After 96 weeks of treatment, the ISENTRESS-based regimen suppressed HIV RNA levels below 50 copies/mL at a rate comparable to the regimen containing efavirenz (81 percent versus 79 percent, respectively); the treatment difference was two percent favoring ISENTRESS with an associated 95 percent confidence interval (CI) of (-4.3, 9.0). Results also showed that patients on the regimen containing ISENTRESS in combination therapy experienced a statistically similar yet numerically greater mean increase in CD4 cell count (240 cells/mm3) than those on the regimen containing efavirenz (225 cells/mm3). The treatment difference was 15 with an associated 95 percent CI of (-13, 42).
Impact on lipid levels and tolerability profile of ISENTRESS
At 96 weeks, ISENTRESS in combination therapy had less impact on lipid levels, including total, low-density lipoprotein (LDL) and high-density lipoprotein (HDL) cholesterol levels, as well as triglycerides than the regimen containing efavirenz in previously untreated adults:
Additionally, 47.0 percent of patients taking the regimen containing ISENTRESS experienced drug-related side effects versus 78.0 percent of patients receiving the efavirenz-based regimen; p-value <0.00.
In the study, the most commonly reported clinical adverse experiences (AEs) in the regimens containing ISENTRESS and efavirenz, respectively, were:
Additional posters on ISENTRESS presented at ICAAC
Three additional posters being presented at the ICAAC meeting described studies that evaluated the safety profile and efficacy of ISENTRESS in combination therapy. These posters include:Metabolic analysis and body composition changes from the 48-week findings in STARTMRK (Poster 329 ) A review of the effect of ISENTRESS on the pharmacokinetics of methadone (Poster 1295) The lack of a clinically important effect of rifabutin on raltegravir pharmacokinetics (Poster 29)