11 Feb 2009 03:00 AM
Phase III Studies Showed ISENTRESS(R) In Combination Therapy Provided Significant Viral Load Reductions
In new subgroup analyses of a Phase III study (STARTMRK) that compared Merck & Co., Inc.'s integrase inhibitor ISENTRESS® (raltegravir) to efavirenz [one of the leading antiretrovirals prescribed for previously untreated (treatment-naïve) HIV-infected patients], ISENTRESS was found to be as effective as efavirenz at suppressing viral load and provided improvements in immune system function across a broad spectrum of patient subpopulations through 48 weeks. The use of ISENTRESS in previously untreated HIV-infected patients is an investigational use of the drug. Both medicines were taken in combination with tenofovir/emtricitabine (Poster 573).
In other Phase III studies, BENCHMRK-1 and -2, ISENTRESS in combination with optimized background therapy (OBT) demonstrated greater reductions in viral load compared to placebo plus OBT through 96 weeks of therapy in treatment-experienced patients with triple-class resistant HIV who were failing antiretroviral therapy (Poster 571b).
These results as well as data from three additional studies were presented today at the 16th Conference on Retroviruses and Opportunistic Infections (CROI) in Montreal, Canada.
"As physicians continue to use ISENTRESS in treatment-experienced patients, newly presented longer-term data from BENCHMRK-1 and -2 continue to inspire confidence among clinicians when treating patients that are more advanced in their treatment course.
Furthermore, the STARTMRK studies in treatment-naïve patients showed that ISENTRESS may become an important new option for a broader spectrum of patients beginning treatment for HIV infection, if the drug is approved for this use," said Daniel S. Berger, M.D., clinical associate professor, College of Medicine, University of Illinois at Chicago and medical director of NorthStar Medical Center.
ISENTRESS is the first integrase inhibitor approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of viral replication with HIV-1 strains resistant to multiple antiretroviral agents…
In other Phase III studies, BENCHMRK-1 and -2, ISENTRESS in combination with optimized background therapy (OBT) demonstrated greater reductions in viral load compared to placebo plus OBT through 96 weeks of therapy in treatment-experienced patients with triple-class resistant HIV who were failing antiretroviral therapy (Poster 571b).
These results as well as data from three additional studies were presented today at the 16th Conference on Retroviruses and Opportunistic Infections (CROI) in Montreal, Canada.
"As physicians continue to use ISENTRESS in treatment-experienced patients, newly presented longer-term data from BENCHMRK-1 and -2 continue to inspire confidence among clinicians when treating patients that are more advanced in their treatment course.
Furthermore, the STARTMRK studies in treatment-naïve patients showed that ISENTRESS may become an important new option for a broader spectrum of patients beginning treatment for HIV infection, if the drug is approved for this use," said Daniel S. Berger, M.D., clinical associate professor, College of Medicine, University of Illinois at Chicago and medical director of NorthStar Medical Center.
ISENTRESS is the first integrase inhibitor approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients with evidence of viral replication with HIV-1 strains resistant to multiple antiretroviral agents…
