Two once-daily oral HIV-1 medicines have been approved by the Food and Drug Administration, according to Merck: Delstrigo, a fixed-dose combination tablet of doravirine (100 mg), lamivudine (300 mg), and tenofovir disoproxil fumarate (300 mg), and Pifeltro (doravirine, 100 mg). Both drugs are indicated for treating HIV-1 infection in adult patients with no prior antiretroviral treatment.
Pifeltro is a nonnucleoside reverse transcriptase inhibitor to be used in combination with other antiretroviral medicines. Delstrigo containsregarding posttreatment acute exacerbation of hepatitis B infection.
Delstrigo and Pifeltro are not curative, according to, which manufactures both drugs.
The FDA approval of Delstrigo was based on findings from the(NCT02403674), which randomized 728 participants with no history of antiretroviral treatment to receive once daily either Delstrigo or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV 600 mg/FTC 200 mg/TDF 300 mg). Delstrigo was associated with sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy when compared with EFV/FTC/TDF (84% vs. 81%, respectively), according to Merck.
Pifeltro was approved based on the results of the(NCT02275780), which randomized 766 participants with no history of antiretroviral treatment to receive either Pifeltro once daily or darunavir 800 mg plus ritonavir 100 mg (DRV+r) once daily, each in combination with either emtricitabine (FTC)/TDF or abacavir (ABC)/lamivudine (3TC), as selected by the investigator. Pifeltro was associated with sustained viral suppression through 48 weeks, meeting its primary endpoint of noninferior efficacy when compared with DRV+r, each in combination with FTC/TDF or ABC/3TC (84% vs. 80%, respectively), according to the Merck announcement.