European Commission approves Delstrigo and Pifeltro for treatment of HIV-1 infection

recently, the usPharmaceutical(http://giant Merck and Co announced that the European Commission (EC) has approved Delstrigo and Pifeltro to treat HIV-1 infectionsthecompanyhttp://has planned to bring the twodrug(http://to the European market in the first half of 2019About Delstrigo
Delstrigo is a three-in-one drug consisting of a fixed dose of new non-nucleoside reverse transcriptase inhibitors (NNRTI) doravirine (DOR, 100mg) and ramifeddine (3TC, 300mg) and fumamatete dipolyphade (TDF, 300mg)Delstrigo is a daily tablet that is intended as a complete treatment for HIV-1 adults infected with past or present evidence of resistance to NNRTI antiviral drugs, 3TC, and TDFAbout Pifeltro
Pifeltine (doravirine, 100mg) is a new, daily NNRTI for hiv-1 adults infected with hiv-1 who have been or are present with no evidence of resistance to NNRTI antiretroviral drugsin the United States, Delstrigo and Pifeltro were approved at the end of August this year for HIV-1 adult sin-1 infections who had not previously received antiviral therapy, both medications were taken daily and could be taken with or without foodDelstrigo's drug label contains a black-box warning that indicates an acute increased risk of HBV infection after treatmentrelated studiesthis approval, based on 2 key, randomized, multicenter, double-blind, active drug control Phase III clinical studies DRIVE-FORand and DRIVE-FORWARD datathese studies assessed the efficacy and safety of Delstrigo and Pifeltro in adult sin-1 infections who had not previously been treated with antiretroviral drugsIn 2 studies, 25.4% of the subjects were from Europe (n?397/1494)In the DRIVE-AHEAD study, Delstrigo had a non-effect on the efficacy of 3 drug programs (Efiveren/Enquentabine/TDF, EFV/FTC/TDF) in the 48th week of treatment (viral inhibition rate (HIV-1 RNA 40 copy/ml): 84% vs 80%, treatment difference: 4.1%)The 96-week data support the 48-week findingAt week 96, the virological inhibition rate (HIV-1 RNA 40 copy/ml) was 76% in the Delstrigo treatment group, 73% in the 3-drug treatment group (EFV/FTC/TDF) and 3.3% for treatment differencesthe discontinued drug rate due to adverse reactions Delstrigo was lower than that of the 3 drug program (EFV/FTC/TDF) group, which was 3% and 6%, respectivelyThe most common adverse reactions (incidence of 5%) in delstrigo treatment groups included nausea (6%) and headache (5%)In the DRIVE-FORWARD study, data for week 48 of the treatment showed that Pifeltro efficacy had a non-disadvantage in contrast to DRV-r (both with FTC/TDF or ABC/3TC: 83% vs 79%, treatment difference: 4.2%)The 96-week data support the 48-week findingIn the 96th week of virological inhibition (HIV-1 RNA 40 copy/ml), Pifeltro was 72% in the Pifeltro treatment group, 64% in the DRV-r treatment group, and 7.6% in the treatment differencea summary ofhttp://
analysis of data from 2 clinical first-treatment patients (P007 and P021/DRIVE-AHEAD) showed that the doravirine (100mg) treatment group (100mg) was lower than the EFV treatment group (2.8% vs 6.1%) in terms of discontinuation rate due to adverse reactions The most common adverse reactions in the Pifeltro treatment group (incidence of 5%) included nausea (6%) and headache (5%)