Glaxo, Viiv: long-acting HIV regimen can succeed in range of US health practices, even in COVID

 

• Healthcare teams from a wide variety of US HIV clinics reported that optimal implementation of long-acting cabotegravir and rilpivirine dosed monthly was achieved within 1 - 3 months, and implementation was acceptable, appropriate and feasible
• Majority of patients (74%) in the study reported few barriers to monthly injection appointments even during COVID-19

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ('GSK'), with Pfizer Inc. and Shionogi Limited as shareholders, today presented positive findings from the CUSTOMIZE (Cabotegravir plus Rilpivirine long acting in the US To Optimize and Measure Implementation and Experience) trial. The study, which included people living with HIV and healthcare teams and overlapped with the COVID-19 pandemic, demonstrated that Cabenuva (a co-pack with two injectable medicines including ViiV Healthcare's cabotegravir and Janssen's rilpivirine) can be successfully implemented across a range of healthcare settings in the US.[i]The 12-month findings were presented at the International AIDS Society Conference 2021 (IAS 2021) being held virtually 18-21 July.

CUSTOMIZE was initiated in 2019 to identify successful methods of integrating the long-acting regimen of cabotegravir and rilpivirine (dosed monthly) for the treatment of HIV-1 after product availability into clinical practices in the US, in a variety of clinic types.1^,[ii] This study included a variety of clinic types from private practices, university clinics and federally qualified health centres, to integrated health care systems.1Regardless of clinic types, the majority of healthcare staff (96%, n=22/23) either agreed, or completely agreed, that the long-acting regimen was feasible to implement in their clinic, and most (78%, n=18/23) felt that optimal implementation was achieved within 1-3 months, with only minor adjustments to clinic logistics required.1

The people living with HIV who participated in the trial agreed that the long-acting regimen was acceptable and appropriate to implement, with the majority (97%, n=99/102) expressing interest in continuing to receive the long-acting regimen over daily oral therapy after the study ended at Month 12.[iii]In addition to assessing the implementation of cabotegravir and rilpivirine long acting into US healthcare practices, the CUSTOMIZE trial also assessed the safety and efficacy of the regimen. Over the course of the study, findings showed that 100% of participants with available viral load results maintained viral suppression ([iv]Injection site reactions were the most common overall adverse event, reported in 72% (78/109) of participants who received ≥1 injection through Month 12.⁴

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