August 10, 2015
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Cabotegravir plus Edurant provides viral suppression in non-antiretroviral population

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The oral antiretroviral regimen of cabotegravir plus Edurant effectively maintained viral suppression after induction therapy in HIV-1 patients who had not yet received ART, according to recent data.

In the Long-Acting Antiretroviral Treatment Enabling (LATTE) trial, a phase 2b multicenter study, David A. Margolis, MD, of ViiV Healthcare, and colleagues randomly assigned 243 ART-naive adults with HIV-1 from the United States and Canada to once-daily oral cabotegravir 10 mg, 30 mg or 60 mg (n = 181) or Sustiva (efavirenz, Bristol-Myers Squibb; n = 62) 600 mg once daily, each with dual nucleoside reverse transcriptase inhibitors (NRTIs). In the 24-week induction phase, the researchers compared the antiviral activity, safety and pharmacokinetics of cabotegravir with NRTIs (all doses) to that of efavirenz with NRTIs. Primary endpoint was the proportion of patients with fewer than 50 copies/mL of HIV-1 RNA at 48 weeks.

The results revealed a strong viral response in all cabotegravir plus NRTI groups by the end of the induction phase. Eighty-six percent of patients in the cabotegravir groups were virologically suppressed compared with 74% of the efavirenz patients, according to the investigators. The time to viral suppression also was shorter in the cabotegravir groups.

At 24 weeks, patients who were virologically suppressed were treated with a course of their originally assigned cabotegravir dose plus 25 mg Edurant (rilpivirine, Janssen Therapeutics) or continued efavirenz NRTI for an additional 72 weeks.

After maintenance treatment at week 96, 76% of cabotegravir plus rilpivirine patients and 63% in the efavirenz plus dual NRTI treatment group remained virologically suppressed.

Adverse events were reported in 51% of the cabotegravir group and 68% of the efavirenz group, according to the researchers. These events led to 3% of patients in the cabotegravir group and 15% of efavirenz patients to withdraw from the study.

“As a two-drug maintenance therapy, cabotegravir plus rilpivirine provided antiviral activity similar to efavirenz plus dual NRTIs until the end of week 96,” Margolis and colleagues wrote. “Combined efficacy and safety results lend support to our selection of oral cabotegravir 30 mg once a day for further assessment.”– by Colleen Owens

Disclosure: Margolis reports being an employee of GlaxoSmithKline at the time of the study, and now being employed by ViiV Healthcare. Please see the full study for a list of all other authors’ relevant financial disclosures.