Delstrigo and Pifeltro Approved to Treat HIV
August 30, 2018 – The U.S. FDA has approved Delstrigo™ (doravirine/lamivudine/tenofovir disoproxil fumarate) and Pifeltro™ (doravirine), both manufactured by Merck, to treat HIV-1 infection in adult patients who have no prior antiretroviral treatment experience.
Doravirine, the active ingredient in Pifeltro, is a novel type of non-nucleoside reverse transcriptase inhibitor (NNRTI) and should be used with other antiretroviral medications. Delstrigo, a combination tablet, provides single-dose treatment that can be taken alone, and includes the new NNRTI and two nucleoside reverse transcriptase inhibitors (NRTIs).
Both Delstrigo and Pifeltro have a recommended standard dose of one tablet per day, taken with food. Delstrigo carries a black box warning that indicates patients co-infected with HIV and hepatitis B (HBV) may be at risk of acute HBV exacerbation if they stop treatment with Delstrigo.
Merck has launched Delstrigo and Pifeltro at wholesale acquisition costs (WAC) of $2,100 (Delstrigo) and $1,380 (Pifeltro) per month.