Merck’s PIFELTRO™ (doravirine) and DELSTRIGO™ (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive US FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed
DELSTRIGO and PIFELTRO do not cure HIV-1 infection or AIDS. “Thanks to developments in HIV science, more treatment options are becoming available to address the medical needs of people living with HIV,” said Dr. Princy Kumar, Chief, Division of Infectious Diseases and Tropical Medicine at MedStar Georgetown University Hospital and Professor of Medicine and Microbiology, Georgetown University School of Medicine, Washington, D.C. “The expanded indications offer certain people with HIV-1 infection, and their doctors, the choice to switch their current antiretroviral therapy to DELSTRIGO or PIFELTRO in combination with other antiretroviral agents.”. At Week 24, participants who switched to DELSTRIGO (doravirine/lamivudine (3TC)/tenofovir disoproxil fumarate (TDF)) on Day 1 showed statistically significant differences in changes from baseline in fasting LDL-cholesterol (LDL-C) and non-HDL-cholesterol (non-HDL-C) compared to those who continued on a boosted protease inhibitor regimen (LDL-C: -16.3 mg/dL vs. -2.6 mg/dL, treatment difference: -14.5, 95% confidence interval: -18.9, -10.1, p<0.0001; non-HDL-C: -24.8 mg/dL vs. -2.1 mg/dL, treatment difference: -22.8, 95% confidence interval: -27.9, -17.7, p<0.0001). No clinically significant drug interactions have been observed following the co-administration of doravirine and the following drugs: dolutegravir, ritonavir, TDF, 3TC, elbasvir and grazoprevir, ledipasvir and sofosbuvir, ketoconazole, aluminum hydroxide/magnesium hydroxide/simethicone containing antacid, pantoprazole, atorvastatin, an oral contraceptive containing ethinyl estradiol and levonorgestrel, metformin, methadone, and midazolam. For DELSTRIGO, no clinically significant drug interactions have been observed in studies conducted in healthy participants between TDF and the following medications: entecavir, methadone, oral contraceptives, sofosbuvir or tacrolimus. If DELSTRIGO (doravirine/lamivudine (3TC)/tenofovir disoproxil fumarate (TDF)) is co-administered with ledipasvir/sofosbuvir or sofosbuvir/velpatasvir, monitor for adverse reactions associated with TDF.