Nice data, but still not as good as ATC's!
This is really good for avx imho. GSK & the others will need to respond to these results, & only ATC is as good (& it's even better).
ISENTRESS® (raltegravir), Merck's First in Class Integrase Inhibitor, Reduced HIV Viral Load and Increased CD4 Cell Counts Through 96 Weeks in Treatment-Naïve HIV-Infected Patients When Taken With Other Anti-HIV Medicines
Efficacy and Tolerability Profile Consistent With Data Seen in Approved Treatment-Experienced Indication
WHITEHOUSE STATION, N.J., Aug. 5, 2008 - ISENTRESS® (raltegravir), Merck & Co., Inc.'s first-in-class integrase inhibitor, in combination with two other anti-HIV medicines, reduced HIV viral load to undetectable levels (less than 50 copies/mL) in 83 percent of previously untreated (treatment-naïve) HIV-infected patients which was comparable to that seen with efavirenz (Sustiva®/STOCRIN®)*, which reduced HIV viral load to undetectable levels in 84 percent of treatment-naïve HIV-infected patients when also combined with the same anti-HIV medicines in patients through 96 weeks of treatment. Patients taking ISENTRESS experienced a mean increase in CD4 cell counts of 221 cells/mm³ without adverse impact on total or low-density lipoprotein (LDL) cholesterol, or triglycerides (exploratory endpoints). Results from this ongoing Phase II study were presented today at the 17th International AIDS Conference (AIDS 2008) in Mexico City, Mexico.
The use of ISENTRESS in treatment-naïve patients is investigational. ISENTRESS is approved for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. This indication is based on analyses of plasma HIV-1 RNA levels up through 24 weeks in two controlled studies of ISENTRESS. These studies were conducted in clinically advanced, three-class antiretroviral [nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs)] treatment-experienced adults. The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response. The safety and efficacy of ISENTRESS have not been established in treatment-naïve adult patients or pediatric patients. There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.
"These findings are consistent with the efficacy and safety data seen with ISENTRESS in treatment-experienced patients," said Martin Markowitz, M.D., study investigator and clinical director of the Aaron Diamond AIDS Research Center in New York. "Viral load reductions were sustained through 96 weeks in this study, the longest conducted to date with ISENTRESS."
http://www.merck.com/newsroom/press_releases/product/2008_0805.html
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