The gospel of AIDS! GlaxoSmithKline's world's first two-in-one HIV compound, Juluca, has been approved by Japan

ViiV Healthcare is an HIV/AIDS drug development company jointly owned by GlaxoSmithKline (GSK), Pfizer and Shionogi. Recently, the company announced that the two-in-one HIV compound new drug Juluca (dolutegravir/rilpivirine, dotiravir/lippivirin, 50mg/25mg tablet) has been approved by the Ministry of Health, Labour and Welfare (MHLW) as a maintenance therapy for long-term treatment of HIV-1 adults who have achieved viral suppression. ViiV submitted Juluca's application for a new drug in Japan on August 1 this year and was approved in just over three months. This approval makes Juluca the first and only single tablet 2 drug complete treatment approved by the Japanese market.
Juluca is a two-in-one compound monolithic in which dolutegravir (Dottellavir, DTG, developed by ViiV) is an HIV-integrated enzyme chain transfer inhibitor (INSTI), and rilpivirine (Lippivirin, RPV, developed by Johnson and Johnson) is a non-nucleoside reverse transcriptase inhibitor (NNRTI). In terms of medication, the usual initial dose is one tablet, once a day, spoken ornially with the meal or immediately after the meal. Juluca cannot be used with other drugs that contain dothrave. When Juluca is used in a joint use with rifabutin, take 25 mg of lipivellin once a day at the same time. When the combined use of Lifo pudding is stopped, lipivellin should also be discontinued. Do not take any medications containing lipivirin except when juluca is used in combined with Lifo pudding.
in the United States and the European Union, Juluca was approved by the FDA and EMA in November 2017 and May 2018, respectively, as a long-term maintenance drug for virological suppression (HIV-1) for antiretroviral programmes that have been in place for at least 6 months. HIV-1 adults with RNA <50 copies/ml) and no history of virological failure and no known or suspected drug-resistant mutations in any non-nucleoside retrovirase inhibitors (NNRTI) or integrated enzyme inhibitors (INSTI).
Juluca is designed to reduce drug exposure, reduce side effects and improve treatment compliance while maintaining a high level of efficacy. Juluca's approval will provide a new treatment option for the vast number of HIV-1 infected groups, will greatly simplify the first-line treatment of AIDS, and fundamentally change the current clinical AIDS treatment strategy: once patients receive the current standard 3 or 4 drug antiretroviral treatment successfully achieved virological inhibition, you can turn to Juluca, a single tablet 2 drug treatment, which will significantly reduce the amount of daily medication patients to significantly improve the dependence of treatment.
approved by Juluca is based on data from phase III clinical project SWORD. The project included more than 1,000 HIV-1 infections who had previously received 3 or 4 drugs (based on integrated enzyme inhibitors, non-nucleoside retrovirase inhibitors, or protease inhibitors) antiretroviral programmes to achieve virological inhibition, and assessed the efficacy, safety and toerability of patients who had switched from 3 or 4 to 2 drug programmes. The project consists of 2 Phase III clinical studies (SWORD-1 (NCT02429791) and SWORD-2 (NCT02422797)), all of which are 148-week, randomized, open-label, non-shoddy studies. In both studies, dolutegravir and rilpivirine were taken in separate tablets once a day, and the 48-week study data were presented at the November 2017 Retrovirus and Opportunity New Infection (CROI) Conference and published in The Lancet in March 2018.
ViiV and Johnson and Johnson's Jansen reached a cooperation agreement in June 2014 to jointly develop and commercialize the Juluca 2-piece, which also represents ViiV's first external collaboration. In August 2014, UNAIDS presented its vision of ending AIDS by 2030, and in line with UNAIDS' call, ViiV reached a broader strategic partnership with Johnson and Johnson. In addition to this two-in-one compound tablet, ViiV is also working with Johnson and Johnson to develop the long-acting two-in-one injection drug cabottegravir/rilpivirine (CAB/RPV), which is given once a month by intramuscular injection (IM) and has successfully completed two Phase III clinical trials. ViiV has plans to submit a monthly application for the long-acting HIV treatment in the future, which, if approved, will provide HIV groups with a treatment option that requires only 12 injections per year (once a month), which will significantly improve treatment compliance and improve patient prognostication. (Bio Valley)