Phase III FLAIR study of cabotegravir + rilpivirine shows efficacy in HIV.- ViiV Healthcare

ViiV Healthcare presented 96-week data from its global phase III FLAIR study of the investigational, long-acting, injectable, 2-drug regimen of ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine for the treatment of HIV. The study demonstrated that the 2DR of once-monthly cabotegravir and rilpivirine continued to provide non-inferior efficacy and comparable safety to the daily, oral, three-drug regimen of Triumeq (abacavir/dolutegravir/lamivudine-ABC/DTG/3TC) at Week 96. Week 96 results from the global phase III FLAIR study continued to build on the previously reported non-inferiority of long-acting cabotegravir and rilpivirine to daily oral Triumeq at Week 48. At Week 96, long-acting cabotegravir and rilpivirine demonstrated non-inferiority to Triumeq as measured by the proportion of participants with plasma HIV-1 RNA of at least 50 copies per millilitre (c/mL) using the FDA Snapshot algorithm at Week 96 (cabotegravir + rilpivirine: 9/283 [3.2%], Triumeq 9/283: [3.2%], adjusted difference: 0.0%, 95% CI: -2.9, 2.9). The study found that rates of virologic suppression (HIV-1 RNA <50 c ml) at week 96 were similar between treatment arms (cabotegravir + rilpivirine: 245 283 [86.6%], triumeq: 253 283 [89.4%], adjusted difference: -2.8%. 95% ci: -8.2, 2.5). no new confirmed virologic failure (cvf) was reported between week 48 and week 96 among individuals who received long-acting cabotegravir and rilpivirine. one participant in the triumeq arm developed cvf at week 64 with no treatment-emergent resistance. treatment with cabotegravir and rilpivirine was generally well-tolerated, with similar rates of severe adverse events (saes) (cabotegravir + rilpivirine: 24 283 [8.4%], triumeq: 22 283 [7.8%]) and aes leading to withdrawal (cabotegravir + rilpivirine: 12 283 [4.2%], triumeq: 4 283 [1.4%]) between both treatment arms.these data were presented at the 2020 conference on retroviruses and opportunistic infections.comment: flair includes 566 men and women living with hiv and is being conducted at research centres in canada, france, germany, italy, japan, the netherlands, russia, south africa, spain, the united kingdom, and the united states.>