Taking the Long View

The past 41 years have seen significant progress in HIV management, affording people living with HIV (PLWH) longer, healthier lives. Despite these advances, people are still burdened by the need for daily medication – sometimes multiple times a day – which can increase stigma and impact adherence. One potential solution? Provide treatment options for PLWH that are informed by their needs and insights.

Now, 12-month real-world data from the CARISEL study has demonstrated that cabotegravir (Vocabria) and rilpivirine (Rekambys) – a long-acting injectable treatment for HIV – can be successfully implemented across a range of European healthcare settings. The study represents a significant milestone for people living with HIV, offering a life without the need for daily medication and the stigma that can accompany visible signs of the disease. We interviewed Harmony Garges, Chief Medical Officer at ViiV Healthcare, about long-acting regimens and what the future might look like for PLWH.

What are long-acting injectables for HIV – and what are the benefits of this type of regimen?

Despite treatment advances since the early days of HIV, some people living with HIV still face challenges with the daily pills required for HIV therapy – including the daily reminder of living with HIV, a fear of disclosure, and the associated stigma. PLWH want options for treating their HIV, including injectable therapies that give them the opportunity to have longer dosing intervals and eliminate daily pills.

The need for a less frequent dosing regimen to help people with adherence anxiety was reinforced in the largest global HIV patient-reported outcomes study to date, Positive Perspectives Wave 2 (2). When participants were asked about their treatment aspirations and attitudes toward “innovative” medications, 55 percent said they would prefer to not have to take medication every day as long as their HIV stays suppressed. In addition, 58 percent noted that taking daily HIV medication acts as a constant reminder of HIV in their lives and up to 38 percent reported anxiety around the fact that taking daily treatment could increase the chance of revealing their HIV status to others.

Tell me about the CARISEL implementation study…

CARISEL is a one-year Phase IIIb open-label multicenter study examining different implementation strategies for long-acting cabotegravir and rilpivirine in a broad range of clinical settings across European countries. Its aim is to identify the strategies that best meet needs in each local context.

Perspectives from healthcare providers and patients played an equally important role in the structure of the CARISEL study. Patients took part in a single-arm study in which they received the long-acting regimen of cabotegravir and rilpivirine – dosed every two months – while completing surveys and interviews that captured their perspectives on the feasibility, acceptability, and appropriateness of the regimen. Providers participated in a two-arm study that examined different implementation strategies to support potential barriers around factors such as medication storage, appointment scheduling, and patient support. In total, 18 clinics across Belgium, France, Germany, the Netherlands, and Spain were randomized to two different implementation support packages, Standard Arm (Arm-S) and Enhanced Arm (Arm-E). Like patients, staff study participants completed surveys and interviews with investigators.

What did you find?

The primary results demonstrate that long-acting cabotegravir and rilpivirine can be successfully implemented across a range of European healthcare settings – offering an innovative treatment option to help address the evolving needs of PLWH. Though most European clinics had no prior experience with long-acting cabotegravir and rilpivirine, there was high acceptability, appropriateness, and feasibility among clinic staff toward both the long-acting regimen and its implementation. Most staff participants reported optimal implementation within one to three months.

PLWH also found long-acting cabotegravir and rilpivirine to be highly acceptable, appropriate, and feasible; in fact, 81 percent of participants with HIV reported that the long-acting regimen was less stigmatizing than daily oral treatment and 99 percent preferred it. Long-acting cabotegravir and rilpivirine also demonstrated high clinical effectiveness and a low rate of viral failure throughout the trial.

How will the study findings help PLWH access better care in future?

Ideally, the results will reassure healthcare providers that the perceived implementation barriers that might come with introducing this treatment into clinical practice can be overcome in most cases. These positive implementation results build on the strong clinical efficacy and safety findings observed in the ATLAS (3), FLAIR (4,5), and ATLAS-2M (6) phase III clinical trials, which demonstrated that the long-acting regimen was as effective as daily oral therapy for HIV management. By combining the findings of this regimen’s clinical development program with the real-world experience supporting its implementation, healthcare providers and administrators have the evidence and tools to help bring this treatment to PLWH.

How long until the findings are implemented in the clinic?

Learnings from CARISEL are already being implemented in clinical practice. Additional findings and analyses from the CARISEL study, along with other research investigating the administration of long-acting cabotegravir and rilpivirine outside of the clinic environment, will be presented at future congresses.