ViiV's long-acting, two-drug regimen for HIV hits main goal of late-stage study

ViiV Healthcare announced Wednesday that a Phase III study of a long-acting, injectable regimen combining cabotegravir with Johnson & Johnson's Edurant (rilpivirine) in patients with HIV-1 met its primary endpoint. ViiV, in which GlaxoSmithKline has a majority stake, with minority shareholders including Pfizer and Shionogi, noted that full results from the trial will be presented at an upcoming scientific meeting.

The ATLAS study, which was initiated at the end of 2016, randomised 618 treatment-experienced HIV patients who had maintained viral suppression for at least six months to switch from their existing antiretroviral therapy (ART) to a combination of cabotegravir and rilpivirine or remain on oral ART. The trial's main goal was non-inferiority as assessed by the proportion of participants with plasma HIV-1 RNA of at least 50 copies per millilitre at week 48.

Headline results showed that the two-drug regimen given once monthly had similar efficacy to the daily, oral three-drug regimen, which consisted of two nucleoside reverse transcriptase inhibitors plus an integrase inhibitor, non-nucleoside reverse transcriptase inhibitor or protease inhibitor. In addition, ViiV noted that the overall safety, virologic response and drug resistance results for the injectable regimen were consistent with data from the Phase II LATTE and LATTE-2 studies.

Wim Parys, head of R&D at Johnson & Johnson's Janssen Pharmaceutica unit said the results "may reduce the impact of treatment on people's lives," adding "this novel approach would signify a much-needed treatment evolution for people living with HIV, moving from dosing 365 days a year to just 12 times per year."

Commenting on the findings, Liberum analyst Roger Franklin, said that ViiV's two-drug regimen has been under-appreciated by the market. "Whilst duals will likely be a slow burn as resistance data is collected and the regimen gains credence among physicians, the prospects are much improved now versus a year ago," Franklin noted.

Headline results from FLAIR, a second pivotal study of the cabotegravir and rilpivirine regimen, are expected later this year. In the trial, treatment-naïve patients receive a 20-week daily oral regimen of ViiV's Triumeq (dolutegravir/abacavir/lamivudine) and are then randomised to switch to a regimen of cabotegravir and rilpivirine, or remain on oral therapy.

Edurant is a non-nucleoside reverse transcriptase inhibitor approved for the treatment of HIV in combination with other antiretrovirals, while cabotegravir is an investigational integrase inhibitor. As well as a long-acting formulation for intramuscular injection, ViiV is developing a once-daily oral tablet version of cabotegravir.

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