Investigational HIV Treatment Shows Promise in Mid-Stage Study

Study finds that 61 to 82% of patients treated with experimental drug achieved undetectable viral replication levels.

Bristol-Myers Squibb (BMS) recently announced positive results from a phase 2 trial evaluating its investigational compound BMS-663068, an HIV-1 attachment inhibitor.

The study compared BMS-663068 with a pharmacoenhanced protease inhibitor, atazanavir sulfate (Reyataz) and ritonavir, in 254 treatment-experienced HIV-1 patients. The research team found that 61 to 82% of patients treated with BMS-663068 achieved HIV-1 RNA levels <50 c/mL (indicating undetectable virus replication), compared with 71% of patients treated with Reyataz and ritonavir.

“The attachment inhibitor clinical development program exemplifies our commitment to focusing on patients living with HIV who have high unmet needs,” Douglas Manion, MD, head of Specialty Development at BMS, said in a press release. “This development is representative of a continued effort at Bristol-Myers Squibb to find innovative approaches to fighting this disease.”

The most common adverse events reported by trial participants treated with BMS-663068 were headache and abdominal pain. The use of BMS-663068 was not associated with dose response safety signals or serious side effects related to treatment, and no patients discontinued the trial due to adverse events.

As a result of the study’s positive results, BMS initiated a Phase 3 clinical trial evaluating BMS-663068 in heavily treatment-experienced patients on February 23, 2015.

“Today, due to tremendous advancements in therapy, many patients living with HIV are able to remain healthier and live longer; however, this means that they are usually exposed to multiple therapies over time, and may often develop drug resistance,” added Jacob Lalezari, M.D., Director of Quest Clinical Research and an Assistant Clinical Professor of Medicine at the University of California-San Francisco/Mount Zion Hospital. “Treatment-experienced patients represent an important patient subset, for whom ongoing research and development of new drug classes is being actively pursued.”