg The recommended dosage is 1200mg (2 tablets 600mg) once a day Tablet), which is suitable for patients in the initial treatment and patients who receive isentress 400mg tablet twice a day to achieve virological inhibition In terms of pricing, isentress HD (2 tablets of 600mg, once a day) will sell for the same price as isentress 400mg twice a day Isentress HD can be used in combination with a wide range of ARV and non retroviral drugs Potential drug drug drug interactions should be considered before and during treatment Isentress HD is not recommended to be used in combination with aluminum and magnesium containing antacids, calcium carbonate antacids, rifampicin, tiranavir / ritonavir, and other strong inducers of drug metabolism enzymes (such as carbamazepine, phenobarbital, phenytoin, etc.) The FDA approval of isentress HD is based on positive top line data from oncemrk, a key phase III clinical study This study is a multicenter, double-blind, randomized, active, non inferiority controlled study It was carried out in adults with HIV-1 (previously untreated, HIV-1 RNA ≥ 1000 copies / ml) The dose of 1200mg / day isentress HD (2 tablets of 600mg) was evaluated as compared with 400mg / day Isentress, combined with tenofovir dipivoxil (TDF) and emtricitabine (emtricitabine) for 96 weeks, was safe, effective, tolerable and pharmacokinetics In this study, patients will be treated for 96 consecutive weeks, and the primary efficacy end point of the study was the proportion of patients who achieved virologic suppression (HIV RNA level < 40 copies / ml) at 48 weeks of treatment Secondary endpoints included changes in CD4 cell count from baseline and tolerance at 48 weeks of treatment The data showed that at the 48th week of treatment, the proportion of patients who achieved virological inhibition (HIV RNA level < 40 copies / ml) in the 1200mg dose isentress HD (2 tablets 600mg, once a day) + TDF + emtricitabine treatment group was 89%; the proportion of patients who achieved virological inhibition in isentress (400mg tablets, twice a day) + TDF + emtricitabine treatment group was 88%, the data reached the statistical non inferiority (treatment difference: 0.5%; 95% CI = - 4.2, 5.2), and reached the main efficacy end point of the study This efficacy data was consistent across demographic groups and various patient groups, including high viral load groups (HIV-1 RNA > 100000 copies / ml) In addition, at the secondary end point, the tolerance and immune efficacy (changes in CD4 cells from baseline at the 48th week of treatment) were comparable in both treatment groups In terms of safety, the rate of treatment interruption caused by adverse events was very low in the two groups (1% in the 1200mg dose of isentress HD [two 600mg tablets, once a day] group and 2% in the isentress [400mg tablets, twice a day] group) No drug-related moderate to severe adverse reactions were found in the two groups The incidence of adverse reactions (all intensity, including mild, moderate and severe) in the two groups was ≥ 2%, including abdominal pain, diarrhea, vomiting and loss of appetite The rate of any drug resistance caused by virus mutation in isentress HD group was lower than 1% (n = 4 / 531) Dr Michael s SAAG, director of the AIDS Research Center at the University of Alabama's Birmingham School of medicine, said isentress has been used as part of the HIV-1 treatment program for the past 10 years The once-a-day version of the FDA approved drug isentress HD will provide patients and their doctors with a more convenient new treatment option to help manage their condition Isentress (raltegravir, latiravir) was developed by mosadon It is the first HIV integrase inhibitor on the market in the world It was approved by FDA in October 2007 This drug is another milestone in the field of HIV treatment 10 years after the emergence of cocktail therapy It has a significant effect on newly treated patients and AIDS patients with drug resistance Isentress is a new drug against HIV / AIDS, which can block the integration of HIV genetic material and human cell chromosome It is often used in combination with other ARV drugs to treat adult patients with HIV-1 infection Up to now, isentress 400mg tablets have been approved by 112 countries in the world for the treatment of HIV-1 adults Isentress chewable tablets have been approved by 69 countries in the world for the treatment of HIV-1 infected children and adolescents aged 2 and over Isentress oral granules have been approved by 33 countries in the world for the treatment of infants with HIV-1 infection for 4 weeks or more.