MSD reports positive Isentress results publication

study data for Isentress (raltegravir) in the New England Journal of Medicine.

The results show the first-in-class integrase inhibitor suppressed HIV-1 viral load and increased CD4 cell counts throughout 48-weeks of therapy in treatment-experienced adult patients when administered in conjunction with other anti-HIV drugs.

Furthermore, in an additional subgroup analysis, the compound was found to reduce viral load and increase CD4 cell counts in patients predicted to be poor responders.

The company notes the use of other drugs in conjunction with Isentress is associated with improved chances of treatment response, while the safety and efficacy of the compound have not been established in adult patients who are treatment-naive or paediatric patients.

Roy Steigbigel, professor of medicine, pathology, microbiology and pharmacology at Stony Brook University School of Medicine, said: “HIV disease is very complex and is especially difficult to manage in patients whose virus has become resistant to therapy.”

He added that when combined with other HIV drugs, Isentress lowered the amount of virus to undetectable levels in 62 per cent of patients, compared to 33 per cent who received placebo with other anti-HIV drugs.

In July 2007, MSD reported that Isentress had shown comparable HIV RNA reduction with efavirenz.