Long-acting formulations of ViiV Healthcare's cabotegravir, Johnson & Johnson's Edurant meet study goal

ViiV Healthcare said Tuesday that a two-drug regimen consisting of long-acting formulations of cabotegravir and Johnson & Johnson's Edurant (rilpivirine) exhibited similar efficacy as an oral three-drug regimen of cabotegravir and two nucleoside reverse transcriptase inhibitors. In the mid-stage LATTE 2 study, cabotegravir and Edurant were dosed every eight weeks or every four weeks. "These initial...data...are promising and build on the results we have seen to date," said ViiV chief medical and scientific officer John Pottage, adding "we look forward to seeing further results as we move into Phase III."

The study included 309 patients with HIV who achieved virologic suppression on oral therapy with once-daily investigational oral cabotegravir in combination with two nucleoside reverse transcriptase inhibitors. The patients were subsequently randomised to treatment with once-monthly or once-bimonthly injections of cabotegravir plus Edurant or maintained on daily oral therapy with the three-drug regimen for 96 weeks.

The viral suppression rates at 32 weeks were 94 percent for patients who received the injections every four weeks and 95 percent for those who received the injections every eight weeks, compared to 91 percent for patients who received daily oral therapy. Meanwhile, adverse events were more commonly seen among patients in the once-monthly arm than in those in the once-bimonthly or daily oral therapy groups. GlaxoSmithKline indicated that the 32-week results from the LATTE 2 study will be presented at an upcoming research conference.

"Going from many pills a day -- like 10, 20 pills a day -- to now one pill, to now one injection every two months is I think a huge medical technical achievement," commented Johnson & Johnson's chief scientific officer Paul Stoffels, who cautioned that although improvements are still required for the injection, the company hopes to launch the combination injection "significantly before 2020." Stoffels noted "it's far too early to say anything about the pricing of this but, as always, I think we have been responsible pricing in this area so that is for later."

Also, on Tuesday, GlaxoSmithKline said at an investor presentation that it plans to advance cabotegravir to late-stage development next year.

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