GlaxoSmithKline PLC - ViiV positive ph3 data for long acting injectable

Comprehensive data from ATLAS and FLAIR studies presented today at the 2019 Conference on Retroviruses and Opportunistic Infections show investigational long-acting injectable to be effective in maintaining viral suppression

London, 7 March 2019 - ViiV Healthcare today presented comprehensive 48-week data from the ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies of the novel, investigational, long-acting regimen of cabotegravir and rilpivirine. These two studies met their primary endpoints, showing that the combination of ViiV Healthcare's cabotegravir and Janssen's rilpivirine, injected every four weeks, was non-inferior in maintaining viral suppression in adults infected with human immunodeficiency virus type-1 (HIV-1) when compared to a standard of care, daily, oral three-drug regimen. These data were presented today at the 2019 Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle, Washington.

John C. Pottage, Jr., M.D., Chief Scientific and Medical Officer of ViiV Healthcare, said: "With FLAIR and ATLAS, we now have positive results from two pivotal phase III studies demonstrating that this long-acting, once-monthly injectable regimen has similar efficacy, safety and tolerability to a daily oral three-drug regimen for the treatment of HIV.  We are also encouraged by patient preference data showing that nearly all participants who switched to the long-acting injectable regimen preferred it over their prior oral therapy. If approved, this two-drug regimen would give people living with HIV one month between each dose of antiretroviral therapy, changing HIV treatment from 365 dosing days per year, to just 12. We look forward to submitting applications to regulatory authorities later this year."

ATLAS 48-week efficacy and safety results

The global, pivotal, phase III ATLAS study met its primary endpoint, with cabotegravir and rilpivirine demonstrating non-inferiority to an oral three-drug regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, as measured by the proportion of participants with plasma HIV-1 RNA ≥50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 48 (cabotegravir + rilpivirine: 5/308 [1.6%], current antiretroviral therapy [CAR]: 3/308 [1.0%], adjusted difference: 0.6%, 95% confidence interval [CI]: -1.2, 2.5). The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 285/308 [92.5%], CAR: 294/308 [95.5%], adjusted difference: -3%, 95% CI: -6.7, 0.7).

FLAIR 48-week efficacy and safety results

The global, pivotal, phase III FLAIR study met its primary endpoint, with cabotegravir and rilpivirine demonstrating non-inferiority to Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC), as measured by the proportion of participants with plasma HIV-1 RNA ≥50 c/mL using the FDA Snapshot algorithm at Week 48 (cabotegravir + rilpivirine: 6/283 [2.1%], Triumeq 7/283 [2.5%], adjusted difference: -0.4%, 95% CI: -2.8, 2.1). The study found virologic suppression rates (HIV-1 RNA <50 c/mL) at Week 48 were similar between treatment arms (cabotegravir + rilpivirine: 265/283 [93.6%], Triumeq: 264/283 [93.3%], adjusted difference: 0.4%. 95% CI: -3.7, 4.5).