Merck presented results from Week 96 of its Phase III DRIVE-FORWARD clinical trial of doravirine in HIV. The data was presented in an abstract at the 22nd International AIDS Conference being held in Amsterdam.
Kenilworth, New Jersey-based Merck presented results from Week 96 of its Phase III DRIVE-FORWARD clinical trial of doravirine in HIV. The data was presented in an abstract at the 22nd International AIDS Conference being held in Amsterdam.
The trial evaluated doravirine (DOR), a non-nucleoside reverse transcriptase inhibitor (NNRTI) in combination with other antiretroviral drugs, to treat HIV-1 patients with no prior antiretroviral treatment history. At Week 96, 73.1 percent of the treatment group receiving once-daily DOR hit viral suppression, which was measured by the proportion of patients who had HIV-1 RNA of less than 50 copies/mL. The group that had once-daily ritonavir-boosted darunavir (DRV+r) had 66 percent suppression.
The company had previously released Week 48 data, that showed once-daily DOR met its primary efficacy endpoint of non-inferiority compared to DRV+r, each in combination with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC). Those data were released at the Conference on Retroviruses and Opportunistic Infections last year.
In DRIVE-FORWARD, 766 patients who were treatment-naïve were randomized and received either 100 mg of DOR once a day or DRV+r (800 mg and 100 mg, respectively) once a day, each in combination with FTC/TDF or ABC/3TC chosen by the investigator.
The most common side effects were diarrhea, nausea, headache, upper respiratory tract infection and viral upper respiratory tract infection. Discontinuation rate of the therapy because of side effects was 1.6 percent in the DOR group and 3.4 percent in the DRV+r group.
“These Week 96 data reinforce the efficacy and safety of doravirine found at 48 weeks, and support the potential use of doravirine in the clinic as an important new treatment option for people living with HIV-1,” said Chloe Orkin, lead for HIV and HIV/Hep C research at Ambrose King Centre, Royal London Hospital, in a statement.
There were several secondary endpoints in the trial, including efficacy at Week 96, evaluation of the effects of DOR and DRV+r on fasting serum lipids, change from baseline in CD4+ T-cell count, and safety and tolerability. Fasting serum blood lipids for the DOR group was -0.4 mg/dL and for the DRV+r group it was 14 mg/dL. For non-high density lipoprotein cholesterol (non-HDL-C) for DOR it was -0.5 mg/DL and 17.7 mg/dL for DRV+r.
“For more than 30 years, Merck has advanced innovative science to help change the trajectory in how HIV is treated,” said George Hanna, vice president and therapeutic area head of infectious diseases, global clinical development, Merck Research Laboratories, in a statement. “Today, our work is focused on clinical research that is designed to truly address unmet patient need. We are encouraged by the 96 Week results of the DRIVE-FORWARD trial which support the efficacy and durability of investigational NNRTI doravirine.”
Earlier this year, Merck’s New Drug Applications for DOR and DOR/3TC/TDF to treat HIV-1 in treatment-naïve adults was accepted by the U.S. Food and Drug Administration (FDA). The target action date for both applications is October 23, 2018.
