FDA approved Delstrigo (doravirine/lamivudine/tenofovir DF) for HIV-1 Infection in Adults and Pediatric PatientsFDA approved New Once-Daily Pill to Treat HIV in Adults and Some Children

Delstrigo is a three-drug combination of doravirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI), and lamivudine and tenofovir disoproxil fumarate, both nucleoside analogue reverse transcriptase inhibitors.

Delstrigo is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior antiretroviral treatment history, OR to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Delstrigo.

One tablet taken orally once daily with or without food in adults and pediatric patients weighing at least 35 kg. Prior to or when initiating Delstrigo, test for HBV infection. Prior to or when initiating Delstrigo, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Delstrigo is not recommended in patients with estimated creatinine clearance below 50 mL per minute. If co-administered with rifabutin, take one tablet of Delstrigo once daily, followed by one tablet of doravirine 100 mg (Pifeltro) approximately 12 hours after the dose of Delstrigo for the duration of rifabutin co-administration.

The efficacy of Delstrigo is based on 96-week data from a randomized, multicenter, double-blind, active-controlled Phase 3 trial (DRIVE-AHEAD, NCT02403674) in participants with no antiretroviral treatment history (n=728). Participants received either Delstrigo or efavirenz 600 mg/emtricitabine 200 mg/tenofovir DF 300 mg once daily. At baseline, median age was 31 years, 15% were female, 52% were Non-White, 3% had hepatitis B or C coinfection, 14% had a history of AIDS, 21% had HIV-1 RNA greater than 100,000 copies/mL, and 88% had CD4+ T-cell count greater than 200 cells/mm3. At week 96, 77% of Delstrigo-treated participants and 74% of efavirenz/emtricitabine/tenofovir DF-treated participants achieved HIV-1 RNA <50 copies/mL (treatment difference 3.8%, 95% CI -2.4% to 10.0%). Mean CD4+ T-cell counts increased from baseline by 238 cells/mm3 with Delstrigo and 223 cells/mm3 with efavirenz/emtricitabine/tenofovir DF.

Not reported in label.

Delstrigo provides a once-daily, single-tablet, three-drug regimen for treatment-naive adults and pediatric patients weighing at least 35 kg, or for virologically suppressed patients seeking regimen simplification, provided they have no history of treatment failure and no known resistance to the components. It is not recommended in patients with estimated creatinine clearance below 50 mL/min. Testing for HBV infection and renal function assessment are required before and during treatment.