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    Home > Biochemistry News > Biotechnology News > HIV treatment 365 days change s12 days! CAB/RPV long-acting two-drug scheme has safety!

    HIV treatment 365 days change s12 days! CAB/RPV long-acting two-drug scheme has safety!

    • Last Update: 2020-06-06
    • Source: Internet
    • Author: User
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    The results showed that at 96 weeks, the monthly long-acting CAB/RPV programme continued to provide comparable efficacy and safety with the daily oral tridot adl (abacavir/dolutegravir/lamivudine, abakawe/droutvewe,ABC/DTG/3TC)In addition, patients switching to a monthly long-acting CA/RPV regimen were more satisfied with treatment than daily oral therapyCAB/RPV is an injection-long-acting two-drug program consisting of ViiV's cabotegravir (CAB, Cabotwe) and Johnson's rilpivirine (RPV, lipitvirin), administered through muscle injection (IM)Among them, RPV is a long-acting non-nucleoside reverse transcriptase inhibitor, and CAB is a long-acting HIV-1 integrated enzyme chain transfer inhibitorCurrently, the long-acting injectable HIV therapy is being developed by ViiV in partnership with Johnson and Johnson Pharmaceuticals, including a monthly program and a 2-monthly programAt the CRIO conference, ViiV published positive 48-week data from the Global Phase III ATLAS-2M Study (NCT03299049) showing that CAB/RPV long-acting therapy: antiviral activity and safety, which is given every 8 weeks (2 months), is comparable to antiviral activity and safety once every 4 weeks (monthly) and is liked by almost all patientsOver the past 20 years, with the progress of science, AIDS has changed from a deadly disease to a controlled chronic disease, but there are still huge unmet medical needs in the field, including reducing the burden of medication, increasing treatment compliance, and reducing drug-resistant mutationsIn 2014, UNAIDS presented its vision of ending AIDS by 2030In response to UNAIDS's call, ViiV and Johnson and Johnson have reached a broader strategic partnership that, if successfully developed and approved for use, will provide the HIV population with a treatment option that requires only 6 or 12 injections per year, greatly improving treatment compliance and improving patient prognosisFLAIR is a random, open label, multi-center, parallel group, non-performance III study, in 566 cases of 20-week Triumeq induction therapy to achieve viral inhibition of HIV-1 infectionIn the study, patients were randomly assigned to the steering CAB/RPV long-acting injection protocol, which was given every 4 weeks, or continued to receive Triumeq, with a virological failure rate at the 48th week of treatmentTriumeq is a three-in-one combination of two nucleoside reverse transcriptase inhibitors (NRTI) abacavir (Abakavir) and lamivudine (lamivudine) and an integrated enzyme chain transfer inhibitor (INI) dolutegravir (dotrorave)The 48-week data released before theshowed that the study reached its main end point: CAB/RPV had a non-disadvantageous effect on Triumeq in terms of the proportion of patients with plasma HIV-1 RNA (c/mL) as determined by the FDA's Snapshot algorithm(CAB/RPV: 6/283 (2.1%), Triumeq: 7/283 (2.5%); adjusted variance: -0.4%, 95% CI: -2.8 to 2.1)In addition, the study found that the virological inhibition rate (HIV-1 RNA 50 c/mL) was similar in the 2 treatment groups at week 48 (CAB/RPV: 265/283 (93.6%), Triumeq: 264/283 (93.3%);the 96-week data released this time continues to support the non-performance observed for 48 weeks: in week 96, CAB/RPV has a ratio of CA/RPV to Triumeq in terms of the proportion of patients with plasma HIV-1 RNA (c/mL) as determined by the FDA's Snapshot algorithm Non-performance (CAB/RPV: 9/283 (3.2%), Triumeq: 9/283 (3.2%); adjusted variance: 0.0%, 95% CI: -2.9 to 2.9) In addition, the study found that the virological inhibition rate (HIV-1 RNA 50 c/mL) was similar in the 2 treatment groups at week 96 (CAB/RPV: 245/283 (86.6%), Triumeq:253/283 (89.4%); the study, two treatment groups identified virological failures (CVF) as uncommon Between weeks 48 to 96, no new cases of CVF were reported in the CAB/RPV treatment group, and one patient in the Triumeq group developed CVF at week 64, but no drug resistance was produced by treatment safety, CAB/RPV is well tolerated, with 2 treatment groups with severe adverse events (SAE; CAB/RPV group- 24/283,8.4%), Triumeq group s 22/28 3 (7.8%)) is similar to the adverse event that led to the exit from the study (CAB/RPV group 12/283 (4.2%), Triumeq group s 4/283 (1.4%)) In the CAB/RPV treatment group, 88% (246/278) reported an injection site reaction (ISR) at some point during 96 weeks of treatment Most injections did not result in ISR reporting, with 12,552 injections and 3,100 ISR incidents reported during the 96-week study period Most ISR events (99.4%) were mild or moderate (mild: 2730/3100, moderate: 352/3100) and lasted an average of 3 days, with the frequency of these events decreasing over time Six subjects (2.1%) withdrew due to injection-related events an HIV treatment satisfaction survey conducted during week 48 showed a significant increase in patient treatment satisfaction after switching from oral Triumeq to long-acting injection protocol CAB/RPV compared to the continuation of oral Triumeq (average difference in HIVTSQ: 4.1, 95% CI,5.5, p 0.001) A patient preference data from week 48 showed that 257/283 (90.8%) of the subjects preferred a long-acting injection regimen, while 2/283 (0.7%) preferred previous oral therapy In week 96, patient treatment satisfaction continued to show a statistically significant increase in treatment satisfaction (average difference in HIVTSQ: 2.3 points, 95% CI 1.1, 3.5, p 0.001) after switching from oral Triumeq to long-acting injection protocol CAB/RPV compared to the continuation of oral Triumeq "The long-term data from the FLAIR study is really exciting and confirms the long-term efficacy and good tolerance of the CAB/RPV long-acting two-drug approach, as well as the potential as an alternative to the current standard oral oral option for standard care," said Chloe Orkin, lead researcher and clinical professor at Queen Mary University of London, For people living with HIV, the option of reducing a drug-giving program from 365 days per year to 12 days is an important new option original origin: ViiVHealth ave long-term data from phase phase III study demonstration ing enefficy and acyy of cabotegravir and rilpivirine, its investigational al, long-acting, injectable regimen in adults living with HIV-1
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