FDA recently approved 2 new treatments, heightening competition in the HIV-1 drug marketplace.
Heightening competition in the HIV-1 drug marketplace, FDA recently approved 2 new treatments.
Merck garnered approval for Delstrigo, a once-daily fixed-dose combination tablet of doravirine, lamivudine, and tenofovir disoproxil fumarate (TDF); and Pifeltro (doravirine), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines.
“Delstrigo and Pifeltro offer a compelling clinical profile for clinicians and people living with HIV,” Carey Hwang, MD, PhD, executive director of infectious diseases and global clinical development for Merck Research Laboratories, told FormularyWatch. “Based on the drug interaction profile of Delstrigo and Pifeltro, these new treatments may be an option for treatment-naÃ¯ve adult patients who are taking other medicines.”
In Merck’s phase 3 trials, a statistically-significant lower proportion of Delstrigo-treated participants reported neuropsychiatric adverse events in the categories of dizziness, sleep disorders and disturbances, and altered sensorium, compared to patients treated with efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF), Hwang said.
In addition, Delstrigo-treated participants showed statistically significant superior lipid profiles versus EFV/FTC/TDF, as measured by changes from baseline in LDL-cholesterol and non-HDL-cholesterol.
The 2 medications, which are expected be available via wholesalers by mid-October, are priced at $46 per day for Pifeltro and $70 per day for Delstrigo.
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“We are working to obtain access for patients in commercial and government-sponsored programs (including Medicare Part D, Medicaid and AIDS Drug Assistance Programs),” Kate Edwards, director of marketing for Merck, told FormularyWatch.
Plus, Delstrigo and Pifeltro are covered products under the Merck Patient Assistance Program, Edwards said.
Delstrigo contains a boxed warning regarding post-treatment acute exacerbation of hepatitis B (HBV) infection. Delstrigo and Pifeltro are contraindicated when co-administered with drugs that are strong cytochrome P450 (CYP) 3A enzyme inducers as significant decreases in doravirine plasma concentrations may occur.