Merck has secured approval from the US Food and Drug Administration (FDA) for its two new HIV-1 treatments, Delstrigo and Pifeltro.
Delstrigo is a once-daily fixed-dose combination tablet of doravirine (100mg), lamivudine (3TC, 300mg) and tenofovir disoproxil fumarate (TDF, 300mg).
Pifeltro (doravirine, 100mg) is a new non-nucleoside reverse transcriptase inhibitor (NNRTI) developed to administer in combination with other antiretroviral medicines.
The new medicines have been approved to treat HIV-1 infection in adult patients with no prior antiretroviral treatment experience, and are administered orally once daily with or without food.
Delstrigo and Pifeltro can be co-administered with a wide variety of non-antiretroviral agents, while Pifeltro can be co-administered with a wide range of antiretroviral agents.
The approval of Delstrigo and Pifeltro was based on data from the pivotal, randomized, multicenter, double-blind and active controlled phase 3 trials such as Drive-Ahead and Drive-Forward.
In Drive-Ahead study, the company randomized 728 participants with no antiretroviral treatment history and provided at least one dose of either Delstrigo or efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV 600 mg/FTC 200 mg/TDF 300mg) once daily.
Delstrigo showed sustained viral suppression through 48 weeks, achieving its primary endpoint of non-inferior efficacy compared to EFV/FTC/TDF.
In Drive-Forward trial, the company randomized766 participants with no antiretroviral treatment history and provided at least one dose of either Pifeltro once daily or darunavir darunavir 800 mg + ritonavir 100 mg (DRV+r) once daily, each in combination with emtricitabine (FTC)/TDF or abacavir (ABC)/3TC selected by the investigator.
Pifeltro also showed sustained viral suppression through 48 weeks, reaching its primary endpoint of non-inferior efficacy compared to DRV+r.
Merck Research Laboratories global clinical development infectious diseases therapeutic area head and vice president Dr George Hanna said: “As part of Merck’s 30-year commitment to the care of people with HIV, we are pleased to now bring forward these two new antiretroviral treatment options, DELSTRIGO and PIFELTRO, which we believe offer a compelling clinical profile for clinicians and people living with HIV.
“We are thankful to the researchers as well as those living with HIV and their communities for the collaboration that made today’s approval possible.”