Delstrigo and Pifeltro for the treatment of HIV-1: approved by European Commission
The European Commission has approved Delstrigo and Pifeltro for the treatment of HIV-1 infection.
Delstrigo is a new once-daily fixed-dose combination tablet of Doravirine ( 100 mg ), Lamivudine ( 3TC, 300 mg ) and Tenofovir disoproxil fumarate ( TDF, 300 mg ).
It is indicated in the European Union for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the non-nucleoside reverse transcriptase inhibitor ( NNRTI ) class of antiviral agents, Lamivudine or Tenofovir.
Pifeltro ( Doravirine, 100 mg ) is a new, once-daily NNRTI indicated ( in the EU ) in combination with other antiretroviral medicines for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the NNRTI class.
In the United States, both Delstrigo and Pifeltro are indicated for the treatment of HIV-1 infection in adults with no prior antiretroviral treatment experience, and are administered orally once daily with or without food.
Delstrigo contains a boxed warning regarding post-treatment acute exacerbations of hepatitis B ( HBV ) infection.
Delstrigo and Pifeltro do not cure HIV-1 infection or AIDS.
The approval from the European Commission was based on data from two pivotal, randomized, multicenter, double-blind, active controlled phase 3 trials, DRIVE-AHEAD and DRIVE-FORWARD, evaluating the efficacy and safety of Delstrigo and Pifeltro, respectively, in participants infected with HIV-1 with no prior antiretroviral treatment history.
Across both of the studies, 25.4% of the participants were based in Europe ( 379/1494 ).
In DRIVE-AHEAD, Delstrigo met its primary endpoint, demonstrating non-inferior efficacy compared to Efavirenz ( EFV ) / Emtricitabine ( FTC ) / Tenofovir disoproxil fumarate ( TDF ) at 48 weeks ( 84% in the Delstrigo group achieved viral suppression of HIV-1 RNA less than 40 copies/mL vs. 80% in the EFV/FTC/TDF group; treatment difference: 4.1%, 95% confidence interval: -1.5, 9.7 ).
The Week 96 data were supportive of the Week 48 findings. At Week 96, 76% in Delstrigo group achieved viral suppression of HIV-1 RNA less than 40 copies/mL vs. 73% in the EFV/FTC/TDF group; treatment difference: 3.3%, 95% confidence interval: -3.1, 9.6.
The rate of discontinuation of treatment due to adverse events was lower in the Delstrigo treatment group than in the EFV/FTC/TDF treatment group, 3% and 6.6% respectively.
Clinical adverse reactions of all grades occurring in more than or equal to 5% of participants in the Delstrigo treatment group included nausea ( 6% ) and headache ( 5% ).
In DRIVE-FORWARD, Pifeltro met its primary endpoint, demonstrating non-inferior efficacy compared to Darunavir plus Ritonavir ( DRV+r ), each in combination with FTC/TDF or Abacavir (ABC)/3TC at 48 weeks ( 83% in the Pifeltro group achieved viral suppression of HIV-1 RNA less than 40 copies/mL vs. 79% in the DRV+r group; treatment difference: 4.2%, 95% confidence interval: -1.4, 9.7 ).
The Week 96 data were supportive of the Week 48 findings. At week 96, 72% in the Pifeltro group achieved viral suppression of HIV-1 RNA less than 40 copies/mL vs. 64% in the DRV+r group; treatment difference: 7.6%, 95% confidence interval: 1.0, 14.2.
In a pooled analysis combining data from two clinical trials of treatment-naïve participants ( P007 and P021/DRIVE-AHEAD ), fewer participants in the combined Doravirine ( 100 mg ) treatment groups ( 2.8% ) discontinued due to an adverse event by week 48 compared with the combined EFV treatment group ( 6.1% ) ( treatment difference -3.4%, p=0.012 ).
Clinical adverse reactions of all grades occurring in greater than or equal to 5% of participants in the Pifeltro treatment group included nausea ( 6% ) and headache ( 5% ). ( Xagena )
Source: Merck ( MSD ), 2018
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