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Abbott Kaletra, Merck Isentress Meet Primary Efficacy Endpoint In Progress Study

The efficacy data collected over the first 48 weeks of the 96-week Progress (PROtease/InteGRasE Simplification Study) study using Abbott's protease inhibitor (PI) Kaletra (lopinavir/ritonavir) and Merck's integrase inhibitor Isentress (raltegravir) met the primary efficacy endpoint, which measured whether a similar proportion of treatment-naive HIV-infected patients reached undetectable viral loads.

Abbott said that the findings compared an HIV regimen of its Kaletra and Merck’s Isentress to a traditional HIV regimen of Kaletra and the nucleotide/nucleoside reverse transcriptase inhibitors (NRTIs) in Truvada (tenofovir and emtricitabine) in antiretroviral-naive adult patients.

Jacques Reynes, MD, professor of medicine, head of the Infectious and Tropical Disease Department at the University Hospital Center of Montpellier in France and a presenting author of the Progress study, said: “The 48-week Progress study results, while not definitive, suggest that the nucleoside-sparing HIV regimen of Kaletra and Isentress may be an alternative treatment option for patients new to HIV therapy, when compared to a standard HIV regimen.

“This further advances our research into new HIV treatment classes and explores the use of alternative drug combinations for patients.”

Scott Brun, divisional vice president of infectious disease development for global pharmaceutical R&D at Abbott, said: “Kaletra is one of the most widely-studied protease inhibitors available, and Abbott believes it is important to look at new ways of combining Kaletra with other HIV medications to explore additional treatment options for patients.

“The Progress study is another step toward understanding the science behind potential new treatment approaches to help people living with HIV and demonstrates Abbott’s continued commitment to HIV research.”