Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinical development program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21. Presentations will feature new data for islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, which is currently being evaluated across a variety of doses, formulations and frequencies for both the treatment of HIV-1 infection in combination with other antiretroviral agents and for the prevention of HIV-1 infection as a monotherapy. These data include results from a late-breaking presentation from a Phase 2a study evaluating the safety and pharmacokinetics (PK) of once-monthly (QM) oral islatravir for pre-exposure prophylaxis (PrEP) through 24 weeks. Additionally, Merck will share 96-week safety data for once-daily islatravir in combination with doravirine in previously untreated adults with HIV-1 infection. There will also be updates from the Phase 3 DRIVE-AHEAD trial evaluating DELSTRIGO™ (doravirine 100 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg) in previously untreated participants with HIV-1.
“Our decades-long commitment to fighting the epidemic is stronger than ever as we continue to build on our legacy of research and innovation in HIV,” said Dr. Joan Butterton, vice president, Global Clinical Development, Infectious Diseases, Merck Research Laboratories. “We believe that islatravir has the potential to serve as the foundation of future treatment and prevention regimens, and we look forward to sharing new data from our HIV portfolio and pipeline.”
An overview of the islatravir treatment and prevention development program is available here.
Select abstracts in the IAS 2021 program include:
- Safety and Pharmacokinetics of Oral Islatravir Once Monthly for HIV Pre-exposure Prophylaxis (PrEP): Week 24 Analysis of a Phase 2a Trial. Late Breaking Oral Presentation OALC01LB03. Abstract 2361. S. Hillier et al.
- Islatravir Safety Analysis Through Week 96 from a Phase 2 Trial in Treatment Naïve Adults with HIV-1 Infection. On-Demand Oral Presentation OAB0304. Abstract 744. D. Cunningham et al.
- Week 96 Metabolic and Bone Outcomes of a Phase 2b Trial of Islatravir and Doravirine. E-poster Presentation PEB149. Abstract 1017. GA. McComsey et al.
- The Safety and Efficacy of Maintenance with Doravirine/Lamivudine/Tenofovir through 192 Weeks in Adults with HIV-1: Results from the DRIVE-AHEAD Clinical Trial. E-poster Presentation PEB147. Abstract 709. C. Orkin et al.
- HIV Recent Infection Test-Based Incidence as a Counter-Factual for New PrEP Trials. E-poster Presentation PEC307. Abstract 2322. N. Parkin et al.
- Safety and Pharmacokinetics of Islatravir in Study Participants with Severe Renal Insufficiency. E-poster Presentation PEB168. Abstract 1914. RP. Matthews et al.
- No Pharmacokinetic Interaction Between Novel NNRTI MK-8507 and Islatravir. E-poster Presentation PEB171. Abstract 1171. W. Ankrom et al.
- NNRTI MK-8507 Does Not Alter the Pharmacokinetics of the Combined Oral Contraceptive Levonorgestrel/Ethinyl Estradiol. E-poster Presentation PEB169. Abstract 688. W. Ankrom et al.
- Higher Comorbidity and Comedication Burden in Women and Young People Living with HIV. On-Demand Oral Presentation OAA0104. Abstract 804. M. Paudel et al.
For more information, including details around the virtual programming, please visit the IAS 2021 website.
