Posted by Michael Wonder on 30 Aug 2018
FDA approves Merck’s Delstrigo (doravirine with lamivudine and 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 appropriate patients
30 August 2018 - Approvals based on findings from the pivotal Phase 3 DRIVE-AHEAD and DRIVE-FORWARD trials evaluating the efficacy and safety of Delstrigo and Pifeltro.
Merck today announced that the U.S. FDA has approved two new HIV-1 medicines: Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg); and Pifeltro (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines. Both Delstrigo and Pifeltro are indicated for the treatment of HIV-1 infection in adult patients 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 exacerbation of hepatitis B (HBV) infection. Delstrigo and Pifeltro do not cure HIV-1 infection or AIDS.
