FDA approves Pifeltro and Delstrigo medicines for HIV-1. - Merck Inc.
Merck & Co. Inc. has announced that the FDA has approved two new HIV-1 medicines, Delstrigo and Pifeltro (doravirine) (MK 1439) The company said Delstrigo is a once-daily fixed-dose combination tablet of doravirine, lamivudine and tenofovir disoproxil fumarate, and Pifeltro is a new non-nucleoside reverse transcriptase inhibitor which is to be administered in combination with other antiretroviral medicines.
A Merck spokesperson said Delstrigo treatments would cost $70 a day, while the price is $46 a day for Pifeltro. The price is $46 a day for Pifeltro.
The approvals are based on data from the Phase III DRIVE-AHEAD and DRIVE-FORWARD studies. In the former, Delstrigo showed non-inferiority to Gilead Sciences' Atripla. In the latter, Pifeltro showed non-inferiority to Johnson & Johnson's Prezista plus 100 mg of ritonavir. Both treatments in DRIVE-FORWARD were administered in combination with either Gilead's Truvada or Epzicom/Kivexa.
Comment: The oral medications are taken once-daily with or without food for adult HIV-1 patients who have never received antiretroviral treatment.
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