Treatment concentration lasts 6 months! Gilead releases early data on HIV-1 shell inhibitors

Recently, Gilead Sciences published data on an ongoing Phase I clinical study at the 23rd International AIDS Congress (AIDS 2020)The study showed that it was working on a new HIV-1 shell function inhibitor lenacapavir (GS-6207) subcutaneous lysual release, with a therapeutic concentration predicted after a single 900 mg dose lasting at least 6 monthsIn this study, lenacapavir had good tolerance and no serious adverse events were reportedLenacapavir is a drug in the research and is developing a long-acting programme in conjunction with other antiretroviral drugsLenacapavir destroys the HIV shell at several stages of the virus's life cycle, a polypolymer shell that is critical to virus replicationIn May 2019, the FDA granted a breakthrough drug qualification to develop lenacapavir in conjunction with other antiretroviral drugs to treat multidrug-resistant HIV-1 infections who have previously received multiple programsOver the past 30 years, significant progress has been made in HIV/AIDS treatment, which has become a manageable chronic diseaseInterventions are urgently needed to improve compliance with long-term treatmentLong-acting antiretroviral therapy may help address the challenges of treating compliance and treatment fatigue, promising to provide important treatment options for people living with HIV and make HIV a more manageable part of their livescurrently, Gilead is conducting a number of clinical studies to evaluate the safety, efficacy and dose regimen of lenacapavirLenacapavir Chemical StructureIn this ongoing randomized, blind, placebo-controlled, single-dose (SAD) phase I study, 30 subjects were randomly injected with lenacapavir (8 cases per group) or placebo (2 cases per group) at a dose of 300 mg (1 x 1.0mL) or 900 mg (1.0mL) or 900 mg (3 x 1.0ML) or 2.5MLAll subjects completed administration and collected pharmacokineticandeandeicande and safety data about 64 weeks after administrationstudy observed a slow initial release of lenacapavir, with a blood concentration of the therapeutic level lasting at least 6 months after a single 900 mg dose (3 x 1.0 ml) injectionSimilar results were observed after a single 900 mg dose was injected in 2 x 1.5mLExposure to Lenacapavir usually increases in dose proportions (from 300 mg to 900 mg) and reaches maximum concentrations 11-14 weeks after administration, with a significant half-life of about 15 weeksLenacapavir has good overall tolerance and no serious or level 3 or 4 adverse events associated with the research drug or causing the discontinuation of the study The most common adverse reactions were hard knots at the injection site (87%), pain (63%) and erythema (70%), all of which were mild No clinical-related laboratory abnormalities of level 3 or above Source: Gilead Sciences Presents Data Supporting a Potential Six-Month Dosing Interval for The Police HIV-1 Capsid Lenacapavir (GS-6207)