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Etravirine bested efavirenz in treatment-naive HIV

Issue: October 2011

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CHICAGO — Researchers for the SENSE trial observed emergent resistant mutations among treatment-naive HIV-infected participants assigned efavirenz compared with no resistant mutations among participants assigned etravirine, according to findings presented here.

Anna Maria Geretti, MD, PhD,of the Institute for Infection and Global Health of Liverpool University and also affiliated with University College London, and colleagues randomly assigned 157 treatment-naive participants from Europe, Russia and Israel with HIV RNA loads greater than 5,000 copies/mL to either once-daily 400 mg etravirine (Intelence, Tibotec) (n=79) or efavirenz (n=78) in combination with two nucleoside reverse transcriptase inhibitors (NRTIs) for 48 weeks.

Overall, 60% of patients received tenofovir/emtricitabine, 26% received abacavir/lamivudine, and 14% received zidovudine/lamivudine. Primary outcome measure was the rate of neuropsychiatric events by week 12; secondary endpoint was viral load suppression less than 50 copies/ml at week 48.

Genotypes were assessed at baseline by standard population sequencing and and retrospectively by low frequency mutation assays.

According to the researchers, patients with transmitted drug resistance mutations (WHO list 2009) detected by population sequencing were excluded from the trial, with the exception of four protocol violations (all four assigned to etravirine). Patients with mutations identified as having a minor impact on responses to etravirine in the DUET trials ( V90I, V106I, E138A) were included in the study.

At baseline, NRTI and NNRTI mutations were detected in five and 12 participants in the etravirine arm, compared with zero and four participants in the efavirenz arm, respectively. This included two and one patients, respectively, with low frequency mutations (one K103N in etravirine arm; and one M184V in each arm). No correlation was observed between baseline NRTI/NNRTI mutations and HIV RNA suppression for either treatment.

Median baseline CD4 count was 302 cells/mcL and HIV RNA load was 4.8 log₁₀ copies/mL, according to the researchers. Intention-to-treat time to loss of virologic response indicated 76% of those in the etravirine arm had HIV RNA less than 50 copies/mL vs. 74% in the efavirenz arm. On-treatment analysis indicated 92% in the etravirine arm had HIV RNA less than 50 copies/mL vs. 89% in the efavirenz arm.

Geretti said the pre-set definition of non-inferiority of etravirine vs. efavirenz was met, although the study was not powered to demonstrate non-inferiority. "There were seven virological failures in the efavirenz arm and of these, three developed classic NRTI and/or NNRTI-resistance mutations after prolonged viremia," Geretti said. "Four patients in the etravirine arm met the definition of virological failure, but plasma HIV RNA levels were low and no patient showed evidence of resistance."

Disclosure: Dr. Geretti reports no relevant financial disclosures.

For more information:

• Geretti AM. #H1-373. Presented at: The 2011 ICAAC; Sept. 17-20; Chicago.

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