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and Hepatitis.com Coverage of the
XVIII International AIDS Conference (AIDS 2010) July 18 - 23, 2010, Vienna, Austria
NRTI-sparing Regimen of Lopinavir/ritonavir plus Raltegravir Works as Well as Traditional 3-drug HAART
HAART regimens to date have typically included a protease inhibitor or non-nucleoside reverse transcriptase inhibitor (NNRTI) plus a "backbone" of 2 NRTIs. Development of new drug classes -- including integrase inhibitors that prevent HIV from inserting its genetic material into host cells -- offers new options for constructing potent combination regimens.
Jacques Reynes and fellow investigators with the PROGRESS (PROtease/InteGRasE Simplification Study [aka M10-336]) team designed this open-label Phase 3 trial to compare a traditional 3-drug HAART regimen and a 2-drug NRTI-sparing combination.
A total of 206 treatment-naive participants were randomly assigned (1:1) to receive 400/100 mg twice-daily lopinavir/ritonavir combined with either 400 mg twice-daily raltegravir -- but no NRTIs -- or else once-daily tenofovir/emtricitabine (Truvada).
Most participants (about 85%) were men, 75% were white, 21% were black, and the average age was 49 years. All had plasma viral load > 1000 copies/mL -- with a mean of about 20,000 -- and the average CD4 count was nearly 300 cells/mm3.
endpoint of undetectable viral load (< 40 copies/mL) at 48 weeks
was reported at AIDS 2010, but follow-up is continuing through 96 weeks.
Based on these findings, the PROGRESS investigators concluded that lopinavir/ritonavir plus raltegravir "resulted in non-inferior efficacy and similar tolerability as a traditional 3-drug antiviral regimen."
"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." Reynes said in a press release issue by Abbott, the maker of lopinavir/ritonavir.
Investigator affiliations: Hôpital Gui de Chauliac, Montpellier, France; Abbott, Abbott Park, IL; Hospital 12 de Octubre, Universidad Complutense de Madrid, Madrid, Spain; Innovative Care PSC, Bayamon, Puerto Rico; Therapeutic Concepts, Houston, TX.