ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, 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. These data were presented at the 2020 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston, Massachusetts.
Kimberly Smith, M.D., Head of Research & Development at ViiV Healthcare, said: “Our focus on creating innovative treatment options for people living with HIV is further supported by these long-term findings of a long-acting injectable HIV treatment regimen. The efficacy and safety data of cabotegravir and rilpivirine at 96 weeks, as well as a high level of treatment satisfaction for the long-acting regimen, further encourage us as we work to bring this treatment option to people living with HIV.”
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 = 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. Of the participants who received cabotegravir and rilpivirine injections, 88 percent (246/278) reported an injection site reaction (ISR) at some point through Week 96. A majority of injections did not result in an ISR being reported, with a total of 12,552 injections administered during the 96-week study period resulting in 3,100 ISR events. Nearly all ISRs (99.4%) were mild or moderate (mild: 2,730/3,100, moderate: 352/3,100), with a median duration of three days and the frequency of these events decreasing over time. Six participants (2.1%) withdrew for injection-related events.
At Week 48, 90.8% of FLAIR participants preferred the long-acting regimen to their previous, oral treatment and expressed a high level of treatment satisfaction. At Week 96, participants continued to demonstrate a statistically significant higher level of treatment satisfaction compared with participants on daily oral Triumeq based on the HIV Treatment Satisfaction Questionnaire (HIVTSQs) mean difference of total scores (between group difference in adjusted mean change from baseline: 2.3 points, 95% CI (1.1, 3.5), p<0.001).
Chloe Orkin, M.D., Consultant Physician and Clinical Professor at Queen Mary University of London and FLAIR principal investigator, said, “Seeing the longer-term data is really exciting. It confirms that the long-acting, two-drug regimen of cabotegravir and rilpivirine has maintained its efficacy and has the potential to be a generally well-tolerated alternative to the standard-of-care, daily, oral pill. For some people living with HIV, reducing their dosing schedules from 365 days per year to 12 may be a realistic option in the future.”
This investigational, long-acting, injectable regimen is being co-developed as part of a collaboration with Janssen Sciences Ireland UC and is not approved by regulatory authorities anywhere in the world.