Merck announced new results from the Phase 3 DRIVE-AHEAD clinical trial evaluating the efficacy and safety of Delstrigo, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg) in treatment-naïve adults with HIV-1 infection. The efficacy findings at Week 96 in DRIVE-AHEAD were consistent with the findings at Week 48 in which Delstrigo demonstrated non-inferior efficacy in comparison to a fixed-dose combination of efavirenz (EFV, 600 mg), emtricitabine (FTC, 200 mg) and TDF (300 mg).
“Long-term data from this pivotal clinical trial further confirm the efficacy and safety of DELSTRIGO in treatment-naïve patients,” said Dr. Jean-Michel Molina, Professor of Infectious Diseases, University of Paris, and Head of the Infectious Diseases Department at Saint-Louis Hospital in Paris, France. “The data position this fixed-dose combination as a new treatment option that can address the needs of people living with HIV today.”
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In DRIVE-AHEAD, 728 participants with no antiretroviral treatment history were randomized and received at least one dose of either Delstrigo or EFV/FTC/TDF once daily. In this trial, after 96 weeks of treatment, the proportion of participants achieving plasma HIV-1 RNA levels less than 50 copies/mL was 77.5 percent in the group treated with Delstrigo (doravirine/3TC/TDF) and 73.6 percent in the group treated with EFV/FTC/TDF (treatment difference: 3.8%, 95% confidence interval: -2.4, 10.0).
No additional viral drug resistance to doravirine was observed in study participants between Week 48 and Week 96, while two study participants in the EFV/FTC/TDF group developed viral drug resistance to EFV.
At Week 96, the rate of discontinuation of therapy due to adverse events was 3.0 percent (11/364) in the DELSTRIGO group and 7.0 percent (27/364) in the EFV/FTC/TDF group. In addition, the three pre-specified neuropsychiatric endpoints of dizziness, sleep disorders/disturbances and altered sensorium were significantly less frequent in the Delstrigo group than in the EFV/FTC/TDF group: dizziness (10.2% vs. 38.2%, treatment difference: -28%, 95% confidence interval: -33.9, -22.1), sleep disorders and disturbances (14.0% vs. 27.5%, treatment difference: -13.5%, 95% confidence interval: -19.3, -7.6) and altered sensorium (4.9% vs. 8.5%, treatment difference: -3.6%, 95% confidence interval: -7.4, 0.1).
The study also reported lower mean changes from baseline in the levels of fasting lipids in the Delstrigo group compared with the EFV/FTC/TDF group at Week 96, including LDL-C (-0.6 mg/dL vs. 10.8 mg/dL, treatment difference: -11.1, 95% confidence interval: -14.8, -7.4) and non-HDL-C (-2.1 mg/dL vs. 15.0 mg/dL, treatment difference: -17.0, 95% confidence interval: -21.1, -13.0).
“At Merck, we are committed to continued scientific innovation as we look for new ways to help improve how HIV is treated. The recent U.S. Food and Drug Administration approval of DELSTRIGO represents this ongoing commitment,” said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, global clinical development, Merck Research Laboratories. “We are pleased to see the efficacy results for Delstrigo at 96 weeks, which support the initial findings seen in the 48 week data.”