MSD chalks up two HIV drug approvals in Europe

MSD has announced the European approval of two of its products for the treatment of HIV: the single-tablet combination Delstrigo (doravirine, lamivudine and tenofovir disoproxil fumarate), and the non-nucleoside reverse transcriptase inhibitor (NNRTI) Pifeltro (doravirine).
Specifically, Delstrigo has been authorised for the treatment of HIV-1 infection without past or present evidence of resistance to NNRTIs, lamivudine or tenofovir, while Pifeltro is approved without past or present evidence of resistance to NNRTIs alone.

Both products have received approval after demonstrating their efficacy in clinical trials. Delstrigo proved itself non-inferior to efavirenz/emtricitabine/tenofovir disoproxil fumarate combination after 48 weeks of treatment, with 84% of participants achieving viral suppression with the former compared to 80% with the latter. After 96 weeks, these figures were 76% versus 73%.

Pifeltro meanwhile showed itself to be non-inferior to darunavir plus ritonavir when each was given in combination with emtricitabine/tenofovir disoproxil fumarate or abacavir after 48 weeks, with 83% achieving viral suppression with the former compared to 79% in the latter. After 96 weeks, these findings stood at 72% versus 64%.

"As a practitioner serving people living with HIV, I welcome new medicines that can help us tailor HIV treatment regimens to the needs of the individual," remarked Dr Esteban Martínez, Senior Consultant and Associate Professor of Medicine, Infectious Diseases, University of Barcelona. "The approvals of Delstrigo and Pifeltro bring important new treatment options to market which have shown demonstrated efficacy and low rates of discontinuation."

Dr George Hanna, Vice President and Therapeutic Area Head of Infectious Diseases, Global Clinical Development at MSD also commented: "We are very pleased that the European Commission has approved Delstrigo and Pifeltro, as this approval marks another important milestone in Merck’s unwavering commitment to the global HIV community. These medicines bring new treatment options with demonstrated efficacy that could potentially address unmet needs for people in Europe living with HIV."

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