Merck to Present New Data from Studies of Investigational HIV Therapy

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from the company are scheduled to be presented at the 22^nd International AIDS Conference (AIDS 2018) taking place July 23-27 in Amsterdam. Presentations include Week 96 data from the Phase 3 DRIVE-FORWARD clinical trial for doravirine (DOR) and additional analyses for DOR and investigational therapy MK-8591. DOR is a non-nucleoside reverse transcriptase inhibitor (NNRTI) under investigation as a single tablet for use in combination with other antiretroviral (ARV) agents and as a fixed-dose combination with lamivudine (3TC) and tenofovir disoproxil fumarate (TDF) for the treatment of HIV-1 infection in adult patients with no prior ARV treatment history (treatment-naïve). MK-8591 is an investigational nucleoside reverse transcriptase translocation inhibitor (NRTTI) currently being evaluated in clinical trials for the treatment of HIV infection.

“While enormous progress has been made in the fight against HIV/AIDS, continued scientific innovation is needed given the unmet need that continues to exist in HIV,” said Dr. George Hanna, vice president and therapeutic area head of infectious diseases, global clinical development, Merck Research Laboratories. “Merck looks forward to presenting these new data from our HIV pipeline at AIDS 2018.”

Presentations include a late-breaking poster of the Week 96 data from the pivotal Phase 3 DRIVE-FORWARD clinical trial evaluating the safety and efficacy of once-daily DOR compared to once-daily ritonavir-boosted darunavir (DRV+r), each administered with either emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or abacavir/lamivudine (ABC/3TC), in treatment-naïve adults with HIV-1 infection. In addition, analyses of the resistance profiles of DOR and MK-8591 will be presented.

Data to be presented include:

• Doravirine Versus Ritonavir-Boosted Darunavir: 96-Week Results of the Randomized, Double-Blind, Phase 3 DRIVE-FORWARD Noninferiority Trial. Abstract LBPEB017. K. Squires. Late-breaking Poster Exhibition: Wednesday, July 25, 12:30-14:30 CET, Poster Exhibition Area, Hall 1
• Understanding the Resistance Profile of the HIV-1 NNRTI Doravirine in Combination with the Novel NRTTI MK-8591. Abstract THPEB068. D. Hazuda. Poster Exhibition: Thursday, July 26, 12:30-14:30 CET, Poster Exhibition Area, Hall 1
• Characterization of Doravirine-Selected Resistance Patterns from Participants in Treatment-Naïve Phase 3 Clinical Trials. Abstract THPDB0101. M. Lai. Poster Discussion: Thursday, July 26, 13:00-14:00 CET, Emerald Room

Earlier this year, the U.S. Food and Drug Administration (FDA) accepted for review New Drug Applications for DOR and DOR/3TC/TDF for the treatment of HIV-1 infection in treatment-naïve adults. The FDA has set a target action date of October 23, 2018 for both applications.

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