MSD’s HIV medicines Delstrigo and Pifeltro have been cleared by the US Food and Drug Administration for adult patients with no prior antiretroviral treatment experience.
Delstrigo is a once-daily fixed-dose combination tablet of doravirine, lamivudine and tenofovir disoproxil fumarate, while Pifeltro is a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines.
In DRIVE-AHEAD trial, 728 participants with no antiretroviral treatment history were randomized and received at least one dose of either Delstrigo or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) once daily.
Results showed that Delstrigo sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy compared to EFV/FTC/TDF (84% versus 81%, respectively).
According to the data, of the 21 percent of study participants with a high viral load at baseline (HIV-1 RNA >100,000 copies/mL), 77 percent in the Delstrigo group and 72 percent in the EFV/FTC/TDF group achieved HIV-1 RNA <50 copies/mL at Week 48.
The rate of discontinuation of treatment due to adverse events was lower in the Delstrigo treatment group than in the EFV/FTC/TDF treatment group (3% and 6%, respectively).
In the DRIVE-FORWARD study, 766 participants with no antiretroviral treatment history were randomised and received at least one dose of either Pifeltro once daily or darunavir plus ritonavir (DRV+r) once daily, each in combination with emtricitabine (FTC)/TDF or abacavir (ABC)/3TC selected by the investigator.
Pifeltro demonstrated sustained viral suppression through 48 weeks, meeting its primary endpoint of non-inferior efficacy compared to the DRV+r based regimen, with 84% achieving viral suppression of HIV-1 RNA <50 copies/mL versus 80%, respectively.
Of the 20 percent of study participants with a high viral load at baseline, 77 percent in the Pifeltro group and 74 percent in the DRV+r group achieved HIV-1 RNA <50 copies/mL at Week 48.
The rate of discontinuation of therapy due to adverse events in either treatment group was low, the firm said, with figures of 2% in the Pifeltro group and 3% in the DRV+r group.
“As a result of the remarkable strides made in the fight against HIV, clinicians and their patients have the opportunity to work together to identify treatment regimens that may be best for each individual, taking into account other aspects of that person’s health, including other medicines they may be taking,” said Dr David Wohl, professor, Division of Infectious Diseases, University of North Carolina (UNC) Chapel Hill School of Medicine and site leader, UNC AIDS Clinical Trials Unit.
The approvals of Delstrigo and Pifeltro “provide two new options for the treatment of HIV-1 in appropriate treatment-naïve adult patients.”