Biotech Values

[DewDiligence]

ABT Reports Results of Phase-4 HIV Nuke-Sparing Study

[This phase-4 study is one of several attempts to show that a “nuke-sparing” regimen has a place in the treatment of HIV. The business impetus for an HIV nuke-sparing regimen was discussed in #msg-49282477 from the standpoint of GSK, but it applies with equal force to ABT and MRK, the protagonists of the study described in this PR.

For treatment-naïve patients, the combination of ABT’s Kaletra (a PI) and MRK’s Isentress (an integrase inhibitor) was non-inferior to Kaletra + Truvada in the proportion of patients with undetectable HIV at 48 weeks, which is the standard efficacy endpoint for evaluating HIV drug cocktails. Although the study reported here was sponsored by ABT, it would seem to benefit MRK more than ABT insofar as Kaletra was a constant in the study design and hence Isentress was effectively being compared to Truvada (http://clinicaltrials.gov/ct2/show/NCT00711009 ).

Two other phase-4 studies are testing the Kaletra+Isentress nuke-sparing regimen in the second-line and first-line “maintenance” settings, respectively: http://clinicaltrials.gov/ct2/show/NCT00700115 and http://clinicaltrials.gov/ct2/show/NCT00931463 .

IDIX is another company with a dog in the HIV nuke-sparing hunt by virtue of GSK’s ongoing DDI study of IDX899 and GSK’s integrase inhibitor, S/GSK1349572 (#msg-48915175).]

http://finance.yahoo.com/news/Abbotts-PROGRESS-Study-of-prnews-437079121.html?x=0&.v=1

›Abbott's PROGRESS Study of Kaletra and Isentress Compared with a Standard HIV Regimen Meets the Pre-Specified Primary Efficacy Endpoint

PROGRESS is the First Study to Present 48-Week Efficacy Results for this Combination When Used in Treatment-Naive Patients with HIV

Monday July 19, 2010, 6:30 am

VIENNA, July 19 /PRNewswire-FirstCall/ -- Abbott (NYSE: ABT) today presented 48-week findings comparing an HIV regimen of its protease inhibitor (PI), Kaletra® (lopinavir/ritonavir), and Merck's integrase inhibitor, Isentress® (raltegravir), 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. Efficacy data were collected over the first 48 weeks of the 96-week PROGRESS (PROtease/InteGRasE Simplification Study) study. These data met the primary efficacy endpoint, which measured whether a similar proportion of treatment-naive HIV-infected patients reached undetectable viral loads. The results were presented at the 28th International AIDS Conference in Vienna, Austria.

"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," said Jacques Reynes, M.D., professor of medicine, head of the Infectious and Tropical Disease Department at the University Hospital Center of Montpellier, France, and a presenting author of the PROGRESS study.

HIV treatment regimens are typically drawn from approximately 20 approved antiretroviral medications in six classes. Standard regimens for treatment-naive patients generally consist of two NRTIs plus either a PI or a non-nucleoside reverse transcriptase inhibitor (NNRTI).

PROGRESS is a global, multicenter, 96-week open-label study of approximately 200 HIV-infected patients. Physicians should use caution when interpreting these results of the PROGRESS study. Key findings through week 48 include:

• A similar proportion of patients had HIV-1 RNA levels less than 40 copies/mL (defined as undetectable) when treated with Kaletra and Isentress, compared to Kaletra and Truvada.

• Both groups, on average, had a similar positive immune response, measured by their increase in CD4+ T-cell counts.

• The safety and tolerability, including incidences of treatment-emergent moderate-to-severe medication-related adverse events, were generally similar between regimens. Lipid (cholesterol and triglyceride) elevations were observed more frequently in the Kaletra and Isentress group.

"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," said Scott C. Brun, M.D., divisional vice president, infectious disease development, Global Pharmaceutical Research and Development, Abbott. "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."‹