Isentress proves effective as competitor in clinical trial

SAN FRANCISCO A drug that recently received an expanded approval from the Food and Drug Administration as a first-time treatment for HIV-1 in adults is as effective as its competitor, according to results of a recent late-stage clinical trial.

Merck & Co. said that Isentress (raltegravir) kept viral load levels at nearly undetectable levels – 50 virus copies per milliliter of blood – while increasing CD4 immune cells over a 96-week period in the phase 3 STARTMRK trial comparing the drug to Bristol-Myers Squibb’s Sustiva (efavirenz). Patients received either 400 mg of Isentress with Gilead Sciences’ Truvada (tenofovir and emtricitabine) or 600 mg of Sustiva and Truvada.

“Results from the 96-week analysis of STARTMRK showed that Isentress in combination therapy was as effective as efavirenz at suppressing HIV viral load and increasing immune system function,” Orlando Immunology Center medical director Edwin de Jesus said in a Merck statement.

Results of the study were presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy in San Francisco Sunday.