The ATLAS 2M study results showed non-inferiority in 2-month dosing compared to 1-month dosing for the cabotegravir and rilpivirine long-acting injectable.
For most people living with HIV (PLWH) the challenge of having to take a daily oral regimen to stay virally suppressed is demanding. While it has enabled PLWH to maintain a mostly healthy lifestyle, there is always the desire for potentially life-improving changes when it comes to therapy regimen.
ViiV Healthcare has developed a number of combination therapies looking at PrEP and HIV care. For example, its cabotegravir and rilpivirine (Cabenuva) therapy is a long-acting injectable that was approved by the Food and Drug Administration (FDA) earlier this year. With the approval, it became the first complete long-acting regimen for the treatment of HIV in adults in those who are virologically stable and suppressed (HIV-1 RNA less than 50 copies per milliliter [mL]).
Last year, ViiV presented at The Conference on Retroviruses and Opportunistic Infections (CROI) with findings of long-term data from its global phase 3b ATLAS-2M study of cabotegravir and rilpivirine at 48 weeks.
At the same conference this year, ViiV presented its 96 week findings, which reinforced the week 48 primary endpoint (proportion of participants with plasma HIV-1 RNA ≥50 c/mL (Snapshot, ITT-E), and secondary endpoints (proportion of participants with plasma HIV RNA ≥50 or <50 c/mL at Week 96 (Snapshot, ITT-E).
ATLAS-2M met its primary endpoint at Week 48, demonstrating that the efficacy of long-acting cabotegravir and rilpivirine dosed every 2 months was non-inferior to monthly dosing. The week 48 primary endpoint (proportion of participants with plasma HIV-1 RNA ≥50 c/mL) results showed every 2-month dosing (9/522 [1.7%]) and monthly dosing (5/523 [1.0%]) were similarly effective (adjusted difference: 0.8%, 95% confidence interval [CI]: -0.6, 2.2).
And the week 96 findings reinforced the primary endpoint: the efficacy of every 2-month dosing was non-inferior to monthly dosing of long-acting cabotegravir and rilpivirine, with 2.1% (11/522) and 1.1% (6/523) of participants, respectively, having HIV-1 RNA ≥50 c/mL (adjusted difference: 1.0%, 95% CI: -0.6-2.5).
The aforementioned data shows the potential for PLWH to alter their current therapy regimen and look at new treatment options. “It really challenges the current treatment paradigm,” Patricia de los Rios, global medical affairs director, ViiV Healthcare. "ATLAS-2M showed that a regimen of monthly injectable cabotegravir plus rilpivirine long-acting could reduce that frequency to 6 times per year with the every two-month dosing regimen.”
She noted that shortly after the FDA’s approval in January, the US Department of Health and Human Services (HHS) HIV treatment guidelines committee added long-acting cabotegravir plus rilpivirine to treatment guidelines as an optimize strategy for people who are already have virus suppression, and they haven’t had treatment failures with other therapies. HHS also mentioned some potential beneficiaries to this treatment including those who might be suffering from pill fatigue, or stigma, or potential improvement of quality of life.
Contagion spoke to de los Rios about the injectable’s mechanism of action, further insights from the ATLAS 2M study including durability data, and follow-up studies to find out more about implementation of the therapy.