Dr. Harmony Garges, CMO at ViiV Healthcare, Shares Insights on Positive Findings from the SOLAR Study of Cabenuva

Shots:

Dr. Harmony gave the details about the positive 12-month findings from the P-IIIb SOLAR trial of the first and only complete long-acting injectable regimen Cabenuva vs. Biktarvy
She also talked about the comparison of the Cabenuva regimen with the other existing & developing products for HIV including the Biktarvy regimen
The interview gives an understanding of how ViiV Healthcare is working to advance the treatment and care for people living with HIV and for those people who are at risk of acquiring

Smriti: To begin with, would you please shed some light on the details (MOA, ROA, formulations, etc) of the Cabenuva regimen?

Harmony Garges: Over the last 30 years, scientific innovation in HIV antiretroviral treatments have improved the lives of people living with HIV. These advances in HIV therapies have resulted in HIV becoming a treatable chronic disease and people living with HIV can live long and healthy lives. With many effective and generally well-tolerated medicines available, we can now switch the focus from keeping people alive to improving their quality of life. Patient choice and satisfaction with treatment are key, and it’s crucial that we now raise awareness with healthcare professionals to ensure treatment choice and patient preference are part and parcel of their discussions with patients.

Globally, most people living with HIV on effective treatment take oral daily pills to suppress the virus. However, we know that these oral single-tablet regimens can bring many challenges to quality of life, including fear of their status being disclosed, the anxiety of remaining adherent, and the daily reminder of their HIV status. New treatment options pave the way for tailored treatment and more choices for people living with HIV, and that’s where Cabenuva, the first and only complete long-acting injectable regimen for HIV, comes in.

Cabenuva contains ViiV Healthcare’s cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial. It is approved for every two-month dosing for the treatment of HIV-1 in virologically suppressed adults.

Smriti: Brief us about the study design of the P-IIIb (SOLAR) clinical trial evaluating the Cabenuva regimen

Harmony Garges: The SOLAR study (Switch Onto Long-Acting Regimen) is the first head-to-head, Phase IIIb study to compare Cabenuva, an injectable every two-month complete long-acting regimen, against the commonly prescribed daily oral pill Biktarvy. Its specific objectives were to evaluate non-inferiority, patient preference, and, very importantly, patient satisfaction - feedback which are called Patient Reported Outcomes and growing in importance alongside clinical trials.

In the study, 670 participants who were virally supressed and taking Biktarvy were randomised 2:1 to switch to Cabenuva administered every two months (447 participants) or continue taking daily oral Biktarvy (223 participants).

The primary endpoint looked at the proportion of patients that had a detectable viral load at month 12. Crucially, the research team wanted to discover what the patients thought of their baseline therapy and switching treatment. At the beginning of the study, 47% of participants reported always or often experiencing one or more challenges with taking their daily therapy, including “being worried about people unintentionally discovering their HIV status,” “being worried about forgetting to take their HIV medication,” or “feeling that taking their HIV medication was an uncomfortable reminder of their HIV status.

The team then repeated the survey at the end of the study.

Smriti: Highlight the key findings obtained from the P-IIIb (SOLAR) clinical trial evaluating the Cabenuva regimen.

Harmony Garges: The SOLAR study showed that Cabenuva dosed every two months had virologic efficacy that was non-inferior to daily oral Biktarvy, and 90% of participants who switched and completed the survey, preferred long-acting therapy versus daily oral pills. Switching treatments during the SOLAR study was found to be efficacious, well-tolerated, and improved treatment satisfaction.

The learnings from the study are two-fold. Cabenuva is as effective as daily oral Biktarvy, and addresses some crucial issues associated with taking daily HIV treatment. And participants preferred the long-acting therapy and experienced an overall improvement in treatment satisfaction.

As healthcare providers, we need to focus on playing our part to ensure that our patients are not just living but living well. It’s imperative that prescribers are fully informed on treatment options and understand the role of patient preference in HIV care to inform individualized HIV treatment and care decisions.

Smriti: How can the injectable Cabenuva regimen provide an alternative to the daily oral Biktarvy regimen? Give our readers a comparative overview of them both.

Harmony Garges: Researchers are doing remarkable things in healthcare, giving people living with HIV the chance of a long-term future when previously there was little hope. We now have effective HIV treatment that can help people living with HIV achieve viral suppression. That means quality of life is an important new focus, with patient satisfaction a fast-growing area of research.

We know from our research that once-daily oral regimens can bring about many treatment challenges and emotional concerns. Having to take pills every day can cause fear of friends and relatives learning about someone’s HIV status and experiencing an unwanted HIV disclosure, anxiety about ensuring they take treatment or worry about missing doses, and daily pills are also a daily reminder of their HIV which can negatively impact mental health and overall health outcomes.

The option of having a complete long-acting regimen dosed every two months means increased flexibility of antiretroviral treatment delivery which could help meet patient needs and improve aspects of quality of life for people living with HIV. Healthcare professionals must drive open and honest conversations with people living with HIV to uncover issues with current treatments impacting their quality of life and offer them the choice they need and deserve.

Smriti: How does ViiV Healthcare’s Cabenuva regimen stand its way out from the other existing & developing products for HIV as many treatment options are being developed for the same indication?

Harmony Garges: Unlike other HIV treatment regimens that require taking a daily-oral pill, Cabenuva is the first and only complete long-acting regimen for HIV treatment. It is unique because it offers people living with HIV the option of dosing every two months, reducing the treatment dosing days from 365 days to as few as six days per year. Some people living with HIV can experience challenges with taking daily oral treatment, and Cabenuva is the only complete long-acting treatment regimen that significantly reduces the frequency of dosing.

Smriti: Are there any other products currently being evaluated under your development pipeline for the treatment of HIV

Patient insight and preference are at the heart of innovation at ViiV Healthcare. Our early pipeline is driven by our desire to develop innovative medicines for those with needs not currently being met, including a broad range of people living with HIV. We exist to develop medicines that delivers clinical efficacy, respond to patients needs and preferences, and that ultimately saves or changes lives for the better.

Guided by this goal, we are researching unique approaches in long-acting and ultra-long-acting medicines that allow for less frequent dosing, new medication delivery systems that provide flexibility for in-clinic or at-home administration, and new chemical and biological candidates with new mechanisms of action, like broadly-neutralising antibodies (bNAbs), that treat HIV differently.

Image Source: Canva

About the Author:

Dr. Harmony Garges is the Chief Medical Officer at ViiV Healthcare. She joined ViiV Healthcare in 2016 and held several roles in Global Medical Affairs before assuming her current role as Chief Medical Officer at the company in 2019. Harmony is responsible for Regulatory, Safety, and Medical Affairs across the company’s innovative pipeline and portfolio. After obtaining her MD degree and completing her pediatrics residency at Duke University, Harmony pursued her interest in infectious diseases further with fellowships in Pediatric Infectious Diseases and Medical Microbiology at Duke, along with her MPH in Epidemiology from the University of North Carolina at Chapel Hill.