Therapy Areas: AIDS & HIV
European Commission Approves Merck's Delstrigo (doravirine / lamivudine / tenofovir disoproxil fumarate), a Once-Daily Fixed-Dose Combination Tablet as a Complete Regimen and Pifeltro (doravirine), an NNRTI, Both for the Treatment of HIV-1 in Ap
5 December 2018 - - The European Commission has approved Delstrigo and Pifeltro for the treatment of HIV-1 infection, US-based biopharmaceutical company Merck (NYSE: MRK) said.

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[1]).

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 infection. Delstrigo and Pifeltro do not cure HIV-1 infection or AIDS.

The approval allows for marketing of Delstrigo and Pifeltro in all 28 European Union member states, plus Iceland, Lichtenstein and Norway, and follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency announced on Sept. 20, 2018.

Marketing authorization applications for Delstrigo and Pifeltro are also under review in other countries, including Australia and Switzerland.

The US Food and Drug Administration approved Delstrigo and Pifeltro on Aug. 30, 2018.

Health Canada approved Pifeltro on Oct. 12, 2018 and Delstrigo on Nov. 9, 2018. Availability for Delstrigo and Pifeltro in the EU is anticipated to begin in the first half of 2019.

The approval from the European Commission was based on data from two pivotal, randomised, 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 /emtricitabine /tenofovir disoproxil fumarate at 48 weeks (84% in the Delstrigo group achieved viral suppression of HIV-1 RNA