SBU Faculty and Alumnus Lead Research on New HIV Therapy Effective In People With Resistant Virus

Stony Brook, N.Y. – In what some are calling one of the most important developments in HIV therapy research in the past decade, two new classes of drugs, called integrase inhibitors, have been found to block virus replication in patients resistant to existing drugs.

The new classes of inhibitors are currently in an international multi-center double-blinded trial at Stony Brook University Medical Center lead by Dr. Roy Steigbigel, and at the University of New Wales, Sydney, Australia with Dr. David Cooper. The Phase III study enrolled patients from two geographic areas: BENCHMRK-1 enrolled patients from Australia, Europe and Peru, while BENCHMRK-2 enrolled patients from North America, and the rest of South America.

In the studies, 462 patients took optimised background therapy (OBT), which could include enfuvirtide and darunavir with raltegravir 400 mg twice daily, while 237 patients received only OBT. At the end of the 16-week interval into the 156-week study, 77 percent of patients who received Raltegravir with OBT achieved viral load reduction, compared to only 31 percent who received only OBT. There were also no difference in adverse events between the experimental and control group in both studies.

"We are very excited by the efficacy and tolerability of Raltegravir after 16 weeks of therapy in this group of patients who have resistance to at least one drug in each of the currently approved classes of HIV medications,” said Dr. Steigbigel.

Dr. Steigbigel, professor of medicine, pathology, microbiology and pharmacology at Stony Brook, and colleagues, presented the results of the trail at the 14th Annual Conference on Retroviruses and Opportunistic Infections (CROI) on February 28th in Los Angeles, CA. Steigbigel presented the findings of BENCHMRK-2, while Dr. Cooper presented findings from BENCHMRK-1.

Steigbigel is also Founder and Director, Comprehensive AIDS Center at Stony Brook. Under his direction, the Center has been heavily involved in the clinical development of the integrase inhibitors. He enrolled the first patient in the world into the initial study for people with HIV infection.

The investigational oral integrase inhibitor known as Raltegravir, formerly referred to as MK-0158, is under development by Merck & Co., Inc. The Lead Scientist in the project development at Merck Research Laboratories is Stony Brook Alumnus, Dr. Daria Hazuda, who received her PhD from the Department of Pharmacology. Based on the studies carried out, the use of Raltegravir in combination with OBT will greatly benefit patients who have drug-resistant HIV and have failed in using other antiviral therapies.

For more information on the ongoing BENCHMRK-2 trial, call Stony Brook University Medical Center HealthConnect® at (631) 444-4000.