HIV virus (yellow) infecting a human cell. Credit: ZEISS Microscopy/Flickr.

ViiV Healthcare has launched a Phase III clinical trial (ATLAS-2M) to assess a long-acting, two-drug regimen of cabotegravir and rilpivirine for the treatment of virally suppressed adults infected with the HIV-1 virus.

ViiV’s cabotegravir is an experimental integrase strand transfer inhibitor (INSTI) and rilpivirine is Janssen Sciences Ireland’s non-nucleoside reverse transcriptase inhibitor (NNRTI).

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The Phase III trial aims to establish the non-inferior antiviral activity at 48 weeks of treatment with the combination given every two months when compared to the administration of the combination for every one month.

ViiV Healthcare chief scientific and medical officer John Pottage said: “We have a patient-centred approach to innovation that seeks to transform how HIV is treated. Our focus on two-drug regimens is key to this strategy.

“HIV treatment regimens that do not require daily dosing could be an important part of making HIV feel like a smaller part of patients’ lives and, with the ATLAS-2M study, we are evaluating the possibility of maintaining viral suppression with six treatments per year of long-acting cabotegravir and long-acting rilpivirine.”

“We are evaluating the possibility of maintaining viral suppression with six treatments per year of long-acting cabotegravir and long-acting rilpivirine.”

The Phase III ATLAS-2M trial is set to enrol around 1,020 subjects across Australia, France, Canada, Germany, Argentina, Italy, South Africa, Mexico, South Korea, Spain, Russia, Sweden, and the US.

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In addition to antiviral activity, pharmacokinetics, safety and tolerability, the trial will evaluate patient satisfaction through to 96 weeks.

Preliminary results from the Phase III trial are expected to be available in 2019.

The long-acting cabotegravir and rilpivirine regimen is also being studied in Phase III ATLAS and FLAIR trials for the treatment of HIV-1 infection.