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Regulatory review reports approval of doravirine/islatravir for virologically suppressed adults with HIV-1, indicating an effective two-drug option free of integrase inhibitors or tenofovir.
The FDA has approved Idvynso (Merck), a once-daily fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) doravirine and the first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI) islatravir, to replace the current antiretroviral (ARV) regimen in adults with HIV-1 infection who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine. Idvynso is the first two-drug regimen for HIV that does not contain an integrase strand transfer inhibitor (INSTI) or tenofovir. Doravirine is also available alone (Pifeltro) and in combination with lamivudine and tenofovir disoproxil fumarate (Delstrigo).
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