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MEXICO CITY, Aug. 7, 2008 --
GlaxoSmithKline (GSK) today announced that 96-week data from the
HEAT study show that once-daily EPZICOM (abacavir + lamivudine)
provides comparable efficacy to once-daily Truvada (tenofovir DF
+ emtricitabine) as a first-line option for the treatment of
HIV. The data were presented today at the 17th International
AIDS Conference in Mexico City, Mexico.
HEAT is the first large, prospective, long-term, head-to-head
trial to evaluate the safety and efficacy of EPZICOM and Truvada
both combined with a boosted protease inhibitor (Kaletra)
administered once-daily in adults
who had no previous exposure to HIV medicines. The study
involved 688 HIV therapy-naive patients: 343 randomized to
treatment with EPZICOM and 345 randomized to treatment with
Truvada.
Results of the study found that through 96 weeks efficacy endpoints for
EPZICOM were comparable to Truvada, regardless of baseline viral
load. At 96 weeks 60% of subjects receiving EPZICOM versus 58%
of subjects receiving Truvada achieved a viral load <50 c/mL.
Patients receiving EPZICOM also experienced similar median CD4+
cell increases to those patients receiving Truvada, 250 vs. 247.
Overall, both regimens were generally well-tolerated with
comparable safety profiles and few study discontinuations due to
adverse events (6% for both treatment arms). Virologic failure
occurred in 14% of patients for both groups.
able results between the two."
Additionally, a review of two important inflammatory biomarkers,
hs-CRP and IL-6, in the HEAT data set showed that levels of both
biomarkers decreased from baseline at 48 weeks and 96 weeks.
Further, there were no
significant differences between EPZICOM and Truvada at any time
points. Elevations of these markers have been associated with
increased risk of cardiovascular events but the degree of
association is still being evaluated.
HEAT Study Explained
HEAT is a head-to-head prospective, randomized, double-blind,
placebo-matched, multicenter study evaluating the safety and
efficacy of EPZICOM and Truvada. The study assigned 688 patients
to receive either EPZICOM QD (n=343) or Truvada QD (n=345) both
in combination with QD lopinavir/ritonavir. The primary efficacy
endpoint was to determine the proportion of subjects with a
viral load of <50 c/mL at 48 weeks and the primary safety
endpoint was to evaluate safety and tolerability of both
regimens at 96 weeks.
Results demonstrate that EPZICOM was comparable to Truvada in
virologic and immunologic efficacy. At 48 weeks, 68% of subjects
receiving EPZICOM versus 67% of subjects receiving Truvada
achieved a viral load <50c/mL. At 96 weeks 60% of subjects
receiving EPZICOM versus 58% of subjects receiving Truvada
achieved a viral load <50c/mL. Of those patients who were able
to achieve a viral load <50c/mL (ITT, M=F), both EPZICOM and
Truvada saw similar success rates regardless of whether baseline
viral load was <100,000c/mL (63% vs. 58%) or greater than or
equal to 100,000c/mL (56% vs. 58%). Median CD4+ increase was
comparable in both arms at week 96 (250 vs. 247).
Adverse events were similar in both arms. Both treatment arms
had 6% of patients prematurely withdraw due to adverse events.
In addition, 15% of patients had drug-related Grade 3-4 adverse
events in both treatment arms.
Patients receiving EPZICOM reported higher rates of suspected
abacavir hypersensitivity reaction compared with Truvada (4% vs.
<1%). Prospective HLA-B*5701 screening was not employed in this
study. One percent of
patients receiving Truvada developed proximal renal tubule
dysfunction (vs. 0% for EPZICOM). Overall, treatment-limiting
adverse events were comparable between the two arms.
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