Top 10 HIV Clinical Developments of 2008 - CD8 T cells - The Body

26 • HIV JournalView—Top 10 HIV Clinical Developments of 2008
FIGURE 12
Study Snapshot: STARTMRK
Design: Randomized, double-blind, non-inferiority clinical trial of raltegravir vs. efavirenz, when taken with tenofovir/emtricitabine,
among HIV-infected, treatment-naive patients.
Population: 563 patients, randomized 1:1 to each treatment arm. Trial participants were mostly male and non-white.
Main Results: At week 48, 86% of patients who had been randomized to raltegravir compared to 82% who had been assigned to efavirenz
achieved a viral load < 50 copies/mL—a 4% difference meeting the condition for non-inferiority. CD4+ cell count gains were seen in both
arms with a statistically significantly greater increase seen with raltegravir than efavirenz (189 cells/mm 3 vs. 163 cells/mm 3 , respectively).
Significance: Viral load responses for raltegravir were comparable with that of efavirenz and tolerability was better overall.
Further studies will determine if this agent can be administered once a day. A “New Drug Application” has been filed with the
U.S. Food and Drug Administration for a treatment-naive indication for raltegravir and an outcome is expected this summer.
Study Snapshot: MERIT
Design: Randomized study comparing the efficacy of zidovudine/lamivudine plus either 600 mg efavirenz, 300 mg maraviroc
once daily or 300 mg maraviroc twice daily in antiretroviral-naive patients.
Population: 740 patients who were treatment-naive and harboring R5-only virus at screening.
Main Results: At 48 weeks, 65.3% of the patients who were taking maraviroc had a viral load < 50 copies/mL vs. 69.3% of
those who were treated with efavirenz (everyone got zidovudine/lamivudine). The difference was 4.2%, with a lower limit bounds
of the 97.5% CI that just exceeded the outer bounds for non-inferiority of 10%. If those with dual/mixed virus detected during
the study are excluded, the difference in the proportion with a viral load of < 50 copies/mL narrows between the arms. If the
participants with previously unrecognized non-R5 virus are excluded from the primary analysis, an identical 68% of those in both
arms get a viral load < 50 copies/mL at week 48.
Significance: These post hoc analyses may soften the stance that this drug is not a contender for first-line status and sway some providers.