At
96 Weeks, Epzicom and Truvada Demonstrate Comparable Efficacy, Safety, and Tolerability
when Combined with Lopinavir/ritonavir (Kaletra)
 | Both
abacavir/lamivudine (Epzicom) and tenofovir/emtricitabine (Truvada) provided comparable
antiviral efficacy, safety, and tolerability when each was combined with lopinavir/ritonavir
(Kaletra) in treatment-naive HIV patients, according to results of the HEAT study.
At week 96, about 68% in both groups had HIV viral load below 50 copies/mL and
the median CD4 increase was about 250 cells/mm3. |
Epzicom
and Truvada are 2 nucleoside reverse
transcriptase inhibitor (NRTI)
fixed-dose coformulations widely used for initial treatment of HIV.
HEAT is the first completed, randomized clinical trial to directly compare the
efficacy, safety, and tolerability of the 2 coformulations, each in combination
with the boosted protease inhibitor lopinavir/ritonavir
in patients stating treatment for the first time. Final results of the study were
published in the July
31, 2009 issue of the journal AIDS.
HEAT was a double-blind,
placebo-matched, non-inferiority study in which 688 participants were randomly
assigned to receive a once-daily regimen of either 600/300 mg abacavir/lamivudine
or 300/200 mg tenofovir/emtricitabine, both with 800/200 mg lopinavir/ritonavir.
Primary
endpoints were the proportion of patients with HIV RNA below 50 copies/mL at week
48 (missing = failure, switch included analysis) and the proportion experiencing
adverse events over 96 weeks. Results
 | At
week 48, 68% of patients in the abacavir/lamivudine group vs 67% in the tenofovir/emtricitabine
group achieved HIV RNA below 50 copies/mL (P = 0.913). | | This
finding demonstrated the non-inferiority of abacavir/lamivudine to tenofovir/emtricitabine
at week 48. | | Non-inferiority
of the 2 regimens was sustained at week 96 (60% vs 58%, respectively; P = 0.603).
| | The
efficacy of both regimens was similar in patients with baseline HIV RNA >
100 000 copies/ml or CD4 cell count below 50 cells/mm3. | | 14%
of patients in both groups experienced virological failure. | | Median
CD4 increases were also similar, 250 cells/mm3 in the abacavir/lamivudine arm
vs 247 cells/mm3 in the tenofovir/emtricitabine arm at week 96. | | 6%
of participants in both groups discontinued the study due to adverse events. |
Based
on these results, the study authors concluded that at 96 weeks both abacavir/lamivudine
and tenofovir/emtricitabine provided comparable antiviral efficacy, safety, and
tolerability when each was combined with lopinavir/ritonavir in treatment-naive
patients.Rush
University Medical Center, Chicago, IL. Articles
on the HEAT Study Posted on HIV and Hepatitis.com
8/04/09
Reference
MS
Shafer, KY Smith, P Patel, and others (for the HEAT Study Team). Randomized, double-blind,
placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine
with lopinavir/ritonavir for initial HIV treatment AIDS 23(12): 1547-1556.
July 31, 2009. (Abstract).
|
| | | | Entry
Inhibitors
(including Fusion Inhibitors) |  Fuzeon
(enfuvirtide,
T-20)
Selzentry
(maraviroc) |
| | |
|
