IDWeek 2013: Complera Works Well Regardless of Viral Load or CD4 Count, Improves Lipid Levels

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The single-tablet regimen Complera (rilpivirine/tenofovir/emtricitabine) worked as well as Atripla (efavirenz/tenofovir/emtricitabine) for treatment-naive people across a range of viral load and CD4 T-cell levels, researchers reported at the Second IDWeek conference last week in San Francisco. Another study found that switching from a boosted protease inhibitor to Complera lowered cholesterol and triglyceride levels.

Calvin Cohen from the Community Research Initiative of New England reported findings from the open-label STaR trial, the first head-to-head comparison of Complera vs Atripla in people starting antiretroviral therapy (ART) for the first time.

Unlike the earlier ECHO and THRIVE trials, which compared the same drug combinations taken as separate pills plus placebos -- requiring multiple daily pills with different food requirements -- all participants in STaR took a single tablet once-daily.

The study included 786 participants. More than 90% were men, about two-thirds were white, one-quarter were black, and the median age was 36 years. The mean baseline CD4 count was approximately 390 cells/mm3. Two-thirds started treatment with a viral load at or below 100,000 copies/mL, about 27% had 100,000 to 500,000 copies/mL and about 7% had above 500,000 copies/mL.

Cohen reported results from a STaR sub-analysis looking at response rates according to baseline viral load and CD4 count.

Results

Cohen noted that this analysis was intended in part to see if rilpivirine is more vulnerable than efavirenz to resistance and treatment failure if patients miss doses. The findings indicated that although "both drugs suffered from missed doses," rilpivirine did not appear to do worse.

While rilpivirine has been associated with fewer CNS side effects in clinical trials, this sub-group analysis showed that the difference in tolerability was much less pronounced among people with CD4 counts above 200 and greater than 95% adherence, though the study could not determine the direction of cause and effect.

Lipid Improvements

Pablo Tebas from the University of Pennsylvania reported findings from the phase 3 SPIRIT study, which looked at outcomes among people with suppressed viral load who simplified treatment by switching from a ritonavir-boosted protease inhibitor plus 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) to Complera.

The study included 476 participants. About 90% were men, three-quarters were white, about 16% were black, the median age was just over 40 years, and they had been on ART for nearly 3 years. The mean CD4 count was high, approaching 600 cells/mm3. At baseline about one-third each were taking boosted atazanavir (Reyataz) and lopinavir/ritonavir (Kaletra), while 20% were on boosted darunavir (Prezista). For NRTIs, 81% used tenofovir/emtricitabine (the drugs in Truvada) and 13% used abacavir/lamivudine (the drugs in Epzicom). Participants were randomly assigned to switch to Complera either immediately or after 6 months.

Tebas' report focused on changes in blood lipids, which are known to affect cardiovascular risk. The researchers used the US National Cholesterol Education Program (NCEP) system, which classifies people as having desirable/optimal, borderline or high lipid levels based on their risk of developing cardiovascular disease.

Results

"Simplifying from a [protease inhibitor/ritonavir] regimen to [Complera] in HIV-1 RNA suppressed patients may be an effective therapeutic choice for maintaining virologic suppression...[and] improving lipid profiles," the researchers concluded.

10/11/13

References

C Cohen, D Wohl, K Henry, et al. STaR study: association of efficacy outcomes with baseline HIV-1 RNA and CD4 count and adherence rate for the single-tablet regimens rilpivirine/emtricitabine/tenofovir DF and efavirenz/emtricitabine/tenofovir DF in ART-naive adults. 2nd IDWeek Conference (IDWeek 2013). San Francisco. October 2-6, 2013. Abstract 671.

P Tebas, F Palella, P Ruane, et al. SPIRIT: simplification to rilpivirine/emtricitabine/tenofovir DF single-tablet regimen from boosted protease inhibitor maintains HIV-1 suppression and improves fasting lipids at week 48. 2nd IDWeek Conference (IDWeek 2013). San Francisco. October 2-6, 2013. Abstract 672.